German company halts delivery of HIV test kits
BMJ 1996; 312 doi: https://doi.org/10.1136/bmj.312.7038.1059c (Published 27 April 1996) Cite this as: BMJ 1996;312:1059The German branch of American pharmaceutical company Abbott last month stopped deliveries of its HIV test kit, Imx HIV-1/HIV-2 Third Generation Plus. The company, based at Wiesbaden, said that it had to take action because the tests had yielded false negative results in four cases detected in Britain, France, and Spain. At the same time HIV test kits in more than 70 other countries, including Britain, were said to have been withdrawn from the market.
Although none of the cases was detected in Germany, some false negative test results may have escaped attention because in Germany only one test is normally performed for routine blood testing for HIV. In other countries, such as Belgium and France, at least two different tests are prescribed by health authorities. In Germany therefore only patients who emerged as HIV positive in the first test, usually an antibody test, would have undergone a second test, such as the anti-HIV enzyme linked immunosorbent assay (ELISA) or the polymerase chain reaction test.
In addition, of the two million third generation test kits delivered by Abbott worldwide since their introduction in July (ELISA) or the polymerase chain reaction test.
In addition, of the two million third generation test kits delivered by Abbott worldwide since their introduction in July 1995, about 650000 were sold in Germany alone.
Although Abbott of Germany immediately issued a warning not to continue using the third generation product and offered to replace it with other products, there are no estimates of the number of people who could be affected.
Test kits may also have been used for HIV testing of donor blood and blood products. In three hospitals in the state of North Rhine-Westphalia alone 3000-5000 units of stored blood will have to undergo renewed HIV testing.
Opinions vary widely on the probability of false negative results from the third generation products. The Federal Office for Sera and Vaccines estimates the chances for false positive results at about 1 in 500 and for false negative results about one in a million. Other experts, such as the microbiologist Professor Lutz Gurtler of Munich, concede, however, that the chance for false negative results may be less than 1 in 100000.
The health ministers of the 16 German states have meanwhile recommended that everyone who has had an HIV test since last summer should be tested again.—HELMUT L KARCHER, medical writer, Munich
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