INSTI HIV-1/HIV-2 Antibody Test kit/48T

General Description:
INSTI HIV-1/HIV-2 Antibody Test is a single use, rapid, flow through (immunofiltration) in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 in human EDTA-venous whole blood, fingerstick whole blood, serum or EDTA-plasma.

Intended Use:
The test is intended for use by trained personnel in medical facilities, clinical laboratories, emergency care situations, physicians’ offices, and field studies as a diagnostic test capable of providing results in less than one minute. Although suitable for near-patient or point-of-care (POC) testing, the test is not suitable for self-testing. All required pre- and post-test counselling guidelines must be followed in each setting in which the INSTI HIV-1/HIV-2 Antibody Test is used.

Technical specifications:
·Technology: Flow through immunonitration in vitro qualitative immunoassay
·Sample type: venous and capillary whole blood, serum, plasma
·Clinical sensitivity:
Fingerstick blood: 99.6%
EDTA whole blood: 99.4%
Plasma: 99.5%
Serum: 99.0%
·Clinical specificity:
Fingerstick blood: 99.3%
EDTA whole blood: 99.7%
Plasma: 99.96%
Serum: 100%
·Time to result: Strictly follow the reading time as per Instruction for Use (IFU).

Manufacturer product reference:
BioLytical Laboratories, Inc., 90-1022.

QMS/Regulatory information:
·ROW (Rest-of-World)
·ISO 13845:2016
·WHO Pre-Qualified product

Items supplied with:
·48 x Membrane Units individually packaged.
·48 x Sample Diluent vials (1.5 ml).
·1 x Colour Developer bottle (85 ml).
·1 x Clarifying Solution bottle (85 ml).
·48 x Sterile lancets, CE Marked. (HTL Strefa S.A. Poland)
·48 x Alcohol swabs. (Lernapharm (Loris) Inc. Canada)
·48 x Single-use pipettes (50µl). (Drummond Scientific LLC. USA)
·1 x IFU.

Items required, but not supplied:
·Personal protective equipment such as gloves, lab coat or gown.
·Appropriate biohazard waste containers.
·Absorbent cotton balls for fingerstick or venipuncture wounds closure.

Shelf life:
15 months from the date of manufacturing; do not use beyond its expiry date.

Weight & volume:
Estimated weight: 1.33 kg.
Estimated volume: 10.951 dm3.

Storage & transportation condition:
The test kit should be stored and shipped at 15°C to 30°C.

Packaging & labelling:
Primary packaging: All contents of INSTI HIV-1/HIV-2 Antibody Test, kit of 48 tests.
Secondary packaging: One kit INSTI HIV-1/HIV-2 Antibody Test kit/48 tests.

General recommendations:
Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).
Do not use any other specimen than those specified.
Apply standard biosafety precautions when handling and disposing of potentially infectious material.
Do not use if any kit components are damaged.
Do not mix reagents from different lots.

Useful Links
Public reports of WHO prequalified in vitro diagnostic products: