November 2018: Question or Question Is Not Applicable

HEMATOLOGY ANALYZERS NOVEMBER 2018 | CAP TODAY 67
Part 1 of 13 Abbott Diagnostics Abbott Diagnostics Abbott Diagnostics

Christy Thiessen christy.thiessen@abbott.com Christy Thiessen christy.thiessen@abbott.com Christy Thiessen christy.thiessen@abbott.com
Abbott Park, IL Abbott Park, IL Abbott Park, IL
See captodayonline.com/productguides for an interactive version of guide 800-323-9100 www.abbottdiagnostics.com 800-323-9100 www.abbottdiagnostics.com 800-323-9100 www.abbottdiagnostics.com
Name of instrument CELL-DYN Emerald* CELL-DYN Emerald 22* CELL-DYN Ruby*
First year installed in U.S./Outside U.S./No. of units sold in 2017 2009/2008/— 2016/2016/— 2006/2006/ —
No. units installed in U.S./Outside U.S./List price >1,700/>2,800/$30,000 —/—/$64,000 >550/>2,700/$185,000
Test menu: • C hartable (standard menu: WBC, RBC, Hb, Hct, MCV, WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, lymph %&#, standard menu (left) plus: RDW, MPV standard menu (left) plus: MPV, RDW, retic %&#
MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso) gran %&#, mid %&#, RDW, MPV
• Laboratory — — —
• Flags dispersional data alerts, suspect measurand flags, and dispersional data alerts, suspect parameter flags, and NRBC, FWBC, NWBC, RRBC, band, IG, blast, variant
count invalidation flags count invalidation flags lymph, RBC morph., DFLT, MCHC, LRI, URI, LURI,
ATYPDEP, high-low interp. message, WBC
FDA-cleared tests not clinically released — — —
Tests not available but submitted for 510(k) clearance — — —
Tests in development — — —
Tests for research use only — — —
Tests unique to analyzer — — atypical depolarization flag
Differential method(s) used impedance counting UNI-FLOW Optical Technology MAPSS (multi-angle polarized scatter separation)
Analytical measurement range: • WBC count/RBC count 0.4–96.1 K/µL/0.22–7.61 M/µL 0.4–90 K/µL/1.2–8.3 M/µL 0.02–246 × 103/µL/0.00–7.50 × 106/µL
• Hemoglobin/Platelet 3.3–24.6 g/dL/9–1,375 K/µL 5.5–22 g/dL/11–1,485 K/µL 0.00–25.0 g/dL/0.00–3,000 × 103/µL
• MCV (fL) or Hct (%) 48.8–115 (MCV), 5.3–75.6% (Hct) 53.2–118.4 (MCV), 12.1–66.1 fL (Hct) 58–139 (MCV), 8.3–79.8% (Hct)
• Reticulocytes — — —
Precision: • WBC count/RBC count 3.5% (95% confidence limit)/2.0% (95% confid. limit) 0.8–2.3% CV/0.7–1.4% CV 2.4%/1.8%
• Hemoglobin/Platelet 2.1% (95% confidence limit)/6.1% (95% confid. limit) 0.2–0.9% CV/2.2–5.2% CV 1.4%/3.8%
• MCV or Hct 0.8% MCV (95% confid. limit), 1.7% Hct (95% confid. limit) 0.3–0.6% CV (MCV), 0.8–1.5% CV (Hct) 0.8% (MCV)
Accuracy of automated differential compared with manual — — neut% r=0.983, slope=0.97, y=-1.98; lymph% r=0.921,
differential (per CLSI H20-A2) slope=0.95, y=0.94; mono% r=0.711, slope=1.10,
y=1.93; eos% r=0.952, slope=1.04, y=0.01; baso%
r=0.146, slope=0.18, y=1.22
Interfering substances: • WBC cryoglobulin, cryofibrinogen, heparin, monoclonal proteins, cryoglobulin, cryofibrinogen, heparin, monoclonal proteins, fragile WBC, neutrophil aggregates, lytic-resistant RBCs,
nucleated red cells, platelet clumping, unlysed red cells, nucleated red cells, platelet clumping, unlysed red cells, NRBCs, PLT clumps, cryofibrinogen, cryoglobulin
clotting, smudge cells, uremia plus immunosuppressants clotting, smudge cells, uremia plus immunosuppressants
• RBC cryoglobulin, cryofibrinogen, giant platelets, high white cryoglobulin, cryofibrinogen, giant platelets, high white elevated WBC, increased numbers of giant PLTs,
cell count (>50,000 K/μL), autoagglutination, clotting, in cell count (>50,000 K/μL), autoagglutination, clotting, in autoagglutination, in vitro hemolysis
vitro hemolysis, microcytic red cells vitro hemolysis, microcytic red cells
• MCV or Hct cryoglobulin, cryofibrinogen, giant platelets, high white cryoglobulin, cryofibrinogen, giant platelets, high white MCV: elevated WBC, hyperglycemia, in vitro hemolysis,
cell count (>50,000 K/μL), hyperglycemia (>600 mg/dL), cell count (>50,000 K/μL), hyperglycemia (>600 mg/dL), increased number of giant PLTs
autoagglutination, clotting, in vitro hemolysis, microcytic autoagglutination, clotting, in vitro hemolysis, microcytic
red cells, reduced red cell deformability, swollen red cells red cells, reduced red cell deformability, swollen red cells
• Platelet cryoglobulin, cryofibrinogen, in vivo and in vitro cryoglobulin, cryofibrinogen, in vivo and in vitro WBC fragments, in vitro hemolysis, microcytic RBCs,
hemolysis, microcytic red cells, red cell inclusions, white hemolysis, microcytic red cells, red cell inclusions, white cryofibrinogen, cryoglobulin, PLT clumping, increased
cell fragments, clotting, giant platelets, heparin, platelet cell fragments, clotting, giant platelets, heparin, platelet number of giant PLTs
clumping, platelet satellitosis clumping, platelet satellitosis
• Hemoglobin carboxyhemoglobin (>10%), cryoglobulin, carboxyhemoglobin (>10%), cryoglobulin, elevated WBC, increased plasma substances
cryofibrinogen, in vivo hemolysis, heparin, high white cryofibrinogen, in vivo hemolysis, heparin, high white (triglycerides, bilirubin, in vivo hemolysis),
cell count (>50,000 K/μL), hyperbilirubinemia, lipemia, cell count (>50,000 K/μL), hyperbilirubinemia, lipemia, lytic-resistant RBCs
monoclonal proteins monoclonal proteins
Interfering substances: differential platelet aggregates, NRBCs, giant platelets, cryoglobulin, platelet aggregates, NRBCs, giant platelets, cryoglobulin, fragile WBC, neutrophil aggregates, lytic-resistant
incomplete lysis of RBCs, small lymphocytes, fibrin incomplete lysis of RBCs, small lymphocytes, fibrin RBCs, NRBCs, PLT clumps, cryofibrinogen, cryoglobulin,
clots, shift in WBC cell distrib. due to EDTA anticoagulant clots, shift in WBC cell distrib. due to EDTA anticoagulant paraproteins
equilibration equilibration
Maximum CBCs per hour/Maximum CBCs and differentials per hour 57/57 45/45 84/84
Minimum specimen volume open/Closed/Sample dead volume closed 9.8 µL/—/— 17 µL/—/— 150 µL/230 µL/1.2 mL
Microsample capability no no no
Prepares microscope slides automatically or flags problems for slide prep yes yes yes
Number of automatic slidemakers available/List price — — —/$125,000
Archives patient data/Previous patient results incl. with recent results yes/no yes/no yes/yes
Maximum archived data accessible when system online 300,000 on USB and 1,500 results on internal memory 300,000 on USB and 1,000 records with histograms on 10,000 results
internal memory
No. specimens for which numeric results saved in memory at once 300,000 on USB and 1,500 results on internal memory 300,000 on USB and 1,000 records with histograms on 10,000 results
internal memory
No. specimens for which histo/cytogram results saved in memory at once 300,000 on USB and 1,500 results on internal memory 300,000 on USB and 1,000 records with histograms on 10,000 results
internal memory
Performs delta checks no no no
Tags and holds results for follow-up, confirmatory testing, or rerun no no yes
Parameters for flags for holding samples defined by user or vendor no no user or vendor
Scattergram display: cell-specific color no yes yes
Histogram display: color with thresholds no yes yes
User interface can display choice of specimen or result information yes yes yes
LIS interface formats supported proprietary (instrument or vendor specific) proprietary (instrument or vendor specific) LIS1/LIS2 CLSI
Information transferred on LIS interface numeric and flag results, instrument to LIS numeric and flag results, instrument to LIS numeric and flag results, histograms and scatterplots,
instrument to LIS; patient demographics, orders, LIS
to instrument—broadcast; host query for patient
demographics and orders
LOINC codes transmitted with all results/Sent in message to LIS/ no/no/no no/no/no no/no/no
Listing of machine codes and corresponding LOINC for each test
Interface available or planned to automated specimen-handling system none none none
Barcode symbologies read on specimen tube Codabar, codes 39 and 128, Interleaved 2 of 5, Chinese post, Codabar, codes 39 and 128, Interleaved 2 of 5, Chinese post, Codabar, codes 39 and 128, Interleaved 2 of 5, ISBT
code 93, EAN8, EAN13, EAN128, IATA, Industrial 2 of 5, Italian code 39 full ASCII, code 93, EAN8, EAN13, EAN128, IATA,
pharmaceutical, Matrix 2 of 5, MSI/Plessey, UK/Plessey, Industrial 2 of 5, Italian pharmaceutical, Matrix 2 of 5, MSI/
Telepen, TriOptic, S-Code, UPC A, UPC E Plessey, UK/Plessey, Telepen, TriOptic, S-Code, UPC A, UPC E
Accommodates barcode placement per CLSI standard AUTO02-A2 yes yes yes
No. of cleaning or maintenance reagents/No. of routine liquid reagents 1/2 1/2 1/3
Time required for daily, weekly, monthly maintenance daily: none; monthly: ~5 min.; biannually: ~10 min. weekly: 15 minutes; quarterly: 2 minutes daily: 30 seconds; weekly: 5 minutes; monthly: 10
minutes (times are estimated)
Onboard diagnostics for troubleshooting/Limited to software problems no/no no/no yes/no
Manufacturer can perform diagnostics via modem no no yes
Distinguishing features (supplied by company) small: sample size, reagent volumes used, and physical small physical footprint, only 3 reagents used (2 of 3 touch-sensitive screen, all optical technology; onboard
size; reliable: system averages one service call per year; reagents stored onboard), and built-in monitor; automated maintenance videos; lyse-resistant RBC mode; rules-
easy to use: system has touchscreen software with start-up, shut-down, and cleaning; 5-part differential using based result annotations
intuitive icons and minimal layers UNI-FLOW optical flow cytometry technology with a patented
lyse allowing for clear separation of the 5 WBC populations
Note: a dash in lieu of an answer means company did not answer *refer to CELL-DYN Emerald operator’s manual for warnings, *refer to CELL-DYN Emerald 22 operator’s manual for warnings, *refer to CELL-DYN Ruby operator’s manual for warnings,
question or question is not applicable limitations, and precautions limitations, and precautions limitations, and precautions
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
68 CAP TODAY | NOVEMBER 2018 HEMATOLOGY ANALYZERS
Part 2 of 13 Abbott Diagnostics Beckman Coulter Beckman Coulter
Christy Thiessen christy.thiessen@abbott.com Matthew Rhyner mnrhyner@beckman.com Matthew Rhyner mnrhyner@beckman.com
Abbott Park, IL Miami, FL Miami, FL
See captodayonline.com/productguides for an interactive version of guide 800-323-9100 www.abbottdiagnostics.com 305-380-3800 www.beckmancoulter.com 305-380-3800 www.beckmancoulter.com
Name of instrument CELL-DYN Sapphire* Coulter Ac•T 5diff Family; Ac•T 5diff AL DxH Connected Workcell
First year installed in U.S./Outside U.S./No. of units sold in 2017 2005/2005/— 2001/2000/—; 2003/2003/— 2014/2014/—
No. units installed in U.S./Outside U.S./List price >165/>750/$250,000 >1,400/>3,900 combined inside, outside of U.S./ 100/200/$690,000
$38,500 (OV and CP), $54,500 (AL)
Test menu: • C hartable (standard menu: WBC, RBC, Hb, Hct, MCV, standard menu (left) plus: MPV, RDW, retic %&#, IRF, NRBC standard menu (left) plus: RDW, MPV standard menu (left) plus: IRF, MPV, MRV, NRBC %&#,
MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso) %&#, CD61, CD3T %&#, CD4T %&#, CD8T %&#, 4/8 RDW-CV, RDW-SD, automated retic #, retic %; body
fluids: total nucleated count and RBC count for synovial,
serous, CSF fluids, and slidemaking
• Flags band, IG, blast, variant lymph, nvWBC, rstRBC, IR, PLT complete operator selectable flagging suspect, system, and exception messages for samples
clump, ASYM, FP, CD61 agglutination, clot detected requiring review
aspiration, short sample
Tests for research use only — PCT, PDW, IMM, ATL body fluid mononuclear %&#, body fluid polymorphonuclear
%&#, early granulated cells %&#, high light scatter
reticulocytes %&#, low hemoglobin density, microcytic
anemia factor, mean sphered cell volume, plateletcrit, platelet
distribution width, reticulocyte distribution width, more
Tests unique to analyzer CD61 for PLTs, CD3/4, CD3/8 (immuno T-cell) — —
Differential method(s) used MAPSS (multi-angle polarized scatter separation) and ACV technology combining cytochemistry, focused Automated Intelligent Morphology using volume,
three-color fluorescence flow impedance, and light absorbance principles of conductivity, and five angles of light scatter, digital signal
measurement processing, advanced algorithm applications, high-
definition cellular resolution, DataFusion
Analytical measurement range: • WBC count/RBC count 0.0–250.0 × 103/µL/0.0–7.50 × 106/µL OV: 0.4–90.0/0.23–7.70; CP: 0.4–91.3/0.30–8.0; 0.050–400.000/0.005–8.500
AL: 0.4–120.0/0.3–8.0
• Hemoglobin/Platelet 1.0–25.0 g/dL/0.0–2,000 × 103/µL OV: 0–22.9/4–1,000; CP: 0.0–22.0/10.0–1,000; 0.10–25.50/3.0–3,000.0
AL: 1.3–24.0/10.0–1,000 (100.0–1,900)
• MCV (fL) or Hct (%) 37.0–179.0 fL (MCV) OV: 1.8–55.9, 56.0–63.8 (Hct); CP: 1.8–55.9, 56.0–63.8 0.00–85.00 (Hct) for operating range, 50.00–150.00
(Hct); AL: 2.0–67.0 (Hct) (MCV) for measuring range
• Reticulocytes 0.0–1,500 × 103/µL — 0.000–30.000
Precision: • WBC count/RBC count <2.7%/≤1.5% <2%/<2% ≤3.0%/≤1.5%
• Hemoglobin/Platelet ≤1.0%/≤4.0% <1%/<5% ≤1.5%/≤3.5%
• MCV or Hct ≤1.0% (MCV) <2.0% (Hct) ≤1.0% (MCV)
Accuracy of automated differential compared with manual neut% r=0.942, slope=0.947, y=0.446; lymph% r=0.936, not available in NCCLS H-20A format neut= ±2.0; lymph, mono= ±3.0; eso, baso= ±1.0 (or
differential (per CLSI H20-A2) slope=0.943, y=2.811; mono% r=0.623, slope=1.057, 10%, whichever is greater)
y=0.851; eos% r=0.446, slope=1.024, y=0.288; baso%
r=0.232, slope=0.257, y=0.350
Interfering substances: • WBC PLT clumps, neutrophil aggregates, HbC crystals, lyse- NRBCs, PLT clumps, large PLTs, lyse-resistant RBCs precipitated elevated proteins, cryoglobulin, fragmented
resistant RBCs, cryoglobulin, cryofibrinogen, fragile WBC, white cells, agglutinated white cells, lyse-resistant RBCs,
NRBCs giant PLTs, PLT clumps, unlysed particles >35 fL in size
• RBC autoagglutination, cold agglutinins, elevated WBC, giant cold agglutinins, PLT clumps, WBC overlinearity very high WBC count, high concentration of very large
PLTs, hemolysis, sm WBC platelets, autoagglutinins
• MCV or Hct autoagglutination, cold agglutinins, elevated WBC, giant Hct: lipemic samples, high WBC, cold agglutinins very high WBC count, high concentration of very large
PLTs, hemolysis, hyperglycemia platelets, autoagglutinins
• Platelet auto and cold agglutinins, cryoglobulin, cryofibrinogen, RBC and WBC fragments platelet clumps, white cell fragments, very small red
giant PLT, micro RBCs, PLT clumps, RBC fragments, WBC cells, red cell fragments, giant platelets, electronic noise
fragments, PLT satellitism
• Hemoglobin lipids>700 mg/dL, WBCs>250 × 109/L, bilirubin>33 mg/ elevated WBC, lipemia severe lipemia, heparin, certain unusual RBC
dL, HbC crystals abnormalities that resist lysing
Interfering substances: differential see WBC lyse-resistant RBCs, NRBCs, lipemia elevated triglycerides, precipitated elevated proteins,
hypogranular granulocytes, agranular granulocytes, lyse-
resistant red cells, very small or multipopulation lymphocytes
Maximum CBCs per hour/Maximum CBCs and differentials per hour 105/105 60/60; 80/80 300/300
Minimum specimen volume open/Closed/Sample dead volume closed 120 µL/120 µL/0.5 mL, 0.3 mL for 10.25 × 64 mm tubes 30 µL for CBC and 53 µL for CBC and differential/30 µL for 165 µL/165 µL/300–400 µL
CBC and 53 µL for CBC and differential/varies by tube size
Microsample capability yes yes yes
Prepares microscope slides automatically or flags problems for slide prep yes no yes
Number of automatic slidemakers available/List price — /$125,000 — —/DxH SMS $165,000
Archives patient data/Previous patient results incl. with recent results yes/yes yes/yes —/yes
Maximum archived data accessible when system online 10,000 results 10,000 samples 90,000 standalone
No. specimens for which numeric results saved in memory at once 10,000 results 10,000 samples 90,000 standalone
No. specimens for which histo/cytogram results saved in memory at once 10,000 results 10,000 samples 90,000
Performs delta checks yes no yes
Tags and holds results for follow-up, confirmatory testing, or rerun yes yes yes
Parameters for flags for holding samples defined by user or vendor user or vendor user or vendor yes
Scattergram display: cell-specific color yes no yes
Histogram display: color with thresholds yes yes yes
LIS interface formats supported ASTM 1394 proprietary; proprietary ASTM CLSI LIS1-A
Information transferred on LIS interface numeric and flag results, instrument to LIS; patient numeric and flag results, histograms and differential numeric and flag results, histograms and scatterplots,
demographics, orders, LIS to instrument—broadcast; plots, instrument to LIS; patient demographics, orders, instrument to LIS; patient demographics, orders, LIS
host query for patient demographics and orders LIS to instrument—broadcast to instrument—broadcast; host query for patient
demographics and orders (available with release of workcell)
LOINC codes transmitted with all results/Sent in message to LIS/ no/no/no no/no/no yes/yes/yes
Interface available or planned to automated specimen-handling system none no Beckman Coulter
Barcode symbologies read on specimen tube Codabar, codes 39 and 128, Interleaved 2 of 5 Codabar, codes 39 and 128, Interleaved 2 of 5, EAN 8 and 13 Codabar, codes 39 and 128, Interleaved 2 of 5, NW7
Time required for daily, weekly, monthly maintenance daily: 30 seconds; weekly: 10 minutes; monthly: none automated shutdown programmable with <1 minute
5 minutes (times are estimated) user time daily
Onboard diagnostics for troubleshooting/Limited to software problems yes/no yes/no yes/no
Manufacturer can perform diagnostics via modem yes no yes
Distinguishing features (supplied by company) 4 optical and 3 fluorescent detectors provide multiple quantitative 5-part WBC differential; aspirates only 30 µL of reduces turnaround time without the need for track-based
scatterplot analysis; 2D optical platelets prevent interferences; sample; requires small space footprint and runs quietly; AL automation; Automated Intelligent Morphology provides 3
fluorescent analysis of reticulocytes, NRBCs, and 3-color has auto repeat based on decision rules independent counts for RBC, WBC, PLT; blast flagging by
monoclonal analysis; OpenFlow MAb test selections; touch- cell lineage; reliable MPV and reliable hemoglobin with few
sensitive screen, interfaces to Accelerator a3600 track system interferences
Note: a dash in lieu of an answer means company did not answer *refer to CELL-DYN Sapphire operator’s manual for warnings,
question or question is not applicable limitations, and precautions
Part 3 of 13 Beckman Coulter Beckman Coulter Beckman Coulter
Matthew Rhyner mnrhyner@beckman.com Matthew Rhyner mnrhyner@beckman.com Mirta Gamez mgamez@beckman.com
Miami, FL Miami, FL Miami, FL
See captodayonline.com/productguides for an interactive version of guide 305-380-3800 www.beckmancoulter.com 305-380-3800 www.beckmancoulter.com 305-380-3800 www.beckmancoulter.com
Name of instrument DxH 600 DxH 800 Unicel DxH 900
First year installed in U.S./Outside U.S./No. of units sold in 2017 2013/2013/— 2008/2008/— 2018/2018/>96 (Q2 2018)
No. units installed in U.S./Outside U.S./List price >600/>100/$209,000 >2,000/>1,500/$229,000 55/29/$259,600
Test menu: • C hartable (standard menu: WBC, RBC, Hb, Hct, MCV, standard menu (left) plus: IRF, MPV, MRV, NRBC %&#, standard menu (left) plus: IRF, MPV, MRV, NRBC %&#, standard menu (left) plus: retic and extended retic panel:
MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso) RDW-CV, RDW-SD, automated retic #, retic %; body RDW-CV, RDW-SD, automated retic #, retic %; body automated retic #&%, MRV, IRF; extended platelet panel:
fluids: total nucleated count and RBC count for synovial, fluids: total nucleated count and RBC count for synovial, MPV; extended RBC panel: NRBC %&#, RDW-CV, RDW-
serous, CSF fluids serous, and CSF fluids SD; body fluids: total nucleated count, RBC count for
synovial, serous, CSF, and BAL fluids
• Flags suspect, system, and exception messages for samples flags and codes for values requiring review: suspect, suspect messages: Abn hemoglobin, cellular inter, dimorphic
requiring review system, and exception messages for samples requiring reds, giant platelets, imm grans, left shift, LY blast, MO blast,
review NE blast, NRBC, RBC frag/micro, red cell aggl, sickled cells,
variant LY, H&H check; customizable definitive messages and
system messages; unlimited customizable lab flagging: free
text for direction at the scope
Tests not available but submitted for 510(k) clearance — — Early Sepsis Indicator
Tests in development — — immature granulocyte: IG%
Tests for research use only body fluid mononuclear %&#, body fluid polymorphonuclear body fluid mononuclear %&#, body fluid polymorphonuclear body fluid mononuclear %&#, body fluid polymorphonuclear
%&#, early granulated cells %&#, high light scatter %&#, early granulated cells %&#, high light scatter %&#, early granulated cells %&#, high light scatter
reticulocytes %&#, low hemoglobin density, microcytic reticulocytes %&#, low hemoglobin density, microcytic reticulocytes %&#, low hemoglobin density, microcytic
anemia factor, mean sphered cell volume, plateletcrit, platelet anemia factor, mean sphered cell volume, plateletcrit, anemia factor, mean sphered cell volume, plateletcrit,
distribution width, reticulocyte distribution width, more platelet distribution width, reticulocyte distribution width platelet distribution width, reticulocyte distribution width,
(RDWR and RDWR-SD), red cell size factor, unghosted red more
cells %&#, leukocyte estimates (UWROP, WDOP, WNOP,
WROP), cell population data research parameters
Tests unique to analyzer — — extended retic panel: MRV; direct count MPV, MCV, MDW,
CMD parameters
Differential method(s) used Automated Intelligent Morphology using volume, Automated Intelligent Morphology using volume, biophysical characterization of blood cells with 5 light-
conductivity, and 5 angles of light scatter, digital signal conductivity, and 5 angles of light scatter, digital signal scatter angles, digital conductivity, and enhanced Coulter
processing, advanced algorithm applications, high- processing, advanced algorithm applications, high- Principle; WBC flagging
definition cellular resolution, DataFusion definition cellular resolution, DataFusion
Analytical measurement range: • WBC count/RBC count 0.050–400.000/0.005–8.500 0.050–400.000/0.005–8.500 0.050–2.000 × 103 cells/μL/0.005–8.500 × 106 cells/μL
• Hemoglobin/Platelet 0.10–25.50/3.0–3,000.0 0.10–25.50/3.0–3,000.0 0.10–25.50 g/dL/3.0–3,000.0 × 103 cells/μL
• MCV (fL) or Hct (%) 50.00–150.00 (MCV) 0.00–85.00 (Hct) for operating range, 50.00–150.00 50.00–150.00 fL
(MCV) for measuring range
• Reticulocytes 0.000–30.000 0.000–30.000 0.000–30.000
Precision: • WBC count/RBC count ≤3.0%/≤1.5% ≤3.0%/≤1.5% ≤3.0%/≤1.5%
• Hemoglobin/Platelet ≤1.5%/≤3.5% ≤1.5%/≤3.5% ≤1.5%/≤3.5%
• MCV or Hct ≤1.0% (MCV) ≤1.0% (MCV) ≤1.0% (MCV)
Accuracy of automated differential compared with manual neut= ±2.0; lymph, mono= ±3.0; eso, baso= ±1.0 (or neut= ±2.0; lymph, mono= ±3.0; eso, baso= ±1.0 (or neut= ±2.0; lymph, mono= ±3.0; eso, baso= ±1.0 (or
differential (per CLSI H20-A2) 10%, whichever is greater) 10%, whichever is greater) 10%, whichever is greater)
Interfering substances: • WBC precipitated elevated proteins, cryoglobulin, fragmented precipitated elevated proteins, cryoglobulin, fragmented possibly: precipitated elevated proteins, cryoglobulin, frag-
white cells, agglutinated white cells, lyse-resistant RBCs, white cells, agglutinated white cells, lyse-resistant RBCs, mented white cells, agglutinated white cells, lyse-resistant
giant PLTs, PLT clumps, unlysed particles >35 fL in size giant PLTs, PLT clumps, unlysed particles >35 fL in size RBCs, giant PLTs, PLT clumps, unlysed particles >35 fL
• RBC very high WBC count, high concentration of very large very high WBC count, high concentration of very large possibly: very high WBC count, high concentration of very
platelets, autoagglutinins platelets, autoagglutinins large platelets, autoagglutinins
• MCV or Hct very high WBC count, high concentration of very large very high WBC count, high concentration of very large possibly: very high WBC count, high concentration of very
platelets, autoagglutinins platelets, autoagglutinins large platelets, autoagglutinins
• Platelet platelet clumps, white cell fragments, very small red platelet clumps, white cell fragments, very small red possibly: platelet clumps, white cell fragments, very small
cells, red cell fragments, giant platelets, electronic noise cells, red cell fragments, giant platelets, electronic noise red cells, red cell fragments, giant platelets, electronic noise
• Hemoglobin severe lipemia, heparin, certain unusual RBC severe lipemia, heparin, certain unusual RBC possibly: severe lipemia, heparin, certain unusual RBC
abnormalities that resist lysing abnormalities that resist lysing abnormalities that resist lysing
Interfering substances: differential elevated triglycerides, precipitated elevated proteins, elevated triglycerides, precipitated elevated proteins elevated triglycerides, precipitated elevated proteins, hypo-
hypogranular granulocytes, agranular granulocytes, lyse- granular granulocytes, agranular granulocytes, lyse-resistant
resistant red cells, very small or multipopulation lymphocytes red cells, very small or multipopulation lymphocytes
Maximum CBCs per hour/Maximum CBCs and differentials per hour >100/>90 >100/>90 300 samples/300 samples
Minimum specimen volume open/Closed/Sample dead volume closed 165 µL/165 µL/250–400 µL 165 µL/165 µL/250–400 µL 165 µL/165 µL/250–400 µL
Prepares microscope slides automatically or flags problems for slide prep yes yes no
Number of automatic slidemakers available/List price —/DxH SMS $165,000 —/DxH SMS $165,000 —
Archives patient data/Previous patient results incl. with recent results —/no yes/no yes/yes
Maximum archived data accessible when system online 40,000 standalone 40,000 standalone 50,000 patient results w/histograms, scatterplots, demographics
No. specimens for which numeric results saved in memory at once 40,000 standalone 40,000 standalone 50,000 patient results w/histograms, scatterplots, demographics
No. specimens for which histo/cytogram results saved in memory at once 40,000 40,000 50,000 patient results w/histograms, scatterplots, demographics
Performs delta checks yes yes yes
Parameters for flags for holding samples defined by user or vendor yes yes yes
Scattergram display: cell-specific color yes yes yes (WBC, nRBC, reticulocyte)
Histogram display: color with thresholds yes yes yes (WBC, RBC, PLT)
LIS interface formats supported CLSI LIS01-A2 CLSI LIS01-A2 CLSI LIS01-A2
Information transferred on LIS interface numeric and flag results, histograms and scatterplots, numeric and flag results, histograms and scatterplots, numeric and flag results, histograms and scatterplots,
instrument to LIS; patient demographics, orders, LIS to instrument to LIS; patient demographics, orders, LIS instrument to LIS; patient demographics, orders, LIS
instrument—broadcast; host query for patient demographics to instrument—broadcast; host query for patient to instrument—broadcast; host query for patient
and orders (available with release of workcell) demographics and orders (available with release of workcell) demographics and orders
LOINC codes transmitted with all results/Sent in message to LIS/ yes/yes/yes yes/yes/yes yes/yes/yes
Interface available or planned to automated specimen-handling system Beckman Coulter Beckman Coulter Beckman Coulter
Barcode symbologies read on specimen tube Codabar, codes 39 and 128, interleaved 2 of 5, NW7 Codabar, codes 39 and 128, interleaved 2 of 5, NW7 Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5, NW7
No. of cleaning or maintenance reagents/No. of routine liquid reagents 5/7 5/7 1 pre-loaded cube with up to 30 cleaning cycles/3 for
CBC/diff incl. Coulter Plt, 1 for retic, extended retic panel
Time required for daily, weekly, monthly maintenance automated shutdown programmable with <1 minute automated shutdown programmable with <1 minute daily: 30 min.; weekly: none; monthly: none; as needed
user time daily user time daily
Manufacturer can perform diagnostics via modem yes yes yes
Distinguishing features (supplied by company) Automated Intelligent Morphology provides 3 independent Automated Intelligent Morphology provides 3 independent DataFusion uses real-time analytics and bypasses special
counts for RBC, WBC, PLT; blast flagging by cell lineage; counts for RBC, WBC, PLT; blast flagging by cell lineage; modes, avoiding reruns; platelets achieve industry-leading
reliable MPV and reliable hemoglobin with few interferences; reliable MPV and reliable hemoglobin with few interferences; accuracy, precision, and low backgrounds with first-pass
Note: a dash in lieu of an answer means company did not answer upper-level linearity for body fluids minimizes dilution steps; 48–72 hour sample stability on CBC parameters technology; near-native state RBC analysis throughout the
question or question is not applicable 48–72 hour sample stability on CBC parameters maturation cycle for direct read and accurate indices
Part 4 of 13 Beckman Coulter CellaVision Clinical Diagnostic Solutions

Mirta Gamez mgamez@beckman.com Ken Childs ken.childs@cellavision.com sales@cdsolinc.com
Miami, FL Durham, NC Plantation, FL
See captodayonline.com/productguides for an interactive version of guide 305-380-3800 www.beckmancoulter.com 919-806-4420 www.cellavision.com 954-791-1773 www.cdsolinc.com
Name of instrument Unicel DxH SMS II CellaVision DM9600/DM1200 Medonic M-Series
First year installed in U.S./Outside U.S./No. of units sold in 2017 2018/2018/— 2004/2003/— 2006/—/250
No. units installed in U.S./Outside U.S./List price 13/9/$177,100 —/—/~$135,000–$175,000 2,000/>25,000/$21,089
Test menu: • C hartable (standard menu: WBC, RBC, Hb, Hct, MCV, — neut %&#, mono, lymph, eos, baso, segmented, bands, WBC, RBC, HGB, Hct, MCV, MCH, MCHC, PLT, gran %&#,
MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso) blast, promyelocytes, myelocytes, metamyelocytes, mid, lymph, RDW, MPV
variant lymphocytes, plasma cells, giant platelets,
platelet clumps, erythroblasts; RBC morphology pre-
characterizations include anisocytosis, poikilocytosis,
polychromasia, microcytosis, macrocytosis, hypochromia
• Flags P flag printed on slide to denote blood detector detected — —
aspiration error
Tests unique to analyzer — analysis of cytocentrifuged samples, body fluids micro-pipette adaptor for capillary sampling
(reported parameters: neutrophils, eosinophils,
lymphocytes, macrophages, including monocytes),
other (basophils, lymphoma cells, atypical lymphocytes,
blast cells, tumor cells)
Differential method(s) used — light microscopy, image analysis, and artificial neural impedance
networks
Analytical measurement range: • WBC count/RBC count — — 0.5–80.0/0.5–7.00
• Hemoglobin/Platelet — — 2.0–23.0/30–1,800
• MCV (fL) or Hct (%) — — —
Precision: • WBC count/RBC count — — 7.0 × 109/L, ≤1.8% (OT CV)/4.59 × 1012/L, ≤0.9% (OT CV)
• Hemoglobin/Platelet — — 14.3 g/dL, ≤0.8% (OT CV)/239 × 109/L, ≤3.0% (OT CV)
• MCV or Hct — — MCV: 86.8 fL/≤0.5% (OT CV)
Accuracy of automated differential compared with manual — seg neut% y=0.97x+1.3, r= 0.987; lymph% y=0.97x —
differential (per CLSI H20-A2) + 1.2, r= 0.979; eos% y=1.01+0.1, r=0.960; mono%
y=0.97+0.2, r=0.941; band neut% y=0.87x+0.1, r=0.917
Interfering substances: • WBC none — NRBCs, unlysed RBCs, hemolysis, leukemias,
chemotherapy, cryoglobulins, multiple myeloma,
lymphocyte count interference
• RBC none — leukocytosis with concurrent anemia, agglutinated RBCs,
cold agglutinins
• MCV or Hct none — red blood cell agglutination, WBC, thrombocytosis
• Platelet none — microcytosis, agglutinated RBCs, giant platelets in

excessive numbers, chemotherapy, hemolysis, ACD
blood, RBC inclusions, platelet agglutination
• Hemoglobin none — unlysed RBCs, leukocytosis, lipemia, hyperproteinemia,
hyperbilirubinemia, fetal blood
Interfering substances: differential none — factors that affect WBC (above) plus: large lymphocytes,
atypical lymphocytes, blasts, basophils in excessive
numbers, metamyelocytes, myelocytes, promyelocytes,
blasts and plasma cells in excessive numbers
Maximum CBCs per hour/Maximum CBCs and differentials per hour 140 slides/— —/35 differentials >60/>60
Minimum specimen volume open/Closed/Sample dead volume closed 90 µL/90 µL/250–400 µL — <110 µL/<250 µL/1 mL
Microsample capability yes — yes
Prepares microscope slides automatically or flags problems for slide prep yes — no
Number of automatic slidemakers available/List price —/$177,000 — —
Archives patient data/Previous patient results incl. with recent results no/no yes/no no/no
Maximum archived data accessible when system online — unlimited —
No. specimens for which numeric results saved in memory at once — ~4,000 >1,000 samples
No. specimens for which histo/cytogram results saved in memory at once — — >1,000 samples
Performs delta checks no no no
Tags and holds results for follow-up, confirmatory testing, or rerun no — no
Parameters for flags for holding samples defined by user or vendor no — user-definable ranges
Scattergram display: cell-specific color no — no
Histogram display: color with thresholds no — yes
User interface can display choice of specimen or result information yes — yes
LIS interface formats supported ASTM 1394, ASTM 1238, IEEE MIB, CLSI LIS1-A, CLSI LIS2-A ASTM 1394 XML/Serial
Information transferred on LIS interface patient demographics, LIS to instrument—broadcast; numeric and flag results, instrument to LIS; patient numeric and flag results, histograms and scatterplots,
host query for patient demographics and orders demographics, orders, LIS to instrument—broadcast; instrument to LIS
host query for patient demographics and orders
LOINC codes transmitted with all results/Sent in message to LIS/ no/no/no no/no/yes (for peripheral blood) no/no/no
Interface available or planned to automated specimen-handling system Beckman Coulter — —
Barcode symbologies read on specimen tube Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5, Codabar, codes 39 and 128, Interleaved 2 of 5, QR, —
NW7 DataMatrix
Accommodates barcode placement per CLSI standard AUTO02-A2 yes — —
No. of cleaning or maintenance reagents/No. of routine liquid reagents 1 pre-loaded cube with up to 30 cleaning cycles/3 (can none/1 1/1
vary): stain, buffer, diluent
Time required for daily, weekly, monthly maintenance daily: up to 20 min.; weekly: up to 30 min.; monthly: as daily: none; weekly: 5 minutes daily: a few minutes; monthly: 10 minutes; 6 months:
needed 75 minutes
Manufacturer can perform diagnostics via modem yes no no
Distinguishing features (supplied by company) hemasphere technology analyzes to overcome variations in fully automated slide handling and oiling available in two micro-pipette adaptor for capillary sampling; only 3-part
blood characteristics to produce an exceptional monolayer models for medium and large laboratories; performs diff with auto sampling capability; no weekly maintenance
smear; flexible rule writing allows for up to 16 slides peripheral blood and body fluid differentials; WBC and
seamlessly triggered by customizable CBC or specific flag other nucleated cells classified into 18 different categories;
results; blood detector for sample check, flagging directly RBC morphology characterized for 6 categories; network
on slide to note aspiration integrity gaps alerting user use allows remote review of blood smears and linking of
Note: a dash in lieu of an answer means company did not answer
multiple analyzers in multiple locations
question or question is not applicable
Part 5 of 13 Diatron MI Diatron MI HORIBA Medical
Frank Matuszak frank.matuszak@diatron.com Frank Matuszak frank.matuszak@diatron.com Jim Knowles jim.knowles@horiba.com
Medley, FL Medley, FL Irvine, CA
See captodayonline.com/productguides for an interactive version of guide 833-228-7931 www.diatron.com 833-228-7931 www.diatron.com 888-903-5001 ext. 4553 www.horiba.com/us/en/medical
Name of instrument Abacus 3CP Abacus 5 Pentra XLR
First year installed in U.S./Outside U.S./No. of units sold in 2017 2013/2013/481 2013/2009/658 2016/2015/—
No. units installed in U.S./Outside U.S./List price 56/1,039/$20,385 35/3,120/$31,850 —/—/$77,500
Test menu: • C hartable (standard menu: WBC, RBC, Hb, Hct, MCV, WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, mono, lymph, standard menu (left) plus: RDW-SD, RDW-CV, MPV standard menu (left) plus: retic %&#, IRF%, CRC%
MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso) RDW%, MPV, GRA%, GRA#
• Flags range flags, measurement condition flags, parameter pathological flags, lab limits (normal ranges), reagents operator selectable flagging
warning and error flags alert, instrumental alerts
Tests unique to analyzer — — automatic dilution for over range WBC and platelet
Differential method(s) used volumetric impedance method, light absorbance for laser light scatter technology, impedance method, light DHSS technology combining cytochemistry, focused flow
HGB measurement absorbance impedance, and light absorbance
Analytical measurement range: • WBC count/RBC count 0.95–83.45/0.44–7.74 0.2–100/0.36–7.19 0–120 (120–360 with CDR)/0–8
• Hemoglobin/Platelet 1.4–23.7/11–975 1.1–22.2/15–2,000 0–24/0–1,900; 1,900–3,800, Hb >2 g/dL with CDR
• MCV (fL) or Hct (%) — — 0–67 (Hct)
• Reticulocytes — — 0–42%
Precision: • WBC count/RBC count <2.7%/<1.7% <2.7%/<1.7% <2%/<2%

• Hemoglobin/Platelet <2.0%/<6% <2.0%/<6% <1%/<5%
• MCV or Hct <1.7% <1.7% <2% (Hct)
Accuracy of automated differential compared with manual — — —
differential (per CLSI H20-A2)
Interfering substances: • WBC >5 NRBCs/100 WBCs, PLT clumps/large PLTs >5 NRBCs/100 WBCs, PLT clumps/large PLTs NRBCs, PLT clumps, lyse-resistant RBCs
• RBC WBC count >50.0 × 103/µL WBC count >75.0 × 103/µL cold agglutinins
• MCV or Hct WBC count >50.0 × 103/µL WBC count >75.0 × 103/µL Hct: extreme leukocytosis
• Platelet PLT clumps/large PLTs PLT clumps/large PLTs microcytes, PLT clumps
• Hemoglobin WBC count >50.0 × 103/µL, lipids >270 mg/dL WBC count >75.0 × 103/µL, lipids >280 mg/dL extreme lipemia, leukocytosis
Interfering substances: differential >5 NRBCs/100 WBCs, PLT clumps/large PLTs >5 NRBCs/100 WBCs, PLT clumps/large PLTs NRBCs, lyse-resistant RBCs, extreme hyperbilirubinemia
Minimum specimen volume open/Closed/Sample dead volume closed 100 µL/100 µL/— 110 µL/110 µL/— 30 µL for CBC and 53 µL for CBC and differential/
100 µL/—
Microsample capability no no yes
Prepares microscope slides automatically or flags problems for slide prep no no no
Number of automatic slidemakers available/List price — — —
Archives patient data/Previous patient results incl. with recent results yes/no yes/no yes/no
Maximum archived data accessible when system online 10,000 results 100,000 results 100,000
No. specimens for which numeric results saved in memory at once 10,000 results 100,000 results unlimited with backup
No. specimens for which histo/cytogram results saved in memory at once 10,000 results 100,000 results unlimited with backup
Performs delta checks no no yes
User interface can display choice of specimen or result information no no no
LIS interface formats supported HL7, Diatron Serial Communication HL7, Diatron Serial Protocol proprietary, ASTM 1394
Information transferred on LIS interface numeric and flag results, histograms and scatterplots, histograms and scatterplots, instrument to LIS; patient numeric and flag results, histograms and scatterplots,
instrument to LIS; patient demographics, orders, LIS to demographics, orders, LIS to instrument—broadcast instrument to LIS; patient demographics, patient orders,
instrument—broadcast LIS to instrument—broadcast; host query for patient
LOINC codes transmitted with all results/Sent in message to LIS/ no/no/no no/no/no no/no/no
Interface available or planned to automated specimen-handling system none none no
Barcode symbologies read on specimen tube Codabar, codes 39 and 128, Interleaved 2 of 5 Codabar, codes 39 and 128, Interleaved 2 of 5 Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5
Accommodates barcode placement per CLSI standard AUTO02-A2 — — yes
Time required for daily, weekly, monthly maintenance daily: 10 minutes; weekly: 15 minutes; monthly: 10 minutes daily: 10 minutes; weekly: 15 minutes; daily: 10 minutes; weekly: 15 minutes;
monthly: 10 minutes monthly: 15 minutes
Onboard diagnostics for troubleshooting/Limited to software problems no/no no/no yes/yes
Manufacturer can perform diagnostics via modem no no no
Distinguishing features (supplied by company) reliable 3-part diff analyzers with two sampling modes: compact, benchtop 5-part laser WBC differential customized dilution ratio for over range WBC up to 360 ×
cap-piercing mode for closed-tube sampling and analyzer provides accurate and precise results; two 103/mm3 and platelet up to 5,600 x 103/mm3; auto-
another for open tubes; operator safety: self-cleaning sampling modes (cap-piercing mode for closed-tube rerun of patient results based on customized criteria;
procedures minimize daily maintenance; user-friendly sampling and another for open tubes); field upgradeable autovalidation of patient results on customized criteria
and easy-to-operate high-resolution touchscreen; USB with optional autosampler with built-in barcode reader,
and barcode option to load QC target values; capable sample capacity: 100 tubes; user friendly and easy to
to read QR codes for reference input data; confidence: operate: easy-to-follow, intuitive icon user interface
system uses easy-to-understand warning messages and
sample flags, employs a comprehensive QC SW package

Part 6 of 13 HORIBA Medical HORIBA Medical Mindray

Jim Knowles jim.knowles@horiba.com Jim Knowles jim.knowles@horiba.com Peggy Chan p.chan@mindray.com
Irvine, CA Irvine, CA Redmond, WA
See captodayonline.com/productguides for an interactive version of guide 888-903-5001 ext. 4553 www.horiba.com/us/en/medical 888-903-5001 ext. 4553 www.horiba.com/us/en/medical 425-881-0361 ext. 3305 www.mindraynorthamerica.com
Name of instrument Pentra 60C+ Hematology Analyzer Pentra XL 80 BC-5390
First year installed in U.S./Outside U.S./No. of units sold in 2017 2000/2000/85 2004/2003/31 2016/2012/—
No. units installed in U.S./Outside U.S./List price >350/>600/$47,313 >250/>900/$76,808 24/1,612/—
Test menu: • C hartable (standard menu: WBC, RBC, Hb, Hct, MCV, standard menu (left) plus: RDW, MPV standard menu (left) plus: automatic dilution of over- standard menu (left) plus: RDW-CV, RDW-SD, MPV,
MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso) range results (WBC × 3, RBC/Hgb/PLT × 2), RDW, MPV mono %&#, lymph %&#, eos %&#, baso %&#
• Laboratory atypical lymphocytes, atypical lymphocytes %, LIC, LIC% atypical lymphocytes, atypical lymphocytes %, LIC, LIC% —
• Flags operator selectable flagging operator selectable flagging WBC scattergram abn., WBC histogram abn., blast,
immature gran, left shift, abn./atypical lym, RBC
lyse resist, NRBC, dimorphic population, turb/HGB
interference, RBC agglutination, PLT histogram abn.,
PLT clump
Tests for research use only PCT, PDW, ATL, LIC PCT, PDW, ATL, LIC —
Tests unique to analyzer — automatic dilution protocol —
Differential method(s) used DHSS technology combining cytochemistry, focused DHSS technology combining cytochemistry, focused flow flow cytometry, light scatter
flow impedance, and light absorbance principles of impedance, and light absorbance
measurement
Analytical measurement range: • WBC count/RBC count 0–120/0–8 0–120/0–8 0.3–200/0.2–8.0
• Hemoglobin/Platelet 0–24/0–1,900 0–24/0–1,900 (>2 g/dL Hb) 0.5–25/5–2,000
• MCV (fL) or Hct (%) 0–67 (Hct) 0–67 (Hct)/0–2,800 (<2 g/dL Hb) 2–75 (Hct%)
Precision: • WBC count/RBC count <2%/<2% <2%/<2% <0.15 (SD) or 3.0% (CV)/<1.5%
• Hemoglobin/Platelet <1%/<5% <1%/<5% <1.5%/<7.5 (SD) or 5% (CV)
• MCV or Hct <2% (Hct) <2% (Hct) <1.5% (MCV)
Accuracy of automated differential compared with manual neut% r=0.99, lymph% r=0.98, mono% r=0.96, eos% neut% r=0.99, lymph% r=0.98, mono% r=0.96, eos% neu%: ±5.00 or ±10.0%; lym%: ±4.00 or ±10.0%;
differential (per CLSI H20-A2) r=0.89, baso% r=0.54 r=0.89, baso% r=0.54 mon%: ±3.00 or ±10.0%; eos%: ±2.00 or ±10.0%;
bas%: ±1.00 or ±10.0%
Interfering substances: • WBC NRBCs, PLT clumps, lyse-resistant RBCs NRBCs, PLT clumps, lyse-resistant RBCs platelet aggregation, lyse-resistant erythrocytes,
erythroblasts, cold agglutinin, cryoglobulin, giant
platelets, lipemia, chylomicronemia
• RBC cold agglutinins cold agglutinins cold agglutinin, fragmented erythrocytes, leukocytosis,
giant platelets
• MCV or Hct Hct: extreme leukocytosis Hct: extreme leukocytosis RBC fragments, very high WBC count, high concentration
of very large platelets, microclots, RBC rouleaux or
agglutinates (autoagglutination)
• Platelet microcytes, PLT clumps microcytes, PLT clumps PLT aggregation or PLT satellitism, giant platelets,
microcytosis, fragmented erythrocytes
• Hemoglobin extreme lipemia, leukocytosis extreme lipemia, leukocytosis leukocytosis, lipemia, chylomicronemia, abnormal protein
Interfering substances: differential NRBCs, lyse-resistant RBCs, extreme hyperbilirubinemia NRBCs, lyse-resistant RBCs, extreme hyperbilirubinemia lysis-resistant RBC, NRBC, PLT aggregates, giant PLT
Minimum specimen volume open/Closed/Sample dead volume closed 30 µL for CBC and 53 µL for CBC and differential/30 µL 30 µL for CBC/53 µL for CBC and differential/0.5 mL —/33 µL, predilute 20 µL/1 mL
for CBC and 53 µL for CBC and differential/—
Prepares microscope slides automatically or flags problems for slide prep yes yes no
Archives patient data/Previous patient results incl. with recent results yes/yes, with MultiLink Data Manager yes/yes, with MultiLink Data Manager yes/yes
Maximum archived data accessible when system online 100,000 100,000 100,000
No. specimens for which numeric results saved in memory at once unlimited with backup unlimited with backup 100,000
No. specimens for which histo/cytogram results saved in memory at once unlimited with backup unlimited with backup 100,000
Parameters for flags for holding samples defined by user or vendor user user yes
Scattergram display: cell-specific color yes yes yes
User interface can display choice of specimen or result information yes — yes
LIS interface formats supported ASTM 1394 and 1238, HL7, IEEE MIB proprietary, ASTM 1394 and 1238, HL7, IEEE MIB HL7
Information transferred on LIS interface numeric and flag results, histograms and scatter- numeric and flag results, histograms and scatterplots, numeric and flag results, histograms and scatterplots,
plots, instrument to LIS; patient demographics, LIS to instrument to LIS; patient demographics, orders, LIS to instrument to LIS; patient demographics, orders, LIS
instrument—broadcast instrument—broadcast to instrument—broadcast; host query for patient
LOINC codes transmitted with all results/Sent in message to LIS/ no/no/no yes/yes/yes yes/yes/yes
Interface available or planned to automated specimen-handling system no yes none
Barcode symbologies read on specimen tube Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5 Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5 Codabar, codes 39, 93, and 128, Interleaved 2 of 5, UPC/EAN
No. of cleaning or maintenance reagents/No. of routine liquid reagents 2/5 1/4

2/5
Time required for daily, weekly, monthly maintenance daily: 10 minutes; weekly: 15 minutes; daily: 10 minutes; weekly: 15 minutes; daily: <10 minutes
Onboard diagnostics for troubleshooting/Limited to software problems yes/yes no/yes yes/no
Manufacturer can perform diagnostics via modem yes, with Data Manager no yes
Distinguishing features (supplied by company) reliable 5-part WBC differential technology; mean time compact 5-part differential instrument with auto- 60 QC files, maximum 40 samples autoloader capacity,
between failures more than 200 days; small footprint; loader and autodilution capability, auto rerun feature, sample adaptors for pediatric and predilution samples,
small sample size of 53 µL autovalidation operation software with built-in data-management
functions, 3 modes of operation: autoloader and opened
and closed tube; customizable patient reports, only 1
maintenance reagent, other maintenance is touch-button
operation, cyanide-free, nontoxic reagent; patented
WBC differential and digital sheath flow technology, top
instrument reliability, mean time between failures >2
Note: a dash in lieu of an answer means company did not answer years of instrument in the same 5-part series
Part 7 of 13 Mindray Roche Diagnostics Siemens Healthineers
Peggy Chan p.chan@mindray.com Krista Curcio krista.curcio@roche.com David Metrena david.metrena@siemens.com
Redmond, WA Indianapolis, IN Hoffman Estates, IL
See captodayonline.com/productguides for an interactive version of guide 425-881-0361 ext. 3305 www.mindraynorthamerica.com 317-217-0801 www.roche.com 800-948-3234 www.usa.siemens.com/diagnostics
Name of instrument BC-3600 cobas m 511 integrated hematology analyzer Advia 120 Hematology System
First year installed in U.S./Outside U.S./No. of units sold in 2017 2015/2011/— —/2017/— 1998/1998/—
No. units installed in U.S./Outside U.S./List price 78/4,120/— —/>5/$400,000 >750/2,700/$169,000–$189,000
Test menu: • C hartable (standard menu: WBC, RBC, Hb, Hct, MCV, WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, gran %&#, standard menu (left) plus: NRBC %&#, MPV, RET %&#, standard menu (left) plus: CHCM, MPV, RDW, HDW, LUC
MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso) lymph %&#, mid %&#, MPV, RDW HGB-RET, and digital images %&#, retic %&#, CHr, CHCMr, MCVr; CSF: WBC, RBC,
PMN, MN, neut, lymph, mono; cellular Hgb
• Laboratory — — % hypo, hyper, macro, micro; calc. Hb, MPXI; % blast, PMN,
MN; large PLT count; RBC fragment count; RBC ghost count;
CSF: WBC, RBC, 3-part differential; body fluids: TNC, RBC
• Flags — atypical lymphs, blasts, immature granulocytes, left left shift, atyp. lymph, blasts, immature grans, myeloperoxi-
shift, giant PLT, PLT clumps, <600 cells counted for dase deficiency, aniso, micro, macro, Hb variation, hypo, hyper,
differential, hemolysis, RBC agglutination NRBC, RBC fragments, RBC ghost, large PLTs, PLT clumps
FDA-cleared tests not clinically released none — —
Tests not available but submitted for 510(k) clearance none — —
Tests in development none — IRF, MPC, MPM
Tests for research use only none — CSF eos
Tests unique to analyzer none — CHCM, HDW, CHr, CHCMr, MPC, MPM; CSF: WBC, RBC,
MN, PMN, neut, lymph, mono
Differential method(s) used impedance method for WBC, RBC, MCV, RDW, PLT, MPV digital multispectral image analysis perox: peroxidase cytochemistry staining with light
and WBC 3-part differential determination, colorimetric scatter and absorption; baso: cytochemistry stripping
method for HGB determination with 2-angle laser light scatter
Analytical measurement range: • WBC count/RBC count 0.3–99.9/0.20–7.99 0.07–404,800/0.37–8.26 whole blood: WBC 0.02–400/RBC 0–7.0;
CSF: WBC 0–5,000/RBC 0–1,500
• Hemoglobin/Platelet 1.0–24.9/10–999 1.1–24.2/9–5,000 0–22.5/5–3,500
• MCV (fL) or Hct (%) — —/3.2–72.2 (Hct) 30–180 (MCV)
• Reticulocytes — 0.003–0.63 (#) 0.2–24.5%
Precision: • WBC count/RBC count WBC ≥4.0: ≤3.0% CV%; 1.0 ≤WBC ≤2.0: ≤7.0% CV%/ 2.72%/1.34% 2.7%/1.2%
≤2.5% CV%
• Hemoglobin/Platelet ≤2.0% CV%/PLT ≥150: ≤6.0% CV%; 20 ≤PLT≤ 50: 1.52%/1.97% 0.93%/2.93%
≤20.0% CV%
• MCV or Hct ≤2.0 CV% (MCV), ≤2.5% CV% (Hct) 0.73% (MCV), 1.46% (Hct) 0.78% (MCV)
Accuracy of automated differential compared with manual — — neut% r=0.997, y=1.02x–0.6; lymph% r=0.997,
differential (per CLSI H20-A2) y=1.00x+0.8; mono% r=0.943, y=0.85x–0.3; eos%
r=0.979, y=0.87x+0.2; baso% r=0.772, y=0.67x+0.0;
luc% r=0.994, y=0.92x+0.6
Interfering substances: • WBC certain unusual RBC abnormalities that resist lysing, leukocyte aggregation, platelet clumps, giant platelets incomplete RBC lysis (peroxidase only)
nucleated RBCs, fragmented WBCs, unlysed particles,
very large or aggregated platelets as when anticoagulated
with oxalate or heparin
• RBC very high WBC count, high concentration of very large erythrocyte aggregation, microerythrocytes, fragmented cold agglutinins, extreme sickle cell
platelets, agglutinated RBCs and smaller RBC RBC
• MCV or Hct very high WBC count, high concentration of very large Hct: erythrocyte aggregation, microerythrocytes, —
platelets, agglutinated RBCs, RBC fragments possibility of fragmented red blood cells
• Platelet very small red blood cells near the upper PLT threshold, platelet clumps, pseudo thrombocytopenia, activated —
cell fragments, clumped platelets as with oxalate or platelets, fragmented leukocytes
heparin, platelet fragments or cellular debris near the
lower platelet threshold
• Hemoglobin very high WBC count, severe lipemia, certain unusual RBC erythrocyte aggregation high WBC, lipemia, extremely high bilirubin, interfere
abnormalities that resist lysing, anything that increases the with cyanmethemoglobin only, none with direct cellular
turbidity of the sample such as elevated levels of triglycerides Hb (CHCM)
Interfering substances: differential known factors that affect the WBC count as listed above, — incomplete lysis of RBCs, complete myeloperoxidase
high triglycerides that can affect lysing deficiency
Maximum CBCs per hour/Maximum CBCs and differentials per hour 60/60 60/60 (including images of all WBCs, RBCs, and platelets) 120/120
Minimum specimen volume open/Closed/Sample dead volume closed 21 µL/21 µL/1 mL 50 µL/480 µL/450 µL 157 µL/157 µL/<300 µL (tube size dependent)
Prepares microscope slides automatically or flags problems for slide prep no yes yes
Number of automatic slidemakers available/List price — included with system —
Archives patient data/Previous patient results incl. with recent results no/no yes/yes yes/no
Maximum archived data accessible when system online — abnormal images maintained for 2 years, numeric data 10,000 samples
for ~10 years; normal images stored for up to 30 days
No. specimens for which numeric results saved in memory at once 40,000 numeric data stored for ~10 years 10,000 samples
No. specimens for which histo/cytogram results saved in memory at once 40,000 normal sample images stored for up to 30 days; abnormal 10,000 samples
images maintained for 2 years; numeric data stored ~10 years
Performs delta checks no yes yes
Tags and holds results for follow-up, confirmatory testing, or rerun no yes yes
Parameters for flags for holding samples defined by user or vendor no yes user or vendor
Scattergram display: cell-specific color no cell images are displayed instead of scattergrams yes
Histogram display: color with thresholds yes yes (view specific cell’s location within the PLT or RBC yes
histogram)
User interface can display choice of specimen or result information no yes yes
LIS interface formats supported HL7 ASTM proprietary (Spec 79)
Information transferred on LIS interface numeric and flag results, instrument to LIS; patient results, flags/messages, QC numeric and flag results, histograms and scatterplots,
demographics, orders, LIS to instrument—broadcast instrument to LIS; patient demographics, orders, LIS to instru-
ment—broadcast; host query for demographics and orders
LOINC codes transmitted with all results/Sent in message to LIS/ yes/yes/no — no/no/yes
Interface available or planned to automated specimen-handling system — — LabCell (Siemens)
Barcode symbologies read on specimen tube Codabar, codes 39 and 128 codes 39 and 128, Interleaved 2 of 5 Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5
Accommodates barcode placement per CLSI standard AUTO02-A2 no yes yes
Time required for daily, weekly, monthly maintenance daily: <10 minutes daily: <5 minutes daily: automated; weekly: 15 minutes; monthly: 15 minutes
Manufacturer can perform diagnostics via modem no yes yes
Distinguishing features (supplied by company) 10.4-inch all-in-one Glance color touchscreen, touch- all CBC parameters are determined using multispectral laser technology provides cellular Hb for RBCs and
button maintenance procedures, and low sample digital image analysis directly from a prepared, stained reticulocytes; 2D PLT analysis eliminates interference
requirement; 40,000 patient results storage, close-tube slide; WBC differential performed using digital cell image from RBC fragments and inclusion of large PLTs; dual
sampling, open-tube sampling for pediatric samples, analysis on every sample; combines 3 separate processes WBC counts with a linearity of up to 400,000; CSF assay
3 types of sample adaptors, barcoded reagent, and 5 (CBC/differential, slide making/staining, slide review) into 1
minutes daily start-up and maintenance; 12 QC files, truly integrated system
Note: a dash in lieu of an answer means company did not answer uploadable QC files, auto-sleep setting, only 1 maintenance
question or question is not applicable reagent, and sample stability between 8 and 24 hours
Part 8 of 13 Siemens Healthineers Siemens Healthineers Siemens Healthineers

David Metrena david.metrena@siemens.com David Metrena david.metrena@siemens.com David Metrena david.metrena@siemens.com
Hoffman Estates, IL Hoffman Estates, IL Hoffman Estates, IL
See captodayonline.com/productguides for an interactive version of guide 800-948-3234 www.usa.siemens.com/diagnostics 800-948-3234 www.usa.siemens.com/diagnostics 800-948-3234 www.usa.siemens.com/diagnostics
Name of instrument Advia 2120 Hematology System Advia 2120i Advia 360 Hematology System
First year installed in U.S./Outside U.S./No. of units sold in 2017 2004/2004/— 2008/2008/130 2015/2015/—
No. units installed in U.S./Outside U.S./List price >200/>3,700/$225,000 >200/>3,700/$225,000 —/—/$24,000
Test menu: • C hartable (standard menu: WBC, RBC, Hb, Hct, MCV, standard menu (left) plus: CHCM, MPV, RDW, HDW, LUC standard menu (left) plus: CHCM, MPV, RDW, HDW, LUC WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, lymph, MID,
MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso) %&#, retic %&#, CHr, CHCMr, cellular Hgb, MCVr; CSF: %&#, retic %&#, CHr, CHCMr, cellular Hgb, MCVr; CSF: GRA, MID%, GRA%, MPV, RDW-CV
WBC, RBC, PMN, MN, neut, lymph, mono WBC, RBC, PMN, MN, neut, lymph, mono
• Laboratory % hypo, hyper, macro, micro; MPXI; % blast, PMN, MN, large % hypo, hyper, macro, micro, MPXI; % blast, PMN, MN, —
PLT count, RBC fragment count; RBC ghost count; NRBC; large PLT count, RBC fragment count, RBC ghost count,
CSF: WBC, RBC, 3-part differential; body fluids: TNC, RBC NRBC; CSF: WBC, RBC, 3-part differential; body fluids:
TNC, RBC
• Flags left shift, atyp. lymph, blasts, immature grans, left shift, atypical lymphocytes, blasts, immature grans, out-of-range flags, measurement condition flags
myeloperoxidase deficiency, aniso, micro, macro, Hb myeloperoxidase deficiency, aniso, micro, macro, Hgb (warnings); flagging on WBC and HGB channels; flagging
variation, hypo, hyper, NRBC, RBC fragments, RBC ghost, variation, hypo, hyper, NRBC, RBC fragments, RBC ghost, on RBC/PLT channel; warning flags of differential
large PLTs, PLT clumps large PLTs, PLT clumps parameters
Tests in development MPC, MPM MPC, MPM —
Tests for research use only IRF, CSF eos IRF, CSF eos —
Tests unique to analyzer CHCM, HDW, CHr, CHCMr, cellular Hgb, MPC, MPM; CHCM, HDW, CHr, CHCMr, cellular Hgb, MPC, MPM; CSF: —
CSF: WBC, RBC, PMN, MN, neut, lymph, mono WBC, RBC, PMN, MN, neut, lymph, mono
Differential method(s) used peroxidase WBC: peroxidase cytochem. staining with peroxidase WBC: peroxidase cytochem. staining with volumetric impedance change for WBC, RBC, PLT; lytic
light scatter and absorption; baso: cytochem. stripping light scatter and absorption; baso: cytochem. stripping reagents with impedance method for 3 subpopulations;
with 2-angle laser light scatter with 2-angle laser light scatter spectrophotometry for HGB
Analytical measurement range: • WBC count/RBC count whole blood: WBC 0.02–400/RBC 0–7.0; whole blood: WBC 0.02–400/RBC 0–7.0; 0.0–85.0/0.00–8.00
CSF: WBC 0–5,000/RBC 0–1,500 CSF: WBC 0–5,000/RBC 0–1,500
• Hemoglobin/Platelet 0–22.5/5–3,500 0–22.5/5–3,500 1.0–25.0/0–1,000
• MCV (fL) or Hct (%) 30–180 (MCV) 30–180 (MCV) 50–120 (MCV)
• Reticulocytes 0.2–24.5% 0.2–24.5% —
Precision: • WBC count/RBC count 2.7%/1.2% 2.7%/1.2% <4.0%/<2.5%
• Hemoglobin/Platelet 0.93%/2.93% 0.93%/2.93% <2.4%/<7.0%
• MCV or Hct 0.78% (MCV) 0.78% (MCV) <2.0% (MCV)
Accuracy of automated differential compared with manual neut% r=0.997, y=1.02x–0.6; lymph% r=0.997, neut% r=0.997, y=1.02x-0.6; lymph% r=0.997, —
differential (per CLSI H20-A2) y=1.00x+0.8; mono% r=0.943, y=0.85x–0.3; eos% y=1.00x+0.8; mono% r=0.943, y=0.85x–0.3; eos%
r=0.979, y=0.87x+0.2; baso% r=0.772, y=0.67x+0.0; r=0.979, y=0.87x+0.2; baso% r=0.772, y=0.67x+0.0;
luc% r=0.994, y=0.92x+0.6 luc% r=0.994, y=0.92+0.6
Interfering substances: • WBC incomplete RBC lysis (peroxidase only) incomplete RBC lysis (peroxidase only) >5 NRBCs/100 WBCs, PLT clumps/large PLTs
• RBC cold agglutinins, extreme sickle cell cold agglutinins, extreme sickle cell WBC count >50.0 × 103/μL
• MCV or Hct — — WBC count >50.0 × 103/μL
• Platelet — — PLT clumps/large PLTs (abnormal histogram)
• Hemoglobin extreme lipemia, high WBC, extremely high bilirubin extreme lipemia, high WBC, extremely high bilirubin WBC count >50.0 × 103/μL, lipids >270 mg/dL
interference with colorimetric Hb only, none with interference with colorimetric Hgb only, none with
cellular Hb cellular Hgb
Interfering substances: differential incomplete RBC lysis, complete myeloperoxidase incomplete RBC lysis, complete myeloperoxidase > 5 NRBCs/100 WBCs, PLT clumps/large PLTs
deficiency deficiency (abnormal histogram)
Minimum specimen volume open/Closed/Sample dead volume closed 175 µL/175 µL/<300 (tube size dependent) 175 µL/175 µL/<300 (tube size dependent) 100 µL/100 µL/—
Microsample capability yes yes —
Prepares microscope slides automatically or flags problems for slide prep if integrated to Advia Autoslide yes no
Number of automatic slidemakers available/List price Advia Autoslide/$98,000 Advia Autoslide/$98,000 —
Archives patient data/Previous patient results incl. with recent results yes/no yes/no yes/no
Maximum archived data accessible when system online 10,000 10,000 samples 10,000
No. specimens for which numeric results saved in memory at once 10,000 10,000 samples 10,000
No. specimens for which histo/cytogram results saved in memory at once 10,000 10,000 samples 10,000

Parameters for flags for holding samples defined by user or vendor user or vendor yes yes
LIS interface formats supported proprietary proprietary (instrument or vendor specific) proprietary, HL7
instrument to LIS; patient demographics, orders, LIS instrument to LIS; patient demographics, orders, LIS instrument to LIS; patient demographics, orders, LIS
to instrument—broadcast; host query for patient to instrument—broadcast; host query for patient to instrument—broadcast; host query for patient
demographics and orders demographics and orders demographics and orders
LOINC codes transmitted with all results/Sent in message to LIS/ no/no/yes no/no/yes yes/yes/yes
Interface available or planned to automated specimen-handling system LabCell (Siemens) LabCell (Siemens) none
Barcode symbologies read on specimen tube Codabar, codes 39 and 128, Interleaved 2 of 5 Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5 Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5
Accommodates barcode placement per CLSI standard AUTO02-A2 — yes —
Time required for daily, weekly, monthly maintenance daily: automated; weekly: 15 minutes; daily: automated; weekly: 15 minutes; daily: 5 minutes; weekly: 20 minutes
Onboard diagnostics for troubleshooting/Limited to software problems yes/no yes/no yes/—
Manufacturer can perform diagnostics via modem yes yes no
Distinguishing features (supplied by company) laser technology provides direct cellular Hb for RBCs and laser technology provides direct cellular Hgb for measures 16 parameters including 3-part WBC
reticulocytes; 2D PLT analysis eliminates interference RBCs and reticulocytes; 2D PLT analysis eliminates differential; efficient manual sampling of both open and
from RBC fragments and inclusion of large PLTs; dual interference from RBC fragments and inclusion of large closed tubes; 60 samples per hour, volume as low as
WBC counts with a linearity of up to 400,000; CSF assay PLTs; dual WBC counts with a linearity of up to 400,000; 100 µL
CSF assay

Part 9 of 13 Siemens Healthineers Sysmex America Sysmex America
David Metrena david.metrena@siemens.com Jennifer Starks communications@sysmex.com Kevin Croghan communications@sysmex.com
Hoffman Estates, IL Lincolnshire, IL Lincolnshire, IL
See captodayonline.com/productguides for an interactive version of guide 800-948-3234 www.usa.siemens.com/diagnostics 800-379-7639 www.sysmex.com/us 800-379-7639 www.sysmex.com/us
Name of instrument Advia 560/560AL Hematology GloCyte Automated Cell Counter for CSF* pocH-100i
First year installed in U.S./Outside U.S./No. of units sold in 2017 2015/2015/— 2016/—/26 2004/2003/>160
No. units installed in U.S./Outside U.S./List price —/—/$56,800 24/—/$9,985 >1,200/>5,000/$19,094
Test menu: • C hartable (standard menu: WBC, RBC, Hb, Hct, MCV, WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, neut %&#, RBC, TNC WBC, RBCs, Hb, Hct, MCV, MCH, MCHC, PLT, neut %&#,
MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso) mono, lymph, eos, baso, LYM%, MON%, EOS%, BAS%, lymph, MXD (mono, eos, baso), RDW-SD, RDW-CV, MPV
RDW-CV, MPV
• Flags pathological (diagnostic) flags; lab limits (normal — WBC, RBC, PLT (histogram)
ranges); reagents alert (3 measurement pre-alert online
reagent replacement); instrumental alerts, internal buffer
for reagents
Tests unique to analyzer — — absolute neutrophil count
Differential method(s) used volumetric impedance change for WBC, RBC, PLT; light — direct current
scattering baso measurement; light scattering 4-diff
measurement LYM, MON, NEU, EOS; spectrophotometry
for HGB
Analytical measurement range: • WBC count/RBC count 0.20–100.0/0.36–7.19 TNC: 3–123 cells/µL reportable range 3–6,500 cells/µL/ 1.0–99.9/0.3–7.0
2–123 cells/µL reportable range 2–615,644 cells/µL
• Hemoglobin/Platelet 1.10–22.2/15.0–1,000 — 0.1–25.0/10–999
• MCV (fL) or Hct (%) 50–120 (MCV) — 10–60 (Hct)
Precision: • WBC count/RBC count <3.4%/<2.0% TNC: 2.5–18.0% repeatability CV/2.7–16.3% ≤3.5%/≤2.0%
repeatability CV
• Hemoglobin/Platelet <2.4%/<7.0% — ≤1.5%/≤6.0%
• MCV or Hct <2.0% (MCV) — ≤2.0% (Hct)
Accuracy of automated differential compared with manual — — neut% r=0.98, lymph% r=0.99, MXD% r=0.75,
differential (per CLSI H20-A2) neut# r=1.00, lymph# r=1.00, MXD# r=0.90
Interfering substances: • WBC >5 NRBCs/100 WBCs, PLT clumps/large PLTs TNC: nucleated RBCs lyse-resistant RBCs, cold agglutinins, cryoglobulins, PLT
aggregation, NRBCs
• RBC WBC count >75.0 × 103/μL — cold agglutinins, severe microcytosis, fragmented RBCs
• MCV or Hct WBC count >75.0 × 103/μL — cold agglutinins, fragmented RBCs, leukocytosis
(>100,000/μL)
• Platelet PLT clumps/large PLTs — PLT aggregation, giant PLTs, microcytic RBCs,
fragmented RBCs
• Hemoglobin WBC count >75.0 × 103/μL, lipids >280 mg/dL — severe lipemia, abnormal protein, leukocytosis
(>100,000/μL)
Interfering substances: differential > 5 NRBCs/100 WBCs, PLT clumps/large PLTs — —
Maximum CBCs per hour/Maximum CBCs and differentials per hour 60/60 CSFs: ~12/— 30/30
Minimum specimen volume open/Closed/Sample dead volume closed 100 µL/100 µL/— 60 µL/—/— 15 µL/15 µL/15 µL
Microsample capability — no yes
Archives patient data/Previous patient results incl. with recent results yes/no no/no yes/yes
Maximum archived data accessible when system online 100,000 — 100 samples
No. specimens for which numeric results saved in memory at once 100,000 1,600 per database 100 samples
No. specimens for which histo/cytogram results saved in memory at once 100,000 — 100 samples
Performs delta checks yes no yes
Tags and holds results for follow-up, confirmatory testing, or rerun yes no no
Parameters for flags for holding samples defined by user or vendor yes no yes
Scattergram display: cell-specific color yes no no
Histogram display: color with thresholds yes no yes
LIS interface formats supported proprietary, HL7 RS232, bidirectional RS-232C
Information transferred on LIS interface numeric and flag results, histograms and scatterplots, numeric and flag results, instrument to LIS; patient, numeric and flag results, histograms and scatterplots,
instrument to LIS; patient demographics, orders, LIS orders, LIS to instrument—broadcast patient demographics, orders, host query for patient
to instrument—broadcast; host query for patient demographics and orders
LOINC codes transmitted with all results/Sent in message to LIS/ yes/yes/yes yes/—/— no/no/yes
Interface available or planned to automated specimen-handling system none none —
Barcode symbologies read on specimen tube Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5 Codabar, codes 39 and 128, Interleaved 2 of 5, Data codes 39 and 128, ASTM, ITF, NW7, JAN-8 and 13
Matrix
Accommodates barcode placement per CLSI standard AUTO02-A2 — yes yes
No. of cleaning or maintenance reagents/No. of routine liquid reagents 1/4 0/2 (RBC and TNC reagents) 1/2
Time required for daily, weekly, monthly maintenance daily: 5 minutes; weekly: 20 minutes change O-ring on vacuum every six months daily: <2 minutes; weekly: <2 minutes; monthly:
<2 minutes
Onboard diagnostics for troubleshooting/Limited to software problems — yes/yes yes/no
Manufacturer can perform diagnostics via modem no no yes
Distinguishing features (supplied by company) 60 samples per hour, volume as low as 110 µL; 1 cell/µL limit of detection for both RBC and TNC; hydrodynamic focusing, automatic floating
measures 20 parameters and employs laser-based consistent turnaround time for standarization and for lean discriminators, ISBT-compliant, data-masking software
optical measurement to provide a 5-part WBC practices; disposable test cartridges eliminate carryover for for blood donor centers; optional upgrade to pocHi Plus
differential; aids in interpreting disease state information infectious samples or pocHi Linc available (data manager and small LIS);
with 2 scattergrams and 2 histograms per result ability to directly link to EMR
Note: a dash in lieu of an answer means company did not answer *Sysmex America is the exclusive distributor of GloCyte in
question or question is not applicable the United States.
Part 10 of 13 Sysmex America Sysmex America Sysmex America

Ann Ludwig communications@sysmex.com Ann Ludwig communications@sysmex.com Ann Ludwig communications@sysmex.com
Lincolnshire, IL Lincolnshire, IL Lincolnshire, IL
See captodayonline.com/productguides for an interactive version of guide 800-379-7639 www.sysmex.com/us 800-379-7639 www.sysmex.com/us 800-379-7639 www.sysmex.com/us
Name of instrument XN-1000 XN-2000 XN-3100
First year installed in U.S./Outside U.S./No. of units sold in 2017 2012/2011/>390 2012/2011/>180 2017/2017/—
No. units installed in U.S./Outside U.S./List price >700/>450/$202,667 >500/>450/$402,667 <10/<10/$562,667
Test menu: • C hartable (standard menu: WBC, RBC, Hb, Hct, MCV, standard menu (left) plus: NRBC %&#, IG %&#, MPV, standard menu (left) plus: NRBC %&#, IG %&#, MPV, standard menu (left) plus: NRBC %&#, IG %&#, MPV,
MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso) PLT-F, IPF, RDW-CV, RDW-SD, retic %&#, IRF, RET-He; PLT-F, IPF, RDW-CV, RDW-SD, retic %&#, IRF, RET-He; PLT-F, IPF, RDW-CV, RDW-SD, retic %&#, IRF, RET-He;
body fluids: RBC-BF, TC-BF, WBC-BF, MN %&#, PMN %&# body fluids: RBC-BF, TC-BF, WBC-BF, MN %&#, PMN %&# body fluids: RBC-BF, TC-BF, WBC-BF, MN %&#, PMN %&#
• Flags blasts/abnormal lymphocytes, left shift, atypical blasts/abnormal lymphocytes, left shift, atypical blasts/abnormal lymphocytes, left shift, atypical
lymphocytes, RBC agglutination, turbidity/HGB interference, lymphocytes, RBC agglutination, turbidity/HGB interference, lymphocytes, RBC agglutination, turbidity/HGB interference,
iron deficiency, HGB defect, fragments, PLT clumps iron deficiency, HGB defect, fragments, PLT clumps iron deficiency, HGB defect, fragments, PLT clumps
Tests unique to analyzer IG %&#, PLT-F, IPF, RET-He; body fluids: two-part IG %&#, PLT-F, IPF, RET-He; body fluids: two-part IG %&#, PLT-F, IPF, RET-He; body fluids: two-part
differential MN %&#, PMN %&# differential MN %&#, PMN %&# differential MN %&#, PMN %&#
Differential method(s) used fluorescent flow cytometry with side fluorescent light, fluorescent flow cytometry with side fluorescent light, fluorescent flow cytometry with side fluorescent light,
forward-scattered and side-scattered light forward-scattered and side-scattered light forward-scattered and side-scattered light
Analytical measurement range: • WBC count/RBC count 0.00–440.00/0.00–8.60 0.00–440.00/0.00–8.60 0.00–440.00/0.00–8.60
• Hemoglobin/Platelet 0.0–26.0/0–5,000 0.0–26.0/0–5,000 0.0–26.0/0–5,000
• MCV (fL) or Hct (%) 0.0–75.0% (Hct) 0.0–75.0% (Hct) 0.0–75.0% (Hct)
• Reticulocytes 0.00–30.00 0.00–30.00 0.00–30.00
Precision: • WBC count/RBC count <3.0%/<1.5% <3.0%/<1.5% <3.0%/<1.5%
• Hemoglobin/Platelet <1.0%/<4.0% <1.0%/<4.0% <1.0%/<4.0%
• MCV or Hct <1.5% (Hct) <1.5% (Hct) <1.5% (Hct)
Interfering substances: • WBC no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin
C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis, C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis, C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis,
30.320 OD for intralipid, 2,880 OD for chyle 30.320 OD for intralipid, 2,880 OD for chyle 30.320 OD for intralipid, 2,880 OD for chyle
• RBC no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin
• MCV or Hct no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin
• Platelet no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin
• Hemoglobin no significant interference up to: 39.4 mg/dL for bilirubin C, no significant interference up to: 39.4 mg/dL for bilirubin C, no significant interference up to: 39.4 mg/dL for bilirubin
37.4 mg/dL for bilirubin F, 199 mg/dL for hemolysis 37.4 mg/dL for bilirubin F, 199 mg/dL for hemolysis C, 37.4 mg/dL for bilirubin F, 199 mg/dL for hemolysis
Interfering substances: differential — — —
Maximum CBCs per hour/Maximum CBCs and differentials per hour 100/100 200/200 varies by configuration/varies by configuration
Minimum specimen volume open/Closed/Sample dead volume closed 88 µL/88 µL/1 mL 88 µL/88 µL/1 mL 88 µL/88 µL/1 mL
Number of automatic slidemakers available/List price — — 1/included
Archives patient data/Previous patient results incl. with recent results yes/yes yes/yes yes/yes
No. specimens for which numeric results saved in memory at once 100,000 100,000 100,000
No. specimens for which histo/cytogram results saved in memory at once 100,000 100,000 100,000
LIS interface formats supported XN series ASTM1381-95/ASTM1894-97 or XN series XN series ASTM1381-95/ASTM1894-97 or XN series XN series ASTM1381-95/ASTM1894-97 or XN series
ASTM1381-02/ASTM1894-97 ASTM1381-02/ASTM1894-97 ASTM1381-02/ASTM1894-97
instrument to LIS; patient demographics, orders, LIS to instrument to LIS; patient demographics, orders, LIS to instrument to LIS; patient demographics, orders, LIS to
instrument—broadcast; host query for demographics instrument—broadcast; host query for demographics instrument—broadcast; host query for demographics
and orders and orders and orders
LOINC codes transmitted with all results/Sent in message to LIS/ no/no/yes no/no/yes no/no/yes
Interface available or planned to automated specimen-handling system none none none
Barcode symbologies read on specimen tube Codabar, codes 39 and 128, ITF, NW7, ISBT 128, JAN/ Codabar, codes 39 and 128, ITF, NW7, ISBT 128, JAN/ Codabar, codes 39 and 128, ITF, NW7, ISBT 128, JAN/
EAN/UPC EAN/UPC EAN/UPC
No. of cleaning or maintenance reagents/No. of routine liquid reagents 1/5 cubitainer reagents, 4 fluorescent dye cartridges 1/5 cubitainer reagents, 4 fluorescent dye cartridges 1/5 cubitainer reagents, 4 fluorescent dye cartridges
Time required for daily, weekly, monthly maintenance daily: <1 minute (operator time) daily: <1 minute (operator time) <3 minutes (operator time), ~15 minutes (analyzer time)

Distinguishing features (supplied by company) reportable parameters include IG %&#, RET-He, fully integrated co-primary hematology solution co-primary hematology solution: 2 analytical modules
fluorescent PLT, body fluid with 2-part differential; onboard consisting of 2 analytical modules connected with plus a fully integrated 5th generation slidemaker/stainer
preloaded decision rules including automated rerun- a single sampler, providing maximum productivity (SP-50); integration of the DI-60 automated cell image
reflex capabilities; optional wagons for complete reagent and efficiency with workload balancing; reportable system providing preclassification for WBC, RBC, and PLT
management; compatible with MySysmex, an easy-to- parameters include IG %&#, RET-He, fluorescent PLT, estimates; compatible with optional RU-20 reagent unit
use mobile assistant that displays real-time analyzer body fluid with 2-part differential, onboard preloaded that allows for use of concentrated Cellpack; optional
performance data, enabling informed decision-making; decision rules including automated rerun-reflex configuration (XN-20) possesses the white cell precursor
compatible with optional RU-20 reagent unit capabilities; optional wagons for complete reagent channel (WPC). It uses this channel to differentiate
that allows for use of concentrated Cellpack management; compatible with MySysmex, an easy-to- a single flag—blast/abnormal lymphocytes—into 2
use mobile assistant that displays real-time analyzer distinct flags: blasts and abnormal lymphocytes
performance data, enabling informed decision-making;
Note: a dash in lieu of an answer means company did not answer compatible with optional RU-20 reagent unit that allows
question or question is not applicable for use of concentrated Cellpack
Ann Ludwig communications@sysmex.com Kanochia Johnson communications@sysmex.com Ann Ludwig communications@sysmex.com
Name of instrument XN-9100 XN-1000V* XN-1000 R
First year installed in U.S./Outside U.S./No. of units sold in 2017 2017/2017/— 2017/2017/— 2014/2015/>105
No. units installed in U.S./Outside U.S./List price <10/<10/varies based on configuration —/—/$227,667 >200/>250/$147,795
Test menu: • C hartable (standard menu: WBC, RBC, Hb, Hct, MCV, standard menu (left) plus: NRBC %&#, IG %&#, MPV, WBC, RBC, Hb, Hct, MCV, MCH, PLT, %&# neut, mono, standard menu (left) plus: NRBC %&#, IG %&#, MPV,
MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso) PLT-F, IPF, RDW-CV, RDW-SD, retic %&#, IRF, RET-He; lymph, eos, baso, NRBC %&#, MPV, PLT-F, PLT-O, IPF, RDW-CV, RDW-SD, retic %&#, IRF, RET-He
body fluids: RBC-BF, TC-BF, WBC-BF, MN %&#, PMN %&# RDW-CV, RDW-SD, retic %&#, IRF, RET-He; body fluids:
RBC-BF, TC-BF, WBC-BF, MN %&#, PMN %&#
• Flags blasts/abnormal lymphocytes, left shift, atypical blasts/abnormal lymphocytes, left shift, atypical blasts/abnormal lymphocytes, left shift, atypical
lymphocytes, RBC agglutination, turbidity/HGB interference, lymphocytes, RBC agglutination, turbidity/HGB interference, lymphocytes, RBC agglutination, turbidity/HGB interference,
iron deficiency, HGB defect, fragments, PLT clumps iron deficiency, HGB defect, fragments, PLT clumps iron deficiency, HGB defect, fragments, PLT clumps
Tests for research use only — not FDA cleared for human use; for research use only —
Tests unique to analyzer IG %&#, PLT-F, IPF, RET-He; body fluids: 2-part PLT-F, PLT-O, IPF, RET-He; body fluids: 2-part differential IG %&#, RET-He
differential MN %&#, PMN %&# MN %&#, PMN %&#
Differential method(s) used fluorescent flow cytometry with side fluorescent light, fluorescent flow cytometry with side fluorescent light, fluorescent flow cytometry with side fluorescent light,
forward-scattered and side-scattered light forward-scattered and side-scattered light forward-scattered light, and side-scattered light
Analytical measurement range: • WBC count/RBC count 0.00–440.00/0.00–8.60 0.00–440.00/0.00–8.60 0–440/0–8.6
• Hemoglobin/Platelet 0.0–26.0/0–5,000 0.0–26.0/0–5,000 0–26/0–5,000
• MCV (fL) or Hct (%) 0.0–75.0% (Hct) 0.0–75.0% (Hct) 0–75 (Hct)
• Reticulocytes 0.00–30.00 — 0.00–30.00
Precision: • WBC count/RBC count <3.0%/<1.5% <3.0%/<1.5% ≤3%/≤1.5%
• Hemoglobin/Platelet <1.0%/<4.0% <1.0%/<4.0% ≤1.0%/≤4.0%
• MCV or Hct <1.5% (Hct) <1.5% (Hct) ≤1.5% (Hct)
Interfering substances: • WBC no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin
• RBC no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin
• MCV or Hct no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin
• Platelet no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin
• Hemoglobin no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin
C, 37.4 mg/dL for bilirubin F, 199 mg/dL for hemolysis C, 37.4 mg/dL for bilirubin F, 199 mg/dL for hemolysis C, 37.4 mg/dL for bilirubin F, 199 mg/dL for hemolysis
Maximum CBCs per hour/Maximum CBCs and differentials per hour >100, varies by configuration/>100, varies by configuration 100/100 100/100
Minimum specimen volume open/Closed/Sample dead volume closed 88 µL/88 µL/1 mL 88 μL/88 μL/1 mL 88 µL/88 µL/1 mL
Number of automatic slidemakers available/List price configurable/included — >1,000/—
Archives patient data/Previous patient results incl. with recent results yes/yes yes/yes yes/yes
Maximum archived data accessible when system online 100,000 30,000 100,000 samples
No. specimens for which numeric results saved in memory at once 100,000 30,000 100,000 samples
No. specimens for which histo/cytogram results saved in memory at once 100,000 30,000 100,000 samples
Parameters for flags for holding samples defined by user or vendor yes yes user or vendor
LIS interface formats supported XN series ASTM1381-95/ASTM1894-97 or XN series proprietary, XN series ASTM1381-95/ASTM1894-97 or XN series ASTM1381-95/ASTM1894-97 or XN series
ASTM1381-02/ASTM1894-97 XN series ASTM1381-02/ASTM1894-97 ASTM1381-02/ASTM1894-97
instrument to LIS; patient demographics, orders, LIS to instrument to LIS; patient demographics, orders, LIS to instrument to LIS; patient demographics, orders, LIS to
instrument—broadcast; host query for demographics instrument—broadcast; host query for demographics instrument—broadcast; host query for demographics
and orders and orders and orders
LOINC codes transmitted with all results/Sent in message to LIS/ no/no/yes yes/yes/no no/no/yes
Interface available or planned to automated specimen-handling system Abbott, Ortho Clinical, Roche, Siemens none none
Barcode symbologies read on specimen tube Codabar, codes 39 and 128, ITF, NW7, ISBT 128, JAN/ Codabar, codes 39 and 128, ITF, NW7, ISBT 128, JAN/ Codabar, codes 39 and 128, ITF, NW7, ISBT 128, JAN/
EAN/UPC EAN/UPC EAN/UPC
No. of cleaning or maintenance reagents/No. of routine liquid reagents 1/5 cubitainer reagents, 4 fluorescent dye cartridges — 1/5 cubitainer reagents, 4 fluorescent dye cartridges
Time required for daily, weekly, monthly maintenance <3 minutes (operator time), ~15 minutes (analyzer time) daily: <1 minute (operator time) —
Onboard diagnostics for troubleshooting/Limited to software problems yes/no yes/no yes/—
Distinguishing features (supplied by company) scalable, modular system that can be configured as customizable, manual gating, low maintenance, remote optional testing licenses/capabilities: body fluid license
an island of automation or connected to TLA systems; diagnostics, online QC, fluorescent optical platelets; that includes reportable WBC, RBC, total nucleated
integration of the DI-60 automated cell image system discrete testing, reagent monitoring, customized count, and 2-part differential, fluorescent PLT-F with
providing preclassification for WBC, RBC, and PLT chartable report formats; for use in toxicology, research, reportable immature platelet fraction (IPF); optional
estimates; tube sorter/archiver (TS-10) and A1c testing and veterinary reference labs accessory wagon for complete reagent management;
(Bio-Rad Variant II Turbo Link) provide complete testing onboard, preloaded decision rules to help manage rerun/
efficiencies; optional configuration (XN-20) possesses reflex testing; compatible with MySysmex, an easy-to-
the white cell precursor channel (WPC). It uses this use mobile assistant that displays real-time analyzer
channel to differentiate a single flag—blast/abnormal performance data, enabling informed decision-making;
Note: a dash in lieu of an answer means company did not answer lymphocytes—into 2 distinct flags: blasts and abnormal compatible with optional RU-20 reagent unit that allows
*XN-1000V is not FDA cleared for human use; for research
question or question is not applicable lymphocytes use only. for use of concentrated Cellpack

Kevin Croghan communications@sysmex.com Carl Trippiedi communications@sysmex.com Carl Trippiedi communications@sysmex.com
Name of instrument XP-300 XN-350, XN-450, XN-550 (XN-L Series) XN-330, XN-430 (XN-L Series)
First year installed in U.S./Outside U.S./No. of units sold in 2017 2013/2012/>250 2017/2015/— 2017/—/—
No. units installed in U.S./Outside U.S./List price >700/>2,000/$28,408 —/—/$75,000–$110,000 —/—/$71,000–$84,000
Test menu: • C hartable (standard menu: WBC, RBC, Hb, Hct, MCV, WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, neut %&#, standard menu (left) plus: IG %&#, MPV, RDW-CV, standard menu (left) plus: IG %&#, MPV, RDW-CV,
MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso) lymph, MXD %&# (mono, eos, baso) RDW-SD RDW-SD
• Flags WBC, RBC, PLT (histogram) blasts/abnormal lymphocytes, left shift, atypical blasts/abnormal lymphocytes, left shift, atypical
lymphocytes, RBC agglutination, turbidity/HGB lymphocytes, RBC agglutination, turbidity/HGB
interference, iron deficiency, HGB defect, fragments, interference, iron deficiency, HGB defect, fragments,
PLT clumps PLT clumps
Tests unique to analyzer absolute neutrophil count immature granulocyte on every sample, optional immature granulocyte on every sample; models available
reticulocyte and body fluid licenses available through authorized distributors for POL and clinic market
Differential method(s) used direct current fluorescent flow cytometry with side fluorescent light, fluorescent flow cytometry with side fluorescent light,
forward-scattered and side-scattered light forward-scattered and side-scattered light
Analytical measurement range: • WBC count/RBC count 1.0–99.9/0.3–7.0 0.00–440.00/0.00–8.60 0.00–440.00/0.00–8.60
• Hemoglobin/Platelet 0.1–25.0/10–999 0.0–26.0/0–5,000 0.0–26.0/0–5,000
• MCV (fL) or Hct (%) 10–60 (Hct) 0.0–75.0% (Hct) 0.0–75.0% (Hct)
Precision: • WBC count/RBC count <3.5%/<2.0% <3.0%/<1.5% <3.0%/<1.5%
• Hemoglobin/Platelet <1.5%/<6.0% <1.0%/<4.0% <1.0%/<4.0%
• MCV or Hct <2.0% (Hct) <1.5% (Hct) <1.5% (Hct)
Accuracy of automated differential compared with manual neut% r=0.98, lymph% r=0.99, MXD% r=0.75, neut# — —
differential (per CLSI H20-A2) r=1.00, lymph# r=1.00, MXD# r=0.90
Interfering substances: • WBC cold agglutinins, PLT clumps, cryoprotein, cryoglobulin, no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin
fibrin, giant PLTs (>1 M/µL) C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis, C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis,
30.320 OD for intralipid, 2,880 OD for chyle 30.320 OD for intralipid, 2,880 OD for chyle
• RBC cold agglutinins, severe microcytosis, fragmented RBCs, no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin
leukocytosis (>100,000/µL), giant PLTs (>1 M/µL) C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis, C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis,
30.320 OD for intralipid, 2,880 OD for chyle 30.320 OD for intralipid, 2,880 OD for chyle
• MCV or Hct cold agglutinins, severe microcytosis, fragmented RBCs, no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin
leukocytosis (>100,000/µL), severe diabetes, uremia, C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis, C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis,
spherocytosis 30.320 OD for intralipid, 2,880 OD for chyle 30.320 OD for intralipid, 2,880 OD for chyle
• Platelet PLT clumps, pseudothrombocytopenia, giant PLTs, severe no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin
microcytosis, fragmented RBCs, fragmented leukocytes, C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis, C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis,
cryoprotein, cryoglobulin 30.320 OD for intralipid, 2,880 OD for chyle 30.320 OD for intralipid, 2,880 OD for chyle
• Hemoglobin severe lipemia, abnormal protein, leukocytosis no significant interference up to: 39.4 mg/dL for bilirubin no significant interference up to: 39.4 mg/dL for bilirubin
(>100,000/µL) C, 37.4 mg/dL for bilirubin F, 199 mg/dL for hemolysis C, 37.4 mg/dL for bilirubin F, 199 mg/dL for hemolysis

Minimum specimen volume open/Closed/Sample dead volume closed 50 µL/—/— 25 µL/25 µL/1.0 mL 25 µL/25 µL/1.0 mL
Archives patient data/Previous patient results incl. with recent results yes/no yes/yes yes/yes
No. specimens for which numeric results saved in memory at once 40,000 100,000 10,000
No. specimens for which histo/cytogram results saved in memory at once 40,000 100,000 10,000
Performs delta checks no yes yes
LIS interface formats supported RS-232C XN series ASTM1381-95/ASTM1894-97 or XN series XN series ASTM1381-95/ASTM1894-97 or XN series
ASTM1381-02/ASTM1894-97 ASTM1381-02/ASTM1894-97
Information transferred on LIS interface numeric and flag results; patient orders, LIS to numeric and flag results, histograms and scatterplots, numeric and flag results, histograms and scatterplots,
instrument—broadcast; host query for patient instrument to LIS; patient demographics, orders, LIS to instrument to LIS; patient demographics, orders, LIS to
demographics and orders instrument—broadcast; host query for demographics instrument—broadcast; host query for demographics
and orders and orders
LOINC codes transmitted with all results/Sent in message to LIS/ no/no/yes yes/yes/no yes/yes/no
Interface available or planned to automated specimen-handling system — none none
Barcode symbologies read on specimen tube Codabar, codes 39 and 128, ITF, NW-7, UPC-A, UPC-E, Codabar, codes 39 and 128, ITF, NW7, ISBT 128, JAN/ Codabar, codes 39 and 128, ITF, NW7, ISBT 128, JAN/
JAN-8, JAN-13 EAN/UPC EAN/UPC
Time required for daily, weekly, monthly maintenance daily: <2 minutes; weekly: <2 minutes; monthly: <2 daily: 2 minutes; weekly: 15 minutes daily: 2 minutes; weekly: 15 minutes
minutes
Manufacturer can perform diagnostics via modem no yes yes
Distinguishing features (supplied by company) automatic floating discriminators, optional upgrade to 6-part WBC differential including immature granulocyte 6-part WBC differential including immature granulocyte
XP-300 Plus or XP-300 Linc available (data manager in a low volume system; standardization of reagents in a low volume system; standardization of reagents
and small LIS); ability to directly link to EMR and controls with existing Sysmex XN-Series analyzers; and controls with existing Sysmex XN-Series analyzers;
XN-L Series includes BeyondCare Quality Monitor, an XN-L Series includes BeyondCare Quality Monitor, an
innovative QC and calibration management program, innovative QC and calibration management program,
standard on all models standard on all models

Part 13 of 13 Sysmex America
See captodayonline.com/productguides for an interactive version of guide

Kevin Croghan communications@sysmex.com
Lincolnshire, IL CAP TODAY product guides
800-379-7639 www.sysmex.com/us
Name of instrument XW-100 help you weigh your options when
it's time for a new instrument
First year installed in U.S./Outside U.S./No. of units sold in 2017 2018/—/100
No. units installed in U.S./Outside U.S./List price 100/—/—
Test menu: • C hartable (standard menu: WBC, RBC, Hb, Hct, MCV,
MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso)
WBC, RBC, Hb, Hct, MCV, Plt, %&# neut, lymph, HGB,
LYM %, LYM #, other WBC #, other WBC % or software system
• Laboratory —
• Flags WBC, WBC Diff, PLT, RBC, alert low, alert high, low, high
32 CAP TODAY | FEBRUARY 2018
AP-LIS vendors talk reports, interfaces, protocols

Customer demand, cancer protocols, and consolidation increased functionality from these labs that they have interfaces in autostainers. We’ve been doing auto-
of pathology practices are some of what CAP TODAY not had in the past. As an example, we’re getting stainers for a very long time in a wide variety of
asked about when it spoke in January with four anatomic requests for optical character recognition, which will manufacturers on almost every project. As far as
pathology computer system companies. Their AP systems help streamline the accessioning process. NovoPath molecular analyzers, we’re seeing more and more 58 CAP TODAY | OCTOBER 2018 AUTOMATED MOLECULAR PLATFORMS
and those of 17 other companies are profiled on pages can actually import information directly from an brands of those. Gyn and cytology, we’re seeing
34–47. “It’s a really good time for our market right now,” Part 11 of 17 Hologic Hologic Part 12 of 17
EMR-generated requisition. We’re also seeing, since plenty of those, and now more and more molecular
FDA-cleared tests not clinically released —

says Joe Nollar of Xifin, “and systems providers need to Glenn Sawyer glenn.sawyer@hologic.com Glenn Sawyer glenn.sawyer@hologic.com
these labs are consolidating, requests to schedule testing for non-gyn sample types and histology See captodayonline.com/productguides San Diego, CA San Diego, CA See captodayonline.com/productguides
be creative in helping their clients get the solutions they
need to be scalable, competitive, and profitable.” Here is pathologists’ workloads throughout the day. If you sample types. for an interactive version of guide 858-410-8000 www.pantherfusion.com, www.hologic.com 858-410-8000 www.hologic.com for an interactive version of guide
more of what they told writer Anne Ford. have four or five labs consolidating, you might have Callahan (NovoPath): We’re seeing an uptick in Name of instrument Panther Fusion System Panther System Name of instrument
15 or 20 pathologists. Some of them have areas in interface demand to whole-slide scanners, and we Country where designed/Manufactured/Reagents manufactured U.S./Switzerland/U.S. U.S./Switzerland/U.S. Country where designed/Manufactured/Reagents manufactured
Tests not available but submitted for 510(k) clearance —

Instrument FDA cleared or approved/Platform
How are your reports submitted, and how do they appear which the pathologists are more skillful at interpret- are happy to comply. Across the entire spectrum, Instrument FDA cleared or approved/Platform yes/preanalytical and analytical yes/preanalytical and analytical
First year sold in U.S./Sold internationally/Installed
First year sold in U.S./Sold internationally/Installed 2017/2017/2017 2012/2010/2010
in your clients’ electronic medical records? ing results. We now we’re starting to see re- Dimensions in inches (H × W × D)/Footprint in square feet/Noise generated in
E T
Dimensions in inches (H × W × D)/Footprint in square feet/Noise generated in dB 69 × 76 × 32/16.8/<60 69 × 48 × 32/10.6/<55
C
Lisa-Jean Clifford, CEO, Psyche Systems: We have can schedule differ- Anatomic pathology computer systems, pages 34–47 quests for interfacing to
ID U
Supplied with UPS/BTU yes/3,412 yes/1,878 per hr. Supplied with UPS/BTU
U D
G O
Physical contamination control features
three options: direct interfaces, if we have a client ent types of tests to equipment in molecular
R
Physical contamination control features closed system, liquid level sensing, pressure-dispense verification closed system, liquid level sensing, pressure-dispense verification, onboard deactiva-
P
Tests in development —
tion, deep-well reaction tube, single sample aspiration and dispense, penetrable cap List price/Price for sample extraction and amplification detection modules
who’s using just one or two client EMRs; an EMR be sent to different labs, to EMRs, and to in- Purchase options/Minimum test volume requirements
List price/Price for sample extraction and amplification detection modules — —
hub, which allows them to do one to many, and that’s pathologists who are working that particular day. struments such as flow cytometers and stainers. Purchase options/Minimum test volume requirements straight purchase, reagent rental, lease/— straight purchase, reagent rental, lease/variable
Co. performs installation, operation, and performance qualifications/Electrical requ
Labor and parts warranties/Advanced operator training
a very cost-effective measure if they have multiple Joe Nollar, associate vice president of product de- Nollar (Xifin): My recollection is that 20 years ago Co. performs installation, operation, and performance qualifications/Electrical requirements yes/190–240 VAC, 50–60 Hz, 1,800 VA single phase yes/100–240 V ± 10% Delivery time/Delivery charges/Installer/Time to install on site
physician offices with a lot of disparate EMR sys- velopment, Xifin: We’re seeing a lot of lab consolida- in the AP world, it was somewhat rare to do interfac- Labor and parts warranties/Advanced operator training 1 year/yes 1 year/yes Training location/No. of techs that can receive initial training/
Delivery time/Delivery charges/Installer/Time to install on site ~1 week/variable at origin and destination/Hologic/1–2 days ~1 week/variable at origin and destination/Hologic/1–2 days
Tests for research use only —

tems; and then we offer a clearinghouse module as tion. Years ago, we developed a multi-entity architec- ing to autostainers and a lot of the histology equip- Training location/No. of techs that can receive initial training/ off site/2/2–3 days/yes on and off site/2/3 days/yes
Length of training/Retraining at company facility
Test menu
well, which serves them very well if they have sev- ture for our LIS that allows a lab organization to run ment, but of course it’s routine now. If it’s an indi- Length of training/Retraining at company facility
eral clients who are on the same EMR system. multiple performing labs on a single platform. So as vidual autostainer or a histology automation system, Test menu CT-GC, CT, GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV CT-GC, CT, GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV
viral load, M. gen, HSV 1&2, Zika, GBS, MRSA, Flu A/B/RSV, Paraflu, AdV/hMPV/RV viral load, M. gen, HSV 1&2, Zika
Rick Callahan, vice president of sales and market- labs consolidate, they can very quickly configure a it’s very common to interact with those devices. And
No. of tests for which analyzer has FDA-cleared applications/CE mark 13/17 9/12
ing, NovoPath: More and more, we’re seeing requests new lab entity and get those users up and operational then of course in more complex lab testing with
Tests unique to analyzer direct current detection method

Tests available on instrument in U.S./Outside U.S. CT-GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV viral load, CT-GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV viral load No. of tests for which analyzer has FDA-cleared applications/CE mark
to have reports pushed out of the AP-LIS directly into on a standard platform. We’ve seen a lot of clients, FISH, flow, molecular, and next-gen devices and HSV 1&2, Zika, GBS, Flu A/B/RSV, Paraflu, AdV/hMPV/RV/CT-GC, CT, GC, HPV, HSV 1&2, Zika/CT-GC, CT, GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV Tests available on instrument in U.S./Outside U.S.
the EMR, if the EMR can accept a PDF. In our world, especially super-regional labs that are merging with analytics solutions, it’s routine to provide an auto- HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV viral load, M. gen, viral load, HBV viral load, M. gen, HSV 1&2, Zika
HSV 1&2, Zika, MRSA, GBS, Flu A/B/RSV, Paraflu, AdV/hMPV/RV
after the report is finalized and signed off by the pa- other practices, take advantage of this feature. mated interface.
M
Tests not available in U.S. but submitted to FDA/Available in other countries only —/CT, GC, MRSA, Bordetella, M. gen —/CT, GC, M. gen
thologist, there is an application that makes it so that, Clifford (Psyche): We are seeing a lot of consolida- So the demand continues to grow for instrument Research-use-only assays/Tests in development —/BV, CV/TV, M. gen —/BV, CV/TV, M. gen Tests not available in U.S. but submitted to FDA/Available in other countries o
in a designated time frame, the report is sent auto- tion. It tends to be more region-based or test-type interfaces. That’s why I think for LIS providers, le- Open-channel capabilities/Start-up and preparation time yes/<15 min. yes/<15 min.
Model type of sample-handling system/Maximum sample load capacity automated onboard/120, with continuous and random access automated onboard/120 Research-use-only assays/Tests in development
matically over the Web to the clinician. This is a big based. Obviously, we think it’s an artifact of the reim- veraging robust connectivity solutions such as Data
Minimum specimen volume/Sample volume flexibility/Other sample volumes available 400 µL/yes (varies by sample type with open channel capability)/yes 400 µL/no/—
difference from the past when clinicians used to have bursement models and the change in the CMS reim- Innovations or other is important for clients who Minimum dead volume/Pediatric sample volume/Primary tube sampling 250 µL/no/yes 250 µL/—/yes
to log in with a secure password and pull the report bursement rates. But for us as a vendor, what we’re want to scale quickly. Obviously, as an LIS provider, Sample tube sizes/Sample barcode reading/Autodiscrimination in 1D or 2D various/yes (automated onboard scanner to maintain positive sample ID)/— various/yes/no Open-channel capabilities/Start-up and preparation time
Sample barcode languages/Sample types available in open mode Codabar codes 39 and 128, Interleaved 2 of 5, JAN13, code 93, UPC, NW7/— Codabar codes 39 and 128, Interleaved 2 of 5, JAN13, code 93, UPC, NW7/— Model type of sample-handling system/Maximum sample load capacity
down. With NovoPath the report is automatically seeing is that through the consolidation, we’re being we do point-to-point interfaces all the time, but if Clot detection/Open extraction platform/Sample types (open extraction) yes/no/— yes/no/— Minimum specimen volume/Sample volume flexibility/Other sample volumes a
ending up in the clinicians’ computers or on their exposed to more laboratories and having the oppor- you can come out of the gate with a library of inter- Amplification reagents or methods supported transcription-mediated amplification, real-time TMA, real-time PCR, Invader Plus transcription-mediated amplification, real-time TMA
printers in their offices. With some of the EMRs we’ve tunity to have a bigger footprint within a lab if it is faces that can be implemented relatively quickly via No. of different assays onboard at once/Programmed or calibrated at once up to 32/up to 32 4/4 Minimum dead volume/Pediatric sample volume/Primary tube sampling
Sample tube sizes/Sample barcode reading/Autodiscrimination in 1D or 2D
Differential method(s) used adaptive cluster analysis

been working with, the EMR may not be able to ac- consolidating. A lot of times we win in those scenar- middleware, it’s much more cost-effective for the Tests per container set/Multiple reagent configurations supported 12, 100, or 250/yes 100 or 250/yes
Sample barcode languages/Sample types available in open mode
Reagent container placed directly on system/Onboard test auto inventory yes/yes yes/yes
cept a PDF embedded in an HL7 message. In this ios. So we’re not generally losing a customer; we’re client and faster for implementation. Determines reagent volume in container/Reagent barcode reading/Reagents barcoded yes/yes/yes yes/yes/yes Clot detection/Open extraction platform/Sample types (open extraction)
case, NovoPath will embed a link in the HL7 message often gaining a customer or gaining more users. Monitors expiration date/Auto lot recognition or calibration yes/yes yes/yes Amplification reagents or methods supported
No. of different assays onboard at once/Programmed or calibrated at once
going into the EMR, allowing the clinician to access What recommendations do you make to clients for use Auto detection of adequate reagent or specimen/Reagents available yes/liquid and dry yes/liquid
Tests per container set/Multiple reagent configurations supported
Reagent reconstitution required/Chemical contamination control no/yes yes/yes
the pathology report through the EMR and pull the How has customer demand in general been changing? of the CAP cancer protocols and cancer checklists? And Onboard test auto inventory/Capable of inventory monitoring by barcode yes/yes yes/yes
Reagent container placed directly on system/Onboard test auto inventory
PDF directly into their patient’s EMR folder. Nollar (Xifin): The biggest demand right now is how has this area of customer practice been changing? Determines reagent volume in container/Reagent barcode reading/Reagents b
System is open to homebrew/General-purpose reagents allowed yes/yes yes/yes
Monitors expiration date/Auto lot recognition or calibration
Leigh Boje, anatomic pathology product manager, the expansion into molecular testing and next-gen- Nollar (Xifin): I think every client looking for an Same capabilities when third-party reagent used/Lot sequestering available — — Auto detection of adequate reagent or specimen/Reagents available
Closed-vial stability for amplification reagents/Extraction reagents assay dependent/assay dependent assay dependent/assay dependent
Orchard Software: Our ideal preference would be eration sequencing and the need to integrate the as- LIS asks about this. The cancer checklists are a critical Storage temp. requirement for amplification reagents/Extraction reagents refrigeration/refrigeration refrigeration/refrigeration
Reagent reconstitution required/Chemical contamination control
Onboard test auto inventory/Capable of inventory monitoring by barcode
for us to submit to them a PDF or a file format where sociated devices and analytics software. Last year, part of formalizing the diagnosis and making sure Shipment temp. requirement for amplification reagents/Extraction reagents assay dependent/assay dependent room temperature/room temperature System is open to homebrew/General-purpose reagents allowed
the pathologist has final say over the format of the we released a new next-gen module providing more that all the information is adequately captured and Minimum/Maximum reagent shelf-life guarantee —/up to 2 years —/up to 2 years Same capabilities when third-party reagent used/Lot sequestering available
report. However, we do have discrete and nondis- robust wet lab processes for next-gen labs. Part of that transmitted to registry, so we’re huge proponents of Autocalibration or autocalibration alert/Multipoint calibration supported yes/no yes/— Closed-vial stability for amplification reagents/Extraction reagents
Storage temp. requirement for amplification reagents/Extraction reagents
Analytical measurement range: • WBC count/RBC count 1–63.2/0.3–7.0

Assay calibrations required by end user/Calibrants can be stored onboard yes/yes yes/yes
crete reporting options. We also see more of our process is integrating with the latest next-gen devices that. We always encourage folks to go with the for- Multiple calibrant lots stored for same assay/Required calibration frequency no/24 hrs. no/24 hrs. Shipment temp. requirement for amplification reagents/Extraction reagents
clients establishing their own physician portals, and analytics platforms that are either standard off- mal CAP-approved process for generating those Length of assay calibration/Typical calibration frequency can be user-defined (assay dependent)/24 hrs. 24 hrs./24 hrs. Minimum/Maximum reagent shelf-life guarantee
maybe as part of the EMR or maybe as a separate the-shelf solutions—Illumina, Thermo Fisher—or a reports. Of course, we offer the cancer checklist Onboard real-time QC/Supports multiple QC lot numbers per assay —/yes —/yes Autocalibration or autocalibration alert/Multipoint calibration supported
Auto shutdown*/Instrument warm-up time/Onboard software reviews QC yes/<15 min./yes yes/<15 min./yes Assay calibrations required by end user/Calibrants can be stored onboard
Web portal. Those are reference labs, mostly. We also homegrown solution within the lab, which may have through our configurable text macro dropdowns, Total number of controls per batch for 24 tests/48 tests/72 tests/96 tests — (not a batch analyzer) — (not a batch analyzer) Multiple calibrant lots stored for same assay/Required calibration frequency
have the ability to install a piece of software that will a proprietary genetic assay it’s running. but whenever we can, we encourage clients to con-
• Hemoglobin/Platelet 0.1–25/10–999
Walkaway capacity/Tech hands-on time (both for batch of 96 samples) 120 samples/<15 seconds per sample 120 samples/<15 seconds per sample Length of assay calibration/Typical calibration frequency
Onboard real-time QC/Supports multiple QC lot numbers per assay
directly print to a local printer, and our system will Callahan (NovoPath): I think the interfacing tool sider CAP eFRM because the synoptic reports are Uses disposable pipette tips/Maximum number of pipette tips stored yes/1,152 yes/576 (2.2 tips per sample)
Auto shutdown*/Instrument warm-up time/Onboard software reviews QC
Time between start and initial result/Instrument automatic shutdown 2.4 hrs./yes 2.7–3.5 hrs. (assay dependent)/no
send that print instruction over the Internet with all of laboratory equipment is always a need. From our integrated and automatically updated. Startup programmable/Remote system monitoring/Waste required for disposables yes/yes/plastics and cardboard yes/yes/plastics and cardboard Total number of controls per batch for 24 tests/48 tests/72 tests/96 tests
the formatting instructions, so it prints out the way perspective, nothing has changed. Everybody wants Boje (Orchard): We’ve seen a steady increase in Windows technology/Mouse or touchscreen/Modular add-on capability yes/touchscreen/yes yes/touchscreen/yes Walkaway capacity/Tech hands-on time (both for batch of 96 samples)
Uses disposable pipette tips/Maximum number of pipette tips stored
the lab wants it to print. us to act as middleware, and we do. In the past, we use of the cancer protocols. Breast cancer has seen
H gh Qua y
Service contracts available/Mean time between failures/To repair failures on-demand, pm only, standard, standard plus, premium, premium plus/—/— on-demand, pm only, standard, standard plus, premium, premium plus/—/—
• MCV (fL) or Hct (%) 10–60% (Hct)

Time between start and initial result/Instrument automatic shutdown
used to see pushback based on pricing, but nowadays the number one adoption rate, but we’re seeing an Turnaround time for problem solving by phone/Email/Field service — —
Startup programmable/Remote system monitoring/Waste required for disposa
No. of U.S. field reps/Service engineer on-site response time/Hours and days available —/standard and standard plus: within 24 hrs., premium and premium plus: —/standard and standard plus: within 24 hrs., premium and premium plus:
Are you seeing consolidation of pathology practices? If it seems like laboratories are more accepting of the uptick in other body sites as well, particularly Windows technology/Mouse or touchscreen/Modular add-on capability
within 18 hrs./on-demand, pm only, and standard: M–F, 5 am–5 pm, PT; within 18 hrs./on-demand, pm only, and standard: M–F, 5 am–5 pm, PT;
Service contracts available/Mean time between failures/To repair failures
so, what are the implications for you as an anatomic need to interface to software and hardware in an ef- thyroid.
C n ca D agno c
standard plus, premium, premium plus: 24–7 standard plus, premium, premium plus: 24–7
Turnaround time for problem solving by phone/Email/Field service
pathology system vendor? fort to streamline their workflow and reduce errors. Clifford (Psyche): We have customers who are Guaranteed response time/Modem servicing avail./System diagnose own malfunctions yes/yes/yes yes/yes/yes
No. of U.S. field reps/Service engineer on-site response time/Hours and days
Order parts via modem/Onboard error codes/Maintenance training demo module no/yes/no no/yes/no
• Reticulocytes —
Boje (Orchard): Yes, we’re seeing quite a bit of interested in taking advantage of the synoptic capa- Guaranteed response time/Modem servicing avail./System diagnose own mal
Average maintenance time for lab personnel/Onboard maintenance records weekly: <5 min.; monthly: <45 min./yes weekly: <5 min.; monthly: <45 min./yes
Order parts via modem/Onboard error codes/Maintenance training demo mod
Reagen
consolidation. One of the hallmarks of our software What are the latest ancillary or middleware needs of an bilities of the LIS, and many of them enjoy the dy- Preventive maintenance per year for sample extraction/Amplification detection 2/2 2/2
Average maintenance time for lab personnel/Onboard maintenance records
Downtime for preventive maintenance/Spare parts on site <1 day/yes <1 day/yes
is that it is a single database platform, so we can in- AP system? What is the demand like for instrument namic report creation capabilities, so we definitely Preventive maintenance per year for sample extraction/Amplification detectio
Software and LIS interface: Downtime for preventive maintenance/Spare parts on site
corporate hybrid comprehensive reports. We can interfaces? recommend that they integrate with the CAP cancer • Patient demographics and insurance data available via rules-based architecture no no Software and LIS interface:
take quantitative data, text, and images, and we can Boje (Orchard): Digital pathology—having some checklists for increased functionality. And then when • Data retrieval or Internet connectivity yes yes • Patient demographics and insurance data available via rules-based architect
create these complex reports that are so much be- sort of steps where the LIS can support a digital we demonstrate the functionality to them, they’re • Online real-time help, QC, stats, and management reports/Evaluates results validity yes/yes yes/yes • Data retrieval or Internet connectivity
• Priority processing yes yes • Online real-time help, QC, stats, and management reports/Evaluates results va
CH50
coming the norm. pathology workflow. And then FISH and flow cy- definitely interested, especially the pathologists. • Supports accession No. redundancy/Specimen carrier and level identification yes/no yes/no • Priority processing
Callahan (NovoPath): Absolutely we’re seeing tometry, middleware, and integrating the results of
Precision: • WBC count/RBC count <3.5%/<2.0%

• Unique barcode per container/Multistop routing (1 tube to many workstations) yes/no yes/no • Supports accession No. redundancy/Specimen carrier and level identificatio
consolidation. And we’re starting to see a request for those analysis tools back into the report. Instrument Anne Ford is a writer in Evanston, Ill. • Specimen scheduling/Routes test to workstation/Automatic reflex, repeat, dilutions yes/—/yes yes/no/yes • Un
• Sample storage and retrieval software supports CLSI standards no no
• LIS(s) interfaced live with lab automation systems/How LIS(s) interfaced with LAS yes/LIS1-A and LIS2-A2 (ASTM) yes/LIS1-A and LIS2-A2 (ASTM)
• QC results transferred automatically to LIS/Data-management capability yes/yes yes/yes
• Interfaces operational in active user sites yes yes
• Hemoglobin/Platelet <1.5%/<6.0%
• Rules-based control subsystem/Process control via control subsystem yes/yes yes/yes
• LIS operates simultaneously with assays running yes yes
0218_32_APintro_3.indd 32
FEBRUARY 2018 page 32 2/6/18 8:48 AM • Uses LOINC to transmit orders and results/Unidirectional interface capability
• Results immediately transmitted to LIS/Interface available to auto specimen-handling system
no/yes
yes/—
no/yes
yes/—
• Stores QC lot files/Worklist edit capability/Viewable PCR graphs —/yes/yes —/yes/—
• Can print, archive, transmit data yes yes
• MCV or Hct <2.0% (Hct)

Distinguishing features (supplied by company) full sample to result automation; random and continuous access; scheduled/ full sample to result automation; random and continuous access; scheduled/
automated maintenance for rapid startup; no return visits required for up to automated maintenance for rapid startup; no return visits required for up to
*for calibration and controls 120 samples/day; no batching requirements; multiple assays from a single 120 samples/day; no batching requirements; runs multiple assays from a
Note: a dash in lieu of an answer means company did not answer sample; ready-to-use reagents for PCR assays; 5-color fluorescence detection; single sample; true positive sample ID; consolidated testing menu on a single
question or question is not applicable 12 independent onboard thermocyclers platform; highest throughput per sq. ft.
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP. All information is supplied by the companies listed. The tabulation does not re
Accuracy of automated differential compared with manual — JULY 2018 page 58

Interfering substances: • WBC —
• RBC —
VISIT
• MCV or Hct — captodayonline.com /productguides
to view, print, and compare
• Platelet —
product information for the
• Hemoglobin — following guides:
Interfering substances: differential — INSTRUMENTS • AP automation: tissue processors, embedders, microtomes, stainers
Maximum CBCs per hour/Maximum CBCs and differentials per hour — • Automated molecular platforms • Bedside glucose testing systems • Chemistry
Minimum specimen volume open/Closed/Sample dead volume closed —/15 µL/1.0 mL and immunoassay analyzers for mid- and high-volume laboratories • Chemistry and
Microsample capability no immunoassay analyzers for point-of-care and low-volume laboratories • Coagulation
Prepares microscope slides automatically or flags problems for slide prep no analyzers • Coagulation analyzers—point of
Number of automatic slidemakers available/List price —
care, self-monitoring • Hematology analyzers
• In vitro blood gas analyzers • Laboratory
42 CAP TODAY | APRIL 2018
Archives patient data/Previous patient results incl. with recent results no/no POC glucose: views on volume, critical care, ACOs
continue to be well positioned should the bar be
Test volume, limitations on devices used in critical care, formity in their glucose measurements so there’s
Maximum archived data accessible when system online — automation systems and workcells
consolidation, and population health is what CAP TODAY
raised even further. consistency in their care path and mode of treating
asked about when it spoke in March with the makers of three
Corrine Fantz, PhD, director of medical and scien- the patients. When we discuss this with European
bedside glucose testing systems. Their systems and those
tific affairs for POC testing, Roche: Generally, the colleagues, what’s important is the alignment of the
of two other companies are profiled on pages 44-49.customers are more aware than ever of the limitations glucose meter method with a definitive method. If
“The customers are more aware than ever of the limita-
No. specimens for which numeric results saved in memory at once 100
in the package inserts from the glucose manufacturers. you read carefully the FDA Oct. 11, 2016 guidance
• Next-generation sequencing instruments

tions that are in the package inserts from the glucose
What we’ve seen is that they’re dedicated to determin- for bedside glucose monitoring systems, they must
manufacturers,” says Corrine Fantz, PhD, director of
ing the best testing approach for their specific popula-
medical and scientific affairs for point-of-care testing, show alignment to a definitive method. Not all of the
tion by first defining the right patient and the right
Roche Diagnostics. But she and Kevin Peacock, clinical glucose meters on the market have demonstrated,
sample in order to achieve high-quality glucose re- through FDA submission, alignment to definitive
No. specimens for which histo/cytogram results saved in memory at once —

marketing manager, HemoCue America, say there is still
sults. We recently sponsored a webinar for customers
confusion. Here is more of what they and others told senior methods. They were approved prior to the guidance.
• Urinalysis instrumentation
editor Amy Carpenter Aquino. that allowed the different integrated hospital networks They’re still in the market. Nova StatStrip was not
to share their approaches, best practices, and lessons only cleared under FDA for use in the hospitals, in-
How has the decline in reimbursement coupled with a retreat learned while undergoing changes in the systems that cluding critically ill patient care settings, but also for
Performs delta checks no

from tight glycemic control affected test volume for patients at had them, or trying to adapt what they were doing to use in the home. Now you have a product that can
the bedside? the new limitations with these meters in critical care go home to clinic to hospital to clinic to home, and
Courtney Sweeney, group marketing manager for settings. They said they have to have the right people there’s uniformity in glucose measurement.
point-of-care testing, Roche Diagnostics: Yes, the at the table and understand what the issues are in their Sweeney (Roche): Generally, we do see growth in
Tags and holds results for follow-up, confirmatory testing, or rerun no

hospital blood glucose market growth has slowed particular setting and what’s relevant to physicians, the ambulatory environment. Consolidation may be
down, likely due to the overall financial pressures in the nursing group, and the laboratory. There needs to driving a connected and standardized approach
the industry. Hospitals are looking for the most ef- be solid communication at all phases with the project. across the health system, which allows for better data
SOFTWARE SYSTEMS • Anatomic

fective ways to manage costs but also optimize pa- The laboratory directors are the bridge between the management as well as point-of-care oversight.
22 CAP TODAY | JANUARY 2018 tient outcomes. We do see that point-of-care blood point-of-care and hospital medical staff responsible
Parameters for flags for holding samples defined by user or vendor no

glucose testing remains a critical part of patient care for the testing. Being more collaborative works, rather How does glucose testing and the management of patients with
in health systems. than the laboratory directing or being an authoritarian diabetes fit into the concern laboratories have now for population
Lab needs driving coagulation analyzer market

The other general trend is toward outpatient
versus inpatient care, and this is attributable to many
type to the clinical staff. You need manufacturers, the
clinical staff, and the laboratory all working in a col-
health and accountable care organizations?
Peacock (HemoCue): As medicine becomes less
Scattergram display: cell-specific color no pathology computer systems

variables that could drive this, including declining laborative environment. centralized and more personal, there’s not a one-size-
Valerie Neff Newitt North America
reimbursement, for Siemens
hospital incentives Health- ity, eliminating
to do interven- reconstitution
All glucose meters have time,limitations
another and 20nominutes
meter to get the blank.
fits-all blueprint for patient care. For instance, a
Customer wish lists help to definetionsineers’ chronic
that impact diseaseasportfolio,
outcomes, well as modifying acclimation time, and
currently repetitivefor
is approved man- But
use with we are now
capillary samples down toconsiderable
a time framepart of our population cannot be diag-
every generation of coagulation ana-tightnotes glycemic thatcontrol
many protocols.
customers are ex- ual pipetting.”
in thatHemosIL
criticallyReadiPlastin
ill population. There of under
is some10 minutes
confu- to nosed
have the or two
effectively monitored with HbA1c alone.
Histogram display: color with thresholds yes

lyzers, test menus, and related tech- Jeffrey panding and gaining
A. DuBois, PhD, more
MBA, oversight for prothrombin
MS, vice presi- sion around time testing on ACL
that still. different samples thatPlasma are needed.
blood glucose continues to be reliable in ef-
• Billing/accounts receivable/
nologies. That’s evident in the recentdent,ofmedical their hospital-affi
and scientific liated offiNova
affairs, ces and Top and ACL
Biomedical: Dr.Top Family
DuBois 50 Series
(Nova): Since platelets
Our customers are adapting are whatfectively
we do, cen- diagnosing and managing our growing
and upcoming launches and the on-I don’t clinics.
think“They
peopleneed simple solutions
are abandoning glycemic systems,
man- for example,
with a focus on has onboard
patient trifugation
safety, while conformingis gettingto a lot of attention
diabetic population.
going work of the companies whoseagement that protocols.
don’t require Theyahave lot of training.
modified stability ofStatStrip
them slight- 10 days,labeling
she says.requirements. fromWhenus.”using
He expectsthe the new centri-(Roche): What we see is that account-
Dr. Fantz
analyzers are profiled in this issue inly, soThey they’rewantnot small analyzers
as stringent. Somethat can
institutions William
have Trolio,
system MBA, MT,
to measure vice on critically
glucose fuge will ill come
patients, to theable
market careas a
organizations are being incentivized to
User interface can display choice of specimen or result information no

the 2018 coagulation analyzer prod-made transmit data, to
adjustments directly
the cutoffor indirectly
levels. That is president
not a and chiefand
StatStrip scientifi c offiXpress2
StatStrip cer, second-generation
are cleared for use unit in thehealth
develop first care delivery models that impact the
RCM systems • Blood bank

uct guide. viafrom
retreat middleware, into their hospital
glycemic management; that’s just of Bio/Data,
refin- with says shortening
arterial, venous, process-
neonatal heel part of this
stick, andyear.
neona- patient population as a whole. This includes preven-
At Helena Laboratories, “We hearing the information
treatmentsystemprotocol. andWhere
ultimately ing time istalparamount
hypoglycemia to his custom-
arterial specimens. The standard “The health
of care in mostcare industry is con-
tive, chronic or outpatient care, and acute care, or the
demands for easier connectivity,may have been defined at 75 mg/dL and below, ers. “Specimen
glycemic processing
management timeprotocols
is solidating,
we’ve seen, hospitals
for are forminginpatient groups. They have interven-
hospitalized
E T
C
smaller sample sizes, greater avail-some institutions now have moved the25–34
hypoglyce- one ofpatient
the more frustrating
safety reasons,parts focuses ongroups,
havinggroups
either are an joining
tions together
that are being implemented to improve glyce-
ID U
Coagulation Analyzers, pages

U D
G O
ability of more specialty tests, likemia threshold to 100 mg/dL and below. And there of platelet
arterial testing,” hewhole
says.blood and reconfi guring, purchasing is inanda other outcomes. Glucose testing and
R
or a venous glucose measure- mic control

P
information systems • Laboratory

low-molecular-weight heparin andare some people who still want to be aggressive and “Platelets
ment. areStatStrip
only good for about no
demonstrated constant
knownstate of flux,” says
clinically managingSusan diabetic
L. patients are essential parts of
LIS interface formats supported none

direct thrombin inhibitors,” says The-haveinto their electronic
the glycemic medical70record
range between to 110. Manyfourofhours. . . . And you
significant may beatthat
interferences up could
Taylor,
cause MS, MT(ASCP),these
erroneous director, STA
interventions. For example, they are expanding
resa Peveto, BSCLS, MT, hemostasisthe institutions systems. Additionally,
have moved the theyrangewantso that theit’splatelets
glucose so results
muchcontributing
during theto patient marketing,
adverseDiagnostica
events. Stago, “and data management solutions to the
point-of-care
product manager. “And everyoneabove technology
100, and it’s that does to
referred notas disrupt preparation Not
safe and effective thatall you won’tglucose
bedside get themonitoring
it is all changing
systems are how the laboratory
outpatient environment. That helps the providers
wants a good activated partial throm-glycemic flow, management.
be it patient flow or workflow right results due to
created platelet
equal. Otheractivation
devices in the must respond.have
marketplace Labs, now recognized
capture and report on outcomes they could not
information systems • Laboratory-

boplastin time point-of-care test that Ifinyou’re an offifocusing
ce or clinic.”
on total glycemic control or compromised
for limitations sampleandconditions—
issues that haveasbeen business
addressed units,inare expected
previously to becapture and report, and those data are
is as reliable as an in-laboratory test.”cardiothoracic For the surgical
health care networks
patients, that on
it depends icterus,
the hemolysis, or lipemia.”
the peer-reviewed literature andcenters
in device of value.”
package helpful for achieving their goals and targets.
Toward that end, Peveto says Helenainstitution. want to Withstandardize
the increasing equipment
number of diabetic Bio/Data is working to modify the
inserts. “‘Easy-to-use, reliable, high- (Nova): It is probably best addressed
Dr. DuBois
Laboratories is well into the develop-patients across the network,
admitted to the “our customers
hospital, the demand centrifugation
for process “to minimize throughput equipment that promotes
by looking at the numbers. When ISO 15197:2003
ment of a new analyzer with an espe-monitoring want anpatients
end-to-end at the enterprisewide
bedside has not come How has the system amount of g-
consolidation—including efficiency andsystem
established flexibility’
wascannot be a and accepted as the guidance for the
published
cially broad platform that will includedown. solution,” Peluso-Lapsley says. clinics, ERs,forces appliedphysician
and acquired and practices—affected
sales pitch,” Taylor POC says. “Whereas
provider links software • Positive

It’s increasing. FDA prior to Oct. 11, 2016, that guidance permitted
Information transferred on LIS interface —

“new assays not normally seen.” I’m not At Instrumentation
aware of any decline Laboratory,
in reimbursement shorten
glucose testing the time patient
for ambulatory so testing?
we used to demonstratefive the skills
percent andof results—below 75 mg, an absolute
For instrumentation, the smallerhaving “Weanhave asked
effect customers,
on bedside glucose‘What do We are
testing. Peacock that(HemoCue):
labs get decent the attributes
We see system consolidationof an instrument,
differencenow of 15 mg—and above 75 mg, plus or mi-
the better. “We will see the industryseeing you anneed and what
increase wouldglucose
in bedside make your testing. samples,”
as an advantage Trolio
for the we mustand
health systems alsothe demonstrate
pa- nus how they If that only has to occur 95 percent
20 percent.
move toward smaller devices, some- life better?’” says Venita Shirley, tients they says. “Right
serve. now professionals
Laboratory actually serve havea specifi
a cofcustomer
the time,inthen that poses a significant public
thing like a glucometer—quick,How are MBA, your MT(ASCP),
customers adaptingdirector
to theoflimitations
hemo- on glucose people tend to
greater understanding do their testing,
of point-of-care work environment,
includ- in real
health time,
risk. When you look at the number of glucose
patient identification products

smaller sample sizes, smaller strips,devices stasis marketing
for critical in North America.
care applications? very slow
ing regulatory risks,spins to
compliance and with their lab
requirements, andteam.tests
Thatperformed
is very on these devices globally, we’re in
less dependent on technique and Kevin One answer,
Peacock, sheclinical
says, is marketing
time-savingmanager, Trolio
begin with—20
testing limitations. As ambulatorydifferent for us,with
sites integrate but customers have a
the neighborhood of 5.6 billion tests. If you multiply
technology,” Peveto predicts. Hemo convenience.
Cue America: “InI response
think we we could have
all hear the hospitalminutes
systems,or lablonger—
supervision right
plays tomoreexpect it.”
of a role, that by five percent that are allowed to be acceptable
Maria Peluso-Lapsley, MBA, se-collective reengineered many reagents to be since andthethat even
is only to prepare halfLaboratorians
the
S
sigh of relief from the industry, in waived clinics. get the science outliers, that means there is the risk of 310 million
nior product marketing manager in2016liquid, ready to use
FDA guidance withto
related robust
strip stabil- sample. Then
meter accuracy behind they have to spin
precision it for
and accuracy. They iemens
get why launched
our inerroneous
2016 its figlucose
rst results published off these devices
was not nearly as restrictive as some predicted. capillary sample is so different from strip point-of-care
meters. PT/INR device.
that could affect patient care. If there is a device that
Frankly, many customers are still very confused and Dr. DuBois (Nova): What is of The Xprecia
interest is to Stride
have ismeets a handheld
both criteria and they’re held to [accuracy] 98
are uncertain as to what devices are appropriate to consistency in glucose measurement coagulation
from home analyzerto thator mimics
99 percent the of the time, then that risk has gone
REVENUE CYCLE SERVICES
TELCOR
use with which patients. HemoCue, having accuracy clinic to hospital and back to home. lookOne of of
a the
smartphone
issues and
down provides
significantly, especially if it agrees with a
levels more associated with central lab results, will care providers are discussing is results that they in want
60 seconds
uni- ordefinitive
under, Pelu- method.
Using our same powerful RCM so-Lapsley says. “While the handheld
concept is not new to the industry,
software, our billing service— what is new is that this device uses
ACCESSIBLE TELCOR Revenue Cycle Services— the same reagents for PT/INR that
LOINC codes transmitted with all results/Sent in message to LIS/ no/no/no Gain efficiencies and a better APRIL 2018 page 42
0418_42_BedsidePG-Intro_2.indd 42 are used in the large analyzer portfo- 4/3/18 11:03 AM
understanding of your AR with full access gives laboratories unmatched access lio. This feature ties into customers’
desire to standardize equipment and
34 CAP TODAY | JUNE 2018
to your data and complete transparency to their AR data for complete control reagents and better correlate results.”
between you and TELCOR.

and transparency. With metrics to Another example of coagulation
METRICS
Instrument acquisition, skilled labor on the table
innovation is preanalytical checks,
successfully manage their business, which “have been on chemistry ana-
From daily billing status to monthly labs have complete confidence lyzers forever,” Taylor says. “Now
MAKERS OF CHEMISTRY, IMMUNOASSAY ANALYZERS ANSWER OUR QUESTIONS profitability analysis to yearly sales trends, coagulation analyzers are starting to
you control the metrics needed to effectively working with our trained billing respond in kind.” Diagnostica Stago
Interface available or planned to automated specimen-handling system none manage your We’re business. team with experience specific to has developed a module that’s in the
Broad menus, efficient workflows, single platforms, rural labs, cybersecurity, and form across the system. You’re able tems, Roche Diagnostics: see-
economics are some of what one CEO and three marketing and product managers to train one set of employees to ing increased interest in standard- presubmission stage with the FDA;
talked to CAP TODAY about when we spoke to four companies whose analyzers are laboratory billing.
profiled in the following product guide (pages 40–46). Details about their analyzers
cover all hospitals. Trying to do
more with less and having a single
ization and a growing need to have
a large assay menu on an integrated FLEXIBLE the company is aiming for a 2019 en-
try into the market. The checks, which
and those of eight other companies are provided in our first combined chemistry/
analyzer that meets the needs platform. Specifi As payer requirements
cally, when it comescontinuously will run on the company’s STA Max
immunoassay product guide, tailored in this issue to the low-volume and point-of- change, andour solution
assays, isit’s
configured to make Discover the laboratory billing service giving generation instruments, will detect
Barcode symbologies read on specimen tube proprietary system (barcodes only)

across the hospital system is ideal to software interface
care markets. (See “Simpler and condensed,” page 38, for more on the revised product
for purchasing agents as well as important tosure haveyour
theclaims
same are compliant.
menu, complete access to your data and unrivaled hemolysis, icterus, and lipemia (HIL).
guide and what to expect next month.)
“The fun part of being a manufacturer,” says Nova Biomedical product manager clinicians. If you’re changing from measuring ranges, and reagents for transparency. Discover TELCOR. Taking a somewhat different ap-
proach, the ACL Top 50 Series sys-
Brad Bullen, “is trying to keep two and three steps ahead of clinical needs while one analyzer to another, there can
be subtle differences in the way
all the platforms.
EXPERIENCE tems from Instrumentation Labora-
providing quality diagnostic results that impact patient care now.” Here is more of
Our industry
855-489-1207 sales@telcor.com
what he and others shared with senior editor Amy Carpenter Aquino. results are produced and the timing Can the industry’s successexperts understand the unique
with auto- tory identify and measure the allow-
nuances of laboratory billing and revenue able threshold for HIL. “With the
of the results. Hospitals want a mation and ease of use successfully ©
2018 TELCOR Inc. All rights reserved. For more information ACL Top 50 Series —continued on 24
What are two key trends in instrument Laboratories are getting drugs-of- singular fix for their point-of-care match the worryingcycle management regardless of lab type
decline in skilled about all TELCOR solutions, please visit telcor.com.
acquisition? abuse screening tests from the emer- diagnostic needs. or size.
labor availability, or does there become
Wayne Brinster, CEO, MedTest gency department or saliva samples The second trend is cybersecu- a point at which this problem must be
Accommodates barcode placement per CLSI standard AUTO02-A2 no

Dx: Our customers are looking for from their occupational health rity. Somebody at a large university addressed by others (in the systems,
flexibility, with the ability to run a group. If these samples are just hospital in California said their schools, societies)?
0118_22-24_Coag.indd 22 1/8/18 3:29 PM
broad menu of tests that allow them added into the normal throughput, laboratory receives about 3,000 Bullen (Nova): As the mean age
to create an efficient workflow. they tend to slow down the larger, external attempts to access their of laboratorians is increasing every
They want the instrument to change highly automated instruments. network daily. Hospital systems year, and with fewer enrollees get-
with the test mix have had their patient health infor- ting into this career path, we’re
E T
C
they’re seeing, mation accessed and held for ran- seeing staff having to do more with
ID U
Chemistry and immunoassay analyzers pages 40–46

U D
No. of cleaning or maintenance reagents/No. of routine liquid reagents 1/2 (1 diluent, 1 lyse)
G O
and they want the som. Hospital systems and patients less. We are not necessarily looking
R
P
flexibility to re- have to have confidence that the at what’s going to happen 12
spond to new tests and not have to We’re seeing a desire to take differ- systems manufacturers provide are months from now but in five years.
do testing offline. They haven’t re- ent types of samples and tests while not going to be susceptible to mali- Nova is developing analyzers that
linquished the requirement for the continuing to have a highly efficient cious software. For a long time, don’t require as much hands-on
Time required for daily, weekly, monthly maintenance daily: 15 minutes

instrument to be efficient as far as core laboratory. They can put one of diagnostic companies relied on the time to provide quality results,
Coming in
the use of reagents, low mainte- our instruments inside their core lab hospital’s firewall to protect patient with plug-and-play technology
nance, and a long time between and dedicate it to offload these less data. Nowadays we can’t do that; and no maintenance. Basically,
failures. All of those things come efficient tests. we need to provide multiple tiers take it out of the box, put it on the
into play to help the laboratorian Brad Bullen, product manager, of defense. shelf, load it up with limited con-
increase the throughput of the highly Nova Biomedical: The first trend is Brittany Greiner, marketing man- sumables, have a 15-minute train-
Onboard diagnostics for troubleshooting/Limited to software problems no/no

automated core instruments. standardization of the hospital plat- ager, low-volume and specialty sys- ing session, and you should be
good to go. That’s the approach we
December:
take when developing our ana-
lyzer platform.
Everyone is being asked to do
Manufacturer can perform diagnostics via modem no

more without an increase in staffing
or reimbursement. Industry has to
New Oxcarbazepine Metabolite Assay come to the table with an analyzer
NEXT GENERATION ASSAYS
that provides outstanding quality
results with limited or no hands-on
time. Providing a flexible analyzer
platform is a necessity because what
might be perfect for one group or
Distinguishing features (supplied by company) CLIA-waived CBC, exclusive distribution through

urinalysis
THERAPEUTIC DRUG MONITORING ASSAYS & URINE DRUG TESTS
department may not meet the clini-
ARK introduces its homogeneous enzyme immunoassay cal demands of another.
technology for the next generation of clinical laboratory testing.
Brinster (MedTest): The industry
ARK assays are in liquid, stable, ready-to-use formulations that deliver has made tremendous strides in
McKesson Medical Surgical Division; contains several

convenience for routine use. ease of use. At the same time, there’s
ARK produces assays of high-quality that yield rapid and reliable results on this bifurcation of lab testing. You
automated clinical chemistry analyzers. have some testing that’s going to-
ward the patient in the format of
safety measures to protect the integrity of patient

instrumentation
EPILEPSY URINE DRUG TESTS CANCER ANTIBIOTIC waived testing; conversely, there are
FDA Cleared Forensic Use Only FDA Cleared In Development O
other testing situations where a
OH
Levetiracetam Pregabalin Methotrexate Linezolid laboratory is needed, such as in the
Lamotrigine larger walk-in clinics. If the current
results; simple operation

In Development
O trend in reduction of med techs
Gabapentin ANTIRETROVIRAL ANTIFUNGAL
EtG Zolpidem OH continues, we will have a real short-
Topiramate N Cleared
Fentanyl Zopiclone CE Mark, Not FDA Cleared CE Mark, Not FDA
age and it will become a problem.
Zonisamide H
Tramadol Gabapentin Efavirenz H3C Voriconazole O There is a need for organizations to
Oxcarbazepine Metabolite NH 2 N
Meperidine continue to work with schools and
In Development NH 2 In Development
N
Ketamine
O Lopinavir N government to try to promote get-
Lacosamide H
Methylphenidate Metabolite
Nevirapine ting more people into medical
OH H2N N N technology. —continued on 36
48089 Fremont Blvd, Fremont, CA 94538 customersupport@ark-tdm.com
877.869.2320 www.ark-tdm.com
0618_34-38_Chem-Immune-Intro.indd 34
JUNE 2018 page 34 6/6/18 4:31 PM

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HEMATOLOGY ANALYZERS NOVEMBER 2018 | CAP TODAY 67

Part 1 of 13 Abbott Diagnostics Abbott Diagnostics Abbott Diagnostics

Part 4 of 13 Beckman Coulter CellaVision Clinical Diagnostic Solutions

• Platelet none — microcytosis, agglutinated RBCs, giant platelets in

Precision: • WBC count/RBC count <2.7%/<1.7% <2.7%/<1.7% <2%/<2%

Accommodates barcode placement per CLSI standard AUTO02-A2 — — yes

Note: a dash in lieu of an answer means company did not answer

Part 6 of 13 HORIBA Medical HORIBA Medical Mindray

No. of cleaning or maintenance reagents/No. of routine liquid reagents 2/5 1/4

Part 8 of 13 Siemens Healthineers Siemens Healthineers Siemens Healthineers

Performs delta checks yes yes yes

Note: a dash in lieu of an answer means company did not answer

Part 10 of 13 Sysmex America Sysmex America Sysmex America

Onboard diagnostics for troubleshooting/Limited to software problems yes/no yes/no yes/no

Part 12 of 13 Sysmex America Sysmex America Sysmex America

Interfering substances: differential — — —

Note: a dash in lieu of an answer means company did not answer

See captodayonline.com/productguides for an interactive version of guide

AP-LIS vendors talk reports, interfaces, protocols

FDA-cleared tests not clinically released —

Tests not available but submitted for 510(k) clearance —

Tests for research use only —

Tests unique to analyzer direct current detection method

Differential method(s) used adaptive cluster analysis

Analytical measurement range: • WBC count/RBC count 1–63.2/0.3–7.0

• MCV (fL) or Hct (%) 10–60% (Hct)

Precision: • WBC count/RBC count <3.5%/<2.0%

• MCV or Hct <2.0% (Hct)

Accuracy of automated differential compared with manual — JULY 2018 page 58

differential (per CLSI H20-A2)

• Next-generation sequencing instruments

No. specimens for which histo/cytogram results saved in memory at once —

Performs delta checks no

Tags and holds results for follow-up, confirmatory testing, or rerun no

SOFTWARE SYSTEMS • Anatomic

Parameters for flags for holding samples defined by user or vendor no

Lab needs driving coagulation analyzer market

Scattergram display: cell-specific color no pathology computer systems

Histogram display: color with thresholds yes

User interface can display choice of specimen or result information no

RCM systems • Blood bank

Coagulation Analyzers, pages

or a venous glucose measure- mic control

information systems • Laboratory

LIS interface formats supported none

information systems • Laboratory-

provider links software • Positive

Information transferred on LIS interface —

patient identification products

Listing of machine codes and corresponding LOINC for each test

Barcode symbologies read on specimen tube proprietary system (barcodes only)

Accommodates barcode placement per CLSI standard AUTO02-A2 no

Chemistry and immunoassay analyzers pages 40–46

Time required for daily, weekly, monthly maintenance daily: 15 minutes

Onboard diagnostics for troubleshooting/Limited to software problems no/no

Manufacturer can perform diagnostics via modem no

Distinguishing features (supplied by company) CLIA-waived CBC, exclusive distribution through

McKesson Medical Surgical Division; contains several

safety measures to protect the integrity of patient

results; simple operation

Note: a dash in lieu of an answer means company did not answer

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