Evaluation of the clinical performance of the SUMASIGNAL HCV assay for detection of hepatitis C virus RNA

Abstract

Introduction: Detection and quantification of the hepatitis C virus genome (HCV RNA) by real time reverse transcription PCR (RT-qPCR) are vital for the diagnosis and antiviral treatment follow-up of hepatitis C patients.

Objective: Evaluate the clinical performance of the SUMASIGNAL HCV assay for quantification of HCV load.

Methods: A panel was formed with 70 serum samples: 46 HCV RNA positive, 12 HCV RNA negative and 12 positive for molecular markers of other viruses. Pearson's correlation coefficient (r) and the Bland-Altman plot were used to compare the HCV viral loads obtained by SUMASIGNAL HCV techniques with reference values, which were expressed as base 10 logarithm (log₁₀) UI/ml. Values of p <0.05 were considered significant.

Results: The clinical sensitivity and specificity of SUMASIGNAL HVC were 100%, and no cross-reactivity was detected with the other viruses evaluated. The study assay exhibited a good correlation (r= 0.89) and strong concordance (mean= -0.01 Log₁₀ UI/ml) with the reference test (p< 0.0001). Reproducibility of the HCV RNA quantification with the SUMASIGNAL HCV test at two different moments displayed an excellent correlation (r= 0.97; p< 0.0001).

Conclusions: The SUMASIGNAL HVC assay provides valid, reproducible and technically reliable data for specific HCV diagnosis. It is also a useful tool to monitor the viral load of this agent in the Cuban National Health System.