Research Findings Point To Need For HIV Testing With Both Blood And Urine

LENEXA, Kan.--Dec. 3, 1998--Clinical Reference Laboratory (CRL), one of the country's leading clinical reference laboratories, announced today results of the largest study to date showing a significant proportion of individuals - approximately one out of every 1,000- within the low risk population test positive for HIV-1 antibodies in their urine and negative in their blood.

Dr. Robert Stout, president of CRL, said, "Test results from two body fluids that do not agree are referred to as 'discordant.' This is the first time we have found HIV-1 discordant results in a large, low risk group using an FDA- licensed urine screening test. The significance of this report is twofold. First, the results suggest that people being tested for HIV antibody should have both their blood and urine screened. Second, the presence of antibody against HIV-1 in the urine indicates, at the very least, a prior exposure to the virus."

The CRL study tested matched blood and urine samples from over 50,000 individuals at low risk for contracting HIV-1 infection. All study subjects had signed consent forms to be tested for HIV-1. The study found 19 out of 50,231 individuals (0.038% or approximately 1 out of every 3,000 Americans) were blood positive for HIV-1, an incidence consistent with the percentage found in the general population within the U.S. The urine test identified 17 out of 18 seropositives identified in the study (one matched urine sample from a seropositive individual could not be tested). In a subgroup of 25,106 individuals, 24 samples were negative by blood tests but positive by a FDA- licensed urine HIV-1 antibody screening test manufactured by Calypte Biomedical Corporation.

An investigational new test showed that the 24 discordant urine-only reactive samples were repeatedly reactive for a parti
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3-Dec-1998