Bioline HCV with accessories, kit/25 T

General description:
Bioline HCV is an in vitro immunochromatographic, rapid assay designed for the qualitative detection of antibodies specific to HCV, in human serum, plasma (heparin, EDTA and sodium citrate) or whole blood. Bioline HCV is intended only for professional use as the initial test, as an aid to diagnosis. Reactive specimens should be reflexed for additional testing, either by nucleic acid testing (NAT) technologies for the detection of HCV RNA or HCV core antigen testing, to identify current HCV infection.

Technical specifications:
Technology: Lateral immuno-chromatographic test
Sample type: Whole blood (Venous whole blood and finger-prick blood), plasma, serum
Sample volume: 10µl
Sensitivite:100%
Specificity: 100%
Reading time: 5-20 mins

Manufacturer product reference:
Abbott Diagnostics Korea Inc., 02FK17

QMS/Regulatory Requirements
ROW
ISO 13845:2016
WHO Pre-Qualified product

Items supplied with:
25 x Test device pouch containing: 1 test device, 1 desiccant
1 x Assay diluent (5.0ml)
25 x Capillary pipettes (10ul) – (Manufacturer: HLB LIFE SCIENCE CO., LTD. Korea)
25 x Sterile safety lancets (Manufacturer: Tianjin Huahong Technology Co., China – CE Marked)
25 x Alcohol swabs (Manufacturer: HLB Co., LTD. Healthcare. Korea – CE Marked)
1 x IFU

Items required, but not supplied:
Micropipette, Protective gloves, Timer and Biohazard container

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

Weight & volume:
Estimated weight: 0.28kg
Estimated volume: 0.001m3

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 HCV with accessories, kit for 25 tests
Secondary packaging: One kit Bioline HCV with accessories, 25 tests

General recommendations:
WHO INT

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