S0003360

FirstResponseHIV1-2.O Cardtest,V2,kit/30


Rapid diagnostic test First Response HIV 1-2.O Card test (Version 2.0), kit/30
Indicative Price 22.50 USD
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General description:
First Response HIV 1-2.O Card Test (Version 2.0) is a rapid, immunochromatographic, qualitative screening, in vitro diagnostic test for detection of antibodies specific to HIV-1 (including Group O) and HIV-2 in human serum, plasma or venous and capillary whole blood. The test can be used as an aid in the diagnosis of HIV-1 and HIV-2.

Technical specifications:
Technology: Rapid immunochromatographic assay
Format: Lateral flow cassette, 30 tests
Sample type: Whole blood, serum, plasma
Sample volume: 20µl (whole blood), 10µl (serum or plasma)
Sensitivity: 100%
Specificity: 100%
Time to result: 15 minutes

Manufacturer product reference: Premier Medical Corporation Private Limited, PI05FRC30

Items supplied with:
•Test device pouch containing: 1 test device, 1 desiccant, 30
•Specimen transfer device, 30
•Assay buffer bottle (2.5ml), 1
•Sterile lancets, 30
•Alcohol swabs, 30
•IFU, 1

Items required, but not supplied:
New pair of disposable gloves, face mask, sterile gauze pad, pen, timer, extra lancets, alcohol swabs and specimen transfer devices, if needed, sharps disposable box, venipuncture blood collection kit (if whole blood is collected by venipuncture), biohazardous waste container

Shelf life:
24 months from the date of manufacturing.

Weight & volume:
Estimated weight: 0.300kg
Estimated volume: 0.0012m3

Storage & transportation condition:
Between 4 - 30°C, protect against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of First Response HIV 1-2.O Card test (Version 2.0) for 30 tests
Secondary packaging: One kit First Response HIV 1-2.O Card test (Version 2.0), 30 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:
WHO list of prequalified in vitro diagnostic products:
http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/
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