NEONATAL 9D88-20 30-5396/R6

NEONATAL BILIRUBIN

This package insert contains information to run the Neonatal Bilirubin assay on the AEROSET System and the ARCHITECT c Systems.

NOTE: Changes Highlighted

NOTE: This package insert must be read carefully prior to product use. Package insert instructions must be followed accordingly. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

Customer Support United States: 1-877-4ABBOTT Canada: 1-800-387-8378 (English speaking customers) 1-800-465-2675 (French speaking customers) International: Call your local Abbott representative

Symbols in Product Labeling

Calibrators 1 and 2 Catalog number/List number

Concentration Serial number Authorized Representative in the Consult instructions for use European Community Ingredients Manufacturer

In vitro diagnostic medical device Temperature limitation

Batch code/Lot number Use by/Expiration date

Reagent 1

ABBOTT LABORATORIES ABBOTT Abbott Park, IL 60064, USA Max-Planck-Ring 2 65205 Wiesbaden Germany +49-6122-580 July 2009 ©2002, 2009 Abbott Laboratories

1 NAME Reagent Storage NEONATAL BILIRUBIN Unopened reagents are stable until the expiration date when stored at 15 to 30°C. Do not pool reagents. INTENDED USE Reagent stability is 41 days if the reagent is uncapped and onboard. The Neonatal Bilirubin assay is used for the quantitation of bilirubin in human or plasma. WARNINGS AND PRECAUTIONS SUMMARY AND EXPLANATION OF TEST Precautions for Users 1. For in vitro diagnostic use. Red blood cells at the end of their circulating life are broken down in the reticulo-endothelial system, mainly the . The resulting , 2. Do not use components beyond the expiration date. once the iron is removed, is then converted to bilirubin. This process 3. Do not mix materials from different kit lot numbers. accounts for about 80% of the 300 mg (500 μmol) of bilirubin formed 4. CAUTION: This product requires the handling of human specimens. daily. Other sources of bilirubin include the breakdown of It is recommended that all human sourced materials be considered and cytochromes and the catabolism of immature red blood cells in the potentially infectious and be handled in accordance with the OSHA bone marrow. Standard on Bloodborne Pathogens.4 Biosafety Level 25 or other 6,7 Once formed, bilirubin is transported to the bound to as it appropriate biosafety practices should be used for materials that is water insoluble. This fraction of bilirubin is referred to as indirect or contain or are suspected of containing infectious agents. unconjugated bilirubin. In the liver, bilirubin is conjugated to (mono- and diglucuronides) to form conjugated bilirubin by the SPECIMEN COLLECTION AND HANDLING uridyl diphosphate glucuronyl transferase. Conjugated bilirubin or direct bilirubin is excreted via the biliary system into the intestine, Suitable Specimens where it is metabolized by bacteria to a group of products known Serum and plasma are acceptable specimens. collectively as . Elimination is almost complete and • Serum: Use serum collected by standard venipuncture techniques serum levels are normally negligible.1 into glass or plastic tubes with or without gel barriers. Ensure Neonatal bilirubin quantitation is used to monitor diseases causing complete clot formation has taken place prior to centrifugation. in the newborn, chiefly erythroblastosis fetalis (also called When processing samples, separate serum from blood cells or hemolytic disease of the newborn or HDN). HDN is associated with gel according to the specimen collection tube manufacturer’s various Rh antibodies, ABO incompatibility, and antibodies involving instructions. additional blood groups including Kidd, Kell, and Duffy.2 Some specimens, especially those from patients receiving The average full-term newborn infant has a peak serum bilirubin anticoagulant or thrombolytic therapy, may take longer to complete concentration of 5 to 6 mg/dL (86 to 103 μmol/L). Exaggerated their clotting processes. Fibrin clots may subsequently form in these physiologic jaundice occurs at values above this threshold (7 to sera and the clots could cause erroneous test results. 17 mg/dL [104 to 291 μmol/L]). Serum bilirubin concentrations higher • Plasma: Use plasma collected by standard venipuncture than 17 mg/dL in full-term infants are no longer considered physiologic, techniques into glass or plastic tubes. Acceptable anticoagulants and a cause of pathologic jaundice can usually be identified in are lithium heparin (with or without gel barrier), sodium heparin, such infants. The primary concern with respect to exaggerated and EDTA. Ensure centrifugation is adequate to remove platelets. hyperbilirubinemia is the potential for neurotoxic effects, but general When processing samples, separate plasma from blood cells or cellular injury also occurs. The term “” was introduced in the gel according to the specimen collection tube manufacturer’s early 1900s to refer to the yellow staining of the observed instructions. 3 in infants who died with severe jaundice. NOTE: Umbilical cord specimens should not be used. Additional causes of are hematoma/hemorrhage, NOTE: Direct spectrophotometric bilirubin measurement methods, such hypothyroidism, Crigler-Najjar syndrome, obstructive jaundice, as Abbott Neonatal Bilirubin, measure total bilirubin galactosemia, , syphilis, , cytomegalovirus, rubella, and are only recommended for use with patients less than 6 weeks old, glucose-6-phosphate dehydrogenase (G-6-PDH) deficiency, pyruvate as cause positive interference.8 kinase deficiency, and spherocytosis.2,3 For total sample volume requirements, refer to the instrument-specific PRINCIPLES OF PROCEDURE ASSAY PARAMETERS section of this package insert and Section 5 of The Neonatal Bilirubin procedure utilizes a differential wavelength the instrument-specific operations manual. method. The absorbance of bilirubin, measured at 444 (450 for Specimen Storage ARCHITECT c 16000 and c 4000) and 548 nm, is directly proportional to the bilirubin concentration in serum or plasma. Serum and plasma: Because both conjugated and unconjugated bilirubin are photo-oxidized when exposed to white or ultraviolet light, Methodology: Spectrophotometric specimens should be protected from direct exposure to either artificial light or sunlight as soon as they are drawn. The sensitivity to light is REAGENTS temperature-dependent; for optimal stability, storage of specimens in 1 Reagent Kit the dark at low temperatures is essential. 9D88 Neonatal Bilirubin is supplied as a liquid, ready-to-use, single reagent kit which contains: Temperature Maximum Bibliographic Storage Reference 4 x 36 mL 20 to 25°C 1 day 9 Estimated tests per kit: 591 Calculation is based on the minimum reagent fill volume per kit. 2 to 8°C 7 days 9, 10 -20°C 6 months 9 Reactive Ingredients Concentration Guder et al.9 suggest storage of frozen specimens at -20°C for TRIS Buffer 10 mmol/L no longer than the time interval cited above. However, limitations of laboratory equipment make it necessary in practice for clinical REAGENT HANDLING AND STORAGE laboratories to establish a range around -20°C for specimen storage. Reagent Handling This temperature range may be established from either the freezer manufacturer’s specifications or your laboratory standard operating Remove air bubbles, if present in the reagent cartridge, with a new procedure(s) for specimen storage. applicator stick. Alternatively, allow the reagent to sit at the appropriate storage temperature to allow the bubbles to dissipate. To minimize NOTE: Stored specimens must be inspected for particulates. If present, volume depletion, do not use a transfer pipette to remove the bubbles. mix and centrifuge the specimen to remove particulates prior to testing. CAUTION: Reagent bubbles may interfere with proper detection of reagent level in the cartridge, causing insufficient reagent aspiration which could impact results.

2 PROCEDURE RESULTS Materials Provided Refer to the instrument-specific operations manual for information on results calculations. 9D88 Neonatal Bilirubin Reagent Kit • ARCHITECT System Operations Manual—Appendix C Materials Required but not Provided • AEROSET System Operations Manual—Appendix A • 1E66 Bilirubin Calibrator, 3 x 5 mL Representative performance data are given in the EXPECTED VALUES • Control Material and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this • Saline (0.85% to 0.90% NaCl) for specimens that require dilution package insert. Results obtained in individual laboratories may vary. Assay Procedure LIMITATIONS OF THE PROCEDURE For a detailed description of how to run an assay, refer to Section 5 of the instrument-specific operations manual. Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this package insert. Specimen Dilution Procedures The ARCHITECT c Systems and the AEROSET System have automatic EXPECTED VALUES dilution features; refer to Section 2 of the instrument-specific operations manual for additional information. Serum and plasma: Specimens with bilirubin values exceeding Serum/Plasma1 51.1 mg/dL (873.8 μmol/L) are flagged and may be diluted using the Range (mg/dL) Range (μmol/L) Automated Dilution Protocol or the Manual Dilution Procedure. Premature Automated Dilution Protocol If using the Automated Dilution Protocol, the system performs a dilution Up to 24 hours 1.0 to 8.0 17 to 137 of the specimen and automatically corrects the concentration by Up to 48 hours 6.0 to 12.0 103 to 205 multiplying the result by the appropriate dilution factor. To set up the 3 to 5 days 10.0 to 14.0 171 to 239 automatic dilution feature, refer to Section 2 of the instrument-specific operations manual for additional information. Full-term Newborn Manual Dilution Procedure Up to 24 hours 2.0 to 6.0 34 to 103 Manual dilutions should be performed as follows: Up to 48 hours 6.0 to 10.0 103 to 171 • Use saline (0.85% to 0.90% NaCl) to dilute the sample. 3 to 5 days 4.0 to 8.0 68 to 137 • The operator must enter the dilution factor in the patient or control order screen. The system uses this dilution factor to automatically To convert results from mg/dL to μmol/L, multiply mg/dL by 17.1. correct the concentration by multiplying the result by the entered It is recommended that each laboratory determine its own reference factor. range based upon its particular locale and population characteristics. • If the operator does not enter the dilution factor, the result must be multiplied by the appropriate dilution factor before reporting the SPECIFIC PERFORMANCE CHARACTERISTICS result. Linearity NOTE: If a diluted sample result is flagged indicating it is less than the Neonatal Bilirubin is linear up to 51.1 mg/dL (873.8 μmol/L). Linearity linear low limit, do not report the result. Rerun using an appropriate was verified using Clinical and Laboratory Standards Institute (CLSI) dilution. protocol NCCLS EP6-P.11 For detailed information on ordering dilutions, refer to Section 5 of the Limit of Detection (LOD) instrument-specific operations manual. The LOD for Neonatal Bilirubin is 0.03 mg/dL (0.52 μmol/L). The LOD is CALIBRATION the mean concentration of an analyte-free sample + 2 SD, where SD = the pooled, within-run standard deviation of the analyte-free sample. Calibration is stable for approximately 41 days (984 hours) and is required with each change in reagent lot number. Verify calibration Limit of Quantitation (LOQ) with at least two levels of controls according to the established quality The LOQ for Neonatal Bilirubin is 0.06 mg/dL (1.03 μmol/L). The LOQ is control requirements for your laboratory. If control results fall outside defined as the lowest analyte concentration at which the CV = 20%. acceptable ranges, recalibration may be necessary. A multi-point calibration (Linear) curve is generated using Bilirubin Interfering Substances Calibrator. Interference studies were conducted using CLSI protocol NCCLS EP7-P.12 Interference effects were assessed by Dose Response and For a detailed description of how to calibrate an assay, refer to Section 6 Paired Difference methods, at the medical decision level of the analyte. of the instrument-specific operations manual. For information on calibrator standardization, refer to the Bilirubin Interfering Interferent Concentration N Target Observed Calibrator package insert. Substance (mg/dL) (% of Target) 250 mg/dL (2.5 g/L) 4 19.9 105.6 QUALITY CONTROL The following is the recommendation of Abbott Laboratories for quality 500 mg/dL (5.0 g/L) 4 19.9 111.4 control. As appropriate, refer to your laboratory standard operating 750 mg/dL (8.5 mmol/L) 4 19.8 99.8 procedure(s) and/or quality assurance plan for additional quality control Human requirements and potential corrective actions. 1,000 mg/dL (11.3 mmol/L) 4 19.8 98.1 • Two levels of controls (normal and abnormal) are to be run every Hemoglobin solutions at the above concentrations were prepared by 24 hours. addition of hemolysate to humans serum pools. Human triglyceride • If more frequent control monitoring is required, follow the established solutions at the above concentrations were prepared by mixing an quality control procedures for your laboratory. elevated triglyceride human serum pool with a normal triglyceride human • If quality control results do not meet the acceptance criteria serum pool. defined by your laboratory, patient values may be suspect. Follow the established 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.

3 SPECIFIC PERFORMANCE CHARACTERISTICS BIBLIOGRAPHY (Continued) 1. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry, Precision 2nd ed. Philadelphia, PA: WB Saunders; 1994:1459–68. 2. Jacobs DS, DeMott WR, Grady HJ, et al. Laboratory Test Handbook, The precision of the Neonatal Bilirubin assay is ≤ 6.5% Total CV. 4th ed. Hudson, OH: Lexi-Comp; 1996:86. Representative data from studies using CLSI protocol NCCLS EP5-T213 are summarized below. 3. Dennery PA, Seidman DS, Stevenson DK. Drug therapy: neonatal hyperbilirubinemia. N Engl J Med 2001;344(8):581–90. Control Level 1 Level 2 4. US Department of Labor, Occupational Safety and Health N8080Administration. 29 CFR Part 1910.1030, Bloodborne Pathogens. 5. US Department of Health and Human Services. Biosafety in Mean (mg/dL) 6.7 16.1 Microbiological and Biomedical Laboratories, 5th ed. Washington, SD 0.03 0.06 DC: US Government Printing Office; January 2007. Within Run 6. World Health Organization. Laboratory Biosafety Manual, 3rd ed. %CV 0.5 0.3 Geneva: World Health Organization; 2004. SD 0.09 0.22 7. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory Between Run %CV 1.4 1.4 Workers from Occupationally Acquired Infections; Approved Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and SD 0.20 0.51 Laboratory Standards Institute, 2005. Between Day %CV 3.0 3.2 8. Tietz NW, editor. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia, PA: WB Saunders; 1995:88–9. SD 0.22 0.56 Total 9. Guder WG, da Fonseca-Wollheim F, Heil W, et al. The Quality of %CV 3.3 3.5 Diagnostic Samples. Darmstadt, Germany: GIT Verlag; 2001:18–9. 10. US Pharmacopeial Convention, Inc. General notices. In: US Method Comparison Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18). Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11. Correlation studies were performed using CLSI protocol NCCLS EP9-A.14 11. Passey RB, Bee DE, Caffo A, et al. Evaluation of the Linearity of Quantitative Analytical Methods; Proposed Guideline (EP6-P). Serum results from the Neonatal Bilirubin assay on the AEROSET Villanova, PA: The National Committee for Clinical Laboratory System were compared with the A-GENT Neonatal Bilirubin assay Standards, 1986. (direct spectrophotometric differential wavelength methodology) on the ABBOTT SPECTRUM Series II System. Of the 56 specimens 12. Powers DM, Boyd JC, Glick MR, et al. Interference Testing in Clinical tested, 41 specimens were from neonates less than 7 days of age. Chemistry; Proposed Guideline (EP7-P). Villanova, PA: The National The remaining 15 specimens were spiked to show correlation through Committee for Clinical Laboratory Standards, 1986. the reportable range. 13. Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision Serum results from the Neonatal Bilirubin assay on an ARCHITECT Performance of Clinical Chemistry Devices–Second Edition; c System were compared with the Neonatal Bilirubin assay on the Tentative Guideline (EP5-T2). Villanova, PA: The National Committee AEROSET System. Of the 166 specimens tested, 91 were from for Clinical Laboratory Standards, 1992. neonates and ranged from 0.60 to 10.30 mg/dL. The remaining 14. Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison 75 specimens were included to show correlation through the reportable and Bias Estimation Using Patient Samples; Approved Guideline range. (EP9-A). Wayne, PA: The National Committee for Clinical Laboratory Standards, 1995. AEROSET ARCHITECT vs. SPECTRUM vs. AEROSET TRADEMARKS N56166The ARCHITECT c System family of instruments consists of c 4000, c 8000, and c 16000 instruments. Y - Intercept 0.275 0.083 A-GENT, ABBOTT SPECTRUM, AEROSET, ARCHITECT, c 4000, c 8000, Correlation Coefficient 0.9995 1.000 c 16000, c System, and Series II are trademarks of Abbott Laboratories in Slope 0.941 1.010 various jurisdictions. All trademarks are the property of their respective owner. Range (mg/dL)* 2.59 to 32.28 0.56 to 49.90 *AEROSET Range

4 ARCHITECT c SYSTEMS ASSAY PARAMETERS

Neonatal 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: NBil Type: Photometric Version: † Assay: NBil Number: 1045 COMPONENT REAGENT / ASSAY WASH Volume Replicates ● Reaction definition о Reagent / Sample о Validity checks R1 ALBG0 Detergent A 345 1 Reaction mode: End up Cuvette Trig 10% Detergent B*** 345 Primary Secondary Read times *** Select “Detergent B” for software prior to version 2.2. Wavelength: ‡ / 548 Main: 7 – 9 Last required read: 9 Absorbance range: ___ – ___ Color correction: ___ – ___ Sample blank type: None Neonatal Bilirubin Serum/Plasma—Conventional Units

о Reaction definition ● Reagent / Sample о Validity checks Configure assay parameters — Results R1 Reagent: NBIL0 Reagent volume: 200 о General о Calibration о SmartWash ● Results о Interpretation Diluent: Saline Water volume: ___ Assay: NBil Assay number: 1045 Diluent dispense mode: Type 0 Dispense mode: Type 0 Dilution default range: Result units: mg/dL †† Diluted Default Low-Linearity: 0.1 Dilution name Sample sample Diluent Water Dilution factor dilution High-Linearity: 51.1 STANDARD : 4.0 ______= 1:1.00 ● Gender and age specific ranges: ______: ______= о GENDER AGE (UNITS) NORMAL EXTREME ______: ______= о

о Reaction definition о Reagent / Sample ● Validity checks Reaction check: None Configure result units Assay: NBil Maximum absorbance variation: ___ Version: † Result units: mg/dL Decimal places: 1 [Range 0 – 4] Configure assay parameters — Calibration Correlation factor: 1.0000 о General ● Calibration о SmartWash о Results о Interpretation Intercept: 0.0000 Assay: NBil Calibration method: Linear ● Calibrators о Volumes о Intervals о Validity checks Calibrator set: Calibrator level: Concentration: Neonatal Bilirubin Serum/Plasma—SI Units Bil Blank: Water 0.0 Cal 1: Bil1 ‡‡ Configure assay parameters — Results Replicates: 3 [Range 1 – 3] Cal 2: Bil2 ‡‡ о General о Calibration о SmartWash ● Results о Interpretation Assay: NBil Assay number: 1045 о Calibrators ● Volumes о Intervals о Validity checks Dilution default range: Result units: μmol/L Calibrator: Bil Diluted Low-Linearity: 1.1†† Calibrator level Sample sample Diluent Water High-Linearity: 873.8 Blank: Water 4.0 ______Gender and age specific ranges: Cal 1: Bil1 4.0 ______GENDER AGE (UNITS) NORMAL EXTREME Cal 2: Bil2 4.0 ______

о Calibrators о Volumes ● Intervals о Validity checks Calibration intervals: Full interval: 984 (hours) Configure result units Calibration type: Adjust type: None Assay: NBil Version: † о Calibrators о Volumes о Intervals ● Validity checks Result units: μmol/L Blank absorbance range: _____ – _____ Decimal places: 1 [Range 0 – 4] Span: Blank – Blank Correlation factor: 1.0000 Span absorbance range: _____ – _____ Intercept: 0.0000 Expected cal factor: 0.00 Expected cal factor tolerance %: 0

† Due to differences in instruments and unit configurations, version numbers may vary. ‡ The c 8000 Primary Wavelength is 444 nm; the c 16000 and c 4000 Primary Wavelength is 450 nm. ‡‡ Refer to concentration specified on calibrator labeling or value sheet. †† The linear low value (Low-Linearity) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.

5 AEROSET SYSTEM ASSAY PARAMETERS

Neonatal Bilirubin Serum/Plasma—Conventional Units Neonatal Bilirubin Serum/Plasma—SI Units Assay Configuration: Outline Page Assay Configuration: Outline Page Assay Name Assay # Line Assay Name Assay # Line NBil 45 A-Line NBil 45 A-Line Quantitative Ranges Quantitative Ranges Min Text Min Panic-L L-Reference-H Panic-H Max Max Text Min Text Min Panic-L L-Reference-H Panic-H Max Max Text * 0.0* 0.0 0.0 0.0 0.0 0.0* * * 0.0* 0.0 0.0 0.0 0.0 0.0* * 0.1** L-Linear Range-H 51.1 1.1** L-Linear Range-H 873.8 Reference Ranges* Reference Ranges* Age Male Female Age Male Female 0 Year 0.0 – 0.0 0.0 – 0.0 0 Year 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0 Year 0 Year 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0.0 – 0.0 0 Year 0.0 – 0.0 0.0 – 0.0 0 Year 0.0 – 0.0 0.0 – 0.0 Qualitative Ranges N/A Qualitative Ranges N/A

Assay Configuration: Base Page Assay Configuration: Base Page Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar Reaction Mode Wavelength-Prim/Sec Read time-Main/Flex AbsMaxVar END UP 444 / 548 7 – 9 / 0 – 0 0.0 END UP 444 / 548 7 – 9 / 0 – 0 0.0 Sample Blank Test Blank Read Time Abs Window Abs Limits Sample Blank Test Blank Read Time Abs Window Abs Limits ____ ( ___ ) 0 – 0 0 – 0 0.0 – 0.0 ____ ( ___ ) 0 – 0 0 – 0 0.0 – 0.0 S.Vol DS.Vol D.Vol W.Vol S.Vol DS.Vol D.Vol W.Vol Standard 4.0 0.0 0 0 Rgt Name/Pos Standard 4.0 0.0 0 0 Rgt Name/Pos Dil 1 4.0 0.0 0 0 Diluent: ______–__* Dil 1 4.0 0.0 0 0 Diluent: ______–__* Dil 2 4.0 0.0 0 0 Type# 0 Dil 2 4.0 0.0 0 0 Type# 0 Rgt Name/Pos R.Vol W.Vol Type# Rgt Name/Pos R.Vol W.Vol Type# Reagent 1 NBIL051 – ___* 200 0 0 Reagent 1 NBIL051 – ___* 200 0 0 Reaction Check Read Time – A/B Range Minimum Reaction Check Read Time – A/B Range Minimum ______1 – 1 / 1 – 1 0.0 – 0.0 0.0 ______1 – 1 / 1 – 1 0.0 – 0.0 0.0 Factor/Intercept Decimal Places Units Factor/Intercept Decimal Places Units 1.0 / 0.0 1 mg/dL 1.0 / 0.0 1 μmol/L

Assay Configuration: Calibration Page Assay Configuration: Calibration Page Calib Mode Interval (H) Calib Mode Interval (H) Linear 984 Linear 984 Blank/Calib Replicates Extrapolation % Span Span Abs Range Blank/Calib Replicates Extrapolation % Span Span Abs Range 3 / 3 0 BLK – 1 0.0 – 0.0 3 / 3 0 BLK – 1 0.0 – 0.0 Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range BLK Water 4.0 0.0 0 0 0.0 – 0.0 BLK Water 4.0 0.0 0 0 0.0 – 0.0 C1 Bil 1 4.0 0.0 0 0 Cal Deviation C1 Bil 1 4.0 0.0 0 0 Cal Deviation C2 Bil 2 4.0 0.0 0 0 0.0 C2 Bil 2 4.0 0.0 0 0 0.0 FAC Limit (%) FAC Limit (%) 10 10

Assay Configuration: SmartWash Page Assay Configuration: SmartWash Page Rgt Probe Rgt Probe Reagent Wash Vol Reagent Wash Vol ——— ——— Cuvette Cuvette Assay Name Wash Vol Assay Name Wash Vol ——— ——— Sample Probe Sample Probe Wash Wash — —

Refer to Assay Configuration in Section 2 of the AEROSET System Operations Manual for information regarding assay parameters. * User defined or instrument defined. ** The linear low value (L-Linear Range) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field.

6 7 8