Trials Show High Accuracy for Rapid HIV Test

Validation trials of new assays for HIV-- blood rapid, oral fluid, and urine-- showed an overall accuracy of 100%, 99.8%, and 99.6%, respectively.

The trials were conducted at the Red Cross Anonymous HIV Clinic in Bangkok (Thailand) in April 2004, and the results were provided to delegates at the XV International AIDS Conference in Bangkok in June 2004. A total of 1,023 subjects participated, comprising 392 seropositive subjects (including 37 receiving antiretroviral therapy) and 631 seronegative subjects.

The true antibody status of these subjects was first determined by testing a blood sample using the standard testing method routinely used by the Anonymous HIV Clinic for diagnostic testing. Then the new HIV tests were used that were developed by Calypte Biomedical Corp. (Pleasanton, CA, USA; www.calypte.com). The Calypte blood rapid test was 100% concordant with the results of the standard blood tests. In the oral fluid test, two false-negative results were from two known positive subjects who were on antiretroviral therapy. The specificity of the oral fluid test and the urine test was 100%.

"The performance of the blood rapid test is on a par with the best laboratory and rapid HIV antibody tests currently on the market,” said Dr. Richard George, president and CEO of Calypte. "The Calypte assays that test noninvasive alternative fluids showed performance comparable to or better than other such assays currently available.” The company believes these results validate its decision to begin manufacturing and commercializing these assays for the international market.




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