All diagnostic and blood screening HIV testing devices in the US are regulated by the US Food and Drug Administration.

The INSTI™ HIV-1* Antibody Test (bioLytical™ LABORATORIES Inc., Richmond, BC.) is a single-use, rapid, in vitro membrane-based qualitative test for the detection of antibodies to Human Immunodeficiency Virus Type 1 in fingerstick blood, venous whole blood, or plasma.

The purpose of this prospective Clinical Study was to evaluate the performance characteristics of the INSTI™ HIV-1* Antibody Test Kit in comparison to “gold standard” licensed or approved laboratory-based tests.

For published details on this completed clinical study please visit www.clinicaltrials.gov

We wished to assess the performance of the INSTI™ HIV-1* Antibody Test Kit, in comparison to Food and Drug Administration (FDA) licensed or approved HIV testing assays, through a large prospective clinical study. The study was conducted in accordance with FDA guidelines for approval for use in POC, clinical and laboratory settings.

Intended Patient/Sample Population:

• The study was conducted using samples from a prospective, voluntary-testing population of 2,486 consenting patients of known and unknown HIV status, representing high and low risk levels (with a mininmum of 500 patients at high risk) in 14 clinical trial sites across the US and one central laboratory (commencing July, 2007).
  

Study Protocol:

• The study was conducted in two parts, first in institutions where HIV testing is routinely performed and where HIV counseling is offered (i.e, POC centers). The second part of the study was conducted in a central laboratory that routinely conducts laboratory-based HIV testing using an FDA-approved HIV-1 comparator assay and licensed Western blot test.
• Each subject received an INSTI™ on fingerstick blood and parallel HIV testing of an EDTA-treated venous whole blood sample conducted at a central laboratory
• POC sites performed one fingrstick test on-site and collected one 10 mL vial of whole blood to be tested at the central laboratory; which performed repeat INSTI™, "gold standard" comparator assay and licensed Western Blot if necessary.
• A minimum of three production lots of INSTI™ kits were tested.
• All staff performing INSTI™ were trained and validated by bioLytical™ prior to testing patient samples.
• Patients were not provided with results of the INSTI™ HIV-1 Antibody Test.
  

To see the results of the Multi-Centre US Clinical Study: Click here