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HCV Rapid Test


HCV Rapid Test Kit

Full name

HCV Rapid Test Serum, Plasma, WB (Cassette) RapiCard InstaTest, Export Use Only

Category Name Hepatitis Panel
Test Bulk or Boxed in 40 Tests
Specificity 99.5%
Sensitivity 99.9%

Item #:                    118773-10-44   Quantity:               

HCV Rapid Test

HCV_118773-1-44_ 2016-09-30 MSDS.pdf

HCV Rapid Test

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HCV Rapid Test description:

"Export Use Only"
Diagnostics Automation Inc. offers a single use, HCV rapid test device for qualitative detection of antibodies to hepatitis C virus (HCV) in human serum, plasma, and whole blood samples. HCV rapid test is used as an aid in the diagnosis of Hepatitis C infection.

Materials Provided with the HCV Rapid Test kit:

1. HCV rapid test device
2. Sample diluent buffer
3. Instructions for use

HCV Rapid Test Background Information
Hepatitis C is a major cause of liver inflammation, liver disease, and liver cancer in North America. HCV is a single stranded positive sense RNA virus belonging to the family of Flaviviridae. Several major genotypes and series of subtypes of HCV have been identified. Isolated in 1989, HCV is now recognized as the major cause for transfusion associated non-A, non-B hepatitis. The disease is characterized with acute and chronic form and more than 50% of the infected individuals develop severe, life threatening chronic hepatitis with liver cirrhosis and hepatocellular carcinomas. Many people who are infected with the hepatitis C virus do not show the symptoms, thus are not aware of the infection. Serological evidence of HCV infection may be obtained by testing for HCV antigens or antibodies in serum of individuals suspected of hepatitis C infection. Antibodies to HCV can be detected throughout infection period. Therefore, the use of highly sensitive antibody assays is the primary approach in serodiagnosis of HCV infection.

HCV Rapid Test Principle
HCV test employs chromatographic lateral flow device in a strip format. Colloidal gold conjugated recombinant antigens (Au-Ag) corresponding to HCV core, NS3/4 and NS5 regions are dry-immobilized at the end of nitrocellulose membrane strip. HCV antigens are bond at the Test Zone (T) and rabbit anti-HCV monoclonal antibodies are bond at the Control Zone (C). Upon sample addition, it migrates by capillary diffusion rehydrating the gold conjugate. If present in sample, HCV antibodies will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (T) zone where they are captured by the HCV antigens generating a visible red line. If there are no HCV antibodies in sample, no red line is formed in the Test Zone (T). The gold conjugate will continue to migrate alone until it is captured in the Control Zone(C) by the rabbit anti-HCV antibodies aggregating in a red line, which indicates the validity of the test.

HCV Rapid Test Results Interpretation
A negative result on the HCV Rapid Test is indicated by only one color band on the control C region, and no apparent band on the test (T) region. The HCV Rapid Test sample is positive when both a pink-colored control C band appears in addition to a distinct pink-colored band in the test (T) region.
For additional details please see the Instructions for use.

HCV Rapid Test Kit Performance & Characteristics
Total 1002 serum samples were tested with this HCV Rapid Test and compared with a reference kit. The results are as follow:
Positive accordance rate 99.43%
Negative accordance rate 97.25%
Total accordance rate 98.40%
Kappa value 0.9
Total 202 pairs of plasma and whole blood were tested and compared with the test results of serum samples.
Whole blood/serum: the results of 200 samples are consistent:
Positive accordance rate 100.00%
Negative accordance rate 98.54%
Total accordance rate 99.01%
Kappa value 0.98
Serum/plasma: the results of 199 samples are consistent:
Positive accordance rate 98.46%
Negative accordance rate 98.54%
Total accordance rate 98.51%
Kappa value 0.97

HCV Related Rapid Test Kits:

Hepatitis Rapid test kits


HCV Ab ELISA Kit (Cat # 1707-12)


HCV IgM ELISA Kit (Cat 1708-12)

Hepatitis ELISA Test Kits

Diagnostic Automation Inc. also provides other Rapid Test Kits:


For more information about Rapid Tests, ELISA Kits, IFA Kits, CLIA Test Kits, or Serology tests, please see our website home page, or contact our Customer Service Representative
at 818-591-3030.

*Not to be sold, shipped, or distributed in the United States.

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