ArticleJournal of clinical laboratory analysis2018
Performance evaluation of the mindray anti-HCV assay for the detection of hepatitis C virus infection.
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 4 papers.
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Who cites it
4 citing papers in PubMed.
- Seroprevalence of hepatitis C virus infection among individuals attending a private clinic in Luanda, Angola.BMC infectious diseases · 2026Article
- The role of a two-assay serological testing strategy for anti-HCV screening in low-prevalence populations.Scientific reports · 2021Article
- Clinical diagnostic performance of light-initiated chemiluminescent assay compared with the Architect chemiluminescence immunoassay for detection of HCV antibody.Journal of clinical laboratory analysis · 2019Article
- Performance evaluation of the mindray anti-HCV assay for the detection of hepatitis C virus infection.Journal of clinical laboratory analysis · 2018Article
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3 authors.
Funding
Abstract
backgroundAnti-hepatitis C virus (anti-HCV) antibody assays are recommended for HCV infection screening. The Mindray anti-HCV assay, based on a third-generation immunoassay, was recently launched in China. We aimed to evaluate its diagnostic performance compared with that of two other widely used assays.
methodsSix HCV infection seroconversion panels were used to evaluate the sensitivity of the assay for early detection. A total of 1952 clinical samples were tested by the Mindray anti-HCV, Elecsys anti-HCV II, and Architect anti-HCV assays. Samples with reactive results using at least one anti-HCV assay were further tested with the recombinant immunoblot assay (RIBA). Inconsistent results were investigated by the HCV RNA assay and HCV core antigen assay. HCV infection diagnosis was made according to the results of laboratory tests and medical records.
resultsThe Mindray anti-HCV assay and Elecsys anti-HCV II assay detected seroconversion in an average of 12.5 days and 10.5 days, respectively, and this difference was not significant (P = .818). Of the 1952 cases, 90 were categorized as "HCV infection" and 1862 were categorized as "no HCV infection." The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) of each assay were as follows: the Mindray anti-HCV assay, 95.6%, 99.2%, 85.1%, 99.8%, 118.6 and 0.045, respectively; the Architect anti-HCV assay, 98.9%, 95.2%, 50.0%, 99.9%, 20.69 and 0.012, respectively; and the Elecsys anti-HCV II assay, 96.7%, 99.9%, 98.9%, 99.8%, 1799.9 and 0.033, respectively. There were significant differences in the specificity, PPV and LR+ among the three assays (P < .001). There were no significant differences in the sensitivity, NPV or LR- among the three assays (P > .05).
conclusionsThe Mindray anti-HCV assay displays a similar sensitivity to the Elecsys anti-HCV II assay with respect to the early detection of HCV infection. The Mindray anti-HCV assay shows excellent diagnostic performance and is suitable for the screening of HCV infection.
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