Zocca, E.; Seraceni, S.; Cafaro, T.; Cervone, T.E.; Cardarelli, L.; Valisi, M.; Polidori, I.; Pieri, M.; Tomassetti, F.; Broccolo, F. Evaluation of Two-Assay Serological Testing Strategies for Anti-HCV Screening in Italian Populations: A Dual Screening Approach. Diagnostics2024, 14, 570.
Zocca, E.; Seraceni, S.; Cafaro, T.; Cervone, T.E.; Cardarelli, L.; Valisi, M.; Polidori, I.; Pieri, M.; Tomassetti, F.; Broccolo, F. Evaluation of Two-Assay Serological Testing Strategies for Anti-HCV Screening in Italian Populations: A Dual Screening Approach. Diagnostics 2024, 14, 570.
Zocca, E.; Seraceni, S.; Cafaro, T.; Cervone, T.E.; Cardarelli, L.; Valisi, M.; Polidori, I.; Pieri, M.; Tomassetti, F.; Broccolo, F. Evaluation of Two-Assay Serological Testing Strategies for Anti-HCV Screening in Italian Populations: A Dual Screening Approach. Diagnostics2024, 14, 570.
Zocca, E.; Seraceni, S.; Cafaro, T.; Cervone, T.E.; Cardarelli, L.; Valisi, M.; Polidori, I.; Pieri, M.; Tomassetti, F.; Broccolo, F. Evaluation of Two-Assay Serological Testing Strategies for Anti-HCV Screening in Italian Populations: A Dual Screening Approach. Diagnostics 2024, 14, 570.
Abstract
(1) Background: Hepatitis C virus (HCV) screening mostly uses a one-assay anti-HCV testing approach, which has a higher probability of false-positive results in populations with low HCV prevalence. (2) Methods: In this investigation, 17,926 participants, were screened for HCV, and the reactives were tested using a two-assay anti-HCV approach: Elecsys ElectroChemiLuminescence (ECL) and a ChemiLuminescence ImmunoAssay (CLIA), respectively. A recombinant immunoblot assay (RIBA) was performed to confirm anti-HCV positivity. Statistical analysis was performed. (3) Results: A total of 350 specimens resulted reactive in the ECL screening, of which CLIA retesting showed that 292 (83.4%) were anti-HCV reactive (283 positive, 9 indeterminate, none negative by RIBA), but 58 (16.6%) were not anti-HCV reactive (15 positive, 12 indeterminate, 31 negative by RIBA). The two-assay strategy significantly improved the positive predictive value (PPV: 95.00%) with χ2: 7.59(p<0.01) then the PPV assessed by one assay (PPV: 90.6%) with χ2: 34.51 (p< 0.001). The ROC curve defined a sensibility and specificity for the dual approach of: 99.66% and 100.00%. (4) Conclusions: Compared with a one-assay testing strategy, the two-assay testing strategy may significantly reduce false positives in anti-HCV testing and identify inactive HCV infection in low seroprevalence populations.
Copyright:
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