bioLytical Laboratories has received approval from the US Food and Drug Administration (FDA) for Insti, its rapid HIV antibody test.
The FDA has approved Insti for the detection of antibodies to HIV-I in whole blood, finger stick blood and plasma specimens.
Insti uses flow-through technology to produce results in 60 seconds. Available procedures use lateral-flow technology and take 15 to 30 minutes to produce a result.
Insti has a unique antigen construct consisting of recombinant proteins for HIV-1 (gp-41) and HIV-2 (gp-36).
Clinical trial data revealed that the Insti had minimum sensitivity and specificity of 99.8% and 99.5% respectively, in finger stick, venipuncture blood and plasma samples.