Calypte Biomedical, a provider of in-vitro diagnostic test products, has completed the internal studies of its Aware HIV-1/2 oral fluid rapid test for the US and international markets.
The trials were conducted at two sites, one in South Africa and one in US, and involved 577 subjects at various levels of risk for HIV infection.
The combined trial results showed that Calypte’s Aware HIV-1/2 oral fluid rapid test demonstrated an accuracy of 100%.
Following the positive results, the company has consulted the US Food and Drug Administration and initiated the process to conduct clinical trials in second half of 2011.