Σellas Products is the exclusive sales and distribution representative of the INSTI™ HIV-1 Antibody Test in numerous countries in Europe, mid-East, Asia and South America. The INSTI™ Kit is a unique, simple-to-use HIV diagnostic product used in the diagnosis of HIV. The INSTI™ HIV diagnostic has received FDA, CE mark (Europe) and Health Canada regulatory approvals.
At 60 seconds for a reading, INSTI™ is the fastest HIV diagnostic assay in the world today. The INSTI™ HIV Antibody Test, developed and manufactured by BioLytical™ Laboratories in Canada is a single-use, rapid, in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 in human whole blood, fingerstick blood, or plasma specimens. The INSTI™ HIV Antibody Test is a manual, visually read, flow-through immunoassay for the qualitative detection of HIV antibodies in human blood obtained from fingerstick or venipuncture, and plasma in as little as 60 seconds.
The test consists of a nitrocellulose filtration membrane positioned atop an absorbent material within a plastic cartridge, referred to as the INSTI™ Membrane Unit. The membrane has been spotted with HIV-1 and HIV-2 recombinant proteins, which react with HIV antibodies in the specimen. Although the membrane contains HIV-1 and HIV-2 proteins, the assay has been validated for detection of HIV-1 antibodies only.
Frequently Asked Questions
What is the Accuracy of the INSTI™ kit?
Proven accuracy of ≥ 99.8% Sensitivity and ≥ 99.5% Specificity.
Are INSTI™ results as accurate as licensed or approved laboratory-based HIV testing procedures?
Yes. INSTI™ is an FDA approved, Health Canada approved and CE Marked medical device and has undergone extensive clinical and non-clinical studies that have demonstrated its accuracy in direct comparison to licensed or approved laboratory-based methods. Data from these clinical and non-clinical studies are published in the INSTI™ package insert.
Does INSTI™ detect HIV antibodies early in the course of infection?
Yes. In commercial HIV seroconversion panels and low titer panels, INSTI™ is equivalent to the most sensitive licensed or approved laboratory-based assays in early antibody detection. However, patients who may be in the “window period” of HIV infection may test Non-Reactive in the INSTI™ test.
What kind of antigen is used?The INSTI™ test utilizes unique recombinant transmembrane proteins from HIV-1 and HIV-2
Does the INSTI™ kit have a built-in sample addition control?Yes, the procedural control for the INSTI™ consists of a protein capable of capturing the IgG normally present in human blood components. IgG is present in blood components in both normal and HIV positive human specimens. Captured IgG reacts with a chromatic agent to produce a visual signal (spot) on the control membrane.
How long does it take to perform a single test?
INSTI™ preparation is minimal and results show up in as little as 60 seconds. Results are interpreted immediately after the absorption of Clarifying Solution (vial #3) into the Membrane Unit.
What is the stability of the test results in the test membrane?
The test results will remain visible in the INSTI™ Membrane Unit for an indefinite period after performing the test. Results are intended to be read immediately. Reading the test results after more than 5 minutes has elapsed following the addition of Clarifying Solution might produce erroneous results.
What kind of storage conditions are needed?
INSTI™ should be stored at 15-30°C (59-86°F).
What is the shelf life?
INSTI™ has a shelf life 12 months in Canada, the U.S. and the European Union. In the rest of the world, INSTI™ has a shelf life of 15 months.
What level of quality assurance do you practice in your manufacturing facility?
bioLytical™ Laboratories is has an ISO 9001 and ISO 13485 certified quality system that meets FDA current Good Manufacturing Practices (cGMP) requirements for the manufacturing of medical devices. Each INSTI™ kit undergoes multiple quality assurance steps and procedures prior to being released for sale.
What are the special benefits of using INSTI™?
Results in as little as 60 seconds, Proven accuracy of ≥ 99.8% Sensitivity and ≥ 99.5% Specificity, Proven early detection, Human IgG-Capture Control ensures proper sample addition, Easy to use and understand.