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-HBs II
PMA Applicant: Roche Diagnostics
Address: 9115 Hague Road
Indianapolis, IN 36250
Approval Date: February 23, 2021
Approval Letter: Approval Order
What is it?
The Elecsys Anti-HBs II is a laboratory test designed to detect human antibodies against the hepatitis B virus (HBV) in a patient’s blood. The presence of antibodies can help determine if a patient has been exposed to HBV or is immune to HBV. However, this test cannot determine if a patient has a recent or long-term HBV infection, or if the patient has recovered from HBV infection.
The Elecsys Anti-HBs II test is used with the cobas e 601 immunoassay analyzer which runs the assay and analyzes results.
The PreciControl HBs and the Anti-HBs CalCheck are used as quality control to ensure that the test is working properly.
How does it work?
A sample of a patient’s blood is collected and sent to a clinical laboratory. In the laboratory, the serum or plasma containing the antibody is separated from the other parts of the blood and then mixed with test chemicals. If HBV antibodies are present in the sample, a light signal is produced and measured by the cobas e 601 immunoassay analyzer.
When is it used?
The Elecsys Anti-HBs II lab test is used when health care providers suspect adults including pregnant women and children may be infected with HBV. The test result in addition to other clinical information and blood tests can be used to decide if a patient is vulnerable to infection by HBV virus before or after they receive the HBV vaccine, or in cases where it is unknown if a patient has received the HBV vaccine.
What will it accomplish?
Health care providers use the test results together with a patient’s medical history, symptoms, and other blood tests to help diagnose HBV infection in patients with signs and symptoms of hepatitis or in patients at-risk for HBV infection. It is also used to decide if someone should be vaccinated to prevent hepatitis B infection.
When should it not be used?
The Elecsys Anti-HBs II should not be used for screening blood, plasma, or tissue donors.