S0004029

Bioline HIV/Syphilis Duo with acc,kit/25


This material replaces the material S0003790 SD Bioline HIV/Syphilis Duo, kit/25. But the product itself remains the same.
Indicative Price 32.50 USD
Disclaimer: The images shown are for illustration purposes only and may not be an exact representation of the product. “No Generic Photo Available" means that there is not an image available for this product.

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. 06FK35

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 non-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: 0.210kg
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_01 79-012-00_BiolineHIVSyphilisDuo_PublicReport_v7.0.pdf

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