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Hep C Core Antigen Assays Show High Sensitivity, Specificity

Certain HCV core antigen assays could replace confirmatory nucleic acid testing for diagnosis of HCV

THURSDAY, June 23, 2016 (HealthDay News) — Testing for hepatitis C virus core antigen (HCVcAg) could be a good alternative for nucleic acid testing (NAT) for diagnosis of chronic HCV, according to a review and meta-analysis published online June 21 in the Annals of Internal Medicine.

J. Morgan Freiman, M.D., from Boston University School of Public Health, and colleagues examined the accuracy of diagnosis of active HCV infection for five HCVcAg tests versus NAT. Data were included from 44 studies that evaluated five index tests.

The researchers found that the highest quality was seen for the Abbott ARCHITECT HCV Ag assay, while the lowest quality was seen for the Ortho HCV Ag enzyme-linked immunosorbent assay (ELISA). In bivariate analyses, the sensitivity and specificity were 93.4 and 98.8 percent, respectively, for Abbott ARCHITECT; 93.2 and 99.2 percent, respectively, for Ortho ELISA; and 59.5 and 82.9 percent, respectively, for the Hunan Jynda Bioengineering Group HCV Ag ELISA. There were insufficient data regarding the Fujirebio Lumipulse Ortho HCV Ag and Eiken Lumispot HCV Ag assays. HCVcAg correlated closely with HCV RNA levels >3,000 IU/mL in three quantitative studies using Abbott ARCHITECT.

“The HCVcAg assays with signal amplification have high sensitivity, high specificity, and good correlation with HCV RNA levels greater than 3,000 IU/mL and have the potential to replace NAT in settings with high HCV prevalence,” the authors write.

One author disclosed financial ties to Cepheid.

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