Wondfo HIV Self-Test, kit/100

General description:
Wondfo HIV Self-Test is a single-use in vitro diagnostic self-test for fingerstick whole blood detection of HIV-1/2. It is intended to be used as a self-test and/or by medical professionals. For in vitro diagnostic use only.

Technical specifications:
Sample type: Capillary whole blood
Sample volume: 10μl
Sensitivity: 95.8%
Specificity: 99.6%
Time to result: 15 - 30 mins

Manufacturer product reference:
Guangzhou Wondfo Biotech Co., Ltd, China. W006P0060

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

Items supplied with:
·100 x Individual pouches, each containing: 1 Test cassette, 1 Desiccant pouch, 1 Cotton swab, 1 Sterile safety lancet (Manufacturer: Ningbo Medsun Medical Co., Ltd. China - CE Marked), 1 Dropper (Manufacturer: Jiangsu Kehua Medical Instrument, China), 1 Buffer vial (0.3ml), 1 Alcohol prep pad (Manufacturer: Beijing Ruicheng Medical Supplies Co., Ltd. China – CE Marked), 1 IFU

Items required, but not supplied:
Timer, tissue and bandage

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

Weight and volume:
Estimated weight: 3.45kg
Estimated volume: 0.0204dm3

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 Wondfo HIV Self-Test for 100 tests
Secondary packaging: One kit Wondfo HIV Self-Test, 100 tests


Link:
https://extranet.who.in t/prequal/sites/default/files/whopr_files/PQDx_0357-004-01_WondfoHIV-Sel f-test_v1.0.pdf

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