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

Transcription

1 PHOSPHORUS 7D71-20 and 7D /R5 PHOSPHORUS This package insert contains information to run the Phosphorus assay on the ARCHITECT c Systems and the AEROSET System. 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: Canada: International: ABBOTT (English speaking customers) (French speaking customers) Call your local Abbott representative Symbols in Product Labeling Calibrators 1 and 2 Concentration Authorized Representative in the European Community Ingredients In vitro diagnostic medical device Batch code/lot number Catalog number/list number Serial number Consult instructions for use Manufacturer Temperature limitation Use by/expiration date Reagent 1 Reagent 2 ABBOTT LABORATORIES Abbott Park, IL 60064, USA ABBOTT Max-Planck-Ring Wiesbaden Germany November , 2006 Abbott Laboratories 1

2 NAME PHOSPHORUS INTENDED USE The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine. SUMMARY AND EXPLANATION OF TEST The majority of the body phosphorus (80% to 85%) is present in the bones as hydroxyapatite. The remainder of the phosphate is present as inorganic phosphorus and phosphate esters. Calcium and phosphorus in serum usually exhibit a reciprocal relationship. Increased serum phosphorus may occur in hypervitaminosis D, hypoparathyroidism, and renal failure. Reduced serum phosphorus levels are seen in rickets (Vitamin D deficiency), hyperparathyroidism, and Fanconi s syndrome. PRINCIPLES OF PROCEDURE Inorganic phosphate reacts with ammonium molybdate to form a heteropolyacid complex. The use of a surfactant eliminates the need to prepare a protein-free filtrate. The absorbance at 340 nm is directly proportional to the inorganic phosphorus level in the sample. Sample blanks must be run to correct for any non-specific absorbance in the sample. Methodology: Phosphomolybdate REAGENTS Reagent Kit Phosphorus is supplied as a liquid, ready-to-use, two-reagent kit which contains: 7D x 59 ml 10 x 84 ml Estimated tests per kit: 13,662* 7D x 27 ml 3 x 40 ml Estimated tests per kit: 1,761* *Calculation is based on the minimum reagent fill volume per kit. Reactive Ingredients Concentration Sulfuric Acid 665 mmol/l Ammonium Molybdate 2.3 mmol/l Sulfuric Acid 665 mmol/l REAGENT HANDLING AND STORAGE Reagent Handling Remove air bubbles, if present in the reagent cartridge, with a new applicator stick. Alternatively, allow the reagent to sit at the appropriate storage temperature to allow the bubbles to dissipate. To minimize volume depletion, do not use a transfer pipette to remove the bubbles. CAUTION: Reagent bubbles may interfere with proper detection of reagent level in the cartridge, causing insufficient reagent aspiration which could impact results. Reagent Storage Unopened reagents are stable until the expiration date when stored at 15 to 30 C. Reagent stability is 65 days if the reagent is uncapped and onboard. WARNINGS AND PRECAUTIONS Precautions for Users 1. For in vitro diagnostic use. 2. Do not use components beyond the expiration date. 3. Do not mix materials from different kit lot numbers. 4. CAUTION: and may be irritating to eyes and skin. Avoid direct contact with eyes and skin. In case of contact, flush with plenty of water. If irritation or signs of toxicity occur, seek medical attention. For reagents not classified as dangerous per European Directive 1999/45/EC as amended, safety data sheet available for professional user on request. 5. CAUTION: This product requires the handling of human specimens. It is recommended that all human sourced materials be considered potentially infectious and handled with in accordance with the OSHA Standard on Bloodborne Pathogens. 1 Biosafety Level 2 2 or other appropriate biosafety practices 3,4 should be used for materials that contain or are suspected of containing infectious agents. SPECIMEN COLLECTION AND HANDLING Suitable Specimens Serum, plasma, and urine are acceptable specimens. Serum: Use serum collected by standard venipuncture techniques into glass or plastic tubes with or without gel barriers. Ensure complete clot formation has taken place prior to centrifugation. Separate serum from red blood cells or gel as soon after collection as possible. Some specimens, especially those from patients receiving anticoagulant or thrombolytic therapy, may take longer to complete their clotting processes. Fibrin clots may subsequently form in these sera and the clots could cause erroneous test results. Plasma: Use plasma collected by standard venipuncture techniques into glass or plastic tubes. Acceptable anticoagulants are lithium heparin (with or without gel barrier) and sodium heparin. Ensure centrifugation is adequate to remove platelets. Separate plasma from red blood cells or gel as soon after collection as possible. Urine: Urine specimens should be collected in 6 mol/l HCl, 20 to 30 ml for a 24 hour specimen, to avoid precipitation of phosphate complexes. 5 Refer to the specimen collection tube manufacturer s instructions for processing and handling requirements. For total sample volume requirements, refer to the instrument-specific ASSAY PARAMETERS section of this package insert and Section 5 of the instrument-specific operations manual. Specimen Storage Serum, plasma, and urine Temperature Maximum Storage Bibliographic Serum/Plasma Urine Reference 20 to 25 C 1 day 2 days at ph < to 8 C 4 days no recommendation 6, 7-20 C 1 year no recommendation 6 Guder et al. 6 suggest storage of frozen specimens at -20 C for no longer than the time interval cited above. However, limitations of laboratory equipment make it necessary in practice for clinical laboratories to establish a range around -20 C for specimen storage. This temperature range may be established from either the freezer manufacturer s specifications or your laboratory standard operating procedure(s) for specimen storage. NOTE: Stored specimens must be inspected for particulates. If present, mix and centrifuge the specimen to remove particulates prior to testing. PROCEDURE Materials Provided 7D71 Phosphorus Reagent Kit Materials Required but not Provided 1E65 Multiconstituent Calibrator, 3 x 5 ml Control Material Saline (0.85% to 0.90% NaCl) for specimens that require dilution Assay Procedure For a detailed description of how to run an assay, refer to Section 5 of the instrument-specific operations manual. Specimen Dilution Procedures The ARCHITECT c Systems and the AEROSET System have automatic dilution features; refer to Section 2 of the instrument-specific operations manual for additional information. Serum and plasma: Specimens with phosphorus values exceeding 25.3 mg/dl (8.17 mmol/l) are flagged and may be diluted using the Automated Dilution Protocol or the Manual Dilution Procedure. Urine: Urine samples are automatically diluted 1:10 by the system using the Standard dilution option, then the system automatically corrects the concentration by multiplying the result by the appropriate dilution factor. This dilution extends urine Phosphorus linearity to mg/dl (60.14 mmol/l). Samples exceeding this concentration are flagged and may be diluted using the Automated Dilution Protocol or the Manual Dilution Procedure. Automated Dilution Protocol If using the Automated Dilution Protocol, the system performs a dilution of the specimen and automatically corrects the concentration by multiplying the result by the appropriate dilution factor. To set up the automatic dilution feature, refer to Section 2 of the instrument-specific operations manual for additional information. 2

3 PROCEDURE (Continued) Manual Dilution Procedure Manual dilutions should be performed as follows: Use saline (0.85% to 0.90% NaCl) to dilute the sample. The operator must enter the dilution factor in the patient or control order screen. The system uses this dilution factor to automatically correct the concentration by multiplying the result by the entered factor. If the operator does not enter the dilution factor, the result must be multiplied by the appropriate dilution factor before reporting the result. NOTE: If a diluted sample result is flagged indicating it is less than the linear low limit, do not report the result. Rerun using an appropriate dilution. For detailed information on ordering dilutions, refer to Section 5 of the instrument-specific operations manual. CALIBRATION Calibration is stable for approximately 41 days (984 hours) and is required with each change in reagent lot number. Verify calibration with at least two levels of controls according to the established quality control requirements for your laboratory. If control results fall outside acceptable ranges, recalibration may be necessary. The urine application uses the serum calibration. For a detailed description of how to calibrate an assay, refer to Section 6 of the instrument-specific operations manual. For information on calibrator standardization, refer to the Multiconstituent Calibrator package insert. QUALITY CONTROL The following is the recommendation of Abbott Laboratories for quality control. As appropriate, refer to your laboratory standard operating procedure(s) and/or quality assurance plan for additional quality control requirements and potential corrective actions. Two levels of controls (normal and abnormal) are to be run every 24 hours. If more frequent control monitoring is required, follow the established quality control procedures for your laboratory. If quality control results do not meet the acceptance criteria 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. RESULTS Refer to the instrument-specific operations manual for information on results calculations. ARCHITECT System Operations Manual Appendix C AEROSET System Operations Manual Appendix A 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. EXPECTED VALUES Reference Range Serum/Plasma 8 Range (mg/dl) Range (mmol/l) EXPECTED VALUES (Continued) Reference Range (Continued) 24 Hour Urinary Excretion To convert results from mg/dl to g/day (24 hour urinary excretion) Where: V = 24 hour urine volume (ml) c = analyte concentration (mg/dl) 24 hour excretion = [(V c) 100,000] g/day To convert results from mmol/l to mmol/day (24 hour urinary excretion) Where: V = 24 hour urine volume (ml) c = analyte concentration (mmol/l) 24 hour excretion = [(V c) 1000] mmol/day SPECIFIC PERFORMANCE CHARACTERISTICS Linearity Phosphorus serum is linear up to 25.3 mg/dl (8.17 mmol/l). Phosphorus urine is linear up to mg/dl (60.14 mmol/l). Linearity was verified using Clinical and Laboratory Standards Institute (CLSI) protocol NCCLS EP6-P. 10 Limit of Detection (LOD) The LOD for Phosphorus serum is 0.25 mg/dl (0.08 mmol/l). The LOD for Phosphorus urine is 2.5 mg/dl (0.8 mmol/l). The LOD is the mean concentration of an analyte-free sample + 2 SD, where SD = the pooled, within-run standard deviation of the analytefree sample. A study performed on an ARCHITECT c System and an AEROSET System produced an LOD for Phosphorus serum is 0.07 mg/dl (0.023 mmol/l) and for Phosphorus urine is 1.80 mg/dl (0.582 mmol/l). Limit of Quantitation (LOQ) The LOQ for Phosphorus serum is 0.62 mg/dl (0.201 mmol/l). The LOQ for Phosphorus urine is 4.39 mg/dl (1.418 mmol/l). The LOQ is the analyte concentration at which the CV = 20%. Interfering Substances 11 Interference studies were conducted using CLSI protocol NCCLS EP7-P. 12 Interference effects were assessed by Dose Response and Paired Difference methods, at the medical decision level of the analyte. Interfering N Target Observed Substance Interferent Concentration (mg/dl) (% of Target) 30 mg/dl (513 µmol/l) Bilirubin 60 mg/dl (1,026 µmol/l) mg/dl (1.25 g/l) Hemoglobin 250 mg/dl (2.50 g/l) ,000 mg/dl (10.0 g/l) Intralipid 2,000 mg/dl (20.0 g/l) Protein 12 g/dl (120 g/l) Bilirubin solutions at the above concentrations were prepared by addition of a bilirubin stock to human serum pools. Hemoglobin solutions at the above concentrations were prepared by addition of hemolysate to human serum pools. Intralipid solutions at the above concentrations were prepared by addition of Intralipid to human serum pools. For the urine application, glucose up to 1,000 mg/dl, ascorbate up to 200 mg/dl, protein up to 50 mg/dl, sodium oxalate up to 60 mg/dl, acetic acid (8.5N) up to 6.25 ml/dl, hydrochloric acid (6N) up to 2.5 ml/dl, nitric acid (6N) up to 5.0 ml/dl, boric acid up to 250 mg/dl, sodium fluoride up to 400 mg/dl, and sodium carbonate up to 1.25 g/dl demonstrated less than 10% interference. Adult 2.3 to to 1.52 To convert results from mg/dl to mmol/l, multiply mg/dl by Urine 9 Range (g/day) Range (mmol/day) On nonrestricted diet 0.4 to to 42.0 To convert results from g/day to mmol/day, multiply g/day by It is recommended that each laboratory determine its own reference range based upon its particular locale and population characteristics. 3

4 SPECIFIC PERFORMANCE CHARACTERISTICS (Continued) Precision Serum The imprecision of the Phosphorus serum assay is 4.6% Total CV. Representative data from studies using CLSI protocol NCCLS EP5-A 13 are summarized below. Control Level 1 Level 2 N Mean (mg/dl) Within Run SD %CV Between Run SD %CV Between Day SD %CV Total SD %CV Urine The imprecision of the Phosphorus urine assay is 4.6% Total CV. Representative data from studies using CLSI protocol NCCLS EP10-A 14 are summarized below. Control Level 1 Level 2 N Mean (mg/dl) Within Run SD %CV Between Run SD %CV Between Day SD %CV Total SD %CV Method Comparison Correlation studies were performed using CLSI protocol NCCLS EP9-A. 15 Serum and urine results from the Phosphorus assay on the AEROSET System were compared with those from a commercially available phosphomolybdate methodology. Serum and urine results from the Phosphorus assay on an ARCHITECT c System were compared with those from the Phosphorus assay on the AEROSET System. Serum AEROSET vs. Comparative Method ARCHITECT vs. AEROSET N Y - Intercept Correlation Coefficient Slope Range (mg/dl)* 1.49 to to *AEROSET Range BIBLIOGRAPHY 1. US Department of Labor, Occupational Safety and Health Administration. 29 CFR Part Occupational Exposure to Bloodborne Pathogens. 2. US Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories. HHS Publication (CDC), 4th ed. Washington, DC: US Government Printing Office, May World Health Organization. Laboratory Biosafety Manual. Geneva: World Health Organization; Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline--Third Edition (M29-A3). Wayne, PA: Clinical and Laboratory Standards Institute, Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry, 2nd ed. Philadelphia, PA: WB Saunders; 1994: Guder WG, Narayanan S, Wisser H, et al. List of analytes preanalytical variables. Annex In: Samples: From the Patient to the Laboratory. Darmstadt, Germany: GIT Verlag; 1996:Annex 20 1, US Pharmacopeial Convention, Inc. General notices. In: US Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18). Rockville, MD: The US Pharmacopeial Convention, Inc; 1994: Henry JB. Clinical Diagnosis and Management by Laboratory Methods, 19th ed. Philadelphia, PA: WB Saunders; 1996: Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry, 2nd ed. Philadelphia, PA: WB Saunders; 1994: Passey RB, Bee DE, Caffo A, et al. Evaluation of the Linearity of Quantitative Analytical Methods; Proposed Guideline (EP6-P). Villanova, PA: The National Committee for Clinical Laboratory Standards, Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed. Washington, DC: AACC Press; 1995: Powers DM, Boyd JC, Glick MR, et al. Interference Testing in Clinical Chemistry; Proposed Guideline (EP7-P). Villanova, PA: The National Committee for Clinical Laboratory Standards, Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline (EP5-A). Wayne, PA: The National Committee for Clinical Laboratory Standards, Krouwer JS, Castaneda-Mendez K, Dawson JM, et al. Preliminary Evaluation of Quantitative Clinical Laboratory Methods; Approved Guideline (EP10-A). Wayne, PA: The National Committee for Clinical Laboratory Standards, Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (EP9-A). Wayne, PA: The National Committee for Clinical Laboratory Standards, TRADEMARKS AEROSET and ARCHITECT are registered trademarks of Abbott Laboratories. c System is a trademark of Abbott Laboratories. All other trademarks, brands, product names, and trade names are the property of their respective companies. Urine AEROSET vs. Comparative Method ARCHITECT vs. AEROSET N Y - Intercept Correlation Coefficient Slope Range (mg/dl)* 6.17 to to *AEROSET Range 4

5 ARCHITECT c SYSTEMS ASSAY PARAMETERS Phosphorus Serum/Plasma Conventional and SI Units Configure assay parameters General General о Calibration о SmartWash о Results о Interpretation Assay: Phos Type: Photometric Version: 1 Number: 1011 Reaction definition о Reagent / Sample о Validity checks Reaction mode: End up Primary Secondary Read times Wavelength: 340 / 380 Main: Last required read: 26 Absorbance range: Color correction: Sample blank type: Self Blank: о Reaction definition Reagent / Sample о Validity checks R1 R2 Reagent: PHOS0 Reagent volume: Diluent: Saline Water volume: 160 Diluent dispense mode: Type 0 Dispense mode: Type 0 Type 0 Diluted Default Dilution name Sample sample Diluent Water Dilution factor dilution STANDARD : 3.2 = 1:1.00 : = о : = о о Reaction definition о Reagent / Sample Validity checks Reaction check: None Maximum absorbance variation: Configure assay parameters Calibration о General Calibration о SmartWash о Results о Interpretation Assay: Phos Calibration method: Linear Calibrators о Volumes о Intervals о Validity checks Calibrator set: Calibrator level: Concentration: MCC Blank: Water 0 Cal 1: MCC1 Replicates: 3 [Range 1 3] Cal 2: MCC2 о Calibrators Volumes о Intervals о Validity checks Calibrator: MCC Diluted Calibrator level Sample sample Diluent Water Blank: Water 3.2 Cal 1: MCC1 3.2 Cal 2: MCC2 3.2 о Calibrators о Volumes Intervals о Validity checks Calibration intervals: Full interval: 984 (hours) Calibration type: Adjust type: None Configure assay parameters SmartWash о General о Calibration SmartWash о Results о Interpretation Assay: Phos COMPONENT REAGENT / ASSAY WASH Volume Replicates Cuvette Trig 10% Detergent B*** 345 *** Select Detergent B for software prior to version 2.2. Phosphorus Serum/Plasma Conventional Units Configure assay parameters Results Conventional units о General о Calibration о SmartWash Results о Interpretation Assay: Phos Result units: mg/dl Assay defaults: Low-Linearity: 0.7 High-Linearity: 25.3 Gender and age specific ranges: GENDER AGE (UNITS) NORMAL EXTREME Either (Y) Configure result units Conventional units Assay: Phos Version: 1 Result units: mg/dl Decimal places: 1 [Range 0 4] Correlation factor: Intercept: Phosphorus Serum/Plasma SI Units Configure assay parameters Results SI units о General о Calibration о SmartWash Results о Interpretation Assay: Phos Result units: mmol/l Assay defaults: Low-Linearity: 0.21 High-Linearity: 8.17 Gender and age specific ranges: GENDER AGE (UNITS) NORMAL EXTREME Either (Y) Configure result units SI units Assay: Phos Version: 1 Result units: mmol/l Decimal places: 2 [Range 0 4] Correlation factor: Intercept: 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 The linear low value (Low-LInearity) is LOQ rounded up to the number of decimal places defined in the decimal places parameter field. Refer to concentration specified on calibrator labeling or value sheet. Displays the number of decimal places defined in the decimal places parameter field. 5

6 ARCHITECT c SYSTEMS ASSAY PARAMETERS Phosphorus Urine Conventional and SI Units Configure assay parameters General General о Calibration о SmartWash о Results о Interpretation Assay: Phos-U Type: Photometric Version: 1 Number: 1042 Reaction definition о Reagent / Sample о Validity checks Reaction mode: End up Primary Secondary Read times Wavelength: 340 / 380 Main: Last required read: 26 Absorbance range: Color correction: Sample blank type: Self Blank: о Reaction definition Reagent / Sample о Validity checks R1 R2 Reagent: PHOS0 Reagent volume: Diluent: Saline Water volume: 160 Diluent dispense mode: Type 0 Dispense mode: Type 0 Type 0 Diluted Default Dilution name Sample sample Diluent Water Dilution factor dilution STD(1:10) : = 1:10.00 : = о : = о о Reaction definition о Reagent / Sample Validity checks Reaction check: None Maximum absorbance variation: Configure assay parameters Calibration о General Calibration о SmartWash о Results о Interpretation Assay: Phos-U Calibration method: Use Cal Factor/Blank Use Cal factor from: Phos Configure assay parameters SmartWash о General о Calibration SmartWash о Results о Interpretation Assay: Phos-U COMPONENT REAGENT / ASSAY WASH Volume Replicates Cuvette Trig 10% Detergent B*** 345 *** Select Detergent B for software prior to version 2.2. Phosphorus Urine Conventional Units Configure assay parameters Results Conventional units о General о Calibration о SmartWash Results о Interpretation Assay: Phos-U Result units: mg/dl Assay defaults: Low-Linearity: 0.5 High-Linearity: 18.6 Gender and age specific ranges: GENDER AGE (UNITS) NORMAL EXTREME Configure result units Conventional units Assay: Phos-U Version: 1 Result units: mg/dl Decimal places: 1 [Range 0 4] Correlation factor: Intercept: Phosphorus Urine SI Units Configure assay parameters Results SI units о General о Calibration о SmartWash Results о Interpretation Assay: Phos-U Result units: mmol/l Assay defaults: Low-Linearity: 0.15 High-Linearity: 6.01 Gender and age specific ranges: GENDER AGE (UNITS) NORMAL EXTREME Configure result units SI units Assay: Phos-U Version: 1 Result units: mmol/l Decimal places: 2 [Range 0 4] Correlation factor: Intercept: The linear low value (Low-Linearity) is LOQ divided by the Standard dilution factor, then rounded up to the number of decimal places defined in the decimal places parameter field. The linear high value (High-Linearity) is Linearity divided by the Standard dilution factor. 6

7 AEROSET SYSTEM ASSAY PARAMETERS Phosphorus Serum/Plasma Conventional Units Assay Configuration: Outline Page Assay Name Assay # Line Phos 11 A-Line Quantitative Ranges Min Text Min Panic-L L-Reference-H Panic-H Max Max Text * 0.0* * * 0.7** L-Linear Range-H 25.3 Reference Ranges* Age Male Female Qualitative Ranges N/A Phosphorus Serum/Plasma SI Units Assay Configuration: Outline Page Assay Name Assay # Line Phos 11 A-Line Quantitative Ranges Min Text Min Panic-L L-Reference-H Panic-H Max Max Text * 0.0* * * 0.21** L-Linear Range-H 8.17 Reference Ranges* Age Male Female Qualitative Ranges N/A Assay Configuration: Base Page Reaction Mode Wavelength-Prim/Sec Read time-main/flex AbsMaxVar END UP 340 / / Sample Blank Test Blank Read Time Abs Window Abs Limits Phos ( 11 ) S.Vol DS.Vol D.Vol W.Vol Standard Rgt Name/Pos Dil Diluent: * Dil Type# 0 Rgt Name/Pos R.Vol W.Vol Type# Reagent 1 PHOS061 * Reagent 2 PHOS062 * Reaction Check Read Time A/B Range Minimum 1 1 / Factor/Intercept Decimal Places Units 1.0 / mg/dl Assay Configuration: Base Page Reaction Mode Wavelength-Prim/Sec Read time-main/flex AbsMaxVar END UP 340 / / Sample Blank Test Blank Read Time Abs Window Abs Limits Phos ( 11 ) S.Vol DS.Vol D.Vol W.Vol Standard Rgt Name/Pos Dil Diluent: * Dil Type# 0 Rgt Name/Pos R.Vol W.Vol Type# Reagent 1 PHOS061 * Reagent 2 PHOS062 * Reaction Check Read Time A/B Range Minimum 1 1 / Factor/Intercept Decimal Places Units 1.0 / mmol/l Assay Configuration: Calibration Page Calib Mode Interval (H) Linear 984 Blank/Calib Replicates Extrapolation % Span Span Abs Range 3 / 3 0 BLK Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range BLK Water C1 MCC Cal Deviation C2 MCC FAC Limit (%) 10 Assay Configuration: SmartWash Page Rgt Probe Reagent Wash Vol Cuvette Assay Name Wash Vol Sample Probe Wash Assay Configuration: Calibration Page Calib Mode Interval (H) Linear 984 Blank/Calib Replicates Extrapolation % Span Span Abs Range 3 / 3 0 BLK Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range BLK Water C1 MCC Cal Deviation C2 MCC FAC Limit (%) 10 Assay Configuration: SmartWash Page Rgt Probe Reagent Wash Vol Cuvette Assay Name Wash Vol Sample Probe 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. Rgt Name listed is for 7D For 7D71-30, change Reagent 1 name to PHOS051; change Reagent 2 name to PHOS052. 7

8 AEROSET SYSTEM ASSAY PARAMETERS Phosphorus Urine Conventional Units Assay Configuration: Outline Page Assay Name Assay # Line Phos-U 42 A-Line Quantitative Ranges Min Text Min Panic-L L-Reference-H Panic-H Max Max Text * 0.0* * * 0.5** L-Linear Range-H 18.6** Reference Ranges* Age Male Female Qualitative Ranges N/A Phosphorus Urine SI Units Assay Configuration: Outline Page Assay Name Assay # Line Phos-U 42 A-Line Quantitative Ranges Min Text Min Panic-L L-Reference-H Panic-H Max Max Text * 0.0* * * 0.15** L-Linear Range-H 6.01** Reference Ranges* Age Male Female Qualitative Ranges N/A Assay Configuration: Base Page Reaction Mode Wavelength-Prim/Sec Read time-main/flex AbsMaxVar END UP 340 / / Sample Blank Test Blank Read Time Abs Window Abs Limits Phos-U ( 42 ) S.Vol DS.Vol D.Vol W.Vol Standard Rgt Name/Pos Dil Diluent: DILUENT C 10* Dil Type# 0 Rgt Name/Pos R.Vol W.Vol Type# Reagent 1 PHOS061 * Reagent 2 PHOS062 * Reaction Check Read Time A/B Range Minimum 1 1 / Factor/Intercept Decimal Places Units 1.0 / mg/dl Assay Configuration: Base Page Reaction Mode Wavelength-Prim/Sec Read time-main/flex AbsMaxVar END UP 340 / / Sample Blank Test Blank Read Time Abs Window Abs Limits Phos-U ( 42 ) S.Vol DS.Vol D.Vol W.Vol Standard Rgt Name/Pos Dil Diluent: DILUENT C 10* Dil Type# 0 Rgt Name/Pos R.Vol W.Vol Type# Reagent 1 PHOS061 * Reagent 2 PHOS062 * Reaction Check Read Time A/B Range Minimum 1 1 / Factor/Intercept Decimal Places Units 1.0 / mmol/l Assay Configuration: Calibration Page Calib Mode Use Cal Factor from Interval (H) UseFac/Blk Phos ( 11 ) 0 Blank/Calib Replicates Extrapolation % Span Span Abs Range 0 / 0 0 BLK Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range BLK C Cal Deviation C Assay Configuration: Calibration Page Calib Mode Use Cal Factor from Interval (H) UseFac/Blk Phos ( 11 ) 0 Blank/Calib Replicates Extrapolation % Span Span Abs Range 0 / 0 0 BLK Sample S.Vol DS.Vol D.Vol W.Vol Blk Abs Range BLK C Cal Deviation C Assay Configuration: SmartWash Page Rgt Probe Reagent Wash Vol Cuvette Assay Name Wash Vol Sample Probe Wash Assay Configuration: SmartWash Page Rgt Probe Reagent Wash Vol Cuvette Assay Name Wash Vol Sample Probe 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 divided by the Standard dilution factor, then rounded up to the number of decimal places defined in the decimal places parameter field. The linear high value (Linear Range-H) is Linearity divided by the Standard dilution factor. Rgt Name listed is for 7D For 7D71-30, change Reagent 1 name to PHOS051; change Reagent 2 name to PHOS052. 8