Uni-Gold HIV Complete E,kit/20

General Description:
Uni-Gold™ HIV is a single use rapid immunoassay, for the qualitative detection of antibodies to HIV-1 and HIV-2 in serum, plasma and whole blood (venepuncture and fingerstick). Uni-Gold™ HIV is intended for use in point of care settings as an aid in diagnosis of HIV-1 and HIV-2 infection.
Requires no sophisticated equipment and can therefore be performed in laboratories with limited facilities and non-laboratory settings. Reading of the results can be done visually i.e. subjectively read.

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: 99.76%.
Specificity: 99.85%.
Time to result: Minimum of 10 minutes. (No later than 12 minutes incubation time.)

Manufacturer product reference: Trinity Biotech, 1206502E-C.

Kit content:
·1x20 individually pouched test devices.
·1x 1 vial Wash Solution (2.0 mL) in dropper bottle.
·1x20 Disposable Pipettes 20 plastic, nonsterile.
·1x20 Sterile lancets.
·1x20 Sterile lancets.
· 1x1 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 contnets 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: 0.302 cbm.

General recommendations:
1.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.
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:
WHO list of prequalified in vitro diagnostic products: