Uni-Gold HIV,kit/100

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, 1206502-100.

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

Kit content:
100 x Test device pouch containing: 1 test device, 1 desiccant.
5 x Wash Solution bottle (2.0ml)
100 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 labeling:
Primary packaging: All contents of Uni-Gold HIV Kit/ Test for 100 tests.
Secondary packaging: Uni-Gold HIV Kit /100 tests.

Weight and volume:
Estimated weight: 1.5 Kg.
Estimated volume: 0.006m3.

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

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