Diagnostic HIV(1+2)Ab colloi-gold Kit/50

General description:
Diagnostic Kit for HIV (1+2) Antibody (Colloidal Gold) V2 is an in vitro, visually-read test for the qualitative determination of antibodies against HIV-1 and HIV-2 in human serum, plasma, venous and capillary whole blood.

Intended Use
This product is intended for use as an aid to detect antibodies against HIV (1+2) from individuals suspected to be infected, by HIV. It is intended to be used by laboratory professional and health care workers at point-of-care.

Technical specifications:
·Technology: Immunochromatographic technology
·Format: Cassette, 50 tests
·Sensitivity: 100%
·Specificity: 100%
·Invalid rate: 0%
·Specimen type: Serum, plasma, venous whole blood, capillary whole blood
·Specimen volume: 40μl
·Reading time: 15-25 mins
·Internal quality control measures included in the test kit: Yes.

Product Code: Shanghai Kehua Bio-engineering Co., Ltd. R-401-50-C-3.

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

Items supplied with:
·50 x Test device pouch containing: 1 test device and 1 desiccant.
·2 x Sample diluent bottle (4.0ml)
·50 x Disposable transfer pipettes
·50 x Sterile safety lancets - CE Marked, Ningbo Medisun Medicals Co., Ltd. China
·50 x Alcohol swabs - Light Medical Manufacturer China
·1 x IFU

Items required, but not supplied:
Consumables: Waste container, gloves. If serum/plasma procedure - blood collection tubes, pipette, pipette tips.
Equipment: Timer.

Shelf life:
24 months from the date of manufacturing.

Weight and Volume:
Estimated Volume: 0.0054 m3.
Estimated Weight: 0.85 Kg.

Storage and temperature instructions:
Temperature: 4-30°C.

Packaging and labeling:
Primary packaging: All contents of HIV (1+2) Ab, with accessories for 50 tests.
Secondary packaging: One kit HIV (1+2) Ab, with accessories, 50 tests.

General recommendations:
Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).
Do not use any other specimen than those specified.
Apply standard biosafety precautions when handling and disposing of potentially infectious material.

Useful Links
Public reports of WHO prequalified in vitro diagnostic products: