Makers of Fastest HIV Test Support Task Force Recommendation on HIV Testing for All

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bioLytical Laboratories' INSTI test best tool in realizing USPSTF recommendations for routine HIV testing for the general US population.

Makers of INSTI™, the only FDA approved 60-second rapid HIV test, have announced support for the recently released recommendation by the United States Preventive Services Task Force (USPSTF) that all adolescents and adults aged 15 to 65 as well as all pregnant women be screened for HIV (

This A grade recommendation means that there is high certainty that the net benefit of testing is substantial and echoes the council of Center for Disease Control (CDC) guidelines, which advocate moving HIV testing to routine care regardless of perceived risk, as benefits substantially outweigh potential harms. The USPSTF also recommends that HIV testing be done on an "opt-out" basis, meaning testing should be performed unless the test subject expressly declines.

“Evidence presented recently at the Canadian Association for HIV Research (CAHR) indicates that people who don’t know they are infected with HIV may pass through the healthcare system multiple times before they are offered an HIV test,” said Dr. Christopher Shackleton, Executive Director at BioLytical Laboratories, manufacturer of the INSTI™ 60-second HIV test. “Early detection is the key to ensuring that HIV positive individuals can be given care as early as possible, thereby improving the quality and duration of their lives as well as effectively reducing the rate of transmission to near-zero. This USPSTF recommendation will create more opportunities to identify these individuals. It marks a significant milestone in the effort to stop the epidemic.”

Further evidence presented at CAHR indicates that when performed in Point of Care (POC) settings, rapid HIV tests such as INSTI™ generate a proportionally higher yield in detecting new cases than do traditional laboratory-based tests. In British Columbia, where INSTI™ is manufactured, data from the BC Centre for Disease Control found that while only 5.6% of HIV testing in the province from April 1, 2011 to September 30, 2012 was performed in POC settings using INSTI™, collectively they detected 30.2% of all new cases of HIV diagnosed during the same period.

“Despite the fact that in aggregate, POC rapid testing comprises a very minor proportion of total testing done in the province, its yield, in terms of new cases identified per number of tests performed appears to be substantially higher than that of more traditional laboratory-based testing algorithms.” Dr. Shackleton added, “on the basis of this data, we would argue that not only is it more efficient in detecting proportionally more cases, it is clearly more cost effective. It is hoped that recommendations such as those of CDC and the USPSTF together with evidence such as that of the BCCDC will further eliminate barriers to HIV testing and get vital health services and information to those who need it.”

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Emaleah Shackleton
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