Uncut sheet for HCV Rapid Test
1. INTEDED USE
The Hepatitis C Virus (HCV) Antibody Rapid Test Device (Uncut sheet format for manufacturing use) is a rapid Colloidal Gold intended for the qualitative detection of antibodies to Hepatitis C Virus (anti-HCV) in human serum, plasma, or whole blood specimens
This test is intended for in vitro diagnostic professional use and serves as an aid in the diagnosis of Hepatitis C virus infection in patients with clinical signs and symptoms suggestive of HCV infection, or individuals at risk of Hepatitis C exposure
The device provides presumptive (preliminary) screening test results. Negative results do not rule out Hepatitis C infection, particularly if the specimen is collected during the seroconversion window period or in immunocompromised patients . Positive results are preliminary and should be confirmed by alternative diagnostic methods such as recombinant immunoblot assay (RIBA) or nucleic acid testing (e.g., RT-PCR), in accordance with current clinical guidelines . This test is not intended for use in infants younger than 18 months of age due to the presence of maternal antibodies, and must not be used for blood donation screening
This product is intended for use by trained healthcare professionals or laboratory personne. This product is for manufacturing use only and is intended for further processing into final device format.
2. PRODUCT SPECIFICATION
| Model No. | HCV Uncut sheet |
| Methodology | Colloidal Gold |
| Sample Type | Serum,Plasma,Whole blood |
| Time to Result | 15 mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 5 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
| 1 | Take out the test device from sealed foil pouch and place on a dry, clean and level surface. |
| 2 | Be sure to label the device with specimen’s ID number. |
| 3 | Fill the pipette dropper with the specimen. Hold the dropper vertically and transfer 1 drop of whole blood/serum/plasma specimen (approximately 10 μL) into the specimen well (S) , and make sure that there are no air bubbles. Then add 3 drops of sample diluent (approximately 80-100 μL) into the diluent well (D) immediately. See illustration below. |
| 4 | Start the timer. |
| 5 | Wait for the colored line(s) to appear. Read test results at 15 minutes. Positive results maybe visible in as short as 1 minute. Negative results must be confirmed at the end of the 20 minutes only. Do not interpret the result after 20 minutes. |
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
