STANDARD Q HCV Ab Test,kit/25

General Description:
STANDARD Q HCV Ab Test is a rapid chromatographic immunoassay for the qualitative detection of specific antibodies to HCV present in human serum, plasma or whole blood as an aid to early diagnosis of HCV infection in patients with clinical symptoms of HCV infection.

Intended Use:
Test is intended to be used by trained healthcare or laboratory professionals or other health care workers who have received appropriate training. This product can be used by trained lay providers operating in point-of-care settings in resource-limited lower- and middle-income countries. This product is not intended for self-testing.

Technical specifications:
Technology: Rapid chromatographic immunoassay.
Format: Test cassette, 25 tests.
Sample type: Serum, plasma and whole blood.
Number of Steps: 2 steps in total 1 step with precision pipetting (for serum/plasma/venous whole blood).
Sample volume: Serum, Plasma 10µl/ Whole Blood 20 µl.
Sensitivity: 100%.
Specificity: 100%.
Time to result: 15 minutes (the test can be read between of 5-20 minutes.)

Manufacturer product reference:
SD Biosensor, 09HCV10D.

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

Kit content:
·25 x Test device pouch containing: 1 test device, 1 desiccant.
·1 x Buffer bottle (4.0ml)
·25 x Capillary tubes (20ul) - HLB LIFE SCIENCE CO., LTD. Korea
·1 x IFU.

Items required, but not supplied:
General Lab equipment’s:
·Anti-coagulant tube containing heparin, EDTA or sodium citrate.
·Blood collection tube.
·Alcohol swab.
·Lancet.
·PPE (Personal Protective Equipment).
·Biohazard container.
·Timing device.

Shelf life:
24 months.

Storage and transportation:
Store the kit unopened at 2 to 40°C.

Packaging and labeling:
Primary packaging: All contents of STANDARD Q HCV Test for 25 tests.
Secondary packaging: One kit STANDARD Q HCV Kit/25T.

Weight and volume:
Estimated weight: 0.25 Kg.
Estimated volume: 0.02 dm3.

General recommendations:
1.Carefully read the instruction for using the STANDARD Q HCV Ab Test.
2.Check the expiry date at the back of the foil pouch. Use another lot, if expiry date has passed.
3.Open the foil pouch and check the test device and the colour indicator desiccant pack in foil pouch.

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