Clinical performance of the MAGLUMI Anti-HCV (CLIA) Test for detection of hepatitis C virus antibodies.

BACKGROUND: Hepatitis C virus (HCV) infection screening and diagnosis are critical to control the hepatitis C epidemic. Testing for anti-HCV antibodies (Ab) in blood samples is the first step to screen people who have been infected with the virus. OBJECTIVES: To evaluate the performance of the MAGLUMI Anti-HCV (CLIA) Test for detection of HCV antibodies. STUDY DESIGN: To assess the diagnostic specificity, serum samples from 5053 unselected donors and 205 blood specimens from hospitalized patients were collected. To evaluate the diagnostic sensitivity, 400 positive HCV Ab samples were collected and 30 seroconversion panels were tested. All samples that met the test criteria were tested with the MAGLUMI Anti-HCV (CLIA) Test according to manufacturer's instruction. Results of the MAGLUMI Anti-HCV (CLIA) Test were compared with the Abbott ARCHITECT anti-HCV reference test. RESULTS: The specificity of the MAGLUMI Anti-HCV (CLIA) Test was 99.75% and 100.00% in blood donor and hospitalized patient samples, respectively. The sensitivity of the Test in HCV Ab positive samples was 100.00%. Seroconversion sensitivity was comparable between the MAGLUMI Anti-HCV (CLIA) Test and the reference assay. CONCLUSIONS: The performance of the MAGLUMI Anti-HCV (CLIA) Test makes it suited for HCV infection diagnosis.