Genedrive HCV ID, kit/10

General Description:
Genedrive HCV ID Kit is an in vitro diagnostic test for the rapid qualitative detection of Hepatitis C Virus (HCV) RNA in human whole blood derived EDTA plasma using the Genedrive instrument.
The test detects HCV RNA in plasma and is intended for use as an aid in the confirmation of HCV infection. It is intended to aid in the diagnosis of current HCV infection in adult specimens containing HCV genotypes 1-6. It is not intended as a screening test to detect the presence of HCV. The test is intended to be performed by a laboratory professional or healthcare worker trained in the use of the test at a decentralized laboratory setting.

Technical specifications:
Technology: Polymerase Chain Reaction (PCR) technology
Format: RT-PCR.
Sample type: Whole blood derived EDTA plasma.
Sample volume: plasma sample using 30µL of sample and 60µL of Nuclease Free Water.
Sensitivity: 98.8 %.
Specificity: 100 %.
Time to result: 1 hour 30 minutes.
Manufacturer product reference: Genedrive ID-HCV-03

Kit content:
·1x1/kit Plasma preparation cartridge (PPCO1).
·1x1/kit HCV ID Assay Tube (HCV01).
·1x2/kit Genedrive assay cartridge lid.
·1x1/kit Nuclease Free Water.
·1x 1/kit Empty tube.
·1x1 IFU.

Items required, but not supplied:
Instruments
·Genedrive instrument (Product code GD-001-HCV) running Genedrive HCV software V2.0.0
General Lab equipment’s
·Gloves.
·Calibrated pipettes.
·Single-use RNase, DNase-free Aerosol resistant pipette tips.

Shelf life:
12.3 months. (375 days)

Storage and transportation:
Store the kit unopened at 2 to 30°C.

Packaging and labeling:
Primary packaging: All contents of Genedrive HCV ID 10kit/box.
Secondary packaging: One kit Genedrive HCV ID 10kit/box.

Weight and volume:
Estimated weight: 0.56 Kg.
Estimated volume: 5.72 dm3.

Useful links:
WHO list of prequalified in vitro diagnostic products: