Determine HIV-1/2 SET, kit/100

General Description:
Determine HIV-1/2 is an In Vitro, visually read, qualitative immunoassay for the detection of antibodies to HIV-1 and HIV-2 in human serum, plasma or whole blood.

Intended Use:
The test is intended as an aid to detect antibodies to HIV-1/HIV-2 from infected individuals. The test is for professional use only.

Technical specifications:
Technology: Lateral flow immunochromatographic assay.
Sample type: Whole blood, serum, plasma.
Sample volume: 50µl.
Sensitivity: 100%.
Specificity: 98.93%.
Time to result: Minimum of 15 mins and up to 60 mins.

Manufacturer product reference: Abbott Diagnostics Medical Co
., Ltd, 7D2343SET

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

Items supplied with:
20 test cards, 5 tests/card
1 x Chase buffer bottle (2.5ml)
100 x Capillary tubes, plastic – manufacturer Drummond Scientific LLC. USA
100 x Sterile non-safety lancets - CE Marked, manufacturer Tianjin Huahong Technology Co. China
1 x IFU.

Items required, but not supplied:
New pair of disposable gloves, timer, micropipette capable of delivering 50μl, alcohol swabs

Shelf life:
18 months for test cards from the date of manufacturing.

Weight and volume:
Estimated weight: 0.350 kg.
Estimated volume: 2.1 dm3.

Storage and transportation condition:
The test kit should be stored at 2 to 30°C, protect against humidity and direct sunlight.

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

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

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