Performance evaluation of the mindray anti-HCV assay for the detection of hepatitis C virus infection.BACKGROUND
 The Mindray anti-HCV assay, based on a third-generation immunoassay, was recently launched in China.  A total of 1952 clinical samples were tested by the Mindray anti-HCV, Elecsys anti-HCV II, and Architect anti-HCV assays.  The Mindray anti-HCV assay and Elecsys anti-HCV II assay detected seroconversion in an average of 12.5 days and 10.5 days, respectively, and this difference was not significant (P = .818).  The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) of each assay were as follows: the Mindray anti-HCV assay, 95.6%, 99.2%, 85.1%, 99.8%, 118.6 and 0.045, respectively; the Architect anti-HCV assay, 98.9%, 95.2%, 50.0%, 99.9%, 20.69 and 0.012, respectively; and the Elecsys anti-HCV II assay, 96.7%, 99.9%, 98.9%, 99.8%, 1799.9 and 0.033, respectively.  The Mindray anti-HCV assay displays a similar sensitivity to the Elecsys anti-HCV II assay with respect to the early detection of HCV infection.  The Mindray anti-HCV assay shows excellent diagnostic performance and is suitable for the screening of HCV infection.
Mindray
A total of 1952 clinical samples were tested by the Mindray anti-HCV, Elecsys anti-HCV II, and Architect anti-HCV assays.  The Mindray anti-HCV assay and Elecsys anti-HCV II assay detected seroconversion in an average of 12.5 days and 10.5 days, respectively, and this difference was not significant (P = .818).  The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) of each assay were as follows: the Mindray anti-HCV assay, 95.6%, 99.2%, 85.1%, 99.8%, 118.6 and 0.045, respectively; the Architect anti-HCV assay, 98.9%, 95.2%, 50.0%, 99.9%, 20.69 and 0.012, respectively; and the Elecsys anti-HCV II assay, 96.7%, 99.9%, 98.9%, 99.8%, 1799.9 and 0.033, respectively.  The Mindray anti-HCV assay displays a similar sensitivity to the Elecsys anti-HCV II assay with respect to the early detection of HCV infection. 
Elecsys
A total of 1952 clinical samples were tested by the Mindray anti-HCV, Elecsys anti-HCV II, and Architect anti-HCV assays.  The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) of each assay were as follows: the Mindray anti-HCV assay, 95.6%, 99.2%, 85.1%, 99.8%, 118.6 and 0.045, respectively; the Architect anti-HCV assay, 98.9%, 95.2%, 50.0%, 99.9%, 20.69 and 0.012, respectively; and the Elecsys anti-HCV II assay, 96.7%, 99.9%, 98.9%, 99.8%, 1799.9 and 0.033, respectively. 
Architect
Samples with reactive results using at least one anti-HCV assay were further tested with the recombinant immunoblot assay (RIBA). 
RIBA
Inconsistent results were investigated by the HCV RNA assay and HCV core antigen assay. 
HCV RNA assay
Inconsistent results were investigated by the HCV RNA assay and HCV core antigen assay. 
HCV core antigen assay