07:00 , Jul 16, 2007 |  BC Week In Review  |  Clinical News

Aware HIV-1/2 OMT regulatory update

CBMC received Indian marketing approval for its Aware HIV-1/2 OMT, an in vitro point-of-care immunoassay to detect HIV-1 and HIV-2 antibodies in oral fluid samples. Calypte Biomedical Corp. (CBMC), Lake Oswego, Ore.   Product: Aware...
08:00 , Jan 16, 2006 |  BC Week In Review  |  Clinical News

Aware HIV-1/2 OMT regulatory update

The Beijing Drug Administration (BDA) of the State Food and Drug Administration (SFDA) of China accepted for review a registration application for Aware HIV-1/2 OMT, an oral fluid test, to diagnose HIV. Calypte Biomedical Corp....
07:00 , Sep 12, 2005 |  BC Week In Review  |  Clinical News

Aware HIV-1/2 OMT diagnostic data

Data from a Chinese trial in 1,259 uninfected and 247 infected subjects showed that the oral fluid test had a sensitivity of 100%, specificity of 99.8% and accuracy of 99.9%. The HIV diagnostic is marketed...
07:00 , May 23, 2005 |  BC Week In Review  |  Clinical News

Aware rapid oral fluid HIV-1/2 test diagnostic data

In a Chinese trial, the Rapid oral HIV-1/2 test had a 99.9% concordance with the ELISA test, which was used as a reference. Calypte Biomedical Corp. (HIV), Pleasanton, Calif.   Product: Aware rapid oral fluid...
08:00 , Feb 21, 2005 |  BC Week In Review  |  Clinical News

Aware rapid oral fluid HIV-1/2 test update

HIV began a Ugandan trial in about 350 patients to evaluate the sensitivity and specificity of its rapid oral fluid HIV-1/2 test. Calypte Biomedical Corp. (HIV), Alameda, Calif.   Product: Aware rapid oral fluid HIV-1/2...