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Providers should take note of changes in the availability of commercial HCV tests
Because of the need for early detection, improved antiviral agents, and changes in the availability of commercial Hepatitis C virus (HCV) tests, the Centers for Disease Control and Prevention (CDC) has issued a new guidance for clinicians and laboratorians.
The CDC published its updated HCV testing guidelines in its May 7, 2013, Morbidity and Mortality Weekly Report Early Release on its website.
Since CDC’s 2003 guidance was written, there have been two important developments, according to the CDC: the availability of a rapid test for HCV antibody and the discontinuation of RIBA HCV.
The OraQuick HCV Rapid Antibody Test features sensitivity and specificity similar to those of FDA-approved, laboratory-conducted HCV antibody assays. In 2011, FDA granted the test a Clinical Laboratory Improvements Amendments waiver.
“The waiver provides wider testing access to persons at risk for HCV infection, permitting use of the assay in nontraditional settings such as physicians’ offices, hospital emergency departments, health department clinics, and other freestanding counseling and testing sites,” the CDC wrote.
Meanwhile, the Chiron Riba HCV 3.0 Strip Immunoblot Assay from Novartis, which was recommended for supplemental testing of blood samples after initial HCV antibody testing, is no longer available.
“As a result, the only other FDA-approved supplemental tests for HCV infection are those that detect HCV viremia,” the CDC wrote.
The new guidance states that an FDA-approved NAT assay should be used to detect HCV RNA in serum or plasma from the blood of at-risk patients whose tests show reactivity for HCV antibody.
The guidance was written by a workgroup comprising experts from the CDC, the Association of Public Health Laborites, state and local public health departments, and testing labs, in consultation with experts from the Veterans Health Administration and FDA.