HIV Tests in Trials in China

A clinical trial has been initiated in China that is evaluating the sensitivity and specificity of three rapid HIV-I and HIV-2 antibody tests and Western blot supplemental tests for HIV-1.

The three rapid tests are blood, oral fluid, and urine, and were developed by Calypte Biomedical Corp. (Pleasanton, CA, USA; www.calypte.com). The trial of around 1,500 people will use no less than seven laboratories to perform the rapid tests and at least three laboratories that will perform the HIV-1 Western blot supplemental tests. The company's objective is to file the required regulatory applications with the Chinese Food and Drug Administration (FDA) in early 2005. Calypte expects to have production from its manufacturing plant available by that time to support the company's launch into China.

There are a reported 840,000 adults and children in China with HIV/AIDS today. According to the Bill & Melinda Gates Foundation, China is one of the "next wave” countries where the number of infections is expected to grow to 15 million by 2010. The Chinese government has announced its commitment to offer voluntary HIV testing to its entire population of 1.36 billion. Calypte believes the only effective way to manage such numbers is to utilize trained nonprofessionals who are able to execute such a program based on safe, alternative fluid testing of oral fluid or urine.

"In accordance with company policy, we will not provide interim data on assay performance in this clinical trial,” noted Dr. Richard George, president and CEO of Calypte. "However, we will release the performance results when the trials have been completed and certified by our Chinese contractor.”




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