ARCHITECT c Systems Service and Support Product Launch Training

ARCHITECT c Systems Service and Support Product Launch Training
Next Generation Lactate Dehydrogenase (LDH) P56-21 Target Launch: October 29, 2010 REF Formal approval and revision history of this document can be found in the Lotus Notes Database Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Agenda Launch Strategy Clinical Utility Methodology Sample Handling
Reagent Handling Calibration Measuring Interval Interference Precision Method Comparison Assay Specific Information Control and CAP Performance Troubleshooting Tips Questions and Answers Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Confidential: Not for customer distribution
Launch Strategy Next Generation LDH Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Next Generation LDH – Launch Strategy
The objective of the Next Generation LDH P56 is to address two primary customer complaints with the current on market LDH assay D69: 1) Lot to lot variability when using lyophilized controls QD Rev 05 2) Pre-analytical variability with heparin plasma samples See ARCHITECT cSystem Troubleshooting Guide Additionally IFCC Traceability improvement was achieved Rosler E, Klauke R, Kasal C, Schumann G, et al. Traceability of the New, Optimized ARCHITECT LDH Assay to IFCC Reference Method. 7th Annual Conference of the German Society for Clinical Chemistry & Laboratory Medicine, 2010, Clin Chem Lab Med 2010;49(9):A142. REF REF Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Lot to Lot Variability with lyophilized controls: Different reagent bulk manufactured by Wako. Reagent Lot to Lot variability at manufacturing release shall not vary by more than 5%, as stated in the product requirement document (PRD): VERIFICATION TESTING PASSED Lot to Lot Tested BioRad Lyphochek Assayed Chem Control UnAssayed Chem Control Acceptance Criterion Level 1 Level 2 % Difference LDH to LDH2 0% 1% < 5% Pass LDH to LDH3 LDH2 to LDH3 Reagent Lot Lot (LDH) Lot (LDH2) Lot (LDH3) Control BioRad Lyphochek Assayed Chem Control BioRad Lyphochek UnAssayed Chem Control Level Level 1 Level 2 Mean 176.65 394.88 184.00 419.89 176.04 392.40 182.00 417.01 175.96 392.24 181.88 417.12 SD 1.23 1.15 1.89 1.51 2.37 2.30 0.93 1.81 1.22 1.37 1.03 1.80 % CV 0.70 0.29 0.36 1.35 0.59 0.51 0.43 0.69 0.35 0.57 Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Pre-analytical variability with heparin plasma samples: The Next Generation LDH P56 will load parameters with a 1:3 default dilution to address the pre-analytical variability. It also offers an “UNDILUTED” protocol which can be used by those customers that run serum samples only. REF Serum (Becton Dickinson Tubes – Glass; BD # ) Lithium Heparin (Becton Dickinson Tubes with barrier; BD # ) Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

A high frequency of duplicate errors has been described by Bakker, et al. in heparin plasma samples1. Heparin plasma samples “may contain thrombocytes, which have a high LDH concentration” 2. “Although the recommendations for LDH measurements state that serum is the preferred sample for LDH, in daily practice heparin plasma is preferred because it is more rapidly available, delayed clotting is absent, and cell lysis is lower than in serum. Therefore, a reliable method for measuring LDH in heparin plasma is necessary”1. Bakker et al. found that the frequency of the duplicate errors was reduced by transferring the plasma to a secondary sample cup. By working with Roche they developed a 1:4 predilution that was very effective in reducing the frequency of the duplicate errors. Bakker AJ, Bakker A, Bierma-Ram A, et al. Improved Reliability of Measurement of Lactate Dehydrogenase by IFCC Method in Heparin Plasma. Clin Chem 2005:51(1);215-7. Bais R, Philcox M. Approved recommendation on IFCC methods for the measurement of catalytic concentration of enzymes. Part 8. IFCC- method for lactate dehydrogenase. Eur J Clin Chem Clin Biochem 1994;32: Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Assay Disk Plans: The Next Generation LDH assay P56 assay files will be published on the GSS Website to bridge the assay disk gap. Until ARCHITECT cSystems assay disk, version releases (Q1 2011), an Abbott assay specialist must install the LDH parameters for customers by creating a disk from the iso. files that will be temporarily available on the GSS website. REF Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Clinical Utility Next Generation LDH Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

LDH – Clinical Utility Background Clinical Utility
LDH is an enzyme found in the cells of many body tissues. It is composed of four peptide chains of two subunits (M form and H form) which result in a possible five different isoenzymes Measurement of the total LDH activity in serum or plasma is non specific and cannot differentiate the tissues of origin of the component isoenzymes. Clinical Utility Historically one of the main clinical uses for LDH and its isoenzymes was in the diagnosis of myocardial infarction. However, that role has now been made obsolete by immunoassays for the myocardial marker, troponin. LDH is used in the differential diagnosis of hemolytic anemia and as a tumor marker in some malignancies such as germ cell tumors. LDH is elevated in hepatitis, glomerular nephritis, pulmonary embolism, muscle disease and many leukemias and lymphomas. Higher than normal levels of LDH are seen in, among other conditions: Blood flow deficiency (ischemia) Cerebrovascular accident Heart attack Hemolytic Anemia Infectious mononucleosis Liver disease (ie. hepatitis) Low blood pressure Muscle injury Muscular dystrophy New abnormal tissue formation (usually cancer) Pancreatitis Tissue death Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Methodology Next Generation LDH Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Next Generation LDH – Methodology
Lactate dehydrogenase is a hydrogen transfer enzyme that catalyzes the oxidation of L-Lactate to Pyruvate with the mediation of NAD+ as a hydrogen acceptor3. Lactate Dehydrogenase L-Lactate NAD Pyruvate NADH H+ Methodology: This method is the IFCC recommended4, 5 forward reaction Lactate to Pyruvate CAP Code Marketing has notified CAP of the impending launch. Per CAP, the code will not change because the methodology is the same as the on-market (L to P) – CAP Method Description: Abbott The next CAP survey will have a place for customers to select which list number of Lactate Dehydrogenase they are using. Burtis CA, Ashwood ER, editors, Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th ed. Philadelphia, PA: WB Saunders; 2006:601-3. Van der Heiden C, Bais R, Gerhardt W, et al. Approved recommendation on IFCC methods for the measurement of catalytic concentration of enzymes. Part 8 IFCC method for lactate dehydrogenase. Eur J Clin Chem Biochem 1994;32: Schumann G, Bonora R, Ceriotti F, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37ºC, Part-3 reference procedure for the measurement of catalytic concentration of lactate dehydrogenase, Clin Chem Lab Med 2002;40(6):643-8. Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Sample Handling Next Generation LDH Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Next Generation LDH – Sample Handling
Specimen Requirements: Serum With or without gel barrier Glass or plastic tubes Plasma Lithium Heparin (with or without gel barrier) Sodium Heparin Sample Volume: Serum volume: 3.2 µL or 35 µL The UNDILUTED or STD (1:3) dilution protocols may be used with serum samples. Plasma volume: 35 µL The STD (1:3) dilution protocol must be used for plasma samples The STD (1:3) dilution protocol addresses pre-analytical variability inherent to platelets and other cellular aggregates present in a layer at the top of heparin plasma samples. Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Next Generation LDH – Sample Handling
Specimen Storage: Temperature Maximum Storage 20 to 25°C 2 to 8°C -20°C 7 days 4 days 6 Weeks NOTE: Stored specimens must be inspected for particulates. If present, mix and centrifuge the specimen to remove particulates prior to testing. NOTE: Hemolyzed specimens must not be used because erythrocytes contain 150 times more LD activity than serum.6 Burtis CA, Ashwood ER, Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th ed. Philadelphia, PA: WB Saunders; 2006:601-3. Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Reagent Handling Next Generation LDH Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Next Generation LDH – Reagent Handling
Reagent is liquid, ready-to-use, 2 reagent kit Storage 2 to 8°C Unopened kit stable to expiration date Reagent onboard stability 30 days 2P56-21 R1=5 X 50 mL R2=5 X 16 mL *1,300 tests/kit *Calculation is based on the minimum reagent fill volume per kit. Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Calibration Next Generation LDH Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Next Generation LDH – Calibration
The next generation LDH enzyme calibration factor (11180) was established based on a method comparison with the IFCC methodology Calibration is a reagent/water blank Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Measuring Interval Next Generation LDH Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Next Generation LDH – Measuring Interval
STD (1:3) Protocol 30 to 2,000 U/L The LH field should be set to 665 U/L when using this protocol (2000 divided by 3) UNDILUTED Protocol 10 to 2,000 U/L (10 to 4,500 Flex Rate) The LH field should be set to 2000 U/L when using this protocol. or High samples will trip the Flex Rate read window, and results are valid to 4500 U/L when the LH field is set to 4500 (the result will have a “FLEX” flag). Limit of Quantitation: The LDH assay is designed to have an LoQ of < 30 U/L for the STD (1:3) dilution protocol and < 10 U/L for the UNDILUTED protocol. Representative data based on a total error of < 18% are summarized below: STD 1:3 UNDILUTED LoB LoD LoQ 7 14 2 5 Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Interference Next Generation LDH Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Next Generation LDH – Interference
Interfering Substances Interfering Substances Interferent Concentration N Target (U/L) Observed (% of Target) Unconjugated Bilirubin Conjugated Bilirubin Intralipid Lipemia 60 mg/dL 20 mg/dL 2,000 mg/dL 2,014 mg/dL 8 239.3 241.6 229.6 312.4 102 101 97 92 Other compounds are known to interfere with LDH assays including anticonvulsants and acetaminophen7. Young’s8 compendium of interfering substances should be consulted for possible additional interferents. Drug interferences were not tested by Abbott during verification. Hemolyzed specimens must not be used because erythrocytes contain 150 times more LD activity.9 Jacobs and DeMott Editors, Laboratory Test Handbook 5th Edition, Lexicomp, Inc. Hudson (Cleveland), OH (2001). Young DS. Effects of Drugs on Clinical Laboratory Tests, 5th ed. Washington, DC: AACC Press; 2000:3-486 – Burtis CA, Ashwood ER, Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th ed. Philadelphia, PA: WB Saunders; 2006:601-3. Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Precision Next Generation LDH Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Next Generation LDH – Precision
The imprecision claim of the LDH assay is < 4.7% Total CV. Representative data from verification studies are summarized below: STD (1:3) Dilution Protocol Control Level 1 Level 2 N Mean (U/L) Within Run SD %CV Between Run Between Day Total UNDILUTED Protocol Control Level 1 Level 2 N Mean (U/L) Within Run SD %CV Between Run Between Day Total Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Method Comparison Next Generation LDH Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Next Generation LDH – Method Comparison
The STD (1:3) dilution protocol runs very close in comparison to the Roche method Positive bias to the current Abbott method due to closer alignment with IFCC Method STD (1:3) Dilution Protocol ARCHITECT c8000 vs Comparative Method ARCHITECT c P56 LDH vs 7D69 LD N Y-Intercept Correlation Coefficient Slope Range (U/L) to to * % Bias at LDH Target Levels Level 1 (220 U/L) Level 2 (250 U/L) Level 3 (330 U/L) REF REF * D69 LD Assay Range REF Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

c4000 and c16000 compared to the c8000 STD (1:3) Dilution Protocol ARCHITECT c16000 vs c8000 2P56 LDH ARCHITECT c4000 vs c8000 2P56 LDH N Y-Intercept Correlation Coefficient Slope Range (U/L) to to % Bias at LDH Target Levels Level 1 (220 U/L) Level 2 (250 U/L) Level 3 (330 U/L) REF REF Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

The UNDILUTED dilution protocol has slight bias in comparison to the Roche method Positive bias to the current Abbott method, but runs closer to IFCC mean UNDILUTED Dilution Protocol ARCHITECT c8000 vs Comparative Method ARCHITECT c P56 LDH vs 7D69 LD N Y-Intercept Correlation Coefficient Slope Range (U/L) to to * % Bias at LDH Target Levels Level 1 (220 U/L) Level 2 (250 U/L) Level 3 (330 U/L) REF REF * D69 LD Assay Range REF Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

UNDILUTED Dilution Protocol
Next Generation LDH – Method Comparison c4000 and c16000 compared to the c8000 UNDILUTED Dilution Protocol ARCHITECT c16000 vs c8000 2P56 LDH ARCHITECT c4000 vs c8000 2P56 LDH N Y-Intercept Correlation Coefficient Slope Range (U/L) to to % Bias at LDH Target Levels Level 1 (220 U/L) Level 2 (250 U/L) Level 3 (330 U/L) REF REF Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Next Generation LDH – IFCC Traceability
Optimal alignment to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) primary reference method through adjustment of the calibration factor. Correlation studies were performed comparing the Next Generation LDH assay to the IFCC reference method10. Representative data from the study is displayed below: Rosler E, Klauke R, Kasal C, Schumann G, et al. Traceability of the New, Optimized ARCHITECT LDH Assay to IFCC Reference Method. 7th Annual Conference of the German Society for Clinical Chemistry & Laboratory Medicine, 2010, Clin Chem Lab Med 2010;49(9):A142. Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Next Generation LDH – IFCC Traceability
Due to improved alignment to the IFCC reference method, you may observe a shift in recovery of control, patient, and proficiency samples when converting from the current LDH (LN 7D69) to the new LDH (LN 2P56). While the shift may vary between laboratories, the expected shifts are shown below: LDH Level (U/L) 124 220 250 330 600 Expected Shift (%) * -3.0 to +11.4 +3.5 to +8.1 +4.5 to +7.6 +6.3 to +8.2 +5.2 to +10.2 * Representative data based on method comparison studies of new LDH (LN 2P56) undiluted and 1:3 auto-dilution vs current LDH (LN 7D69). Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Assay Specific Information
Next Generation LDH Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Next Generation LDH – Assay Specific Information
Assay Method: Lactate to Pyruvate forward reaction (IFCC recommended) Reagent LN: 2P56-21 Calibration: Factor Water blank Assay Stability: Rgt on board stability = 30 days Calibration stability = 30 days Sample and Reagent Volumes: Sample: (UNDIL) 3.2 µL (STD 1:3) 35 µL S vol. w/ 3.2 µL DS vol. R1 Reagent: 160 µL R2 Reagent: 40 µL Precision: Total CV < 4.7% Reportable Range: 30 to 2000 U/L (STD 1:3 Protocol) High Linearity configured as 665 10 to 2000 U/L (UNDILUTED Protocol) High Linearity configured as 2000 LoB: 7 U/L (STD 1:3) 2 U/L (UNDILUTED) LoD: 14 U/L (STD 1:3) 5 U/L (UNDILUTED) LoQ: 14 U/L (STD 1:3) 5 U/L (UNDILUTED) Acceptable Specimen: Serum Plasma Lithium Heparin Sodium Heparin Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Control and CAP Performance
Next Generation LDH Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Next Generation LDH – BioRad Control Performance
Bio-Rad Lyphochek Assayed Controls: Levels 1 & 2 Lot Number Exp Date Units Conv/SI Level I Mean Range (Low-High) Level II Mean Range (Low-High) /31/2013 U/L 176 ( ) 408 ( ) 14190 04/30/2012 167 ( ) 388 ( ) 14180 09/30/2011 165 ( ) 366 ( ) 14170 06/30/2011 156 ( ) 372 ( ) Individual laboratory means should fall within the corresponding range; however laboratory means may vary from the listed values during the life of this control. Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Next Generation LDH – BioRad Control Performance
Bio-Rad Liquid Assayed Multiqual Controls: Levels 1, 2 & 3 Lot Number Exp Date Units Conv/SI Level I Mean Range (Low-High) Level II Mean Range (Low-High) Level III Mean Range (Low-High) 45610 05/31/2013 U/L 112 (90-134) 165 ( ) 404 ( ) 45600 10/31/2011 115 (92-138) 163 ( ) 373 ( ) 45590 05/31/2011 113 (90-136) 171 ( ) 405 ( ) Individual laboratory means should fall within the corresponding range; however laboratory means may vary from the listed values during the life of this control. Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Observed Mean LDH (U/L) CAP Peer Group Mean (U/L)
Next Generation LDH – CAP Performance The table below is a summary of observed LDH ( P56) versus the Abbott ARCHITECT cSystems/AEROSET peer group* means. Difference of observed means LDH (STD 1:3 dilution) for CZVM-A 2010 REF CAP CZVM-A 2010 Observed Mean LDH (U/L) CAP Peer Group Mean (U/L) Evaluation Criteria Difference (U/L) % Difference CAP CHM-1 122 121 +/- 20% 1 0.8 CAP CHM-2 220 207 13 6.3 CAP CHM-3 444 397 47 11.8 CAP CHM-4 246 235 11 4.7 CAP CHM-5 218 5.3 CAP CHM-6 153 151 2 1.3 CAP CHM-7 234 221 5.9 CAP CHM-8 367 331 36 10.9 CAP CHM-9 447 399 48 12.0 CAP CHM-10 363 32 9.7 * CAP does not provide an All Method evaluation for enzymes. Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Troubleshooting Tips Next Generation LDH Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Next Generation LDH – Troubleshooting Tips
The default dilution protocol is STD (1:3) to reduce the occurrence of repeat variability in heparin plasma samples. The assay may be more susceptible to precision issues than undiluted assays due to faulty aspiration/dispense components when maintenance has been neglected. If a high degree of variability exists during repeat testing of samples Probable Cause(s) Corrective Action(s) A heparin plasma sample is being Either use a serum sample, used during testing with the or use the STD (1:3) dilution UNDILUTED protocol. protocol. Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Questions and Answers Next Generation LDH Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Next Generation LDH – Questions and Answers
Is the new LDH assay aligned to the IFCC reference method. The Next Generation LDH is aligned to the IFCC reference method. The enzyme calibration factor was established based on the IFCC methodology. Will we have data to support this alignment and/or will the Enzyme Traceability brochure get updated. The IFCC traceability data will be presented to the customer in a Product Information Letter. Does the customer have an option of what dilution protocol to use with this assay? Which protocol should be used for external proficiency testing – does it matter? It is recommended that all customers use the STD (1:3) protocol since it addresses pre-analytical variability in heparin plasma. There may be some risk that a random heparin plasma sample may be used even in a lab that primarily uses serum. This protocol can be used on serum samples as well as plasma. Therefore, the STD (1:3) protocol will be the default dilution when the assay file is installed. Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Should a lab run both dilution protocols? Asking labs to run both UNDILUTED and STD (1:3) is too much. It would increase their reagent and sample usage. Why is there such a negative bias in c4000 and c16000 from c8000? Will the differences cause issues with reporting to external proficiency or BioRad Unity programs? The negative bias is not clinically significant. It may be due to instrument to instrument variability during Dallas verification testing. When using the STD (1:3) dilution protocol the linear range should be larger than that for undiluted samples - so why do I need to divide the LH value by the dilution factor. Because the STD (1:3) protocol was only linear to 2000 U/L during the linearity verification studies. If a sample generates a “HH” flag, and gets repeated using the 1:5 protocol, how high is the linearity for that protocol. The linearity will flag at 3325 U/L (665 X 5) if the initial result was obtained using the STD (1:3) default dilution. Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

Does the Next Generation LDH have the same calibration instability issue as the current LD assay D69? No. The Next Generation LDH assay has been proven to be stable beyond its stated 30 day calibration interval during verification testing. REF Confidential: Not for customer distribution For information only unless accompanied by the Lotus Notes form that contains electronic signatures. c8000 Project Notebook, , version 1

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