BiolineHIV/SyphilisDuowsafelancet,kit/25

General description:
Bioline HIV/Syphilis Duo test is a rapid, qualitative test for the detection of antibodies to all isotypes (IgG, IgM, IgA) specific to HIV1 including subtype-O, HIV-2, and Syphilis (Treponema pallidum) in human serum, plasma or whole blood. The Bioline HIV/Syphilis Duo is intended only for professional use, and for in vitro diagnostic use.

Technical specifications:
Sample type: Whole blood (Venous whole blood and finger-prick blood), plasma, serum
Sample volume: 20μl (Whole blood), 10μl (Serum, Plasma)
Clinical sensitivity: 99.91% (HIV), 99.67% (Syphilis)
Clinical specificity: 99.67% (HIV), 99.72% (Syphilis)
Reading time: 15-20 mins

Manufacturer product reference:
Abbott Diagnostics Korea Inc., Republic of Korea. 06FK37

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

Items supplied with:
·25 x Test devices, individually foil pouched with a desiccant
·1 x Assay diluent (4.0ml)
·25 x Capillary pipettes (20ul) (Manufacturer: Jiangsu Kehua Medical Instrument, China)
·25 x Sterile safety lancets (Manufacturer: Shandong Lianfa Medical Plastic Products Co Ltd., China - CE Marked)
·25 x Alcohol swabs (Manufacturer: HLB Co., LTD. Healthcare, Korea)
·1 x IFU

Items required, but not supplied:
Disposable gloves, timer, container for biohazard disposables, micropipette

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

Weight & volume:
Estimated weight: 0.280kg
Estimated volume: 1.359dm3

Storage & transportation condition:
The test kit should be stored at 1°C to 30°C, protect against humidity and direct sunlight. Do not freeze reagents.

Packaging & labelling:
Primary packaging: All contents of Bioline HIV/Syphilis Duo with accessories, kit for 25 tests
Secondary packaging: One kit Bioline HIV/Syphilis Duo with accessories, 25 tests

General recommendations:
https:// extranet.who.int/prequal/sites/default/files/whopr_files/PQDx_0179-012-0 0_BiolineHIVSyphilisDuo_PublicReport_v7.0.pdf

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