ArticleJournal of clinical laboratory analysis2018
Diagnostic reliability of Architect anti-HCV assay: Experience of a tertiary care hospital in India.
Article in Journal of clinical laboratory analysis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
3 citing papers in PubMed.
- 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
- 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
- Diagnostic reliability of Architect anti-HCV assay: Experience of a tertiary care hospital in India.Journal of clinical laboratory analysis · 2018Article
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND &
aimsAnti-HCV assays are prone to false positive results. Thus, accurate detection of HCV infection is critical for the timely therapeutic management. This study ascertained the reliability of Architect anti-HCV assay (Abbott) and to estimate the agreement of this assay with Ortho HCV 3.0 ELISA Test System with Enhanced SAVe (Ortho), HCV Tri-dot (Tri-dot) and HCV-PCR in a tertiary care setting.
methodsA total of 78 788 consecutive sera were routinely screened for anti-HCV antibodies using Architect. All repeatedly reactive anti-HCV sera (n=1000) and anti-HCV negative sera (n=300) were tested in Ortho and in Tri-dot assays. Representative proportions of sera (n=500) with various signal-to-cut-off (S/Co) ratio were also compared with HCV-PCR.
resultsWhen Architect was compared with Ortho, Tri-dot, and HCV-PCR, the level of agreement as assessed by kappa were .26, .16, and .27 respectively. Using Latent class analysis (LCA), we found that sensitivity and specificity were 100% and 36.1% for Architect, 93.8% and 100% for Ortho and 63.8% and 100% for Tri-dot respectively. The median S/CO ratio of Architect and Ortho anti-HCV assays were significantly different between HCV-PCR positive and negative results (P<.0001). Furthermore, Architect S/CO ratio of >8 showed higher accuracy indices in both anti-HCV assays.
conclusionsArchitect can be used as a screening assay because of its high sensitivity, high throughput, and short turnaround time. However, S/Co ratios of ≥1 to <8 in Architect necessitates HCV PCR to identify current infection and or EIA to distinguish true positivity from false biological positivity.
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