HIV/HCV Test Improves Safety of Donated Blood

A highly sensitive nucleic acid amplification test (NAT) can detect the presence of all known HIV-1 subtypes and hepatitis C virus (HCV) genotypes in whole blood and plasma during the early stages of infection known as the "window period,” when they cannot be detected by immunodiagnostic tests. The NAT test has been cleared by the US Food and Drug Administration (FDA).

Since March 1999, the test, called the Proleix Assay, has been used to screen more than 20 million donations from US blood banks. During that time, the test identified seven HIV-1 positive and 88 HCV positive donations that would otherwise have entered the blood supply. A single unit of donated blood can be transfused into as many as three recipients. The five-part test system comprises an assay to detect HIV-1 and HCV, a semiautomated instrument system to process the test, supporting software systems, proficiency panels, and external quality controls.

The Proleix Assay, developed and manufactured by Gen-Probe Incorporated (San Diego, CA, USA), will be marketed worldwide by Chiron Corp. (Emeryville, CA, USA). A similar test has been developed by Roche (Basil, Switzerland). Some experts believe the relatively small number of donations found infected may not be worth the extra US$6-$10 cost of the new test for each unit of blood. Another process for detecting bacteria and viruses in blood, called pathogen inactivation, is being developed by Cerus Corp (Concord, CA, USA).

"We believe Gen-Probe's combination assay is a significant enhancement to the safety of the blood supply,” said Dr. Claude Lenfant, director of the US National Heart, Lung, and Blood Institute (NHLBI).




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