OraQuick HCV Rapid Antibody Test Kit 25

General 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.

Intended Use:
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.
Number of steps: 3 without precision required.
Sample type: Serum (and serum separator tubes), plasma (EDTA, sodium heparin, lithium heparin and sodium citrate), venous whole blood, capillary whole blood, oral fluid
Sensitivity: 100%.
Specificity: 99.7%.
Invalidity: 0%.
Reading time: 20 minutes.

Manufacturer product reference:
OraSure Technologies, Inc. 1001-0270.

QMS/Regulatory Requirements
·CE Mark
·ISO 13845:2016.
·WHO Pre-Qualified product.

Supplied with:
25 x Test device pouch containing: 1 OraQuick HCV Rapid Antibody Test, 1 absorbent packet and 1 OraQuick HCV Developer Solution
5 x Reusable plastic test stands
25 x Collection loops, plastic (5µl)
1 x IFU

Items required but not provided:
Consumables
OraQuick HCV Kit Controls 2 Vials Vial 1 - 1x HCV positive control; Vial 2 -1x HCV negative control. Sufficient to run approximately 25 tests.
Equipment: Timer,

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

Storage and transportation:
2 to 30 °C.

Weight and volume:
Estimated weight: 1 Kg.
Estimated volume: 0.1 cbm.

Packaging and labeling:
Primary packaging: Unit presentation: 1 (one) OraQuick HCV Rapid Antibody Test device, pack of 25 kit.
Secondary packaging: all content of the kit pack of 25 kit.

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).