PG-3 Assessment of internationally-available diagnostic test kits for their suitability to meet manufacturers' claims

Abstract

Background: Diagnostic 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, syphilis, hepatitis, and other varieties of test kits from a number of manufacturers at considerable expense, and expects them to perform adequately when provided to countries. Objective: To assess a large number and variety of rapid test kits, purchased for many countries, to determine if they meet the claims of the manufacturers. Methods: From September 2010 through July 2018, a total of 1502 lots of rapid test kits from 16 manufacturers, representing 11 different types of tests from 26 countries, were received for evaluation at the IHV. The performance of each test kit was assessed for performance characteristics using panels of sera (n = 30–160) that included positives (n = 20–80), and negatives (n = 20–80). Greater than 1 false positive or false negative result constituted failure. Results: Of the 1502 rapid test kit lots, 1491 (99.3%) successfully passed the evaluation. Of the 11 lots from 5 manufacturers that did not pass, 3 lots were found to produce high background that interfered with reading, 2 lots performed inadequately with high-temperature testing, 4 lots gave 2 false-positive results, and 2 lots gave 2 false-negative 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 another case, the manufacturer acknowledged that their internal lot release results indicated a less than usual level and that it was subsequently addressed. Conclusions: In our evaluation of a large number and variety of rapid test kit lots from 16 manufacturers that were sent to or targeted for 26 countries, nearly all performed as expected and met the manufacturers' claims. An evaluation system for the monitoring of test kit performance is essential to identify test kits that may not meet manufacturers' claims.