Rapid Immunoassay Detects Antibodies to HIV

The test is designed for use with whole blood, finger-stick blood, or plasma specimens and uses flow-through rather than lateral-flow technology to reduce processing time.

The single-use rapid test known as INSTI HIV-1 also includes a "unique antigen construct" composed of recombinant proteins for HIV-1 (gp-41) and HIV-2 (gp-36). Clinical trial data showed minimum sensitivity and specificity of 99.8% and 99.5%, respectively, in finger-stick whole blood samples; HIV-1 was detected with 99.9% sensitivity and 100% specificity in venipuncture whole blood and plasma samples. As with all rapid HIV tests, positive findings must be confirmed before a diagnosis of HIV infection can be established.

The immunoassay is manufactured by bioLytical Laboratories, Inc, (Richmond, Canada). The test is intended for use by trained personnel in point-of-care and laboratory situations to aid in the diagnosis of HIV-1 infections. If multiple rapid HIV tests are available, this test is suitable for use in appropriate multitest programs. The assay is packaged as a kit containing INSTI membrane units, sample diluent, color developer and clarifying solution, and is available in point-of-care use packaging, or packaging suitable for laboratory use.

Niel Constantine, PhD, a professor at the University of Maryland, (Baltimore, MD, USA), said, "The unique antigen used in the INSTI assay is important because the HIV testing community appears to be headed toward a multi-rapid test algorithm in which we must deploy tests with different antigens, so bioLytical's use of a unique antigen satisfies that requirement".

The assay has been approved by the US Food and Drug Administration, (FDA, Silver Springs, MD, USA). The 60-second HIV test previously was approved for use in 56 other countries, including Canada and member states of the European Union.

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