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Kevin P. Delaney, MPH, Bernard Branson, MD, and Carol Fridlund
Centers
for Disease Control and Prevention (CDC)
Background: One-step rapid HIV antibody
tests suitable for point-of-care testing offer many advantages if
they can be performed in outreach
settings by persons with minimal training.
Purpose: To evaluate whether persons with no laboratory
experience can successfully perform a rapid HIV test.
Methods: In the first phase of a multi-part prospective study, Health
care workers (including HIV counselors) without laboratory experience
performed the OraQuick Rapid HIV Antibody test on specimens previously
tested with EIA and Western blot, after reading only the written
instructions from the manufacturer. In the second phase, a similar
cohort of participants
(without laboratory experience) each conducted OraQuick on a panel
of 4 specimens of known HIV status (including negative, strong- and
weak- positive specimens), again using only written instructions.
For both phases, performing the test correctly and recording a result
that
matched the known serostatus of the sample was considered successful
completion of the test. Potential covariates, such as occupation
and comfort with performing the test, were collected via questionnaire.
Results: The 259 participants performed
943 rapid tests. Eighty-seven tests (9%) were performed incorrectly
and yielded no result. Of
the remaining 856 tests, participants obtained the correct result
on 827
(96.6%). Excluding tests with no result, participants obtained
220 (96.1%) correct results with strong positive specimens, 463 (97.3%)
with negative specimens, and 144 (95.4%) with a weak positive specimen.
Stratified analyses showed consistent results across study sites
and participant characteristics.
Conclusions: Overall, untrained
participants obtained a correct result on 96.6% of all Oraquick tests.
By comparison, the Clinical
Laboratory
Improvement Amendments (CLIA) requires trained laboratory technicians
to achieve an overall testing score of 80% correct on proficiency
testing.
Submitted as late breaker abstract, American Public
Health Association Annual Meeting, October 2002.
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