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-HBe
PMA Applicant: Roche Diagnostics
Address: 9115 Hague Road
Indianapolis, IN 46250
Approval Date: February 3, 2021
Approval Letter: Approval Order
What is it?
The Elecsys Anti-HBe is a laboratory test used to detect human antibodies against the hepatitis B virus e antigen (Anti-HBe) in a patient’s blood. Anti-HBe may be detectable in patients with a recent (acute) hepatitis B virus (HBV) infection and in some patients with long-term (chronic) HBV infection.
This test is used with the cobas e 602 immunoassay analyzer, which runs the assay and analyzes the results.
The PreciControl Anti-HBe is used as a quality control to ensure that the test is working properly.
How does it work?
A sample of a patient’s blood is obtained and sent to a clinical laboratory. The serum or plasma containing the antibody is separated from the other parts of the blood and then mixed with the test chemicals. If there is Anti-HBe in the sample, a light signal is produced and measured by the cobas e 602 analyzer.
When is it used?
The Elecsys Anti-HBe is intended to be used to aid doctors in the diagnosis of HBV infection in adult patients previously shown to have hepatitis B virus e (HBeAg).
What will it accomplish?
Doctors use the test results together with a patient’s medical history and other blood tests to help diagnose HBV infection in patients with signs and symptoms of hepatitis or in patients at risk for hepatitis B infection. In patients with chronic HBV infection, a change from having HBeAg detected in their blood to having anti-HBe antibody may mean improvement in health, reduced chance of infection, and better outcomes.
When should it not be used?
The Elecsys Anti-HBe should not be used for screening blood, plasma or tissue donors.