INSTI HIV-1 HIV-2 Antibody Test - Sample, Pour, and Read Your Results Immediately. The Rapid HIV Test is intended for use by trained personnel in medical facilities, clinical laboratories, emergency care situations, and physicians’ offices as a screening assay capable of providing test results in as little as 60 seconds.
-
The World’s Fastest HIV Test: Get accurate results in just one minute - no waiting, no stress.
-
Sensitive: Detects IgM and IgG Antibodies
-
Easy to Use: Simple steps with clear instructions - no experience needed.
-
Results You Can Trust: Reliable and clinically proven, for peace of mind when it matters most.
The test uses flow-through technology to detect HIV-1 and HIV-2 antibodies using a drop of human fingerstick blood.
To further ensure accuracy, bioLytical employs a rigorous testing and validation process. Before a product is released to the market, it undergoes extensive testing to ensure that it meets the company's high standards.
How it works
-
Collect Blood: Use the lancet to prick your finger and collect a drop of blood.
-
Add Blood Sample: Add your blood into bottle 1 and shake it three times.
-
Pour Solutions: Pour solutions one at a time and wait for your results in one minute.
Specifications
| Run Time |
1 MIN |
| Sensitivity |
100% |
| Specificity |
99.5% |
| Specimens Collection |
Fingerstick whole blood, serum, plasma |
| Detects HIV-1 |
Yes |
| Detects HIV-2 |
Yes |
| Specimen Volume |
50 μL |
| Method |
Flow-through |
| Authorizations / approvals |
CE, Health Canada, WHO PQ, FDA |
Ordering
| Code |
Price-list description |
Pack |
| 90-1015 |
HIV POC Test CE 50T |
50-test kit |
| 90-1008 |
INSTI HIV POC Ab Test (Singles) 50ea |
50 single tests |
FAQ
Does bioLytical follow ISO quality standards and guidelines?
bioLytical follows ISO 13485 and the Medical Device Single Audit Program (MDSAP) Certified Quality Management System. MDSAP is a new program that allows a single regulatory audit to be conducted and satisfies the requirements of multiple regulatory jurisdictions (USA, Canada, Australia, Brazil and Japan).
How should the INSTI HIV-1/HIV-2 Antibody Test be stored?
The storage temperature for the INSTI Test is 2 - 30-C (35.6 - 86-F). TB-010 can be sent to customer as a reference.
Can I get infected with HIV from the INSTI HIV-1/HIV-2 Antibody Test Kit?
There is no risk of being infected with HIV from the INSTI Test. There is no HIV present in the product (solution bottles, membrane unit, or any test components). The INSTI Test does not detect HIV itself, but rather the antibodies produced in response to the virus.
Is the INSTI Test CLIA waived?
The INSTI Test is CLIA-waived for fingerstick blood samples, which means external assessment is not required by Federal (CLIA) regulations when used at a CLIA-waived site. A CLIA Certificate of Waiver is required to perform the test in a waived setting. Furthermore, the test is classified as Moderately Complex for venous whole blood or plasma samples and testing using these sample types may not be performed in CLIA-waived settings.
When should INSTI Test Control samples be run?
The schedule and frequency of testing with INSTI Controls should be determined by the end user and their testing facility. However, controls are recommended to be run under the following circumstances: - To verify a new INSTI operator prior to performing testing on patient specimens - When switching to a new lot number of INSTI test kits - Whenever a new shipment of kits is received - When there are deviations in storage or testing location temperature
Documents
