HIV antibody assay that gave false negative results: multicentre collaborative study

Objective: To identify false negative results arising from the use of a commercial kit to detect antibody to HIV-1 and HIV-2 between July 1995 and March 1996. Design: The 56 laboratories in the United Kingdom that were using the assay were asked to retrieve and retest specimens with an alternative assay for HIV-1 and HIV-2. Details of false negative results were obtained and these serum samples further investigated. Subjects: 24 181 patients tested with the assay who were reported as being negative for HIV antibody. An additional 497 patients were confirmed as HIV positive with the assay. Results: Serum samples of 20 973 of the patients were retested, and four patients were found to have had false negative results with the kit; three further patients were found to have had false negative results in the course of other laboratory testing. The seven patients with false negative results with the kit were of diverse risk group and HIV-1 subtype. Four had evidence of recent HIV infection. Conclusion: The commercial kit had a sensitivity of 99.2% (497/501), or less if the additional three patients with false negative results were taken into account. Key messages Dual screening should be considered for patients known to be at increased risk of HIV infection Although assay kits for HIV antibody generally show high sensitivity, false negative results may still arise during routine use and go undetected Tested serum samples should be stored so that they may, if necessary, be checked. Any kit failures should be reported to the Medical Devices Agency or Adverse Incident Centres, as well as to the manufacturer All laboratories should be informed of test kit failures, whether or not they have used the suspect kit