Picture of the device, indicating pack tubes, pack shutter, pack labels, bottles, and well.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: VITROS® Immunodiagnostic Products Anti-HBe Reagent Pack, Calibrator and Controls (VITROS Anti-HBe Test)

PMA Applicant: Ortho-Clinical Diagnostics, Inc.

Address: 100 Indigo Creek Drive, Rochester, New York 14626-5101

Approval Date: July 20, 2011

Approval Letter:

What is it? VITROS® Immunodiagnostic Products Anti-HBe Reagent Pack, Calibrator and Controls is a laboratory test used to detect antibodies produced by the immune system in patients who are chronically infected with hepatitis B virus (HBV). Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. This test is designed for use with the VITROS® ECi/ECiQ Immunodiagnostic System, which runs the assay and analyzes the results.

How does it work? A person’s blood sample is mixed with the test chemicals. If anti-HBe antibodies are present in the blood, a light signal is generated through special chemical reactions. The amount of produced light is measured by the analyzer and the result, reactive or non-reactive for anti-HBe, is printed out.

When is it used? Anti-HBe is present in the blood of most patients with chronic HBV infection. The VITROS® Anti-HBe test result is used in combination with other blood tests and clinical information to aid in the laboratory diagnosis and staging of the HBV disease in individuals with hepatitis B infection. It is also used during treatment with antiviral agents to aid in patient management.

This test should not be used to test cord blood specimens. This test has not been FDA-licensed for screening blood, plasma, tissue donors and it has not been FDA-approved for testing immunocompromised or immunosuppressed persons or for testing children under the age of 2 years.

What will it accomplish? Presence of anti-HBe antibodies usually indicates a lowered viral activity . Results of this lab test, in combination with other laboratory blood tests and clinical information, may be used to aid the clinician in treatment decisions.

When should it not be used? There are no known contraindications.

Additional information: Summary of Safety and Effectiveness and labeling are available online.  

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