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® HBeAg Immunoassay and Elecsys® PreciControl HBeAg
PMA Applicant: Roche Diagnostics
Address: 9115 Hague Road, Indianapolis, IN 46250
Approval Date: March 14, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130015a.pdf
What is it? The Elecsys HBeAg Immunoassay is a laboratory test used to detect human hepatitis B e antigen associated with the hepatitis B virus (HBV) infection. Hepatitis B e antigen is a protein of the hepatitis B virus which is sometimes present in the blood during an acute infection, usually disappearing afterward but sometimes persists in chronic disease.
The presence of the hepatitis B e antigen can help determine if a person is acutely infected or chronically infected with HBV, or is recovered from HBV infection. This test is designed for use on the MODULAR ANALYTICS E170 immunoassay analyzer which runs the assay and analyzes the results.
The Elecsys PreciControl HBeAg is used as a quality control to ensure that the test is working properly.
How does it work? A person’s blood sample is mixed with the test chemicals in a tube. If there is hepatitis B e antigen in the blood, it attaches to special anti-HBe antibodies to generate a light signal. The light signal is measured by the MODULAR ANALYTICS E170 analyzer.
When is it used? The test result is used in combination with other clinical information and blood tests to aid in the laboratory diagnosis of adult patients with acute or chronic hepatitis B, or recovering from hepatitis B infection.
What will it accomplish? Results of this test, in combination with other clinical information and laboratory blood tests, may be used by the clinician to aid in the laboratory diagnosis of individuals with acute or chronic hepatitis B, or recovering from hepatitis B infection.
When should it not be used? This test has not been FDA licensed for screening blood, plasma, tissue donors or for testing immunocompromised or immunosuppressed persons.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.