New Oral Test for HIV-1 and HIV-2

A rapid test for HIV-1 and HIV-2 has been developed that can be performed on an oral fluid sample and produce results within 20 minutes.

In-house evaluations of the assays against commercial serum panels spiked into oral fluid at a dilution that simulates actual oral fluid samples was shown to be highly accurate, with sensitivity comparable to most laboratory-based enzyme immunoassays. Specificity based on more than 500 combined samples from several sources was shown to be 99.8%. In addition, the test has been in an independent clinical study, showing encouraging results. The test was developed by Calypte Biomedical Corp. (Alameda, CA, USA), which has announced plans to manufacture the tests in China and Thailand.

"Our blood rapid test is fully validated and transfer of this technology to our manufacturing partner is under way,” said Dr. Richard George, president and CEO of Calypte. "Urine and oral fluid are in the final phases of field testing and if testing continues at the current level of performance, we expect that these tests will be ready for market in the second half of 2004.”




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