Rapid Test for Antibody to Hepatitis C Virus

This test is a single use, rapid device intended for qualitative detection of antibodies to hepatitis C virus (HCV) in human serum/ plasma/ whole blood samples. It is intended for use in medical institution as an aid for the diagnosis and management of patients related to infection with HCV and for screening of blood donors, or blood products as well.

Release form

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Price

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Product Description

Producer:

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd

Country of production:

China

Article:

WJ-1310ES, WJ-1350ES

Brief description:

This test is a single use, rapid device intended for qualitative detection of antibodies to hepatitis C virus (HCV) in human serum/ plasma/ whole blood samples. It is intended for use in medical institution as an aid for the diagnosis and management of patients related to infection with HCV and for screening of blood donors, or blood products as well.

Appointment:

Qualitative detection of antibodies to hepatitis C virus (HCV)

Materials provided:

Test Cassette
Diluent
Lancet
Disposable pipette
Alcohol wipe

Materials required but not provided:

Clock or timer, sampling container, centrifuge, biohazard container.

Performance characteristics

Total 1002 serum samples were tested with this HCV rapid test and compared with a reference kit. The results show that 16 samples were inconsistent between this rapid test and the reference kit, the positive accordance rate is 99.43%, negative accordance rate is 97.25%, total accordance rate is 98.40%, Kappa value is 0.97. Then the 16 samples were tested again with third-party kit, the results show that 8 out of 16 samples were consistent with this HCV rapid test.

Sample Type:

whole blood / serum / plasma

Delivery

Implemented by Nova Poshta. If the order is above 1500 UAH, the sender pays the shipping cost

Instructions for use (PDF) Certificate of Compliance (PDF) Declaration of Conformity (PDF)