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INSTI™ FREQUENTLY ASKED QUESTIONS

What is the Accuracy of the INSTI™ kit?


Proven accuracy of ≥ 99.8% Sensitivity and ≥ 99.5% Specificity


Is a Reactive INSTI™ test conclusive of HIV diagnosis?


No. As in all assays for HIV antibody, false Reactives can occur infrequently with INSTI™. INSTI™ is considered as an initial test only, and all patients with Reactive or Indeterminate INSTI™ results should be re-tested with a licensed or approved HIV confirmatory assay before final HIV antibody status can be determined.


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

Does INSTI™ detect HIV 1 & 2 in the US?


The INSTI antigen matrix includes HIV-1 gp41 and HIV-2 gp36. However, currently in the US, INSTI is approved for HIV-1 only.


Is INSTI™ CLIA Waived?


Yes, INSTI is CLIA waived for fingerstick blood.


What is the read window? The PI says I must read the results immediately.


The kit is designed to produce a very rapid result, and therefore be interpreted immediately. 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.

Where can I learn more about bioLytical™ and INSTI™?


For inquiries or to learn more, please continue browsing our website and visit our resources page.


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