Determine HIV Early Detect SET, kit/100

General Description:
Determine HIV Early Detect is an in vitro, visually read, qualitative immunoassay for the detection of antibodies (Ab) to HIV-1 and HIV-2 and the detection of non-immunocomplexed (free) HIV-1 p24 antigen (Ag) in human capillary and venous whole blood, plasma, or serum.

Intended Use:
The test is for professional use only and to be used as an aid in the diagnosis of HIV-1/HIV-2 infection in adults and children over the age of 18 months.

Technical specifications:
Technology: Lateral flow immunochromatographic assay.
Sample type: Whole blood, serum, plasma.
Sample volume: 50µl.
Sensitivity: 100%.
Specificity: 99.4%.
Time to result: Minimum of 20 mins and up to 40 mins.

Manufacturer product reference:
Abbott Diagnostics Medical Co., Ltd, 7D2843SET.

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

Items supplied with:
20 Determine HIV Early Detect test cards, 5 tests/card
1 x Chase buffer bottle (2.5ml)
100 x Capillary tubes, plastic - Jiangsu Kehua Medical Instrument, China ,
100 x Sterile non-safety lancets - CE Marked, 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: 0.326 kg.
Estimated volume: 16.2 x 6.1 x 21.3 cm.

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 Early Detect SET for 100 tests.
Secondary packaging: One kit Determine HIV Early Detect 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 report of WHO prequalified in vitro diagnostic products: