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?
bioLytical is in the process of applying for CLIA Waiver.
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.
