Determine HIV-1/2, kit/20

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. 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, 7D2342

Items supplied with:
·Determine HIV-1/2 test cards, 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): Single use sterile lancet 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-1/2 for 20 tests
Secondary packaging: One kit Determine HIV-1/2, 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: