For In Vitro Diagnostic Use. Rx Only. Reviewed by Date Reviewed by Date

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1 SYNCHRON System(s) Chemistry Information Sheet 2014 Beckman Coulter, Inc. All rights reserved. SALY Salicylate For In Vitro Diagnostic Use ANNUAL REVIEW Rx Only Reviewed by Date Reviewed by Date PRINCIPLE INTENDED USE SALY reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Salicylate Calibrator, is intended for quantitative determination of salicylate concentration in human serum or plasma. CLINICAL SIGNIFICANCE Salicylates are a class of analgesic, antipyretic, and anti-in ammatory drugs that includes aspirin. Salicylate overdose results in disturbances of the central nervous system and the gastrointestinal tract as well as encephalopathy and renal failure. 1 METHODOLOGY SALY reagent is used to measure SALY concentration by a timed-endpoint method. In the reaction, salicylate hydroxylase catalyzes the conversion of salicylate and NADH to catechol and NAD in the presence of oxygen. The SYNCHRON System(s) automatically proportions the appropriate sample and reagent volumes into a cuvette. The ratio used is one part sample to 56 parts reagent. The system monitors the change in absorbance at 340 nanometers. This change in absorbance is directly proportional to the concentration of SALY in the sample and is used by the System to calculate and express the SALY concentration. CHEMICAL REACTION SCHEME MAY 2015 Page 1 of 11

2 SPECIMEN TYPE OF SPECIMEN Biological uid samples should be collected in the same manner routinely used for any laboratory test. 2 Freshly drawn serum or plasma are the specimens of choice. Acceptable anticoagulants are listed in PROCEDURAL NOTES section of this chemistry information sheet. Whole blood is not recommended for use as a sample. SPECIMEN STORAGE AND STABILITY 1. Tubes of blood are to be kept closed at all times and in a vertical position. It is recommended that the serum or plasma be physically separated from contact with cells within two hours from the time of collection Separated serum or plasma should not remain at room temperature longer than 8 hours. If assays are not completed within 8 hours, serum or plasma should be stored at +2 C to +8 C. If assays are not completed within 48 hours, or the separated sample is to be stored beyond 48 hours, samples should be frozen at -15 C to -20 C. Frozen samples should be thawed only once. Analyte deterioration may occur in samples that are repeatedly frozen and thawed. 3 Additional specimen storage and stability conditions as designated by this laboratory: SAMPLE VOLUME The optimum volume, when using a 0.5 ml sample cup, is 0.3 ml of sample. For optimum primary sample tube volumes and minimum volumes, refer to the Primary Tube Sample Template for your system. CRITERIA FOR UNACCEPTABLE SPECIMENS Refer to the PROCEDURAL NOTES section of this chemistry information sheet for information on unacceptable specimens. Criteria for sample rejection as designated by this laboratory: PATIENT PREPARATION Special instructions for patient preparation as designated by this laboratory: SALY EN Chemistry Information Sheet A18551 AM Page 2 of 11 MAY 2015

3 SPECIMEN HANDLING Special instructions for specimen handling as designated by this laboratory: REAGENTS CONTENTS Each kit contains the following items: Two SALY Reagent Cartridges (2 x 45 tests) One bottle Salicylate Calibrator (liquid), 5 ml VOLUMES PER TEST Sample Volume 4 µl Total Reagent Volume 225 µl Cartridge Volumes A B 150 µl C 75 µl REACTIVE INGREDIENTS REAGENT CONSTITUENTS Salicylate NADH Reagent: NADH (1.2 mmol/l) Salicylate Enzyme Reagent: Salicylate Hydroxylase (> 770 U/L) 9.3 ml 4.6 ml Also non-reactive chemicals necessary for optimal system performance. CALIBRATOR CONSTITUENTS Sodium Salicylate [20.7 mg/dl (1.5 mmol/l)] 5 ml Also non-reactive chemicals necessary for optimal system performance. GHS HAZARD CLASSIFICATION Salicylate Reagent (Compartment B) WARNING H316 Causes mild skin irritation. MAY 2015 Page 3 of 11

4 P332+P313 If skin irritation occurs: Get medical advice/attention. Tris(hydroxymethyl) aminomethane 1-5% Safety Data Sheet is available at techdocs.beckmancoulter.com EUROPEAN HAZARD CLASSIFICATION Salicylate Reagent (Compartment B) Xn;R22 R22 R36/37/38 Harmful if swallowed. Irritating to eyes, respiratory system and skin. MATERIALS NEEDED BUT NOT SUPPLIED WITH REAGENT KIT At least two levels of control material Saline (low calibrator) REAGENT PREPARATION No preparation is required. ACCEPTABLE REAGENT PERFORMANCE The acceptability of a reagent is determined by successful calibration and by ensuring that quality control results are within your facility s acceptance criteria. REAGENT STORAGE AND STABILITY SALY reagent, when stored unopened at +2 C to +8 C, will obtain the shelf-life indicated on the cartridge label. Once opened, the reagent is stable for 60 days at +2 C to +8 C unless the expiration date is exceeded. DO NOT FREEZE. Reagent storage location: CALIBRATION CALIBRATOR REQUIRED SYNCHRON Systems Salicylate Calibrator (included in reagent kit) Saline (low calibrator) CALIBRATOR PREPARATION No preparation is required. CALIBRATOR STORAGE AND STABILITY SYNCHRON Systems Salicylate Calibrator is stable until the expiration date printed on the label if stored capped in the original container at +2 C to +8 C. DO NOT FREEZE. SALY EN Chemistry Information Sheet A18551 AM Page 4 of 11 MAY 2015

5 Calibrator storage location: CALIBRATION INFORMATION 1. The system must have a valid calibration curve in memory before control or patient samples can be run. 2. Under typical operating conditions the SALY reagent cartridge must be calibrated every 30 days and also with certain parts replacements or maintenance procedures, as de ned in UniCel DxC 600/800 System Instructions For Use (IFU) manual. This assay has within-lot calibration available. Refer to the UniCel DxC 600/800 System Instructions For Use (IFU) manual for information on this feature. 3. For detailed calibration instructions, refer to the UniCel DxC 600/800 System Instructions For Use (IFU) manual. 4. The system will automatically perform checks on the calibration and produce data at the end of calibration. In the event of a failed calibration, the data will be printed with error codes and the system will alert the operator of the failure. For information on error codes, refer to the UniCel DxC 600/800 System Instructions For Use (IFU) manual. CALIBRATOR ASSIGNED VALUES The assigned value for Salicylate Calibrator was achieved based upon the addition of sodium salicylate to achieve a target concentration of 20.7 mg/dl (1.5 mmol/l). The calibrator values are speci c to the assay methodologies of the SYNCHRON Systems. Values by other methodologies may be different. CALIBRATOR SUMMARY SYNCHRON Systems Salicylate Calibrator is prepared in an aqueous solution by weighing the appropriate amount of sodium salicylate to achieve 20.7 mg/dl (1.5 mmol/l). The calibrator is designed for generation of a two-point calibration curve using saline as a low-level calibrator. CALIBRATOR LIMITATIONS The SYNCHRON Systems Salicylate Calibrator should be used only in conjunction with SYNCHRON Systems and SYNCHRON SALY reagents. TRACEABILITY Salicylate measurand (analyte) in this calibrator is traceable to the manual Trinder method. 4 The traceability process is based on pren ISO The values were veri ed using representative samples from this lot of calibrator and are speci c to the assay methodologies of the SYNCHRON System(s). Values determined by other methodologies may be different. Such differences, if present, may be caused by inter-method bias. QUALITY CONTROL At least two levels of control material should be analyzed daily. In addition, these controls should be run with each new calibration, with each new reagent cartridge, and after speci c maintenance or troubleshooting procedures as detailed in the appropriate system manual. More frequent use of controls or the use of additional controls is left to the discretion of the user based on good laboratory practices or laboratory accreditation requirements and applicable laws. The following controls should be prepared and used in accordance with the package inserts. Discrepant quality control results should be evaluated by your facility. MAY 2015 Page 5 of 11

6 Table 1.0 Quality Control Material CONTROL NAME SAMPLE TYPE STORAGE TESTING PROCEDURE(S) 1. If necessary, load the reagent onto the system. 2. After reagent load is completed, calibration may be required. 3. Program samples and controls for analysis. 4. After loading samples and controls onto the system, follow the protocols for system operations. For detailed testing procedures, refer to the UniCel DxC 600/800 System Instructions For Use (IFU) manual. CALCULATIONS The SYNCHRON System(s) performs all calculations internally to produce the nal reported result. The system will calculate the nal result for sample dilutions made by the operator when the dilution factor is entered into the system during sample programming. REPORTING RESULTS Equivalency between the SYNCHRON LX and UniCel DxC 600/800 Systems has been established. Chemistry results between these systems are in agreement and data from representative systems may be shown. REFERENCE INTERVALS The values given below are intended to act only as a guide. The pharmacological response to serum salicylate level is subject to considerable individual variation. The therapeutic levels are less than 30 mg/dl, toxic levels are considered to be 30 mg/dl (2.2 mmol/l) or greater, and concentrations greater than 60 mg/dl (4.34 mmol/l) are often lethal. 5 Table 2.0 Reference intervals Laboratory INTERVALS SAMPLE TYPE CONVENTIONAL UNITS S.I. UNITS Refer to References (5,6,7) for guidelines on establishing laboratory-speci c reference intervals. SALY EN Chemistry Information Sheet A18551 AM Page 6 of 11 MAY 2015

7 Additional reporting information as designated by this laboratory: PROCEDURAL NOTES ANTICOAGULANT TEST RESULTS The following anticoagulants were assessed by Deming regression analysis with a minimum of 47 paired serum and plasma samples. Values of serum (X) ranging from 5 mg/dl to 95 mg/dl were compared with the values of plasma (Y) yielding the following results. Table 3.0 Acceptable Test Results ANTICOAGULANT LEVEL OF ANTICOAGULANT TESTED DEMING REGRESSION ANALYSIS Lithium Heparin 14 Units/mL Y = 1.006X + 0.2; r = Sodium Heparin 14 Units/mL Y = 0.996X + 0.2; r = EDTA 1.5 mg/ml Y = 0.992X + 0.3; r = LIMITATIONS None identi ed INTERFERENCES 1. The following substances were tested for interference with this methodology: Table 4.0 Interferences SUBSTANCE SOURCE LEVEL OBSERVED EFFECT Hemoglobin RBC hemolysate 300 mg/dl -5.9 mg/dl Bilirubin a Porcine 12 mg/dl NSI b Lipemia Human 2+ NSI a With 18 mg/dl bilirubin, there is a 3 mg/dl positive interference at 24 mg/dl salicylate. b NSI = No Signi cant Interference (within ±3.0 mg/dl or 10%). 2. Lipemic samples should be ultra-centrifuged (90,000 x g for 10 minutes) prior to analysis. 3. Refer to References (8,9,10) for other interferences caused by drugs, disease and preanalytical variables. PERFORMANCE CHARACTERISTICS ANALYTIC RANGE The SYNCHRON System(s) method for the determination of this analyte provides the following analytical range: MAY 2015 Page 7 of 11

8 Table 5.0 Analytical Range SAMPLE TYPE CONVENTIONAL UNITS S.I. UNITS Serum or Plasma mg/dl mmol/l Samples with concentrations outside of the analytical range will be reported as "<4.0 mg/dl" ("<0.3 mmol/l") or ">100.0 mg/dl" (">7.2 mmol/l"). Samples reported out as greater than the analytical range may be con rmed by diluting with saline and reanalyzing. The appropriate dilution factor should be applied to the reported result. REPORTABLE RANGE (AS DETERMINED ON SITE): Table 6.0 Reportable Range SAMPLE TYPE CONVENTIONAL UNITS S.I. UNITS SENSITIVITY Sensitivity is de ned as the lowest measurable concentration which can be distinguished from zero with 95% con dence. Sensitivity for SALY determination is 4 mg/dl (0.3 mmol/l). EQUIVALENCY Equivalency was assessed by Deming regression analysis of patient samples to accepted clinical methods. a Serum or plasma (in the range of 5 to 95 mg/dl): Y (SYNCHRON LX Systems) = 1.096X ± Intercept = N = 75 MEAN (SYNCHRON LX Systems) = 47.5 MEAN (Abbott TDx) a = 43.5 CORRELATION COEFFICIENT (r) = TDx is a registered trademark of Abbott Laboratories. Refer to References (11) for guidelines on performing equivalency testing. PRECISION A properly operating SYNCHRON System(s) should exhibit precision values less than or equal to the following: Table 7.0 Precision Values a 1 SD CHANGEOVER VALUE TYPE OF a PRECISION SAMPLE TYPE mg/dl mmol/l mg/dl mmol/l % CV Within-run Serum/Plasma Total Serum/Plasma When the mean of the test precision data is less than or equal to the changeover value, compare the test SD to the SD guideline given above to determine the acceptability of the precision testing. When the mean of the test precision data is greater than the changeover value, compare the test % CV to the guideline given above to determine acceptability. Changeover value = (SD guideline/cv guideline) x 100. SALY EN Chemistry Information Sheet A18551 AM Page 8 of 11 MAY 2015

9 Comparative performance data for the SYNCHRON LX System evaluated using the NCCLS Approved Guideline EP5-A appears in the table below. 12 Each laboratory should characterize their own instrument performance for comparison purposes. Table 8.0 NCCLS EP5-A Precision Estimate Method a TYPE OF IMPRECISION Within-run Total SAMPLE TYPE No. Systems No. Data Points a EP5-A Calculated Test Mean Point Estimates Value (mg/dl) SD %CV Serum/Plasma Serum/Plasma Serum/Plasma Serum/Plasma Serum/Plasma Serum/Plasma The point estimate is based on the pooled data from one system, run for twenty days, two runs per day, two observations per run on an instrument operated and maintained according to the manufacturer s instructions. NOTICE These degrees of precision and equivalency were obtained in typical testing procedures on a SYNCHRON LX System and are not intended to represent the performance speci cations for this reagent. ADDITIONAL INFORMATION For more detailed information on UniCel DxC Systems, refer to the appropriate system manual. Beckman Coulter, the Beckman Coulter Logo, Synchron, UniCel and DxC are trademarks of Beckman Coulter, Inc and are registered in the USPTO. SHIPPING DAMAGE If damaged product is received, notify your Beckman Coulter Clinical Support Center. REVISION HISTORY Revision AE Revised Quality Control section, and removed the sodium azide warning. Revision AF Updated corporate address. Revision AG Added Revision History. Revision AH Revised Interferences section. MAY 2015 Page 9 of 11

10 Revision AJ Added new language requirement: Czech, and Korean. Revision AK Removed references to CX and LX systems as they are discontinued effective 12/2013. Added Beckman Coulter trademark statement and disclaimer. Revision AL Added GHS Classi cation information Revision AM Added GHS Classi cation information SALY EN Chemistry Information Sheet A18551 AM Page 10 of 11 MAY 2015

11 REFERENCES 1. Burtis, C. A., Ashwood, E. R., Tietz, Textbook of Clinical Chemistry, 3rd Edition, W. B. Saunders, Philadelphia, PA (1999). 2. Tietz, N. W., "Specimen Collection and Processing; Sources of Biological Variation", Textbook of Clinical Chemistry, 5th Edition, W. B. Saunders, Philadelphia, PA (2005). 3. National Committee for Clinical Laboratory Standards, Procedures for the Handling and Processing of Blood Specimens, Approved Guideline, 2nd Edition, NCCLS publication H18-A, Villanova, PA (2000). 4. Trinder, P., "Rapid Determination of Salicylate in Biological Fluids", Biochem Journal, 57 pp (1954). 5. Tietz, N. W., ed., Fundamentals of Clinical Chemistry, 6th Edition, W. B. Saunders, Philadelphia, PA (2007). 6. National Committee for Clinical Laboratory Standards, How to Define, Determine, and Utilize Reference Intervals in the Clinical Laboratory, Approved Guideline, 2nd Edition, NCCLS publication C28-A, Villanova, PA (2000). 7. Henry, J. B., Clinical Diagnosis and Management by Laboratory Methods, 22nd Edition, W. B. Saunders Company, Philadelphia, PA (2006). 8. Young, D. S., Effects of Drugs on Clinical Laboratory Tests, 5th Edition, AACC Press, Washington, D. C. (2000). 9. Friedman, R. B., Young, D. S., Effects of Disease on Clinical Laboratory Tests, 4th Edition, AACC Press, Washington, D.C. (2001). 10. Young, D. S., Effects of Preanalytical Variables on Clinical Laboratory Tests, 3rd Edition, AACC Press, Washington, D. C. (2007). 11. National Committee for Clinical Laboratory Standards, Method Comparison and Bias Estimation Using Patient Samples Approved Guideline, NCCLS publication EP9-A, Villanova, PA (1995). 12. National Committee for Clinical Laboratory Standards, Evaluation of Precision Performance of Clinical Chemistry Devices, Approved Guideline, Vol. 19, No. 2, NCCLS publication EP5-A, Villanova, PA (1999). Beckman Coulter Eurocenter S.A., 22, rue Juste-Olivier. Case Postale 1044, CH Nyon 1, Switzerland Tel: +41 (0) Beckman Coulter, Inc., 250 S. Kraemer Blvd., Brea, CA U.S.A. MAY 2015 Page 11 of 11