P-E3 Assessment of internationally-available HIV test kits for their suitability to meet manufacturers' claims

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Background:HIV test kits, particularly rapid HIV tests, are used throughout the world as a primary measure to protect the blood supply and provide diagnosis to save lives. The US government purchases large numbers of HIV tests at considerable expense, and expects them to perform adequately.Objective:To assess a large number and variety of HIV test kits to determine if they meet the claims of the manufacturers.Methods:From September 2010 through July 2017, a total of 1,123 lots of HIV test kits from 14 manufacturers and representing 11 different tests from 26 countries, were received for evaluation at the INSTITUTE OF HUMAN VIROLOGY. Each test kit was assessed for performance characteristics using panels of sera (n=30 or 160) that included positives for HIV-1 and HIV-2 (n=8 or 80), and negatives (n=22 or 80). Several HIV-1 positive samples were weak positives derived from seroconversion panels (SeraCare). Test kits were also assessed for precision using several HIV-1 weak positive samples tested in replicate.Results:Of the HIV test kit lots evaluated, 99.2% successfully passed the evaluation with perfect performance. Of the 9 lots that did not pass, 3 were found to produce high background that interfered with reading, 2 performed inadequately with high-temperature testing, and 4 exhibited greater than one false-positive result. In one assessment, a country had reported poor performance of a test kit, but the test kit passed the evaluation; this resulted in a visit to the country to assess the laboratory's activities.Conclusion:In our evaluation of a large number and variety of HIV test kit lots from 14 manufacturers, nearly all performed as expected and met the manufacturers' claims.

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