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. 2023 May;38(3):362-371.
doi: 10.3904/kjim.2022.350. Epub 2023 Apr 11.

The diagnostic significance of hepatitis C virus antibody levels for chronic hepatitis C virus infection

Jin Gu Kang  1   2 , Myoung Kuk Jang  1   2 , Jung Hee Kim  2   3 , Jang Han Jung  2   3 , Ji Won Park  2   4 , Sung Eun Kim  2   4 , Sang Hoon Park  2   5 , Myung Seok Lee  2   5 , Ki Tae Suk  2   6 , Dong Joon Kim  2   6 , Hyoung Su Kim  1   2
Affiliations

The diagnostic significance of hepatitis C virus antibody levels for chronic hepatitis C virus infection

Jin Gu Kang et al. Korean J Intern Med. 2023 May.

Abstract

Background/aims: Although anti-hepatitis C virus (HCV) assay is widely used to screen for HCV infection, it has a high false-positive (FP) rate in low-risk populations. We investigated the accuracy of anti-HCV signal-to-cutoff (S/CO) ratio to distinguish true-positive (TP) from FP HCV infection.

Methods: We retrospectively analyzed 77,571 patients with anti-HCV results. A receiver operating characteristic (ROC) curve analysis was performed to evaluate the diagnostic accuracy of anti-HCV S/CO ratio in anti-HCV positive patients.

Results: Overall, 1,126 patients tested anti-HCV positive; 34.7% of patients were FP based on HCV RNA and/or recombinant immunoblot assay (RIBA) results. The age and sex-adjusted anti-HCV prevalence was 1.22%. We identified significant differences in serum aspartate transaminase and alanine transaminase levels, anti-HCV S/CO ratio, and RIBA results between groups (viremia vs. non-viremia, TP vs. FP). Using ROC curves, the optimal cutoff values of anti-HCV S/CO ratio for HCV viremia and TP were 8 and 5, respectively. The area under the ROC curve, sensitivity, specificity, positive and negative predictive values were 0.970 (95% CI, 0.959-0.982, p < 0.001), 99.7%, 87.5%, 87.4%, and 99.7%, respectively, for predicting HCV viremia at an anti-HCV S/CO ratio of 8 and 0.987 (95% CI, 0.980-0.994, p < 0.001), 95.3%, 94.7%, 97.1%, and 91.4%, respectively, for TP HCV infection at an anti-HCV S/CO ratio of 5. No patients with HCV viremia had an anti-HCV S/CO ratio below 5.

Conclusion: The anti-HCV S/CO ratio is highly accurate for discriminating TP from FP HCV infection and should be considered when diagnosing HCV infections.

Keywords: Hepatitis C; Hepatitis C antibody; Prevalence.

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Conflict of interest statement

Conflicts of interest

The authors disclose no conflicts.

Figures

Figure 1
Figure 1
Flow chart of patients enrolled in this study. Anti-HCV, antibodies to hepatitis C virus; RIBA, recombinant immunoblot assay; TP, true-positive; FP, false-positive.
Figure 2
Figure 2
Age and sex-specific prevalence of antibodies to hepatitis C virus (anti-HCV).
Figure 3
Figure 3
Receiver operating characteristic (ROC) curves of the antibodies to hepatitis C virus (anti-HCV) signal-to-cutoff (S/CO) ratio for predicting HCV viremia and true positive HCV infection. (A) The area under the ROC (AUROC) of the anti-HCV S/CO ratio for the differentiation of the HCV viremia group from the HCV non-viremia group was 0.970 (95% confidence intervals [CI], 0.959–0.982; p < 0.001). (B) The AUROC of the anti-HCV S/CO ratio for the differentiation of true-positive HCV infection from false-positive HCV infection was 0.987 (95% CI, 0.980–0.994; p < 0.001).
Figure 4
Figure 4
Age and sex-specific prevalence of antibodies to hepatitis C virus (anti-HCV) according to an anti-HCV signal-to-cutoff ratio of 5.
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