ArticleAnnals of laboratory medicine2018
The Role of the Signal-to-Cutoff Ratio in Automated Anti-HCV Chemiluminescent Immunoassays by Referring to the Nucleic Acid Amplification Test and the Recombinant Immunoblot Assay.
Article in Annals of laboratory medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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11 citing papers in PubMed, 21 citations in OpenAlex.
- Is Geenius HCV Supplemental Assay an Alternative to HCV Confirmatory Western Blot INNO-LIA HCV Score in Repeatedly Reactive Blood Donations After First Line Screening?Journal of clinical laboratory analysis · 2026Article
- Revisiting Anti-HCV Seropositivity: Signal Intensity, Diagnostic Uncertainty, and the Limitations of Fixed Cut-Offs.Diagnostics (Basel, Switzerland) · 2026Article
- Detection of anti-HCV antibodies in the clinical classification and epidemiological surveillance of HCV infection.Molecular biology reports · 2025Review
- Evaluation of Two-Assay Serological Testing Strategies for Anti-HCV Screening in Italian Populations: A Dual Screening Approach.Diagnostics (Basel, Switzerland) · 2024Article
- The diagnostic significance of hepatitis C virus antibody levels for chronic hepatitis C virus infection.The Korean journal of internal medicine · 2023Article
- A new double-antigen sandwich test based on the light-initiated chemiluminescent assay for detecting anti-hepatitis C virus antibodies with high sensitivity and specificity.Frontiers in cellular and infection microbiology · 2023Article
- High false discovery rate of the Architect anti-HCV screening test in blood donors in Uganda and evaluation of an algorithm for confirmatory testing.Vox sanguinis · 2022Article
- The signal-to-cutoff ratios to predict HCV infection among people who inject drugs.Virusdisease · 2022Article
- The impact of nucleic acid testing as a blood donor screening method in transfusion-associated hepatitis C among children with bleeding disorders in Indonesia: a single-center experience.Blood research · 2022Article
- The role of a two-assay serological testing strategy for anti-HCV screening in low-prevalence populations.Scientific reports · 2021Article
- Comparison of diagnostic performance of transcription-mediated amplification with chemiluminescent microparticle immunoassay in the detection of hepatitis C virus in dialysis patient group.Asian journal of transfusion scienceArticle
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFollowing discontinuation of the recombinant immunoblot assay (RIBA), the only available supplementary test for the detection of hepatitis C virus (HCV) is the nucleic acid amplification test (NAAT). However, the NAAT does not adequately detect past HCV. Consequently, it is hard to distinguish between past HCV infection and biological false positivity with an anti-HCV result alone. We assessed the diagnostic performance of two immunoassays: the ARCHITECT anti-HCV chemiluminescent microparticle immunoassay (CMIA; Abbott Diagnostics, Wiesbaden, Germany) and the Access HCV Ab PLUS chemiluminescent immunoassay (CIA; Bio-Rad, Marnes-la-Coquette, France). We also explored an optimized algorithm to determine the anti-HCV results.
methodsWe tested 126,919 patients and 44,556 individuals who underwent a medical checkup. RIBA and NAAT were conducted for samples that tested anti-HCV-positive using CMIA and CIA. We assessed the optimal signal-to-cutoff (S/CO) ratio in HCV-positive samples.
resultsIn total, 1,035 blood samples tested anti-HCV-positive. Of these, RIBA was positive in 512, indeterminate in 160, and negative in 363 samples. One hundred sixty-five samples were NAAT-positive. Diagnostic sensitivity and positive predictive value (PPV) were 96.7% and 52.1%, respectively, for CMIA, and 94.7% and 72.3%, respectively, for CIA. The optimal S/CO ratio was 5.2 for CMIA and 2.6 for CIA at 95% PPV. In total, 286 samples tested positive in CMIA and 444 in CIA, while 443 samples tested positive in both assays.
conclusionsIt is hard to determine anti-HCV positivity based on the S/CO ratio alone. However, this study elucidated the role of the S/CO ratio by using the NAAT and RIBA.
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