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. The test is for professional use only and intended 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

Items supplied with:
·Determine HIV Early Detect Test Card, 10 cards of 10 tests/card
·Chase buffer (7D2243), 1 bottle x 2.5ml
·EDTA capillary tubes (7D2222), 100
·Blood lancets (7D2233), 100
·Instructions for use, 1

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.
24 months for chase buffer from the date of manufacturing.

Weight and volume:
Estimated weight: 0.33kg
Estimated volume: 0.568dm³

Storage and transportation condition:
The test kit should be stored at 2 - 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: