Professional Documents
Culture Documents
Precision
WBC RBC HGB HCT PLT
CV%: 1.00 0.58 0.4 0.5 3
Limits 3% 2% 1% 2% 4%
Sensitivity Verification
Sensitivety parameters are calibrated in the factory prior to shipment and verified by the Sysmex
representative on installation. They do not need to be calibrated at the laboratory.
Calibration is performed to compensate for any bias generated by the pneumatic system, hydraulic system, and electrical system which may
influence the accuracy of results. It is therefore vital in maintaining consistent system accuracy. Compensation for bias is accomplished by entering a
compensation factor into the instrument's computer.
Initial calibration is performed during installation by the Sysmex representative. Following installation calibration, the operator is requested to verify
the instrument calibration every 6 months or on an 'as needed' basis, and maintain good QC practices, to ensure the accuracy of the system.
Sysmex Service will perform the initial instrument-to-instrument calibration and correlation verification upon installation of your new analyzers.
Service procedures are based on recommendations found within CLSI document H26A/H26-P2.
Subsequent verification of correlation may be done as required by your laboratory following procedures found in Product information document
number 63-1002 02-2010.
Test Instrument
XN-L S/N 0 WBC RBC HGB HCT MCV PLT RET %
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
Mean: #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
Reference Instrument
XN-L 2 S/N 0 WBC RBC HGB HCT MCV PLT RET %
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
0 0.00 0.00 0.0 0.0 0.0 0 0.00
Mean: #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
WBC RBC HGB HCT MCV PLT RDW-SD RDW-CV MPV MCH MCHC
XN-Cal-110 7.45 4.43 12.2 36.8 83.1 265 48.1 15.9 10.3 27.5 33.2
XN-Cal-109 7.53 4.44 12.4 36.9 83.1 272 48.3 16.0 10.3 27.9 33.6
XN-Cal-108 7.38 4.40 12.3 36.6 83.2 274 47.6 15.7 10.4 28.0 33.6
XN-Cal-107 7.30 4.43 12.3 36.9 83.3 262 48.0 15.9 10.3 27.8 33.3
XN-Cal-106 7.35 4.41 12.3 36.6 83.0 262 48.2 15.7 10.4 27.9 33.6
XN-Cal-105 7.29 4.40 12.3 36.6 83.2 256 48.1 15.9 10.1 28.0 33.6
XN-Cal-104 7.45 4.38 12.3 36.4 83.1 254 48.1 15.8 10.4 28.1 33.8
XN-Cal-103 7.33 4.38 12.3 36.4 83.1 250 48.2 16.0 10.3 28.1 33.8
XN-Cal-102 7.32 4.44 12.2 36.8 82.9 248 48.0 15.9 10.3 27.5 33.2
XN-Cal-101 7.41 4.46 12.3 37.0 83.0 248 48.3 15.9 10.6 27.6 33.2
Mean: 7.38 4.42 12.3 36.7 83.1 259 48.1 15.9 10.3 27.8 33.5
Standard Deviation: 0.07 0.03 0.1 0.2 0.1 9 0.2 0.1 0.1 0.2 0.2
CV %: 1.00 0.58 0.4 0.5 0.1 3 0.4 0.6 1.2 0.8 0.7
CV Range: 3.0% 1.5% 1.0% 1.5% 1.0% 4.0% 2.0% 2.0% 3.0% 2.0% 2.0%
NEUT# LYMPH# MONO# EO# BASO# NEUT% LYMPH% MONO% EO% BASO% WBC-D
XN-Cal-110 3.10 2.29 0.81 0.85 0.40 41.6 30.7 10.9 11.4 5.4 7.45
XN-Cal-109 3.09 2.38 0.73 0.86 0.47 41.1 31.6 9.7 11.4 6.2 7.53
XN-Cal-108 3.20 2.15 0.79 0.84 0.40 43.4 29.1 10.7 11.4 5.4 7.38
XN-Cal-107 3.07 2.27 0.70 0.84 0.42 42.0 31.1 9.6 11.5 5.8 7.30
XN-Cal-106 3.12 2.18 0.80 0.83 0.42 42.4 29.7 10.9 11.3 5.7 7.35
XN-Cal-105 3.01 2.30 0.79 0.78 0.41 41.3 31.6 10.8 10.7 5.6 7.29
XN-Cal-104 3.08 2.39 0.75 0.84 0.39 41.3 32.1 10.1 11.3 5.2 7.45
XN-Cal-103 3.17 2.20 0.74 0.81 0.41 43.2 30.0 10.1 11.1 5.6 7.33
XN-Cal-102 3.10 2.30 0.75 0.80 0.37 42.4 31.4 10.2 10.9 5.1 7.32
XN-Cal-101 3.23 2.29 0.77 0.68 0.44 43.6 30.9 10.4 9.2 5.9 7.41
Mean: 3.12 2.28 0.76 0.81 0.41 42.2 30.8 10.3 11.0 5.6 7.38
Standard Deviation: 0.06 0.07 0.03 0.05 0.03 0.9 0.9 0.5 0.7 0.3 0.07
CV %: 2.00 3.30 4.35 6.15 6.32 2.1 2.9 4.4 5.9 5.6 1.00
CV Range: 8.0% 8.0% 20.0% 25.0% 40.0% 8.0% 8.0% 20.0% 25.0% 40.0% 3.0%
Reagents
Background Counts
Counts Counts
WBC-C <0.10 x 10/3uL 0.000 HGB < 0.1 g/dl 0.0
WBC-D <0.10 x 10/3uL 0.000 PLT < 10 x 10/3uL 0
RBC < 0.02 x 10/6uL 0.00
Laser Adjustments
DCL FINE
FSC (X) FSC (W)
Mean #DIV/0! #DIV/0!
Target 100+/- 30 < 0.35
1. Verify the HGB Blank and Aspiration Sensor is within specifications. Adjust if nessessary.
2. Enter acceptable results into the appropriate areas below. Acceptable ranges are shown.
Note: Please transfer data using CSV output after running the samples required for completion of Sensitivities, Calibration, Precision for this
Certificate
Use XN-Cal-101 as the name assigned to the first sample in precision runs.
1. Analyze XN-Cal in Calibrator mode 10 times each.
2. Cut and paste the ten results into the appropriate "Cal-Precision DATA" worksheet Tab. Acceptable CV% limits are shown.
WBC RBC HGB HCT MCV PLT RDW-SD RDW-CV MPV MCH MCHC
CV %: 1.0 0.6 0.4 0.5 0.4 3.5 0.4 0.6 1.2 0.8 0.7
Limits: 3.0% 1.5% 1.0% 1.5% 1.0% 4.0% 2.0% 2.0% 3.0% 2.0% 2.0%
NEUT# LYMPH# MONO# EO# BASO# NEUT% LYMPH% MONO% EO% BASO% WDF
CV %: 2.0 3.3 4.3 6.2 6.3 2.1 2.9 4.4 5.9 5.6 1.0
Limits: 8.0% 8.0% 20.0% 25.0% 40.0% 8.0% 8.0% 20.0% 25.0% 40.0% 3.0%
Manually or electronically enter the Target and Acceptable Limits information from the XN-CAL Assay Sheet into the
"Sensitivities CSV Research" worksheet tab
Use "XN-CAL-SENSE-01" as the name assigned to the first sample in the sensitivities runs and select discrete testing for CBC, DIFF and RET for
Manual Analysis.
1. Enter into "Mode" of the IPU "Service Menu" analyze XN-Cal in "Calibrator" 3 times each.
2. Enter into "Sensitivity" of the IPU "Service Menu" program verify results to assay sheet and make appropriate adjustments
3. Cut and paste three acceptable results into the appropriate "Sensativity DATA" worksheet Tab. Acceptable CV% limits are shown.
Calibration
PLEASE REVIEW THE ACCOUNTS INSIGHT REPORTS PRIOR TO MAKING CHANGES TO COCs
ALWAYS make a backup copy of the customer Cal File .
Manually or electronically enter the Target and Acceptable Limits information from the XN-CAL Assay Sheets into the "Calibration" worksheet tab
Cut and paste the XN-CAL-SENSE data into the Calibration worksheet Xn-cal table.
This data will give a coarse adjustment starting point for the COCs.
Proceed with preliminary COC adjustments in Calibration and repeat calibration steps as needed below.
Use XN-Cal-COC-01 as the sample number assigned to the first sample of each calibrator product and select discrete testing for CBC, DIFF and
RET in Manual Analysis for appropriate calibrator run.
1. Enter into Mode in the Service Program select Calibrator for product to be run
2. Aspirate XN Calibrator six times
3. Discard the first result and record the last five results in the appropriate "Cal-Prec CSV 1 DATA" worksheet tab
Note: WBC is calibrated using the WDF COC. Calibrate WBC-C using DUMMY-012 COC.
WBC RBC HGB HCT MCV PLT RET % WDF WBC-C
Mean 6.98 4.21 11.7 33.8 80.3 251 0.00 6.98 7.44
Target 7.04 4.24 11.7 33.9 80.0 246 NA 7.04 7.40
Lower Limit 6.64 4.15 11.4 32.9 78.0 235 NA 6.64 7.10
Upper Limit 7.44 4.33 12.0 34.9 82.0 257 NA 7.44 7.70
Difference (%) 0.9 0.8 0.2 0.4 -0.3 -1.9 #VALUE! 0.9 -0.5
RBC-O MPV RET-He WBC-BF RBC-BF
Mean 0.00 9.7 Mean 0.00 Mean 0.00 0.00
Target NA 9.8 Target NA Target 0.00 0.00
Lower Limit NA 9.4 Lower Limit NA Lower Limit 0.00 0.00
Upper Limit NA 10.2 Upper Limit NA Upper Limit 0.00 0.00
Difference (%) #VALUE! 0.8 Difference (%) #VALUE! Difference (%) #DIV/0! #DIV/0!
NOTE: Instrument calibration should be verified by qualified lab personnel according to the Operator's Manual
and appropriate lab procedures.
1. Verify that all precision, calibration and sensitivities meet manufacturers specifications.
2. Attach copies of all precision, calibration and sensitivitie worksheets to
this completed Verification of Manufacturers Specifications Certificate and file in logbook
3. Save this workbook for back-up and email to resourcecenter@sysmex.com for validation and archiving purposes.
File nomenclature: Account Name_Model_S/N_Date
To: resourcecenter@sysmex.com)
FSC (X) FSC (W) SFL (X) SFL (W) SSC (X) SSC (W)
1. Dispense FSC mix directly into the reaction chamber (Middle chamber inside right side cover).
2. While in the "Optical Axis Alignment - Fine" mode (Controller -> Service ->), press the manual start switch. Repeat "Step 1" 4 times.
3. Discard the first result and record the mean of the last three results on the Laser Alignment worksheet.
4. If the mean is out of range, adjust and repeat the above steps.
5. Verify the wave form is a single peak and the distribution width is within range
6. If the mean (X) is out of range, adjust and repeat the above steps
7. If the mean of (W) is out of range, clean the flow cell and/or realign the laser.
RBC Abnorm
RBC SuspecPLT AbnormPLT SuspectWBC Info. PLT Info. Rule ResultValidate Validator Action Mes
WBC-D PLT-I None 1 sysmex
WBC-D PLT-I None 1 sysmex
WBC-D PLT-I None 1 sysmex
WBC-D PLT-I None 1 sysmex
WBC-D PLT-I None 1 sysmex
WBC-D PLT-I None 1 sysmex
WBC-D PLT-I None 1 sysmex
WBC-D PLT-I None 1 sysmex
WBC-D PLT-I None 1 sysmex
WBC-D PLT-I None 1 sysmex
Action MesAction MessSample Co Patient Na Birth Sex Patient Co Ward NameDoctor Na Output
GH
GH
GH
GH
GH
GH
GH
GH
GH
GH
Sequence NIP ABN(WBCIP ABN(WBCIP ABN(WBCIP ABN(WB IP ABN(WBCIP ABN(WBCIP ABN(WBCIP ABN(WBCIP ABN(WBC
22
21
20
19
18
17
16
15
14
13
IP SUS(WBC)
IP SUS(WBCIP SUS(RBC)IP SUS(RBC)IP SUS(RBC)IP SUS(RBC IP SUS(RBC IP SUS(PLT)Q-Flag(Bla (Reserved)
0
0
0
0
0
0
0
0
0
0
MPV(fL) MPV/M
10.3
10.3
10.4
10.3
10.4
10.1
10.4
10.3
10.3
10.6
IRF/M RET-He(pg)RET-He/M
(Reserved)
(Reserved) (Reserved)
(Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved)
(Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved)
(Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved)
(Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved)
(Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved)
Action MesAction MesAction MessSample Co Patient Na Birth Sex Patient Co Ward NameDoctor Na
Output Sequence NIP ABN(WBCIP ABN(WBCIP ABN(WBCIP ABN(WB IP ABN(WBCIP ABN(WBCIP ABN(WBCIP ABN(WBC
GH 22
GH 21
GH 20
GH 19
GH 18
GH 17
GH 16
GH 15
GH 14
GH 13
(Reserved) IP SUS(WBC)
IP SUS(WBCIP SUS(RBC)IP SUS(RBC)IP SUS(RBC)IP SUS(RBC IP SUS(RBC IP SUS(PLT)Q-Flag(Bla
0
0
0
0
0
0
0
0
0
0
Q-Flag(PLT Clumps?)
[~NRBC%(%[~NRBC%/M]
0
0
0
0
0
0
0
0
0
0
[~TNC-D(10[~TNC-D/M[~NEUT#&(1[~NEUT#&/[~NEUT%&([~NEUT%&/[~LYMP#&(1[~LYMP#&/[~LYMP%&([~LYMP%&/
7.45 2.26 30.3 1.93 25.9
7.53 2.31 30.7 1.97 26.2
7.38 2.36 32 1.81 24.5
7.3 2.28 31.2 1.9 26
7.35 2.3 31.2 1.81 24.7
7.29 2.18 29.9 1.9 26.1
7.45 2.25 30.2 2.02 27.1
7.33 2.3 31.3 1.8 24.5
7.32 2.27 31.1 1.89 25.8
7.41 2.4 32.4 1.91 25.8
[~PLT-O(10^[~PLT-O/M][~RBC-He(p[~RBC-He/M[~Delta-He([~Delta-He [~RET-Y(ch)[~RET-Y/M][~RET-RBC-Y[~RET-RBC-
[~HF-BF#(10[~HF-BF#/M[~HF-BF%(/[~HF-BF%/
[~NE-BF#(1[~NE-BF#/M[~NE-BF%(%[~NE-BF%/ [~LY-BF#(10[~LY-BF#/M[~LY-BF%(%[~LY-BF%/M[~MO-BF#(1[~MO-BF#/
[~MO-BF%([~MO-BF%/[~EO-BF#(1[~EO-BF#/M[~EO-BF%(%[~EO-BF%/ [~RBC-BF2([~RBC-BF2/[~HGB-BLANK]
4891
4895
4902
4913
4923
4934
4945
4958
4974
4984
(Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved)
(Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved)
(Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved)
(Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved)
0.00
#DIV/0!
Test Instrument
Serial Number
Reference Instrument
Serial Number
Acceptable Limit: +/- 5% +/- 2.5% +/- 2% +/- 2.5% +/- 2.5%
Reference Instrument
Instrument Model: XN-10
Serial Number
WBC RBC HGB HCT MCV
0 12/30/1899 0 0 0 0 0
0 12/30/1899 0 0 0 0 0
0 12/30/1899 0 0 0 0 0
0 12/30/1899 0 0 0 0 0
0 12/30/1899 0 0 0 0 0
0 12/30/1899 0 0 0 0 0
0 12/30/1899 0 0 0 0 0
0 12/30/1899 0 0 0 0 0
0 12/30/1899 0 0 0 0 0
0 12/30/1899 0 0 0 0 0
MEAN: 0.00 0.00 0.00 0.00 0.00
% Difference: #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
Acceptable Limit: +/- 5% +/- 2.5% +/- 2% +/- 2.5% +/- 2.5%
Serial Number
Serial Number 0
+/- 15%
XN-L 2
Whole Blood XN_00-0x(Buildx)_Sample_1of2.csv
Nickname Instrument ID Date Time Sample No. WBC(10^3
RBC(10^6
#DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
#DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
Mean #DIV/0!
XN-L 2
Whole Blood XN_00-0x(Buildx)_Sample_2of2.csv
Nickname Instrument ID Date Time Sample No. [~PDW(fL)]
MEAN: #DIV/0!
#DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
#DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
#DIV/0!
(Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) (Reserved) [~WBC-C(10
#DIV/0!
[~WBC-C/M[~TNC-C(10[~TNC-C/M]
XN_00-0x(Buildx)_Sample_1of2.csv
Nickname Analyzer ID Date Time Rack Position
XN_00-0x(Buildx)_Sample_2of2.csv
Nickname Analyzer ID Date Time Rack Position
[NE-BF%(%)[NE-BF%/M[LY-BF#(10^[LY-BF#/M][LY-BF%(%)[LY-BF%/M][MO-BF#(10[MO-BF#/M[MO-BF%(%[MO-BF%/M
[EO-BF#(10[EO-BF#/M][EO-BF%(%)[EO-BF%/M[RBC-BF2(1[RBC-BF2/M[HGB-BLAN[HGB-SAMP[R-MFV(fL)][S-RBC(10^6
[DLT-PLTO] [Unclassified]
[WBC-N2(10[TNC-N2(10[WBC-D2(10[TNC-D2(10^3/uL)]
[HGB_NONSI
[HGB_SI(mm
[HGB_SI2(m[WNR_TOTA[WDF_TOTA[WDF_PLOT_COUNT] [RET_TOTAL_COUNT]
[HGB-O(g/d[HGB-O/M] [Delta-HGB([Delta-HGB
[MCHC-O(g/[MCHC-O/M]