Federal health officials yesterday approved the first urine test to detect H.I.V., the virus that causes AIDS, but said it was not as accurate as the standard blood test.
The urine test was approved as a supplemental diagnostic test, but is not meant to substitute for the standard blood test to screen donors at blood banks, officials of the Food and Drug Administration said.
The reason is that studies showed that the number of times the urine test failed to detect evidence of H.I.V. in an individual known to be infected was higher than for the standard blood test. Also, the urine test indicated that some people were H.I.V.-infected when it was known that they were not.
Those who test positive for H.I.V. with the urine test are advised to get a second urine test, and if that is also positive, they then need a blood test for confirmation. The F.D.A. has advised doctors who use the test to counsel those who use the urine test and explain that a negative test is not a guarantee of being free of infection.
Dr. Curtis Scribner, an official of the Federal Food and Drug Administration, said that with further improvement the urine test ”could develop into” a first-line test for H.I.V.
A urine test ”could become a significant weapon in the battle to slow the AIDS epidemic because it makes testing safer, easier and more accessible” compared with the standard blood test, Darrel Cummings, deputy executive director of the Los Angeles Gay and Lesbian Community Services Center, said in a statement released by Calypte Biomedical Corp. of Berkeley, Calif.
Calypte developed the test, which detects antibodies to H.I.V. present in simple plastic-cup specimens of urine. Calypte has licensed Seradun Inc. of Indianapolis to market the test under the name Sentinel.
The urine test does not require specially trained health-care workers to administer it or needles that could pose hazards to those who withdraw blood from an individual’s vein.
The F.D.A. limited its approval for the urine test to health professionals so that individuals would have to give urine samples to doctors in hospitals, offices and clinics. The test may also be used in examinations to obtain insurance.
Dr. Luc Montagnier, a co-discoverer of the AIDS virus and a scientific adviser to Calypte, said the relative simplicity of the urine test ”holds particular important promise for developing countries” where trained health professionals are in short supply.
Calypte’s stock rose $2 yesterday to close at $9.625 on the Nasdaq. The company went public in late July,
Approval of the urine test was based on comparing it with the blood test in several studies involving more than 800 individuals known to have AIDS, to be H.I.V.-infected, or to be at high risk for the disease.
In one study, 298 individuals diagnosed with AIDS gave urine and blood samples. The urine test was positive in 99.3 percent of the cases, the F.D.A. said.
In other studies involving individuals known to be H.I.V.-infected, some of whom had developed symptoms from damaged immune systems, the urine test missed about 1 to 2 infections in every 100 tested.
Still other studies showed that the urine test would falsely indicate H.I.V. infection when none was present in 1 to 2 people in 100 tested, compared to 1 in 1,000 with a blood test.
Additional studies included gay men, drug users who were injecting drugs, and other individuals in groups considered at high risk for AIDS. While the urine test falsely indicated infection in from 1 to 3 out of 100 such individuals, it was as high as 18 percent in some groups, Dr. Scribner said.
Correction: August 9, 1996, Friday An article on Wednesday about the Government’s approval of the first urine test to detect H.I.V., the AIDS virus, misspelled the name of the company that will market the test. It is Seradyn (not Seradun) Inc.