Colloidal Gold, HIV RDT (Ab) HIV/Kit/50

General Description:
Wantai Rapid Test for Antibody to Human Immunodeficiency Virus (HIV) (Colloidal Gold Device) is a single use, rapid device for qualitative detection of antibodies against Human Immunodeficiency Viruses (HIV) 1+2 in human serum, plasma, or whole blood specimens.

Intended Use:
The device is intended for use in medical institutions by trained staff as an aid for the diagnosis of clinical conditions related to infection with HIV-1 and / or HIV-2 - the etiological agents of the acquired immunodeficiency syndrome (AIDS). The product is not intended for blood donor screening.

Technical specifications:
Technology: Chromatographic lateral flow device in a cassette format.
Format: Cassette, 50 tests, Single use only.
Sample type: Serum/Plasma/Whole Blood.
Sample volume: 50µl of whole blood,80µl of serum/plasma.
Sensitivity: 100%.
Specificity: 98.48%.
Reading time: Read the results from 10 minutes after specimen and buffer loading, to maximum of 30 minutes. Do not read the results after 30 minutes.

Manufacturer product reference:
Beijing Wantai Biological Pharmacy Enterprise Co. WJ-1850E.

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, 1 desiccant.
·3 x Diluent buffer bottle (3.0ml).
·50 x Disposable pipette (40-50μl) - Cangzhou ShengFeng Plastic products, China.
··50 x Sterile non safety lancet - CE Marked, Tianjin Huahong Technology Co. China
·50 x Alcohol swab - CE Marked, Taizhou Kangping Medical Science and Technology Co. China
·1 x IFU.

Items required, but not supplied:
Clock or timer, specimen collection container, centrifuge, and biohazard waste container.

Shelf life:
18 months.

Weight and Volume:
Estimated Weight: 0.6 Kg.
Estimated Volume: 3.5 dm3.

Storage and transportation:
2 - 30°C.

Material safety data sheet information (MSDS):
No environmental hazards.

Packaging and labeling:
Primary packaging: All contents of Rapid Test for Antibody to HIV for 50 tests.
Secondary packaging: One kit Rapid Test for Antibody to HIV, 50 tests.

General recommendations:
Public reports of WHO prequalified in vitro diagnostic products.
Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).