S0003947

Determine HIV Early Detect, kit/20


This material replaces the material S0003565 Alere HIV Combo, kit/20. But the product itself remains the same.
Indicative Price 53.35 USD

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, 7D2842

Items supplied with:
·Determine HIV Early Detect Test Card, 2 cards of 10 tests/card
·Instructions for use, 1

Items required, but not supplied:
·For testing Whole Blood Samples: Chase Buffer (7D2243) 1 Bottle (2.5 mL) containing phosphate buffered saline, preservative and antimicrobial agent
·For testing Whole Blood Samples (fingerstick assay): Blood lancets, sterile (7D2232 or 7D2233) and EDTA capillary tube (7D2222)
·New pair of disposable gloves, timer, micropipette capable of delivering 50μl, alcohol swabs

Shelf life:
18 months from the date of manufacturing.

Weight and volume:
Estimated weight: 0.08kg
Estimated volume: 0.38dm³

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 for 20 tests
Secondary packaging: One kit Determine HIV Early Detect, 20 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:
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