P-E15 Performance Evaluation of HIV Test Kits from 20 Countries to Determine their Suitability as claimed by Manufacturers

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Abstract

Background:

HIV test kits 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 from a variety of manufacturers at considerable expense.

Objective:

To evaluate a large number and variety of HIV test kits from many countries to determine if they meet the claims of the manufacturers.

Methods:

From September 2010 through June 2016, a total of 666 lots of HIV test kits from 14 manufacturers were received at the IHV from over 20 countries. The performance of each test kit was assessed for sensitivity, specificity, and precision using panels of sera that included positives for HIV-1 and HIV-2, negatives, and HIV-1 seroconversion panels. Test kits were also assessed for their ability to perform accurately at the higher range of allowed temperature (28C) to challenge the kits at temperatures that are not uncommon in many countries.

Results:

Of the 666 HIV test kit lots, 662 (99.4%) successfully passed the evaluation with perfect performance. Of the 4 lots from 2 manufacturers that did not pass, 3 were found to produce high background that interfered and 1 gave substantial false-positive results. In one case, the failure resulted in cessation of bulk purchase of test kits by the US Government and removal from WHO’s e-catalogue. In one case, a country reported poor performance while the test passed the evaluation, resulting in a visit to the country to assess activities that were subsequently found to be unsuitable.

Conclusions:

In our evaluation of a large number and variety of HIV test kit lots from 14 manufacturers and from over 20 countries, nearly all performed perfectly and met the manufacturers’claims.

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