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The FDA on Thursday to the first point-of-care test for hepatitis C virus (HCV), enabling at-risk adults to be rapidly diagnosed and immediately linked to care if needed.

The test -- the Xpert HCV test and GeneXpert Xpress System -- detects HCV RNA and is indicated for those with signs or symptoms of hepatitis C.

Unlike before, when samples had to be sent to a central lab, the test can be used at doctors' offices, urgent care centers, substance use disorder treatment facilities, emergency rooms, and any other setting with a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver.

The test can deliver results within an hour using a fingertip blood sample, allowing providers to quickly diagnose and discuss treatment options or link patients to care if necessary, all during the same visit.

"Despite the existence of a safe and highly effective oral cure for hepatitis C, many people do not know they have the disease due partly to the lack of availability of convenient, widespread testing options," Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, said in a statement.

"Equipping healthcare providers with tools to diagnose and treat patients in the same visit can result in hundreds of thousands more hepatitis C patients being diagnosed and treated, preventing individual disease progression and additional spread of the virus," he added.

As many as 4 million people in the U.S. have hepatitis C. Effective direct-acting antivirals for HCV have been available for a decade, but cure rates remain remarkably low in the U.S.

In 2020, the CDC recommended that all adults be screened for HCV at some point in their lives, and that pregnant women be screened during each pregnancy. Testing is currently a multistep process requiring separate appointments for testing, results, and sometimes additional testing, which can lead to patients with infections being lost to follow-up and not receiving a diagnosis or treatment.

While some individuals with HCV infections have no symptoms or only mild illness, more than half develop chronic infection, and these infections can progress to liver cancer or liver failure if left untreated. In 2022, hepatitis C was associated with more than 12,000 deaths. Signs and symptoms of infection can include jaundice, poor appetite, nausea and vomiting, stomach pain, fever, dark urine, light-colored stool, joint pain, and fatigue.

"A third of people with hepatitis C in the United States don't even know they have a deadly, yet curable, infection," Jonathan Mermin, MD, MPH, director of CDC's National Center for HIV, Viral Hepatitis, STD, and TB Prevention, said in FDA's announcement. "This new test provides hope that more people will be cured, but it will only succeed if it is affordable and available."

The agency noted that the test is not for monitoring patients undergoing treatment for hepatitis C and is not to be used for screening blood or tissue donors. Risks of the test include false-positive and false-negative results and the consequences of either -- unnecessary fears or worries, treatment delays, etc.

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