Recently, the Food and Drug Administration (FDA) approved INSTI Rapid HIV Test, a single rapid test for the detection of antibodies to HIV-1. The new test claims to deliver results in as little as 60 seconds, in contrast to the six previously approved rapid HIV tests, which tend to take 10 – 20 minutes. The test is developed by bioLytical Laboratories of Canada.
About the product
The INSTI Rapid HIV Antibody Test is a rapid in vitro qualitative test for the detection of antibodies to Human Immunodeficiency Virus Type 1 in human whole blood, serum or plasma. The test uses flow-through rather than lateral-flow technology to reduce processing time. The test also includes a “unique antigen construct” comprised of recombinant proteins for HIV-1 (gp-41) and HIV-2 (gp-36).
The test is intended for use by trained personnel in medical facilities, clinical laboratories, emergency care situations, and physicians’ offices as a screening assay capable of providing test results in less than 60 seconds. The 60-second HIV test has already been approved for use in 56 other countries, including Canada and member states of the European Union.
About the Test procedure
The Insti test requires pricking a finger to draw a blood sample, then mixing the sample with a reagent and color developer. One blue “control spot” reveals the absence of HIV antibodies (nonreactive results), two spots reveal the presence of such antibodies (reactive), and...
the absence of a spot indicates that the results are invalid.
Because this is a first-line test, all reactive (HIV-positive) results must be confirmed by a second testing system, the company advises, and all invalid tests should be conducted again with a new blood sample.
The test is highly stable and does not require refrigeration or specialized storage.
Basis of FDA Approval
FDA approval was based on clinical trial data showing 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.
“We believe the speed, accuracy, and unique technology of our 60-second HIV test will make the testing and early treatment of HIV/AIDS more efficient in all patient settings, including hospital emergency rooms and public health clinics,” stated bioLytical Laboratories President Philip Bligh in the news release.
I hope the test will be a valuable addition in detecting the HIV antibodies rapidly that can help curb the spread of infection.