Performance Evaluation of the AccuPower Hepatitis C Virus Quant Assay Compared to the Cobas 6800 Hepatitis C Virus Assay.

OBJECTIVE

Hepatitis C virus (HCV) causes chronic liver disease, affecting 58 million people globally. Although antibody testing is cost-effective for screening, nucleic acid testing (NAT) enables early detection and treatment monitoring. Automated systems improve HCV RNA quantification efficiency. This study evaluates the lyophilized AccuPower HCV Quant Kit on ExiStation FA, comparing its performance with Cobas 6800 for viral load testing.

METHODS

AccuPower kit was evaluated on ExiStation FA96. Precision, linearity, limit of detection (LOD), and lower limit of quantitation (LLOQ) were assessed using World Health Organization (WHO) standards. Agreement and correlation were evaluated by comparing results with the Cobas HCV test using 368 clinical serum samples.

RESULTS

The assay demonstrated intra- and inter-assay variability lower than CVs of 5% across evaluated concentrations and showed strong linearity with expected concentration (R2=0.99). The LOD and LLOQ of the assay were 3.37 IU/mL and 7.50 IU/mL, respectively. Clinical comparison showed almost perfect agreement (κ=0.98) and correlation (r=0.971). Bland-Altman analysis revealed minimal bias (mean bias of -0.27±0.67 log10 IU/mL).

CONCLUSIONS

The AccuPower HCV Quant Kit used with the ExiStation FA system provides reliable and accurate HCV RNA quantification with operational advantages, supporting its suitability for both HCV screening and clinical management.