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 HCV
PMA Applicant: Abbott Molecular, Inc.
Address: 1300 E. Touhy Avenue; Des Plaines, IL 60018
Approval Date: March 23, 2020
Approval Letter: Approval Order
What is it?
The Alinity m HCV is a laboratory test used to help diagnose people who currently have hepatitis C virus (HCV) infection. It is a molecular test (RT-PCR assay) that detects the amount of ribonucleic acid (RNA) from HCV found in the patient’s blood sample.
How does it work?
A sample of the patient’s blood is sent to a clinical laboratory. At the laboratory, the blood is inserted into the the Alinity m Instrument, where the RNA is separated from the blood and mixed with test chemicals. If HCV RNA is detected, a light signal is produced and measured by the system.
When is it used?
The Alinity m HCV is used when doctors want to determine whether a patient has current HCV infection. The test is also used when a doctor wants to find out how a patient responded to treatment for HCV.
What will it accomplish?
The test helps doctors diagnose a current (active) HCV infection and manage the treatment of patients who are going through HCV treatment.
When should it not be used?
This lab test should not be used to screen blood donors because FDA has not licensed it for this purpose.