Rapid Anti-HCVTest wthaccessories,kit/40

General description:
Rapid Anti-HCV Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of antibodies to hepatitis C virus (HCV) in human whole blood (venous and fingerstick), serum or plasma specimens in adults.

Intended Use:
The test is intended for healthcare professionals and trained healthcare workers to use as an aid for diagnosis of HCV infection.

Technical specifications:
Technology: Immunochromatographic assay.
Format: Cassette, 40 tests.
Sample type: Serum, plasma (EDTA, heparin sodium or sodium citrate), whole blood.
Number of steps: 2 without precision pipetting required.
Sensitivity: 100%.
Specificity: 99.7%.
Invalid rate: 0%.
Reading time: 15-20 minutes.

Manufacturer product reference:
InTec PRODUCTS, INC., ITPW01153-TC40.

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

Items supplied with:
·40 x Test device pouch containing: 1 test device, 1 desiccant.
·4 x Sample diluent bottles (2.0ml)
·40 x Droppers - Cangzhou Huaao Plastic Products Co., China
·40 x Sterile safety lancets - CE Marked, SteriLance Medical (Suzhou) Inc. China
·40 x Alcohol swabs - CE Marked, Tianjin Huahong Technology Co. China
·1 x IFU"

Items required, but not supplied:
Timer or stopwatch • Blood sampling tools (sterile gauze pad, venous puncture device, collection tube with EDTA/heparin sodium/sodium citrate for whole blood or plasma, collection tube with no anticoagulant for serum.) • Biohazard waste container • Disposable gloves.

Shelf life:
24 months from the date of manufacturing; do not use beyond its expiry date.

Weight and volume:
Estimated weight: 0.46 kg
Estimated volume: 2.35x1.55x0.62 dm3.

Storage and transportation condition:
Between 2 to 30°C, protect against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of Rapid Anti-HCV Test with accessories, kit of 40 tests.
Secondary packaging: One kit Rapid Anti-HCV Test with accessories, 40 tests.

General recommendations:
Public reports of WHO prequalified in vitro diagnostic products can be found here:
Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).