Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
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A comparison survey of the blood tests of several known HIV patients performed during an "integrity protocol" at Instituto de Cardiologia de Corrientes, Argentina this week turned up a misdiagnosed case. Dr. Afzal Chowdhury, a U.S. microbiologist, was running tests of the Novatek HIV Whole Blood Diagnostic Device on Institute blood bank samples in the presence of Dr. R. J. Badaracco, Executive Director of the Institute when the error was discovered. The purpose of Chowdhury's call was not only to illustrate the accuracy of Novatek's test, but to demonstrate its time and cost-effectiveness.
Initially judged by Dr. Badaracco to be a malfunction in the Novatek test, the sample was retested at Chowdhury's insistence that the Novatek device was accurate. At the same time two more time-consuming and expensive comparison assay tests were also run, a Western Blot and the ELISA, which was being re-tested. The ELISA results were once again "positive," while the Western Blot -- the industry standard -- showed the same negative results as the Novatek test, confirming Dr. Chowdhury's accuracy claims.
The Provincial Minister, present when the Western Blot results were read, contacted Dr. L. Luciano Quisarrello, Director of Corrientes' Blood Bank to request further testing. Quisarrello and Dr. Rafael Garillo, Associate Director of the bank asked Chowdhury to run the Novatek test on 6 selected blood samples. They stopped Chowdhury after only two tests were run, convinced of the accuracy of the Novatek test. According to Dr. Quisarrello one of the two samples Chowdhury tested had been run previously several times using other methods, including the ELISA. Results remained unclear until Quisarrello and Garillo ran a Western Blot on the sample, which showed negative for HIV. Novatek's test matched the Western Blot here, as well.
The success of the Novatek HIV test in Corrientes has accelerated negotiations between other Argentinean provinces and Novatek as well.
CONTACT: Mary Maguire or Mindy L. Gaynor, 202-659-0330, both for Novatek International
Copyright (c) 1996/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
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