Minute Man Wows Attendees at CDC HIV Diagnostics Conference

Minute Man Wows Attendees at CDC HIV Diagnostics Conference

Atlanta, GA. Dec. 12-14 2012. bioLytical Laboratories Chief Technical Officer Rick Galli was invited by Centers for Disease Control HIV Diagnostics Conference organizers to present INSTIs impressive CLIA trial data last week in Atlanta. The conference was attended by laboratorians, State Departments of Health HIV program directors, and HIV test manufacturers from across the United States and presented the latest developments and recommendations in early detection of the virus. Although the conference focused on laboratory methods for testing, Rapid-Rapid algorithms were also discussed and INSTI was singled out by Associate Director for HIV Laboratory Diagnostics at the CDC, Bernie Branson, as the leader in early detection among rapid HIV tests; in fact, the INSTI CLIA waiver approval made the front cover of the conference book as the highlight of 2012.

Although INSTI is perhaps best known for its speed and accuracy, its ability to detect much earlier than every other rapid test currently on the market was of particular interest at the conference, where a major theme was detecting acute or early HIV infection. Branson referenced a slide prepared by his colleague at the CDC, Michelle Owen, which shows INSTI as detecting HIV antibodies a full 9 days earlier than Western Blot, the former gold standard of laboratory testing, making INSTI the most sensitive rapid test. All other rapid tests, including OraQuick, Clearview and Unigold, only detect about 1-2 days earlier than Western Blot.

Gallis presentation of the INSTI CLIA waiver trial garnered much interest by conference participants as the trial was considerably more rigorous than those previously required by the FDA. The INSTI trial differed from all other previously CLIA waived rapid tests in that it was prospective, included the finger-stick and blood collection portion of the procedure, and included a diverse operator demographic. The audience of laboratory scientists was impressed and slightly amused by the fact that the data for the prospective clinical trial by untrained users was actually slightly better than that of the laboratory professionals seen in INSTIs PMA trial for FDA approval.

Additionally, there was considerable interest in INSTI at the bioLytical booth, where bioLytical sales members were on hand to answer questions, perform INSTI demonstrations and liaise with opinion-leaders and decision makers from health departments and community-based organizations. Nicknamed the Minute Man,, an moniker derived from INSTIs lightening fast speed, Galli said he was honored to be invited to the conference and feels passionately about the role of rapid testing in diagnosing unknown HIV positive individuals. Since over 25% of HIV infected individuals in the US are unaware of their status, making HIV testing more widely accessible to the most at risk populations is paramount. Fast, accurate rapid testing remains the best tool in fight against HIV.

According to a 2012 report issued by the National Alliance of State & Territorial AIDS Directors, nearly 60% of HIV testing conducted in health department supported programs in the US is performed using a rapid HIV test.

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