Implications for the Public Health Laboratories from Expansion of Rapid Testing

1. Implications for the Public Health Laboratories from Expansion of Rapid Testing Arthur Kazianis Massachusetts Department of Public Health State Laboratory Institute HIV Laboratory

2. Background HIV Laboratory Existing Relationships

3. HIV Laboratory • Has provided HIV antibody screening and confirmatory testing since 1985 for DPH and CDC funded clinics. • Algorithm: EIA screening followed by Western blot confirmation • Laboratory staff: • Skilled technicians • epidemiologists

4. Laboratory Staff • Perform all testing (screening and confirmatory) • Reporting • Technical support of Counseling and Testing staff • Perform QA/QC functions

5. Laboratory Epidemiologists • Daily contact with HIV lab staff • Liaison between the HIV lab and • AIDS Bureau program staff • Surveillance staff • C & T staff • Incidence and Resistance Coordinators for Massachusetts

6. HIV Laboratory Provides: • Daily contact via telephone for reporting and consultation to C & T personnel • Laboratory tours • Input at monthly meetings with C & T supervisors

7. Specimens Processed by Year

8. Initial Concerns for the Laboratory

9. Clinical and C & T Staff not Experienced with Performing Screening • C & T staff are not laboratorians • Counselors have misunderstood reactive screening results despite training • Makenoassumptions: Clinical staff, not only lay counselors, require clarification about these laboratory tests.

10. Purpose of “Screening” and “Confirmation” not Completely Understood • All screening tests: EIAs and OraQuick reactives require confirmation • Significance of OraQuick reactive as screening vs. Western blot as confirmation

11. Some Perceptions of Reactive OraQuick Results • OraQuick reactive ≠ Western blot positive • “Preliminary positive “ language can be misleading • OraQuick testing is always rapid for a negative interpretation.

12. Rapid Testing in MA 2004(from PMS-1 Sites Only) • Total OraQuick tests performed: 9980 • OraQuick reactive: 114 • Confirmed + (Wb): 94 • Confirmed – (Wb): 7 • Indeterminate: 6 • No serum follow-up received: 7

13. Positive Predictive Value (PPV) • Calculated if the total tested (denominator) is known • If your laboratory no longer receives samples for screening, how do you determine the denominator associated with those sent to the lab for confirmation?

14. PPV During OraQuick Post-marketing Phase (PMS-1 only) for Massachusetts • PPV = 88 % • GoodNews: • More reactive and/or positive clients received their results • BadNews: • Increased number of false reactive results reported

15. Lab Issues

16. Reduced Testing Volume Affects Lab Infrastructure • Significant reduction in serum submissions • Lack of specimens for other requested or approved testing • Reduced screening performed • Smaller pool for negative controls • Equipment not used as frequently- maintenance issues • Tasks normally done daily may require less frequent scheduling. Lab staff will have less familiarity with such tasks.

17. But also… • Less screening could also provide greater opportunities to participate in incidence/resistance and other laboratory initiatives.

18. Some Lab Activities will Always Remain • Screening and confirmatory testing continue but at reduced levels • QA/QC Activities continue • Use of controls • Equipment maintenance • Proficiency testing • Competency assessment

19. Request from C & T for Faster Confirmation • Should an OraQuick reactive serum follow-up sample be tested by “rapid” Western blot confirmation?

20. Counseling and Testing Issues • Significant changes in counseling strategy • Scheduling issues • Preparation time to deliver positive result • Counselors have limited or no experience in reporting reactive screening results • How does an OraQuick reactive screening result differ from a “final” result obtained from the lab?

21. Public Health Lab’s Role in Oversight

22. Components of Testing Unfamiliar to Counseling and Testing Staff • Screening • Confirmation • Quality Assurance / Quality Control • CLIA

23. Training Counseling Staff in the Use of OraQuick • Pre-analytical concerns • Analytical processes • Interpretation of results • Post-analytical activities • Reporting • Required documentation

24. Continuous QA/QC Support • Regular maintenance and support from the lab to clinics on QA/QC issues: • Assist with lab documents • Training new employees • Competency Assessment • Proficiency testing

25. Public Health Lab’s Role in Transition

26. Take the Lead in Education • What is screening and confirmation? • What is a Control? • What is QA and QC? • State regulations regarding HIV testing and reporting • CLIA licensure • FDA approval

27. Provide Continuous Support • Answering questions – a daily activity • QA / QC • Records management • Maintaining required lab documents for testing, equipment maintenance, temperature charts, etc. • Provide QA/QC documentation that mimics that of traditional laboratory setting.

28. Support Continued… • Some counselors have refused to perform rapid test. • Laboratory safety: new concept for most counselors • Handling inactivated controls as infectious • Maintaining supply inventory • Control and kit expiration dates • Consistent labeling

29. Laboratory’s Role in Rapid Testing QA/ QC Program

30. Lab Staff May Visit Clinics for: • Initial rapid testing orientation • Practical training • Visit sites when problems arise

31. Determine Acceptability of Site for Testing • Appropriate lab space • Lighting • Location for test development • Waiting area for clients

32. Provide with Training: • Written test • Test panel (practical assay performance) • Mandatory competency assessment

33. Provide QA/QC Documents • Log sheets • Temperature charts • Follow-up documentation

34. Concluding Remarks

35. Laboratory’s Role in Support of Rapid Testing • Continue to provide Western blot confirmation • Provide mechanism for continuing education • New employees will always need training: lab staff as well as counselors at clinics • Epidemiologists with lab experience and other members of the lab can assist with ongoing QA efforts.

36. Changes for the Laboratory • New testing environment: fewer screening performed while Western blot confirmation continues • Greater role for handling specimens for incidence & resistance • Gain familiarity with rapid tests • Participation in OraQuick training as an expanded laboratory activity