OraQuick HCV Rapid Antibody Test Kit 100

General Description
OraQuick HCV Rapid Antibody Test Kit 100

Product Description
OraQuick® HCV Rapid Antibody Test is a single-use, in vitro diagnostic medical device. It is an immunoassay for the qualitative detection of immunoglobin G (IgG) antibodies to hepatitis C virus (anti-HCV) in oral fluid, fingerstick whole blood, venipuncture whole blood, plasma specimens (EDTA, sodium heparin, lithium heparin, and sodium citrate), and serum (serum separator tube (SST), and from individuals 11 years or older. OraQuick® HCV Rapid Antibody Test assay results may be used to provide presumptive evidence of infection with HCV in individuals with signs and symptoms of hepatitis and in individuals at risk for hepatitis C infection.

Technical Specifications:
Technology: Linear immuno-chromatographic assay
Format: Cassette
Sample type: Whole blood, serum, plasma, oral fluid
Sensitivity: 100%
Specificity: 99.7%
Invalidity: 0%
Reading time: 20 minutes

Manufacturer product reference: 1001-0274

Supplied with:
100, Test pouches, each contains 1 test device, 1 desiccant, and 1 developer solution
10, Reusable plastic test stands
100, 5 µl collection loops, plastic
1, Instructions for use

Items required but not provided:
- OraQuick® HCV Rapid Antibody Test Kit Controls (Product reference: 1001-0278), Available as an accessory to the kit
- Timer, a biohazard disposable container, sterile lancet, alcohol swabs, disposable gloves, centrifuge, sterile gauze

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

Storage and transportation: 2- 30 °C

Packaging and labeling:
Primary packaging:
Unit presentation: 1 (one) OraQuick HCV Rapid Antibody Test device, packed and sealed with a desiccant ad developer solution.

Secondary packaging:
100-unit presentations, accessories, and IFU must be contained in a kit.