HCV Rapid test withaccessories, kit/40

General description:
HCV Hepatitis C Virus Rapid Test Device (Whole blood/Serum/Plasma) is a single use, visually read, rapid chromatographic immunoassay for the qualitative detection of antibodies to Hepatitis C Virus in human venous and capillary whole blood, serum or plasma.

Intended Use:
The test is intended to be used as an aid in the diagnosis of individuals at risk of Hepatitis C infection. The test provides preliminary results. Negative or positive results do not preclude Hepatitis C infection and may need to be confirmed using other methods according to current guidelines. The test is intended for professional use in a laboratory or near-patient environment. This test device is not intended for self-testing or testing in infants younger than 18 months of age and must not be used for blood donation screening.

Technical specifications:
Technology: Immunochromatographic assay.
Format: Cassette, 40 tests.
Sample type: 50 µL (2 drops) of serum, plasma (EDTA, sodium citrate, sodium heparin, lithium heparin), venous whole blood (EDTA, sodium citrate) or capillary whole blood.
Number of steps: 2 without in total, one step with precision pipetting (optional, only for serum/plasma).
Sensitivity: 100%.
Specificity: 100%.
Reading time: 10 minutes. (Can be read between 10-20 minutes after addition buffer).

Manufacturer product reference:
Abon Biopharma (Hangzhou) Co., Ltd. IHC-402-WC.

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.
2 x Buffer bottles (3.0ml)
40 x Specimen dropper (For Serum/ Plasma/ Venipuncture Whole Blood) - Jiangsu Kehua Medical Instrument, China,
40 x Capillary tubes (For Fingerstick Whole Blood)
40 x Sterile safety lancets - CE Marked, SteriLance Medical (Suzhou) Inc. China
40 x Alcohol swabs - CE Marked, Changzhou Maokang Medical Products Co., Ltd. China
1 x IFU.

Items required, but not supplied:
Timer or stopwatch • 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: 0.223 kg
Estimated volume: 18.5x12.1x6.6 cm3.

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 (Whole blood/Serum/Plasma) with accessories, kit of 40 tests.
Secondary packaging: One kit Rapid Anti-HCV Test (Whole blood/Serum/Plasma) 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).