Uni-Gold HIV 1/2, kit/100

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 (venous and fingerstick). Uni-Gold™ HIV is intended for use in point of care settings as an aid in the diagnosis of HIV-1 and HIV-2 infection.

Technical specifications:
Technology: Lateral immuno-chromatographic assay
Format: Cassette
Antigen: HIV 1/2 recombinant proteins
Sensitivity: 99.76%
Specificity: 99.85%
Invalid rate: 0.09%
Specimen type: Serum, plasma or whole blood
Specimen volume: 60μl
Reading time: 10 mins
Product Code:
(Trinity Biotech) 1206502N-100

Items supplied with:
100 x test devices, individually packed in a pouch
100 x Disposable pipettes
5 x Wash solution, 2 ml
1 x Instruction for use

Items required, but not supplied:
Safety lancet, blood collection devices, sterile wipes, sterile gauze pads, adhesive bandages, clock or timer, biohazard waste container, protective gloves

Shelf life:
20 months

Weight and Volume:
Estimated Volume: 5.57 dm3
Estimated Weight: 1.045 kg

Storage and temperature instructions:
2-27°C

Packaging and labeling:
Primary packaging: All contents of Uni-Gold HIV 1/2 for 100 tests
Secondary packaging: One kit Uni-Gold HIV 1/2, 100 tests

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

Useful links:
WHO list of prequalified in vitro diagnostic products:
http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/