en

TOTAL BILIRUBIN
6L45
307147/R04
B6L4U0

TOTAL BILIRUBIN
This package insert contains information to run the Total Bilirubin assay on the ARCHITECT c Systems.

Read Highlighted Changes: Revised November 2016.

Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are
any deviations from the instructions in this package insert.

Customer Service: Contact your local representative or find country-specific contact information on
www.abbottdiagnostics.com.

Key to Symbols
Authorized Representative in
Catalog number/List number
the European Community
Identifies products to be used
Serial number
together
Information needed for United
Consult instructions for use
States of America only
In Vitro Diagnostic Medical
Do not shake/agitate
Device

Batch code/Lot number Manufacturer

Manufactured for Protect from light

PRODUCT OF CANADA Product of Canada Sufficient for

Reagent 1 Temperature limitation

Reagent 2 Use by/Expiration date

1
NAME REAGENTS (Continued)
TOTAL BILIRUBIN Reagent Kit (Continued)
INTENDED USE Reactive Ingredients Concentration
The Total Bilirubin assay is used for the quantitative analysis of total Surfactants 4.51%
bilirubin in human serum or plasma of adults and neonates on the HCl 8.204 g/L
ARCHITECT c Systems.
2, 4-dichloroaniline 0.81 g/L
SUMMARY AND EXPLANATION OF TEST HCI 5.563 g/L
Sodium nitrite 0.345 g/L
Red blood cells at the end of their circulating lives are broken down in
the reticuloendothelial system, mainly the spleen. The resulting heme Surfactant 1.96%
is converted to bilirubin upon removal of iron. This process accounts REAGENT HANDLING AND STORAGE
for about 80% of the 500 µmol (292 mg) of bilirubin formed daily.
Other sources of bilirubin include the breakdown of myoglobin and Reagent Handling
cytochromes and the catabolism of immature red blood cells in the bone NOTE: Do not invert reagent cartridges prior to use. Reagents are
marrow. susceptible to the formation of foam and bubbles.
Once formed, bilirubin is transported to the liver bound to albumin. This Remove air bubbles, if present in the reagent cartridge, with a new
fraction of bilirubin is referred to as indirect or unconjugated bilirubin. applicator stick. Alternatively, allow the reagent to sit at the appropriate
In the liver, bilirubin is conjugated to glucuronic acid (mono‑ and storage temperature to allow the bubbles or foam to dissipate. To minimize
diglucuronides) by the enzyme uridyl diphosphate glucuronyl transferase volume depletion, do not use a transfer pipette to remove the bubbles.
to form conjugated bilirubin. Conjugated bilirubin or direct bilirubin is CAUTION: Reagent bubbles may interfere with proper detection of reagent
excreted via the biliary system into the intestine, where it is metabolized level in the cartridge, causing insufficient reagent aspiration which could
by bacteria to a group of products known collectively as stercobilinogen. impact results.
Elimination is almost complete and serum levels are normally negligible.
Reagent Storage
Total bilirubin is the sum of the unconjugated and conjugated fractions.
Total bilirubin is elevated in hepatitis, cirrhosis, hemolytic disorders, Unopened reagents are stable until the expiration date when stored
several inherited enzyme deficiencies, and conditions causing hepatic at 2 to 8°C and protected from light. Store Total Bilirubin reagents in the
obstruction. box.
Neonatal bilirubin quantitation is used to monitor diseases causing Reagent stability is 21 days if the reagent is uncapped and onboard.
jaundice in the newborn, chiefly erythroblastosis fetalis (also called Indications of Deterioration
hemolytic disease of the newborn or HDN). HDN is caused by maternal Instability or deterioration should be suspected if there are precipitates,
alloimmunization to RhD, antibodies involving additional blood groups, visible signs of leakage, extreme turbidity, microbial growth, if calibration
and ABO incompatibility.1 does not meet the appropriate package insert and/or ARCHITECT System
The average full-term newborn infant has a peak serum bilirubin Operations Manual criteria, or if controls do not meet the appropriate
concentration of 5 to 6 mg/dL (86 to 103 µmol/L). Physiologic criteria.
jaundice is seen at serum bilirubin concentrations from 7 to 17 mg/dL
(120 to 291 µmol/L). Serum bilirubin concentrations greater than WARNINGS AND PRECAUTIONS
17 mg/dL may be pathologic. The primary concern is the potential for
bilirubin encephalopathy or kernicterus. The term “kernicterus” was Precautions for Users
introduced in the early 1900s to refer to the yellow staining of the basal •
ganglia observed in infants who died with severe jaundice.2 • For In Vitro Diagnostic Use.
Additional causes of neonatal jaundice are hematoma/hemorrhage, • Do not use components beyond the expiration date.
hypothyroidism, Crigler-Najjar syndrome, obstructive jaundice, • Do not mix materials from different kit lot numbers. 
galactosemia, sepsis, syphilis, toxoplasmosis, cytomegalovirus, rubella, • CAUTION: This product requires the handling of human specimens.
glucose‑6‑phosphate dehydrogenase (G-6-PDH) deficiency, pyruvate It is recommended that all human sourced materials be considered
kinase deficiency, and spherocytosis.1,2 potentially infectious and be handled in accordance with the OSHA
Standard on Bloodborne Pathogens.7 Biosafety Level 28 or other
PRINCIPLES OF PROCEDURE appropriate biosafety practices9,10 should be used for materials that
Traditional methods of measuring bilirubin are based on the reaction contain or are suspected of containing infectious agents.
of bilirubin with a diazo reagent to form the colored compound • The following warnings and precautions apply to and :
azobilirubin. The diazo reaction can be accelerated by the addition DANGER. contains hydrochloric acid and sodium
of various chemicals. For example, Malloy-Evelyn3 used methanol, borohydride. contains hydrochloric acid.
Jendrassik‑Gróf4 used caffeine, and Walters-Gerarde5 used dimethyl H314 Causes severe skin burns and eye damage.
sulfoxide (DMSO). Modifications of these methods included the addition H290 May be corrosive to metals.
of surfactants as solubilizing agents.6
Prevention
Total (conjugated and unconjugated) bilirubin couples with a diazo P234 Keep only in original container.
reagent in the presence of a surfactant to form azobilirubin. The diazo P260 Do not breathe mist/vapors/spray.
reaction is accelerated by the addition of surfactant as a solubilizing
agent. The increase in absorbance at 548 nm due to azobilirubin is P264 Wash hands thoroughly after handling.
directly proportional to the total bilirubin concentration. P280 Wear protective gloves/protective
clothing/eye protection.
Methodology: Diazonium Salt Response
P301+P330 IF SWALLOWED: Rinse mouth. Do NOT
REAGENTS +P331 induce vomiting.
Reagent Kit P303+P361 IF ON SKIN (or hair): Remove/Take off
Total Bilirubin is supplied as a liquid, ready-to-use, two‑reagent kit which +P353 immediately all contaminated clothing.
contains: Rinse skin with water/shower.
P305+P351 IF IN EYES: Rinse cautiously with water for
6L45-21 +P338 several minutes. Remove contact lenses, if
10 x 53 mL present and easy to do. Continue rinsing.
10 x 17 mL P310 Immediately call a POISON CENTER or
Estimated tests per kit: 2,750* doctor/physician.
P390 Absorb spillage to prevent material damage.
6L45-41 Disposal
8 x 93 mL P501 Dispose of contents/container in
8 x 28 mL accordance with local regulations.
Estimated tests per kit: 3,840* • Safety Data Sheets are available at www.abbottdiagnostics.com or
*Calculation is based on the minimum reagent fill volume per kit. contact your local representative.

2
SPECIMEN COLLECTION AND HANDLING PROCEDURE
Suitable Specimens Materials Provided
Serum and plasma are acceptable specimens. 6L45 Total Bilirubin Reagent Kit
• Serum: Use serum collected by standard venipuncture or capillary Materials Required but not Provided
collection techniques into glass or plastic tubes with or without • 1E66 Bilirubin Calibrator
gel barriers. Ensure complete clot formation has taken place prior
to centrifugation. Centrifuge according to tube manufacturer’s • Control Material
instructions to ensure proper separation of serum from blood cells. • Saline (0.85% to 0.90% NaCl) for specimens that require dilution
Some specimens, especially those from patients receiving Assay Procedure
anticoagulant or thrombolytic therapy, may take longer to complete For a detailed description of how to run an assay, refer to Section 5 of
their clotting processes. Fibrin clots may subsequently form in these the ARCHITECT System Operations Manual.
sera and the clots could cause erroneous test results. Specimen Dilution Procedures
• Plasma: Use plasma collected by standard venipuncture or capillary The ARCHITECT c Systems have an automatic dilution feature; refer to
collection techniques into glass or plastic tubes. Acceptable Section 2 of the ARCHITECT System Operations Manual for additional
anticoagulants are lithium heparin (with or without gel barrier), sodium information.
heparin, and EDTA. The use of tubes containing sodium fluoride/
potassium oxalate is not recommended due to the potential for Serum and Plasma: Specimens with total bilirubin values exceeding
hemolysis with this anticoagulant. Ensure centrifugation is adequate 25.0 mg/dL (427.5 µmol/L) are flagged and may be diluted by following
to remove platelets. Centrifuge according to tube manufacturer’s either the Automated Dilution Protocol or the Manual Dilution Procedure.
instructions to ensure proper separation of plasma from blood cells. Automated Dilution Protocol
Matrix Comparison Data Analysis If using the Automated Dilution Protocol, the system performs a 1:5
Serum vs. plasma matrices were compared utilizing a Least-Squares or a 1:10 dilution of the specimen and automatically corrects the
Linear Regression analysis for glass serum tube (x-axis) vs. various tube concentration by multiplying the result by the appropriate dilution factor.
types (y-axis). Manual Dilution Procedure
Tube Type N Correlation Slope Intercept Manual dilutions should be performed as follows:
Coefficient • Use saline (0.85% to 0.90% NaCl) to dilute the sample.
• The operator must enter the dilution factor in the patient or control
Serum Separator Tube (SST) 30 0.9999 1.00 -0.01 order screen. The system uses this dilution factor to automatically
K2 EDTA Plasma Tube 30 0.9995 1.07 -0.15 correct the concentration by multiplying the result by the entered
(non-gel) factor.
Lithium Heparin Plasma Tube 30 0.9998 1.00 -0.01 • If the operator does not enter the dilution factor, the result must be
(non-gel) multiplied by the appropriate dilution factor before reporting the result.
Lithium Heparin Plasma Tube 30 0.9999 1.00 0.00 NOTE: If a diluted sample result is flagged indicating it is less than the
(Plasma Separator Tube–PST) linear low limit, do not report the result. Rerun using an appropriate
with gel dilution.
For detailed information on ordering dilutions, refer to Section 5 of the
Sodium Heparin Plasma Tube 30 0.9999 0.99 -0.01 ARCHITECT System Operations Manual.
(non-gel)
For total sample volume requirements, refer to the ASSAY PARAMETERS CALIBRATION
section of this package insert and Section 5 of the ARCHITECT System Calibration is stable for approximately 14 days (336 hours) and is
Operations Manual. required with each change in reagent lot number. Verify calibration with
at least two levels of controls according to the established quality control
Specimen Storage requirements for your laboratory. If control results fall outside acceptable
Serum and Plasma: Specimens should be protected from bright light ranges, recalibration may be necessary.
as bilirubin is photolabile.11 Bilirubin is stable in serum and plasma as
follows: For a detailed description of how to calibrate an assay, refer to Section 6
of the ARCHITECT System Operations Manual.
Temperature Maximum Storage Bibliographic For information on calibrator standardization, refer to the Bilirubin
Reference Calibrator package insert.
20 to 25°C 1 day 12 QUALITY CONTROL
2 to 8°C 7 days 12, 13 The following is the recommendation of Abbott Laboratories for quality
-20°C 6 months 14 control. As appropriate, refer to your laboratory standard operating
procedure(s) and/or quality assurance plan for additional quality control
-80°C 6 months 14 requirements and potential corrective actions.
Limitations of laboratory equipment make it necessary in practice for • Two levels of controls (normal and abnormal) are to be run every
clinical laboratories to establish a range around -20°C and/or -80°C for 24 hours.
specimen storage. The temperature ranges may be established from • If more frequent control monitoring is required, follow the established
either the freezer manufacturer’s specifications or your laboratory quality control procedures for your laboratory.
standard operating procedure(s) for specimen storage. • If quality control results do not meet acceptance criteria defined by
NOTE: Stored specimens must be inspected for particulates. If present, your laboratory, patient values may be suspect. Follow the established
mix and centrifuge the specimen to remove particulates prior to testing. quality control procedures for your laboratory. Recalibration may be
necessary.
• Review quality control results and acceptance criteria following a
change of reagent or calibrator lot.

RESULTS
Refer to Appendix C of the ARCHITECT System Operations Manual for
information on results calculations.
Representative performance data are given in the EXPECTED VALUES
and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this
package insert. Results obtained in individual laboratories may vary.

LIMITATIONS OF THE PROCEDURE

Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC
PERFORMANCE CHARACTERISTICS sections of this package insert.

3
For patients undergoing evaluations involving the administration of SPECIFIC PERFORMANCE CHARACTERISTICS
indocyanine green (ICG), it is recommended that samples are drawn (Continued)
after ICG has been eliminated. See the Interfering substances section
for additional information.15,16 Interfering Substances
Interference studies were conducted using CLSI protocol NCCLS
EXPECTED VALUES EP7-A2.23 Interference effects were assessed by Dose Response and
Paired Difference methods at two testing intervals. A bias outside the
Reference Range limits of ±10% or ±0.3 mg/dL is considered significant interference.
Range (mg/dL) Range (µmol/L)
Interfering Interferent N Target Observed*
Adult (serum and plasma)17 0.2 to 1.2 3.4 to 20.5 Substance Concentration (mg/dL) (mg/dL) (%)
A study was conducted with a similar methodology (Total Bilirubin 8G62) 1,000 mg/dL (10 g/L) 7 1.07 1.13 105
using 135 serum samples from volunteers ranging in age from 25 to
2,000 mg/dL (20 g/L) 7 1.07 1.09 101
66 years. Data were analyzed as described in Clinical and Laboratory Hemoglobin
Standards Institute (CLSI) protocol NCCLS C28-A.18 From this study, 1,000 mg/dL (10 g/L) 7 14.08 14.11 100
95% of all results were within 0.2 to 1.2 mg/dL with results ranging from 2,000 mg/dL (20 g/L) 7 14.08 14.07 100
0.2 to 1.8 mg/dL.
A confirmation study was conducted with 6L45 Total Bilirubin using 26 750 mg/dL (7.5 g/L) 7 1.27 1.57 123
serum and plasma samples from adult volunteers. Data were analyzed 1,000 mg/dL (10 g/L) 7 1.27 1.78 140
as described in CLSI protocol NCCLS C28-A3c.19 From this study, 96% Intralipid
750 mg/dL (7.5 g/L) 7 16.50 16.62 101
of results were within the range of 0.2 to 1.2 mg/dL, confirming the adult
reference interval. 1,000 mg/dL (10 g/L) 7 16.50 16.81 101
Range (mg/dL) Range (µmol/L) 0.175 mmol/L 7 1.32 1.59 120
Premature (serum)20 0.200 mmol/L 7 1.32 1.65 125
Indican
< 24 hours < 8.0 < 136.8 0.750 mmol/L 7 16.01 16.83 105
< 48 hours < 12.0 < 205.2 1.000 mmol/L 7 16.01 16.96 106
3 to 5 days < 15.0 < 256.5 18.8 mg/L (24.2 µmol/L) 3 1.53 1.77 115
7 days < 15.0 < 256.5
Indocyanine 25.0 mg/L (32.3 µmol/L) 3 1.53 1.85 121
Full-term Newborn (serum)20 Green 75.0 mg/L (96.8 µmol/L) 3 14.27 15.18 106
< 24 hours < 6.0 < 102.6
100.0 mg/L (129.0 µmol/L) 3 14.27 15.46 108
< 48 hours < 10.0 < 171.0
* Percentages have been rounded to whole numbers.
3 to 5 days < 12.0 < 205.2
Hemoglobin solutions at the above concentrations were prepared by
7 days < 10.0 < 171.0
addition of hemolysate to solutions of human serum albumin. Intralipid
For additional information on neonatal bilirubin values, refer to the solutions at the above concentrations were prepared by addition of
American Academy of Pediatrics recommendation in Management Intralipid to solutions of human serum albumin.
of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Taki et al. reported indoxyl sulfate concentrations up to 8.62 mg/dL
Gestation.21 (0.40 mmol/L), with an average of 3.52 mg/dL (0.17 mmol/L), in
224 hemodialysis (HD) patients.24 Indoxyl sulfate falsely increases bilirubin
To convert results from mg/dL to µmol/L, multiply mg/dL by 17.1. results when assayed by this methodology; however, the use of an earlier
It is recommended that each laboratory determine its own reference read time has been shown to reduce Indican interference.25 Testing at
range based upon its particular locale and population characteristics. Abbott Laboratories (Main Read Time 20-22) demonstrated that addition of
0.20 mmol/L 3-indoxyl sulfate potassium salt, at a targeted total bilirubin
SPECIFIC PERFORMANCE CHARACTERISTICS of 1.3 mg/dL, increased the total bilirubin concentration by 0.3 mg/dL.
Indocyanine green solutions at the above concentrations were prepared by
Linearity the individual addition of indocyanine green to two pools of plasma, one
Linearity for Total Bilirubin is 0.1 to 25.0 mg/dL (1.71 to 427.5 µmol/L). with a high concentration of bilirubin and one with a low concentration of
Linearity was verified using a modified CLSI protocol NCCLS EP6-A.22 bilirubin.
Limit of Detection (LOD) Interferences from medications or endogenous substances may affect
The LOD for Total Bilirubin is 0.05 mg/dL (0.86 µmol/L). LOD is the results.26
lowest amount of analyte in a sample that can be detected with Precision
95% probability. The imprecision of the Total Bilirubin assay is ≤ 5% Total CV.
Limit of Quantitation (LOQ) Representative data from studies using CLSI protocol NCCLS EP5-A227
The LOQ for Total Bilirubin is ≤ 0.1 mg/dL (≤ 1.71 µmol/L). The LOQ is are summarized below.
the analyte concentration at which the CV = 20%.
Control Level 1 Level 2 Level 3 Level 4
N 80 80 80 80
Mean (mg/dL) 0.75 4.11 5.86 15.70
SD 0.01 0.02 0.03 0.05
Within Run
%CV 1.2 0.5 0.4 0.3
SD 0.00 0.03 0.02 0.08
Between Run
%CV 0.4 0.8 0.4 0.5
SD 0.01 0.05 0.06 0.12
Between Day
%CV 1.5 1.1 1.0 0.8
SD 0.01 0.06 0.07 0.16
Total
%CV 2.0 1.4 1.2 1.0

4
SPECIFIC PERFORMANCE CHARACTERISTICS BIBLIOGRAPHY (Continued)
(Continued) 14. Young DS. Effects of Preanalytical Variables on Clinical Laboratory
Tests, 2nd ed. Washington, DC: AACC Press; 1997:3-85.
Method Comparison
Correlation studies were performed using CLSI protocol NCCLS 15. Donnachie EM, Seccombe DW, Urquhart NI. Indocyanine Green
EP9‑A2.28 Interference in the Kodak Ektachem Determination of Total Bilirubin.
Clin Chem 1989; 35(5): 899-900.
Results from the Total Bilirubin assay on an ARCHITECT c System
were compared with those from a commercially available liquid 16. Meijer DKF, Weert B, Vermeer GA. Pharmacokinetics of Biliary
2,5-dichloro-phenyldiazonium tetrafluoroborate methodology. Excretion in Man. VI. Indocyanine Green. Eur J Clin Pharmacol 1988;
35: 295-303.
Results from the Total Bilirubin assay on the ARCHITECT c 8000 System
were compared with those from the Total Bilirubin assay on 17. Data on file at Abbott Laboratories.
the ARCHITECT c 16000 System. 18. Sasse EA, Aziz KJ, Harris EK, et al. How to Define and Determine
Reference Intervals in the Clinical Laboratory; Approved Guideline
Adult (C28-A). Villanova, PA: The National Committee for Clinical
Laboratory Standards, 1995.
Serum and ARCHITECT vs. ARCHITECT c 8000 vs.
Plasma 19. Horowitz GL, Altaie S, Boyd JC, et al. Defining, Establishing, and
Comparative Method ARCHITECT c 16000 Verifying Reference Intervals in the Clinical Laboratory; Approved
N 138 138 Guideline—Third Edition (C28-A3c). Wayne, PA: The National
Committee for Clinical Laboratory Standards, 2008.
Y - Intercept 0.10 -0.04
20. Jacobs DS, Oxley DK, editors. Laboratory Test Handbook, 5th ed.
Correlation Hudson, OH: Lexi-Comp; 2001:117–8.
0.999 1.000
Coefficient
21. American Academy of Pediatrics Subcommittee on
Slope 1.02 1.01 Hyperbilirubinemia. Management of hyperbilirubinemia in the
Range (mg/dL) 0.1 to 23.5 0.1 to 23.5 newborn infant 35 or more weeks of gestation. Pediatrics
2004;114(1):297–316.
22. Tholen DW, Kroll M, Astles JR, et al. Evaluation of the Linearity
Neonatal
of Quantitative Measurement Procedures: A Statistical Approach;
Serum ARCHITECT vs. ARCHITECT c 8000 vs. Approved Guideline (EP6-A). Wayne, PA: The National Committee for
Comparative Method ARCHITECT c 16000 Clinical Laboratory Standards, 2003.
23. McEnroe RJ, Burritt MF, Powers DM, et al. Interference Testing in
N 54 53 Clinical Chemistry; Approved Guideline—Second Edition (EP7-A2).
Y - Intercept 0.32 0.02 Wayne, PA: The National Committee for Clinical Laboratory
Standards, 2005.
Correlation
0.997 1.000 24. Taki K, Tsuruta Y, Niwa T. Indoxyl sulfate and atherosclerotic risk
Coefficient
factors in hemodialysis patients. Am J Nephrol 2007;27:30–5.
Slope 0.99 1.00
25. McPhaul L, Kershaw M, Tilque D, et al. A 2,4-dichlorophenyl
Range (mg/dL) 1.0 to 19.1 1.0 to 19.1 diazonium-based method for total bilirubin without interference from
indican in uremic sera. Clin Chem 1985;31:1229–31.
BIBLIOGRAPHY 26. Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
1. Jacobs DS, DeMott WR, Grady HJ, et al. Laboratory Test Handbook, Washington, DC: AACC Press; 1995:3-90–3-105.
4th ed. Hudson, OH: Lexi-Comp; 1996:86. 27. Tholen DW, Kallner A, Kennedy JW, et al. Evaluation of Precision
2. Dennery PA, Seidman DS, Stevenson DK. Drug therapy: neonatal Performance of Quantitative Measurement Methods; Approved
hyperbilirubinemia. N Engl J Med 2001;344(8):581–90. Guideline—Second Edition (EP5-A2). Wayne, PA: The National
Committee for Clinical Laboratory Standards, 2004.
3. Malloy HT, Evelyn KA. The determination of bilirubin with the
photoelectric colorimeter. J Biol Chem 1973;119:481–90. 28. Kennedy JW, Tholen DW, Garber CC, et al. Method Comparison and
Bias Estimation Using Patient Samples; Approved Guideline—Second
4. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Edition (EP9-A2). Wayne, PA: The National Committee for Clinical
Chemistry, 3rd ed. Philadelphia, PA: WB Saunders; 1999:1136–7. Laboratory Standards, 2002.
5. Walters MI, Gerarde HW. An ultramicromethod for the
determination of conjugated and total bilirubin in serum or plasma.
Microchemical J 1970;15:231–43. TRADEMARKS
6. Winsten S, Cehelyk B. A rapid micro diazo technique for measuring The ARCHITECT c System family of instruments consists of c 4000,
total bilirubin. Clin Chim Acta 1969;25(3):441–6. c 8000, and c 16000 instruments.
7. US Department of Labor, Occupational Safety and Health ARCHITECT, c 4000, c 8000, c 16000, c System, and SmartWash are
Administration. 29 CFR Part 1910.1030. Bloodborne Pathogens. trademarks of Abbott Laboratories in various jurisdictions.
8. US Department of Health and Human Services. Biosafety in All other trademarks are property of their respective owners.
Microbiological and Biomedical Laboratories, 5th ed. Washington,
DC: US Government Printing Office, December 2009.
9. World Health Organization. Laboratory Biosafety Manual, 3rd ed.
Geneva: World Health Organization, 2004.
10. Clinical and Laboratory Standards Institute (CLSI). Protection
of Laboratory Workers From Occupationally Acquired Infections;
Approved Guideline—Fourth Edition. CLSI Document M29-A4.
Wayne, PA: CLSI; 2014.
11. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry,
3rd ed. Philadelphia, PA: WB Saunders; 1999:1169.
12. Guder WG, Narayanan S, Wisser H, et al. List of
analytes—preanalytical variables. Annex In: Samples: From the
Patient to the Laboratory. Darmstadt: GIT Verlag; 1996:Annex 8–9.
13. US Pharmacopeial Convention, Inc. General notices. In: US
Pharmacopeia National Formulary, 1995 ed (USP 23/NF18).
Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11. Abbott Laboratories Abbott GmbH & Co. KG
Diagnostics Division Max-Planck-Ring 2
Abbott Park, IL 60064 USA 65205 Wiesbaden
Germany
307147/R04 November 2016 +49-6122-580
©2010, 2016 Abbott Laboratories
Abbott Laboratories

5
ARCHITECT c SYSTEMS ASSAY PARAMETERS

Total Bilirubin Serum/Plasma—Conventional and SI Units

Configure assay parameters — General Configure assay parameters — SmartWash

● General о Calibration о SmartWash о Results о Interpretation о General о Calibration ● SmartWash о Results о Interpretation
Assay: BiliT Type: Photometric Version: † Assay: BiliT
Number: 1094
COMPONENT REAGENT / ASSAY WASH Volume Replicates
Run controls for onboard reagents by: Lot
R1 BILD0 Detergent A 345 1
● Reaction definition о Reagent / Sample о Validity checks R2 BILD0 0.5% Acid Wash 345 1
Reaction mode: End up
Primary Secondary Read times
Wavelength: 548 / 604 Main: 20 – 22
Last required read: 22
Absorbance range: ___ – ___ Color correction: ___ – ___
Sample blank type: Self Blank: 14 – 16 Total Bilirubin Serum/Plasma—Conventional Units
Configure assay parameters — Results
о Reaction definition ● Reagent / Sample о Validity checks о General о Calibration о SmartWash ● Results о Interpretation
R1 R2 Assay: BiliT Assay number: 1094
Reagent: BILIT Reagent volume: 160 40 Dilution default range: Result units: mg/dL
Diluent: Saline Water volume: ___ ___ Low-Linearity: 0.1†††
Diluent dispense mode: Type 0 Dispense mode: Type 0 Type 0 High-Linearity: 25.0
Diluted Default Gender and age specific ranges:*
Dilution name Sample sample Diluent Water Dilution factor dilution GENDER AGE (UNITS) NORMAL** EXTREME
STANDARD : 2.6 ___ ___ ___ = 1:1.00 ● Either 0 – 130 (Y) 0.2 – 1.2
1:5 : 20.0 2.6 80 ___ = 1:5.00 о
1:10 : 10.0 2.6 90 ___ = 1:10.00 о
Configure result units
Assay: BiliT
о Reaction definition о Reagent / Sample ● Validity checks Version: †
Reaction check: End Subtraction
A B Result units: mg/dL
Read time: 14 – 16 7–9 Decimal places: 1 [Range 0 – 4]
Calculation limits: -0.1000 – 0.0045 Correlation factor: 1.0000
Intercept: 0.0000
Maximum absorbance variation: ___

Configure assay parameters — Calibration Total Bilirubin Serum/Plasma—SI Units

о General ● Calibration о SmartWash о Results о Interpretation Configure assay parameters — Results
Assay: BiliT Calibration method: Linear
о General о Calibration о SmartWash ● Results о Interpretation
● Calibrators о Volumes о Intervals о Validity checks Assay: BiliT Assay number: 1094
Calibrator set: Calibrator level: Concentration: ‡‡ Dilution default range: Result units: µmol/L
Bil Blank: Water 0.0 Low-Linearity: 1.8†††
Cal 1: Bil1 ‡ High-Linearity: 427.5
Replicates: 3 [Range 1 – 3] Cal 2: Bil2 ‡ Gender and age specific ranges:*
GENDER AGE (UNITS) NORMAL** EXTREME
о Calibrators ● Volumes о Intervals о Validity checks Either 0 – 130 (Y) 3.4 – 20.5
Calibrator: Bil Diluted
Calibrator level Sample sample Diluent Water Configure result units
Blank: Water 2.6 ___ ___ ___
Assay: BiliT
Cal 1: Bil1 2.6 ___ ___ ___
Version: †
Cal 2: Bil2 2.6 ___ ___ ___
Result units: µmol/L
Decimal places: 1 [Range 0 – 4]
о Calibrators о Volumes ● Intervals о Validity checks Correlation factor: 1.0000
Calibration intervals: Intercept: 0.0000
Full interval: 336 (hours)
Calibration type:
Adjust type: None

о Calibrators о Volumes о Intervals ● Validity checks

Blank absorbance range: _____ – _____
Span: Blank – Blank
Span absorbance range: _____ – _____
Expected cal factor: 0.00
Expected cal factor tolerance %: 0

† Due to differences in instrument systems and unit configurations, version numbers may vary.
‡‡ Displays the number of decimal places defined in the decimal places parameter field.
‡ Refer to the concentration specified on calibrator labeling or value sheet. These values are defined on the Configure calibrator set screen.
††† The linear low value (Low-Linearity) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.
* User defined.
** Adult reference range.