Performance evaluation of the mindray anti‐<scp>HCV</scp> assay for the detection of hepatitis C virus infection

Yue, Zhihong; Xia, Changsheng; Wang, Hui

doi:10.1002/jcla.22600

Cited by 3 publications

(3 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…ChIVD LiCA anti‐HCV assay showed a high sensitivity of 96.39% and excellent specificity of 99.95%, PPV of 89.58%, and NPV of 99.97%, which were superior to those of the Architect anti‐HCV assay. And the diagnostic performance of ChIVD LiCA anti‐HCV assay was similar to that of Elecsys reported in other studies …”

Section: Discussionsupporting

confidence: 84%

“…As the screening method, chemiluminescence and electrochemiluminescence immunoassays for HCV antibody (the antibodies of HCV core, NS3‐4, and NS5 proteins) have been widely used to diagnose HCV infection in clinical laboratories. Previous studies have compared the diagnostic performance of different methods and revealed that the false positive rates of these assays are relatively high . Also, these methods for anti‐HCV detection require several washing steps so that the detection speed is limited.…”

Section: Discussionmentioning

confidence: 99%

“…For the 116-weak reactive samples with the S/CO ratio between 1.0 and 5.0, 38 samples were indeterminate by confirmatory methods. Previous studies hadrevealed that the diagnostic performance of electrochemiluminescence immunoassays was better than Architectanti-HCV assay and other comparative assays 17,21. ChIVD LiCA anti-HCV assay showed a high sensitivity of 96.39% and excellent specificity of 99.95%, PPV of 89.58%, and NPV of 99.97%, which were superior to those of conclusion, the CHIVD LiCA anti-HCV assay provided a highly sensitive, specific, rapid, and reliable tool for screening HCV infection in clinical laboratories.…”

mentioning

confidence: 99%

See 2 more Smart Citations

Clinical diagnostic performance of light‐initiated chemiluminescent assay compared with the Architect chemiluminescence immunoassay for detection of HCV antibody

Yang

Zhang

et al. 2019

Clinical Laboratory Analysis

View full text Add to dashboard Cite

BackgroundHepatitis C virus antibody (anti‐HCV) test had been approved as a preliminary screening test for HCV infection. Light‐initiated chemiluminescent assay (LiCA) was a homogenous method. We aimed to assess the clinical diagnostic performance of LiCA and compare it with that of chemiluminescence immunoassay (CLIA) which was widely used in clinical laboratories.MethodsA total of 10 772 patients from the Peking University Third Hospital were enrolled. The serum samples were detected on the ChIVD LiCA500 and Abbott Architect i2000SR platforms. Recombinant immunoblot assay (RIBA) and HCV RNA assay were used for confirmation.ResultsThe negative agreement rate between ChIVD LiCA anti‐HCV assay and Abbott Architect anti‐HCV assay was 99.91%, the positive agreement rate was 37.31%, the total agreement rate was 98.74%, and the kappa coefficient (κ) was 0.519. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ChIVD LiCA anti‐HCV assay were 96.39%, 99.95%, 89.58%, and 99.97%, respectively, which were superior to those of Abbott Architect anti‐HCV assay (93.98%, 99.25%, 51.90%, and 99.95%, respectively).ConclusionChIVD LiCA anti‐HCV assay was a highly sensitive, specific homogenous method with good diagnostic performance, and was applicable for the routine screening of HCV infection in clinical laboratories.

show abstract

Section: Discussionsupporting

confidence: 84%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

See 1 more Smart Citation

Clinical diagnostic performance of light‐initiated chemiluminescent assay compared with the Architect chemiluminescence immunoassay for detection of HCV antibody

Yang

Zhang

et al. 2019

Clinical Laboratory Analysis

View full text Add to dashboard Cite

show abstract

The role of a two-assay serological testing strategy for anti-HCV screening in low-prevalence populations

Huang

Pan

Gao

et al. 2021

Sci Rep

View full text Add to dashboard Cite

HCV screening depends mainly on a one-assay anti-HCV testing strategy that is subject to an increased false-positive rate in low-prevalence populations. In this study, a two-assay anti-HCV testing strategy was applied to screen HCV infection in two groups, labelled group one (76,442 people) and group two (18,415 people), using Elecsys electrochemiluminescence (ECL) and an Architect chemiluminescent microparticle immunoassay (CMIA), respectively. Each anti-HCV-reactive serum was retested with the other assay. A recombinant immunoblot assay (RIBA) and HCV RNA testing were performed to confirm anti-HCV positivity or active HCV infection. In group one, 516 specimens were reactive in the ECL screening, of which CMIA retesting showed that 363 (70.3%) were anti-HCV reactive (327 positive, 30 indeterminate, 6 negative by RIBA; 191 HCV RNA positive), but 153 (29.7%) were not anti-HCV reactive (4 positive, 29 indeterminate, 120 negative by RIBA; none HCV RNA positive). The two-assay strategy significantly improved the positive predictive value (PPV, 64.1% & 90.1%, P < 0.05). In group two, 87 serum specimens were reactive according to CMIA screening. ECL showed that 56 (70.3%) were anti-HCV reactive (47 positive, 8 indeterminate, 1 negative by RIBA; 29 HCV RNA positive) and 31 (29.7%) were anti-HCV non-reactive (25 negative, 5 indeterminate, 1 positive by RIBA; none HCV RNA positive). Again, the PPV was significantly increased (55.2% & 83.9%, P < 0.05). 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.

show abstract

Progress in evaluating the status of hepatitis C infection based on the functional changes of hepatic stellate cells (Review)

et al. 2020

View full text Add to dashboard Cite

Performance evaluation of the mindray anti‐HCV assay for the detection of hepatitis C virus infection

Abstract: The 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.

Cited by 3 publications

References 12 publications

Clinical diagnostic performance of light‐initiated chemiluminescent assay compared with the Architect chemiluminescence immunoassay for detection of HCV antibody

Clinical diagnostic performance of light‐initiated chemiluminescent assay compared with the Architect chemiluminescence immunoassay for detection of HCV antibody

The role of a two-assay serological testing strategy for anti-HCV screening in low-prevalence populations

Progress in evaluating the status of hepatitis C infection based on the functional changes of hepatic stellate cells (Review)

Contact Info

Product

Resources

About