FirstResponseHCV Cardtest kit/25

General description:
First Response HCV Card Test is a chromatographic immunoassay for the qualitative detection of the antibodies against hepatitis C virus (HCV Ab) in human serum, plasma or whole blood (capillary whole blood & venous whole blood) specimens.

Intended Use:
It is intended to be performed by trained users (in either laboratory or point of care settings). The product is intended to use as an aid for the diagnosis of patients related to infection with hepatitis C.


Technical specifications:
Technology: Lateral flow immunochromatographic assay.
Sample type: 1 drop (35µL) of serum, plasma (EDTA, heparin or sodium citrate), venous whole blood (EDTA, heparin or sodium citrate) or capillary whole blood.
Number of steps: 2 steps in total 0 step with precision pipetting.
Clinical sensitivity: 100%.
Clinical specificity: 99.7%.
Time to result: Interpret the test result at 15.

Manufacturer product reference: Premier Medical Corporation Private Limited
, PI03FRC25.

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

Items supplied with:
·25 x Test device pouch containing: 1 test device, 1 desiccant.
·1 x Assay buffer bottle (2.5ml)
·25 x Specimen transfer devices - V2 MANUFACTURERS, INDIA
·25 x Sterile non-safety lancets - CE Marked, Shangdong Lianfa Medical Plastics Products Co Ltd,. China
·25 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: 0.24 kg.
Estimated volume: 0.0117975dm3.

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 HVC Card test for 25 tests.
Secondary packaging: One kit First Response HCV Card test 25 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 can be found here: