Uni-Gold HIV1/2,kit/20

General Description:
Uni-Gold HIV test is a single use rapid immunoassay, for the qualitative detection of antibodies to HIV-1 and HIV2 in serum, plasma and whole blood (venipuncture and fingerstick)

Intend Use:
Uni-Gold HIV test is intended for use in point-of-care settings as an aid in diagnosis of HIV-1 and HIV-2 infection.

Technical specifications:
Technology: Rapid immunoassay based on the immunochromatographic sandwich principle.
Format: Test cassette.
Sample type: Serum, plasma, or whole blood.
Sample volume: 60 µL.
Sensitivity: 98.7%-100%.
Specificity: 99.2%-100%.
Time to result: Minimum of 10 minutes. (No later than 12 minutes incubation time.)

Manufacturer product reference:
Trinity Biotech, 1206502.

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

Kit content:
·20 x Test device pouch containing: 1 test device, 1 desiccant.
·1 x Wash Solution bottle (2.0ml)
·20 x Disposable Pipettes - CE Marked, Zhejiang Sorfa Life Science Research Co. China
·1 x IFU.

Items required, but not supplied:
Consumables
·Blood collection devices. For testing of venipuncture whole blood, serum or plasma.
·Biohazard disposal waste container.
Fingerstick Samples:
·Sterile gauze pads.
·Adhesive bandages.
Equipment:
·Timer or stopwatch.
·PPE

Shelf life:
20 months.

Storage and transportation:
Store the kit unopened at 2 to 27°C.

Packaging and labelling:
Primary packaging: All contents of Uni-Gold™ HIV Kit/ Test for 20 tests.
Secondary packaging: One kit Uni-Gold™ HIV Kit Kit/20T.

Weight and volume:
Estimated weight: 0.28 Kg.
Estimated volume: 0.002m3.

General recommendations:
1.Read the Instructions for Use completely before using the product. The instructions must be followed carefully.
2.Uni-Gold™ HIV is for diagnostic use only and is not to be used for screening donors of blood, plasma, cells or tissues.
3.Perform test at room temperature.

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