British Columbia firm bioLytical™ Laboratories Inc. has received FDA approval for the company’s rapid HIV test, that has a reported minimum sensitivity and specificity of 99.8% and 99.5% respectively. According to the press release, the FDA approved INSTI™ Rapid HIV Test for the detection of antibodies to HIV-1 in whole blood, finger stick blood, or plasma specimens. The firm is still seeking US regulatory approval for HIV-2 detection.
More about the test:
INSTI includes a unique antigen construct comprised of recombinant proteins for HIV-1 (gp-41) and HIV-2 (gp-36). “These unique antigens ensure that the test will be a critical addition to any rapid testing algorithm,” said Rick Galli, bioLytical chief technical officer. As with all rapid HIV tests, positive results are considered preliminary and must be confirmed before establishing a diagnosis of HIV infection.
“The unique antigen is important because the HIV testing community appears to be headed toward a multi-rapid test algorithm, eliminating the need for the more costly and time-consuming Western Blot and Indirect Fluorescent Antibody (IFA) tests,” said Niel Constantine, Ph.D., professor of pathology, University of Maryland School of Medicine Institute of Human Virology, an INSTI clinical trial investigator. “Using a multi-test rapid algorithm, we must deploy tests with different antigens, so bioLytical’s use of a unique antigen satisfies that requirement. And since INSTI also utilizes a novel flow-through technology, it would be a strong addition to a rapid/rapid algorithm."
INSTI also includes a unique, enhanced procedural control, utilizing a true human IgG sample addition feature. The test will only react when the correct quantity of human blood is added, reducing user error that can lead to inaccurate results. The test is highly stable and does not require refrigeration or specialized storage.
Press release: FDA Approves bioLytical Laboratories’ INSTI™ Rapid HIV Test …
Product page: INSTI™ HIV-1/HIV-2 Rapid Antibody Test …