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

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.

Intended Use:
First Response HIV 1-2.O Card Test is intended for use by healthcare professionals and qualified laboratory personnel. The test can be used as an aid in the diagnosis of HIV-1 and HIV-2. The product can be used for symptomatic, asymptomatic, and pregnant women populations. The test kit is not automated and does not require any additional instrument. Reactive specimens should be confirmed by supplemental testing. The product is not intended for blood donor screening.

Technical specifications:
Technology: Lateral flow immunochromatographic assay.
Sample type: Venous and capillary whole blood, serum, plasma.
Clinical sensitivity: 100%.
Clinical specificity: 100%.
Time to result: Interpret the test result at 15 minutes after adding assay buffer. Do not read test result after 25 minutes.

Manufacturer product reference: Premier Medical Corporation Private Limited
, PI05FRC30.

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

Items supplied with:
·30 x Test device pouch containing: 1 test device, 1 desiccant.
·1 x Assay buffer bottle (2.5ml)
·30 x Specimen transfer devices - V2 MANUFACTURERS, INDIA
·30 x Sterile non-safety lancets - CE Marked, Shangdong Lianfa Medical Plastics Products Co Ltd,. China
·30 x Alcohol swabs - CE Marked, Medtrue Enterprise Co., Ltd. China
·1 x IFU.

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; do not use beyond its expiry date.

Weight & volume:
Estimated weight: 0.27 kg
Estimated volume: 0.00118 m3.

Storage & transportation condition:
The test kit should be stored at 4 to 30°C. Do not freeze.

Packaging & labelling:
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.
Do not use if any kit components are damaged.
Do not mix reagents from different lots.

Useful links:
Public reports of WHO prequalified in vitro diagnostic products.