Bioline HIV1/2 3.0 SafetyLancet,kit/25

General Description:
The Bioline HIV 1/2 3.0 kit is a rapid, qualitative test for the detection of antibodies to all isotypes (IgG, IgM, IgA) specific to HIV-1 and HIV-2 simultaneously in human serum, plasma, or whole blood.

Intended Use:
The Bioline HIV 1/2 3.0 test is intended only for professional use and for in vitro diagnostic use. This test may not be suitable for diagnosis of early infection or blood donation screening. Positive samples should be confirmed by a supplemental assay such as ELISA or Western Blot test.

Technical specifications:
Technology: Lateral immuno-chromatographic test.
Format: Cassette, 25 tests.
Sample type: Whole blood (Venous whole blood and finger-prick blood), plasma, serum
Sample volume: 20μl (Whole blood), 10μl (Serum, Plasma).
Sensitivity: 100%.
Specificity: 99.8%.
Reading time: 10-20 mins.

Manufacturer product reference:
Abbott Diagnostics Korea Inc., 03FK17.

QMS/Regulatory information:
ROW (Rest-of-World)
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 bottle (4.0ml).
25 x Specimen transfer devices (20μl) - HLB LIFE SCIENCE CO., LTD. Korea.
25 x Sterile safety lancets - CE Marked, Tianjin Huahong Technology Co. China.
25 x Alcohol swabs - 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: 0.28 kg.
Estimated volume: 1.311dm3.

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 1/2 3.0 with safety lancet, kit for 25 tests.
Secondary packaging: One kit Bioline HIV 1/2 3.0 with safety lancet, 25 tests.

Useful links:
Public reports of WHO prequalified in vitro diagnostic products.