View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
December 6, 2010

bioLytical Receives FDA Approval for HIV Test

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-t

By cms admin

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Get important industry news and analysis sent to your inbox
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Hospital Management