INSTI™ FREQUENTLY ASKED QUESTIONS
What is the Accuracy of the INSTI™ kit?
Proven accuracy of 99.96%
Is a reactive INSTI™ test conclusive of HIV diagnosis?
No. As in all assays for HIV antibody, false positives can occur infrequently with INSTI™. INSTI™ is considered as a first-line test only, and all patients with reactive or indeterminate INSTI™ results should be re-tested with an HIV confirmatory assay before final HIV antibody status can be determined.
Are INSTI™ results as accurate as laboratory-based HIV testing procedures?
Yes. INSTI™ is a registered and approved medical device and has undergone extensive clinical trials that have demonstrated its accuracy in direct comparison to laboratory-based methods. Much of these data 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 ‘real life’ documented seroconversion cases, INSTI™ is equivalent to the most sensitive laboratory-based assays in early antibody detection. However, patients who are in the pre-antibody “window period” of HIV infection may not be reactive in the INSTI™ test.
What kind of antigen is used?
The INSTI™ test utilizes recombinant transmembrane proteins from
HIV-1/HIV-2*. Use of these proteins overcome sensitivity and specificity problems associated with a test based on viral lysates or a combination of core antigen and other viral proteins.
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 sign (dot) on the control membrane.
How long does it take to perform a single test?
INSTI™ preparation is minimal and results show up in 60 seconds. Results are interpreted immediately after pouring the Clarifying Solution (vial #3) into the test unit.
What is the stability of the test results in the test membrane?
The test results will remain visible in the INSTI™ test unit for an indefinite period after performing the test. We recommend reading the results immediately within the first 5 minutes after the test. The results may fade over time.
What kind of storage conditions are needed?
INSTI™ should be stored at 15-30°C.
What is the shelf life?
INSTI™ presently has a shelf life of 12 months. All products are made to order to ensure that no short-dated products are shipped.
What level of quality assurance do you practice in your manufacturing facility?
bioLytical™ Laboratories is an ISO 9001 and ISO 13485 certified
manufacturing facility that has been inspected and approved by Health
Canada for the manufacturing of medical devices. Each INSTI™ test kit undergoes multiple quality assurance steps and procedures prior to being released for sale.
What are the special benefits of using INSTI™?
- Results in 60 seconds
- Proven accuracy of 99.96%
- Proven early detection
- Built in sample addition control
- Easy to use and understand
Where can I learn more about bioLytical™ and INSTI™?
For enquiries or to learn more, please continue browsing our website and visit our resources page.
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