All diagnostic and blood screening HIV testing devices in Canada are regulated through the Bureau of Medical Devices, Health Canada. Currently there are no rapid HIV testing devices approved for use in point-of-care (POC) settings in Canada.

The INSTI™ HIV-1/HIV-2* Antibody Test (biolytical™ LABORATORIES Inc., Richmond, BC.) is a rapid (60 second) in vitro membrane-based qualitative test for the detection of antibodies to Human Immunodeficiency Virus Type 1 in human whole blood, serum or plasma.

The purpose of this prospective Clinical Study is to evaluate the performance characteristics of the INSTI™ HIV-1/HIV-2* Rapid Antibody Test Kit in comparison to “gold standard” licensed laboratory-based tests.

We wished to assess the performance of the INSTI™ HIV-1/HIV-2* Antibody Test Kit through a large scale prospective clinical trial, conducted in accordance with the Medical Devices Regulations, Health Canada, for approval for use in POC, clinical and laboratory settings.

Intended Patient/Sample Population:

• A prospective, cross-sectional, voluntary-testing population of 2,500 consenting patients of unknown HIV status, from 3 provinces (BC, Alberta, Ontario), representing all risk levels, plus 1,000 combined archived and prospective samples from patients with confirmed HIV-1/HIV-2* infection (commencing Sept, 2003).
• 25 commercial seroconversion panels, to measure early antibody detection.
  

Study Protocol:

• Patients were enrolled in the study through participating POC sites including Medical, STD, Family Planning, Anonymous Testing and hospital-based Immunodeficiency Clinics in Vancouver, Calgary and Toronto. Patients from the Vidus (Vancouver injection drug user study) and Vanguard (Vancouver gay men’s study) cohorts were also included.
• Finger-stick whole blood was collected and tested with the INSTI™ kit at the POC sites. Matching venous blood was also collected in EDTA tubes from all patients and forwarded to the Provincial Public Health Laboratories (PHL). A subset of matching red-top blood samples (for serum) was collected in selected clinics.
• At the PHL, INSTI™ testing was carried out on matching EDTA blood as well as plasma and serum, within 48 hours of collection. Gold standard serology testing by the PHL test of record (Abbott AxSym MEIA HIV 1/2 GO in all PHL sites) was conducted on serum and/or plasma, with discordant and/or indeterminate results resolved via supplemental EIA, Western Blot, and p24Ag as necessary.
• 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/HIV-2* Antibody Test.
  

• INSTI™ HIV-1/HIV-2* Antibody Test cassette consists of a synthetic filtration membrane positioned atop an absorbent material within a plastic cartridge. The membrane has been specifically treated with HIV-1/HIV-2* recombinant proteins, which react with HIV-1/HIV-2* antibodies in the specimen to produce a distinct visual signal on the membrane.
• The membrane also includes a human IgG-capture control which consists of a protein-A treated spot capable of binding IgG antibodies normally present in blood and blood components. If the control spot does not appear, the test is considered invalid.
• All INSTI™ results were compared to licensed gold standard test kit results. The INSTI™ procedure is illustrated in the following PDF file: View this document in PDF format
  

To see the results of the Multi-Centre Canadian Clinical Trial: Click here

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