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Alinity m CMV Assay – P210022

Alinity m CMV Assay

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: Alinity m CMV Assay
PMA Applicant: Abbott Molecular, Inc.
Address: 1300 E. Touhy Avenue, Des Plaines, IL 60018 USA
Approval Date: May 5, 2022
Approval Letter: Approval order

What is it?

The Alinity m CMV Assay Test is a laboratory test used to measure the amount of cytomegalovirus (CMV) genetic material, or viral DNA, in a patient’s blood. The test is designed for use on the Alinity m system, which runs the assay and analyzes the results.

Cytomegalovirus (CMV) is a virus found around the world. Once CMV is in a person's body, it stays there for life. Most people with CMV don't get sick and don't know that they've been infected. But infection with the virus can be serious in people with weak immune systems, including people who have had solid organ or hematopoietic stem cell transplants.

This test is indicated for use in patients who underwent solid organ transplant or hematopoietic stem cell transplant and are now receiving treatment for a CMV infection.

How does it work?

A sample of the patient’s blood is sent to a clinical laboratory. At the laboratory, the blood sample is processed to separate the plasma. DNA from the plasma sample is automatically separated and purified by the Alinity m system. The DNA collected from the plasma sample is mixed with test chemicals. The Alinity m system then measures and reports the amount of CMV viral DNA found in the plasma.

When is it used?

The Alinity m CMV is used together with clinical information and other laboratory results to help manage patients who had solid organ transplants and are now undergoing anti-viral treatment for CMV.

What will it accomplish?

Measurement of viral DNA levels in a patient’s plasma, combined with other clinical information and test results, helps doctors determine how well a solid-organ or hematopoietic stem cell transplant patient is responding to treatment.

When should it not be used?

The Alinity m CMV Assay should not be used as a screening test for detecting CMV viral DNA in blood or blood products.

Additional information (including warnings, precautions, and adverse events):

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