Results of HIV Test Trials

Clinical trials conducted by the Chinese Centers for Disease Control (Beijing) have confirmed the performance of five HIV tests developed by Calypte Biomedical Corp. (Lake Oswego, OR, USA).

A rapid test for use with blood (BSP) showed 100% sensitivity, 99.3% specificity, and 99.4% accuracy; a rapid test for use with oral fluid (OMT) showed 100% sensitivity, 99.8% specificity, and 99.9% accuracy; and a rapid test for use with a urine sample (U) showed 97.2% sensitivity, 100% specificity, and 99.5% accuracy.

The serum and the urine HIV Western blot tests also performed well, reports Calypte, showing sensitivity of 100% and 98.4%, respectively. The tests were evaluated on their performance in various Chinese provinces and populations. The trial involved 1,506 subjects, 247 of whom were infected and 1,259 who were uninfected.

"We are extremely encouraged by the excellent outcome of the China clinical trial,” stated Dr. Richard George, president and CEO of Calypte. "The Chinese CDC did an admirable job of conducting these studies and preparing the report.” Dr. George noted that the first application to be filed for accelerated review will be for the Aware HIV-1/2 OMT test, to be followed soon by the Aware HIV-1/2 urine test.





Related Links:
Chinese Centers for Disease Control
Calypte