United States: Specifically, the FDA has given the nod to the Xpert HCV test in tandem with the GeneXpert Xpress System by Cepheid as the first rapid test of hepatitis C virus in point-of-care clinics.
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The agency said the test identifies HCV RNA by utilizing a fingertip blood sample and can give results within an hour.
The FDA’s authorization “enables a test-and-treat approach” that would allow a clinician to test an individual at high risk for HCV and, if the person tests positive, would get the relevant care and possibly the treatment in the same visit.

Jeff Shuren, MD, JD, and the director of the FDA’s Center for Devices and Radiological Health, said during a Cepheid press release, “Equipping health care 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,” as healio.com reported.
Shuren added, “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.”
“Equipping health care 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 continued.
Previous methods of HCV testing
The FDA reported that before HCV testing was a complex, protracted process, and patients needed other follow-up appointments to receive the test results and get more tests. This resulted in patients not receiving the right diagnosis and treatment.
This “rapid, point-of-care test” could be conducted in establishments that fall under the Clinical Laboratory Amendments Certificate of Waiver, which may encompass some substance use treatment centers, correctional centers, SUs, doctor’s offices, emergency departments, and urgent care centers, the agency explained, as healio.com reported.
Nonetheless, the measurement of the test should not be employed to assess the patients receiving treatment or to screen blood, plasma, or tissue donors.
Other risks associated with the test are related to a high rate of false positive and false negative tests that can lead to “inappropriate diagnosis of, and unnecessary treatment” for HCV or a “delay in effective treatment.”
The Xpert HCV test and GeneXpert Xpress System were assessed via the FDA’s de novo classification premarket pathway. In collaboration with the FDA, validation data were obtained through the Independent Test Assessment Program (ITAP), which is an NIH RADx Tech program in 2021 “to accelerate test evaluation to support the FDA’s regulatory review and the availability of high-quality, accurate and reliable diagnostic tests to the public.”
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