This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Elecsys® Anti-HCV Immunoassay and
Elecsys® PreciControl Anti-HCV on the
cobas e 601 Immunoassay Analyzer
PMA Applicant: Roche Diagnostics
Address: 9115 Hague Road, Indianapolis, IN 46256 USA
Approval Date: April 29, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090008a.pdf
What is it? The Elecsys® Anti-HCV Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis C virus (HCV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. The presence of the antibodies associated with HCV (anti-HCV antibodies) can help determine if a person is currently infected or has previously been infected with HCV. This test is designed for use on the cobas e 601 Immunoassay Analyzer which runs the assay and analyzes the results.
How does it work? A person’s blood sample is mixed with the test chemicals. If the individual has antibodies to the hepatitis C virus, they attach to special microparticles to generate a light signal. The light signal is measured by the cobas e 601 analyzer. The Elecsys® PreciControl Anti-HCV is used as a quality control to ensure that the test is working properly.
When is it used? This is the initial laboratory test used for adult individuals who might be infected with the hepatitis C virus.
What will it accomplish? Results of this lab test, in combination with other clinical information and laboratory blood tests, may be used by the clinician to aid in the diagnosis of patients with the symptoms of hepatitis and who may be at risk for the HCV infection. A positive test result should be confirmed with a supplemental test as false positive results may occur.
When should it not be used? This test should not be used to determine final diagnosis of the HCV infection or to determine the stage of infection. This test has not been FDA-licensed for screening blood, plasma, tissue donors, or immunocompromised or immunosuppressed persons or for testing children under the age of 21 years.
Additional information: Summary of Safety and Effectiveness and labeling are available online.