INSTI HIV rapid antibody test is the fastest rapid kit for HIV 1 / 2
detection with results in 60 seconds. The test uses specimen of
convenience ie. whole blood (fingerstick blood) .It can also test
specimen like serum or plasma.
Test has built in procedural control and true biological IgG
control. This IgG control allows a safeguard against errors in the
field and performance inconsistencies.
INSTI is highly Accurate since it utilizes recombinant transmembrane
proteins from HIV-1 and HIV-2. This overcomes sensitivity and
specificity problems associated with a test that based on viral
lysates or a combination of core antigen and other viral proteins.
Detects antibodies to all subtypes of HIV including the known
circulating recombinant forms and group O.
It can be stored at Room temperature thus avoiding cost of cold
storage. A very simple and easy to use test with easily read visual
end-point.
INSTI enhances the efficiency of Voluntary Counseling & Test Centers
as preliminary results as known immediately during the patients
visit as this saves a lot of time and manpower and further increases
the chances of tracing HIV positive patients and as a result timely
directing them to proper care and support.
Some of the Approvals for INSTI HIV Antibody Test:
USAID Approval with PEPFAR (African and Caribbean countries).
CE approval for the European Union.
Extensively tested on BBI and sero conversion panels.
Health Canada FDA approval (Only product with a class 4
designation for HIV testing at Point of Care, clinical trial was
over 2 years and involved 16,500 samples.
ISO 13485 and 9001 compliance
GMP manufacturing compliance
INSTI has accuracy levels of 99.96% in proven clinical studies and
evaluations around the world.The kit is extremely accurate. It
consistently scores over 99.96%, in many tests run by independent
assessment laboratories, as well as in the multi-center Canadian
clinical trials. INSTIβ’ is the only Health Canada approved kit for
point of care use on the market to date.