INSTI HIV Self-Test, kit/1T

General description:
INSTI HIV Self-Test is a qualitative immunoassay that is used as a self-test for the detection of antibodies to HIV-1 and HIV-2 in infected individuals using a drop of human fingerstick blood.

Technical specifications:
Specimen type: Whole blood
Sensitivity: 99.8%
Specificity: 99.5%
Time to result: Immediately and within 5 mins

Manufacturer product reference:
BioLytical Laboratories Inc., Canda. 90-1071

QMS/Regulatory information:
·CE Marked
·ISO 13845:2016
·WHO Pre-Qualified product

Items supplied with:
·1 x Blotted Membrane Unit
·1 x 1.5ml Sample diluent bottle (Bottle 1)
·1 x 1.5ml Colour developer bottle (Bottle 2)
·1 x 1.5ml Clarifying solution bottle (Bottle 3)
·1 x Sterile safety lancet (Manufacturer: HTL Strefa S.A. Poland – CE Marked)
·1 x Alcohol swab (Manufacturer: Lernapharm (Loris) Inc. Canada)
·1 x Adhesive bandage
·1 x Instructions for Use (IFU)

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

Weight and volume:
Estimated weight: 0.0405kg
Estimated volume: 0.787dm³

Storage and transportation condition:
The test kit should be stored at 2 - 30°C, protect against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of INSTI HIV Self-Test for 1 test
Secondary packaging: One kit INSTI HIV Self-Test, 1 test

General recommendations:
PQDx_0002-002- 01_INSTI-HIV_SelfTest_v4.0.pdf (who.int)

Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).