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
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).
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