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bioLytical's INSTI HIV Test Detects gp41 specific IgM Antibodies

RICHMOND, BC, Sept. 3, 2015 /PRNewswire/ - bioLytical Laboratories Inc., a leader in rapid diagnostic assays, is pleased to announce its study "Sensitivity of a rapid point of care assay for early HIV antibody detection is enhanced by its affinity for HIV gp41 IgM antibodies" has been published in the Journal of Clinical Virology.  This study highlights INSTI's ability to detect early HIV infection. 

BioLytical researchers presented their findings at the 8th annual International AIDS Society Conference, which highlighted early HIV detection using INSTI HIV-1/HIV-2 Antibody Test.  The study demonstrated that both recombinant gp41 antigen and protein-A in the HIV screening assay have affinity to human IgM.  When IgM was removed from early seroconversion samples that were once reactive with INSTI, the results were non-reactive or barely reactive.  The study concluded that INSTI can detect anti-HIV-1 IgM antibodies, which enhances its utility in early HIV diagnosis.  Given our findings, the Company was pleased to reveal that INSTI is now considered a 3rd generation HIV assay.

Early detection provides significant advantage in the fight against HIV/AIDS.  INSTI HIV-1/HIV-2 Antibody Test's ability to detect early HIV antibodies is key to providing earlier diagnosis leading to earlier treatment.  Previous U.S. CDC data shows INSTI to be the most sensitive CLIA-waived rapid antibody test on the market today, detecting HIV infection 9 days earlier than the standard laboratory confirmatory test, Western Blot (1).

"bioLytical's scientists have pinpointed INSTI's proven performance in early HIV infection to be primarily due to IgM detection." said Rick Galli, Chief Technical Officer of bioLytical Laboratories.  "Combined with its speed, INSTI is a compelling tool for providers and offers meaningful clinical and logistical advantages for patients, healthcare professionals, and public health organizations."

Although a specific anti-HIV-1 IgM response is variable across individuals with early HIV infection, and generally does not persist beyond three months following its development, the clinical application of an assay such as the INSTITM HIV-1/HIV-2 Antibody Test that detects anti-HIV-1 IgM in addition to anti-HIV-1 IgG allows for reliable early detection of HIV infection.  Rick Galli further mentions "Early detection is key in the global efforts to eliminate HIV by 2030. It enables effective treatment to be initiated sooner after infection occurs so that infected patients can live longer and healthier lives.  Early diagnosis also prevents transmission due to highly effective treatment regimens and patients who are aware of their infection are much more likely to take action to prevent transmission."

The full study is available at:

Learn more at our upcoming educational webinar September 23, 2015 at 12PM EST/9AM PST.  To sign up, complete the contact form at

1. Masciotra S, McDougal JS, Feldman J, et al. Evaluation of an alternative HIV diagnostic algorithm using specimens from seroconversion panels and persons with established HIV infections. J Clin Virol. 2011 Dec;52 Suppl 1:S17-22. doi: 10.1016/j.jcv.2011.09.011.

About bioLytical Laboratories

bioLytical Laboratories is a privately owned Canadian company engaged in the research, development and commercialization of rapid, point-of-care in vitro medical diagnostics using its proprietary INSTI™ technology platform.  Today, the company markets and sells its signature INSTI™ HIV test and has a world-wide footprint of regulatory approvals including U.S. FDA approval, Health Canada approval and CE mark from European regulators.  Their product provides a highly accurate HIV test result in as little as 60 seconds translating into a compelling value proposition for patients, healthcare professionals and public health organizations.  For more information on bioLytical Laboratories, please visit

SOURCE bioLytical Laboratories
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