Testing for HCV Infection

Jane P. Getchell, DrPH; Kelly E. Wroblewski, MPH; Alfred DeMaria Jr, MD; Christine L. Bean, PhD; Monica M. Parker, PhD; Mark Pandori, PhD; D. Robert Dufour, MD; Michael P. Busch, MD, PhD; Mark E. Brecher, MD; William A. Meyer, PhD; Rick L. Pesano, MD, PhD; Chong-Gee Teo, MD, PhD; Geoffrey A. Beckett, MPH; Aufra C. Araujo, PhD; Bernard M. Branson, MD; Jan Drobeniuc, MD, PhD; Rikita Hatia, MPH; Scott D. Holmberg, MD, MPH; Saleem Kamili, PhD; John W. Ward, MD

Disclosures

Morbidity and Mortality Weekly Report. 2013;62(18):362-365. 

In This Article

Changes in HCV Testing Technologies

Since the 2003 guidance was published,[4] there have been two developments with important implications for HCV testing:

  1. Availability of a rapid test for HCV antibody. The OraQuick HCV Rapid Antibody Test (OraSure Technologies) is a rapid assay for the presumptive detection of HCV antibody in fingerstick capillary blood and venipuncture whole blood. Its sensitivity and specificity are similar to those of FDA–approved, laboratory-conducted HCV antibody assays.[8] In 2011, a Clinical Laboratory Improvements Amendments waiver was granted to the test by FDA. The waiver provides wider testing access to persons at risk for HCV infection, permitting use of the assay in nontraditional settings such as physician offices, hospital emergency departments, health department clinics, and other freestanding counseling and testing sites.

  2. Discontinuation of RIBA HCV. The Chiron RIBA HCV 3.0 Strip Immunoblot Assay (Novartis Vaccines and Diagnostics) that was recommended[4] 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.

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