CheckNOW HIV Self Test, kit/1T

General description:
CheckNOW HIV SELF TEST is a single-use, in vitro (outside the body) visually read rapid immunoassay that uses a blood sample from a finger puncture for the qualitative detection of antibodies to HIV-1 and HIV-2 in blood. The CheckNOW HIV SELF TEST is intended to be used manually by untrained lay users (self testing) who are 14 years older to aid in the diagnosis of HIV-1 or HIV-2 infection. This test is not intended to be used as an HIV screening test for blood donation.

Technical specifications:
Sample type: Capillary whole blood
Sample volume: One drop
Sensitivity: 99.5%
Specificity: 98.50%
Time to result: 15 - 20 mins

Manufacturer product reference:
Abbott Rapid Diagnostics Jena GmbH, Germany. 29012-W01

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

Items supplied with:
·1 x Test device pouch containing: 1 test device, 1 desiccant
·1 x Buffer
·1 x Sterile plaster
·1 x Sterile safety lancet (Manufacturer: SteriLance Medical (Suzhou) Inc. China - CE Marked)
·1 x Specimen dropper (Manufacturer: Jiangsu Kehua Medical Instrument, China)
·2 x Alcohol pads (Manufacturer: Changzhou Maokang Medical Products Co., Ltd. China - CE Marked)
·1 x IFU

Items required, but not supplied:
Timer and tissue

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

Weight and volume:
Estimated weight: 0.058kg
Estimated volume: 0.602dm3

Storage 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 CheckNOW HIV Self Test for 1 test
Secondary packaging: One kit CheckNOW HIV Self Test, 1 test


General recommendations:
https://extranet.who.int/prequal/sites/default/files/whopr_files/PQDx_04 81-032-00_CheckNOW-HIV-SELFTEST_v2.0.pdf

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