1. Quality Assurance Programmes for Laboratory Testing - An Overview Elizabeth M. Dax National Serology Reference Laboratory, Australia www.nrl.gov.au Elizabeth M. Dax National Serology Reference Laboratory, Australia www.nrl.gov.au

2. Quality Assurance Is the series of procedures that ensure that a correct result is achieved in a standard, reproducible and traceable manner.

3. Quality Assurance System Kit Evaluation Performance Monitoring Strategy development Trouble shooting Tertiary Reference Testing Specificity monitoring Quality Control QAP (Batch testing) PERFORMANCE QUALITY PERFORMANCE Pre-marketing PERFORMANCE QUALITY PERFORMANCE

4. Document Control/SOPs Equipment maintenance QAP Safety Training Trouble Shooting Specimen Collection Specimen Processing Testing QC Reporting Other Management Controls

5. Quality Assurance Programme 1. Test Kit Evaluation 1. Test Kit Evaluation when what, how Pre-market Post-market 7. Re-evaluation 4. QC 3. QAP 8. Strategy development 5. Monitoring 2. Batch Testing 6. Trouble shooting NRL Laboratories Collaborative who, where

6. 1. Evaluation (Re-evaluation) l Reasons l Requirements l Resources required l Reasons l Requirements l Resources required l Assess test, baseline data for QA l Evaluation panels l Regulations, serum panels, storage facilities

7. Evaluations An evaluation is the appropriate assessment of the working performance of a test kit or an assay at a point in time. An evaluation is the appropriate assessment of the working performance of a test kit or an assay at a point in time.

8. 7. Use the results 7. Use the results 6. Collate and analyse the data 6. Collate and analyse the data 5. Perform the testing 4. Select an evaluation panel 3. Write evaluation protocol 2. Examine the data 1. Gather information on the kit 1. Gather information on the kit Evaluation Process

9. Distributions of +ve & -ve samples in a “perfect” assay cutoff OD/Co Frequency

10. cutoff OD/Co Frequency Distributions of +ve & -ve Samples in a Serological Assay

11. cutoffcutoff OD/CoOD/Co FrequencyFrequency OTHER FACTORS (unrelated to antibody) (unrelated to antibody) High IgMHigh IgM Rheumatoid factorRheumatoid factor Sample related factorsSample related factors Physical disruptionPhysical disruption OTHER FACTORS (unrelated to antibody) (unrelated to antibody) High IgMHigh IgM Rheumatoid factorRheumatoid factor Sample related factorsSample related factors Physical disruptionPhysical disruption

12. Pathogenesis SeroconversionSeroconversion AsymptomaticAsymptomatic ARC/AIDSARC/AIDS 4-5 weeks Up to 12 years 2-3 years Neutralising Antibody p24 Ag - Viraemia NAA viral load

13. 2. Pre-marketing Batch Testing l Usually by regulation l Usually by central laboratory l Other measures may be used “in- house” l Usually by regulation l Usually by central laboratory l Other measures may be used “in- house”

14. 3. Quality Assessment Programme l Reasons l Requirements l Resources required l Reasons l Requirements l Resources required l Assess laboratory processes l QAP panels, data processing,questionnaires l Materials, QA coordination

15. Quality Assessment (also known as proficiency testing) Method by which the quality of results generated by a particular laboratory is determined.

16. Quality Assessment Programme l Definition:  Method by which the entire testing process including the quality of results generated by a particular laboratory is assessed. l Definition:  Method by which the entire testing process including the quality of results generated by a particular laboratory is assessed.

17. 1A. Questionnaire 1B. New Participants 2. Preparation of Panels 3. Panel Distribution 4. Data Collection 5. Preliminary report 6. Data Analysis 7. Final report QAP Process

18. Quality Assurance Programme Element: Performance Monitoring l Reasons l Requirements l Resources required l Reasons l Requirements l Resources required l Check performance in use, check batches l QC, data collection, batch testing l Communication, infrastructure (Lab network)

19. 4. Quality Control Programme Measures that are used to ensure that a test is working to the highest standard.

20. Process for the use of Quality Controls 1. QC Sample 2. Determine Acceptable Ranges 3. Include in all test runs 4. Data Collection 5. Data Analysis 6. Accept or Reject Run 7. If Variation Identified  Investigate 7. If Variation Identified  Investigate

21. NRL QC Data 0 1 2 3 4 5 Mean - 2SD 15/8/97 date Mean +2SD Mean 10/3/98 Invalid Kit Controls Invalid QC sample Batch 2 Batch 3 Batch 1

22. 5. Performance Monitoring l Reasons l Requirements l Resources required l Reasons l Requirements l Resources required l Check performance in use, check batches l QC, data collection, batch testing l Communication, infrastructure (Lab network)

23. Monitoring Assay Performance-- ongoing evaluation of assay performance l Monitoring specificity l Monitoring sensitivity l Monitoring specificity l Monitoring sensitivity

24. 6. Trouble shooting l Reasons l Requirements l Resources required l Reasons l Requirements l Resources required l Prevention of problems l Panels, testing l Quality control program, regulations

25. “Trouble- Shooting” Sorting out testing problems

26. Reported problems Sample Equipment Methods Personnel Assay Trouble Shooting

27. 8. Strategy development l Reasons l Requirements l Resources required l Reasons l Requirements l Resources required l Assure testing is accurate & efficient l Testing samples, collecting data l Data collection and analysis skills

28. Strategy Development A strategy is a series of scientifically verified testing steps using a combination of assays that are employed to reach the correct diagnosis.

29. Strategy Development l Understanding the predictive values of the tests l Obtaining the appropriate data l Multivariant analyses of the data to assess the predictive value of test combinations used in sequence l Understanding the predictive values of the tests l Obtaining the appropriate data l Multivariant analyses of the data to assess the predictive value of test combinations used in sequence

30. Quality Assurance System Kit Evaluation Performance Monitoring Strategy development Trouble shooting Tertiary Reference Testing Specificity monitoring Quality Control QAP (Batch testing) PERFORMANCE QUALITY PERFORMANCE Pre-marketing