Arthur Kazianis, Massachusetts State Laboratory Institute
Issues: Massachusetts Department of Public Health C&T sites began using the OraQuick Rapid HIV-1 screening test as part of a continuing mission to provide accurate and timely reporting of HIV antibody results. Such screening was initially limited to a subset of DPH funded C&T clinics participating in the Post-marketing Surveillance (PMS-1) of this product. The information presented here describes the success of HIV rapid testing in Massachusetts, practical concerns for its implementation, and the HIV laboratory’s commitment to provide continuous training, quality assurance and technical support.
Description: Informational and practical training sessions for C & T staff were conducted. Training modules included the performance of OraQuick, QA/QC, document requirements and laboratory safety. The QA program followed our laboratory practice by including a written test, interpreting a visual panel and performing the assay using proficiency panels. Participants were instructed to submit serum follow-up specimens to the lab and were advised to consult with the HIV lab for answers to technical concerns. Trainers also assessed environmental conditions at all proposed testing venues.
Lessons Learned: MA State Lab Institute received 101 serum follow-up specimens for confirmation of which 85 tested positive for HIV-1 antibody using EIA and Western blot. Six were indeterminate and 10 were negative. All negative and indeterminate samples tested non-reactive by HIV-2 EIA. The HIV lab staff also tested these follow-up samples using OraQuick and all were again reactive. Despite the training, there was lack of understanding by clinical/C&T personnel that OraQuick is a screening assay. Reactive OraQuick interpretations followed by negative “final” results, and the use of the “preliminary positive” language was interpreted as evidence of poor OraQuick performance. In fact, results were well within the 95% CI for this test.
Conclusions: OraQuick Rapid HIV-1 screening can be successfully implemented in traditional C & T settings. Laboratory participation is a practical way to train C & T staff. Whenever possible, attempts should be made to mimic pre- and post-analytical processes of the traditional laboratory. Trainers should be mindful to caution counselors about misuse of screening results. Laboratory staff must be available to provide continuous support.

Last Update: April 8, 2005