Evaluation of the VIDAS Anti-HCV Assay for Detection of Hepatitis C Virus Infection

Hyun, Jungwon; Ko, Dae-Hyun; Kang, Hee Jung; Whang, Dong Hee; Joο, Young Eun; Kim, Hyun Soo

doi:10.3343/alm.2016.36.6.550

Cited by 8 publications

(7 citation statements)

References 12 publications

(22 reference statements)

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“…Secondly, performance analysis of ten different assays indicated that generally all assays' performance was worse than reported [12][13][14][15][16][17][18][19][20] or claimed by their instructions, which may be mainly due to sample source. Large amount of false positive samples increased the di culty of testing a lot and false positive results of an assay during the rst screening are likely to be false positives again.…”

Section: Discussionmentioning

confidence: 93%

Multicenter evaluation of EIAs and CLIAs in the detection of hepatitis C virus antibody among blood donors in China

Chang

Guo

et al. 2021

Preprint

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Background: Recent data on anti-HCV screening assays among large population of blood donors is limited. The present study aimed to perform a multicenter evaluation of EIAs and CLIAs for detection of anti-HCV among blood donors in 16 different Chinese blood establishments.Methods: A total of 1,309 samples including 582 anti-HCV screening negatives and 727 positives collected from 15 blood establishments all over China. Ten different anti-HCV assays (eight EIAs and two CLIAs) were evaluated in 16 different blood centers/banks. Confirmatory testing was performed using recombinant immunoblot assay and HCV RNA tests.Results: The plasma panel contained 963 negative samples, 261 positives, and 85 indeterminate samples, based on the results of confirmatory test. False positive rate of screening tests was 39.67% (382/963) and the positive prediction value was only 35.76% (260/727). Among ten anti-HCV assays, Roche and InTec had the highest sensitivity (98.47%), while KHB and Wantai (indirect) had the highest specificity (99.23%). Then we analyzed the combined performance of these assays with two assays’ strategy widely used in China: Ortho or Abbott together with InTec could find all the true positives and Wantai (indirect) with Livzon (sandwich) got a highest specificity of 97.80%. Indeterminate samples showed quite different signal to cutoff (S/CO) ratios tested by Roche compared with confirmed positives (4.84 vs 19.36, p<0.0001), and higher S/CO ratios than confirmed negatives (4.84 vs 2.94, p=0.020). Conclusion: False reactivity in anti-HCV screening should be treated as urgent issue. RIBA indeterminate donations may be a special group, while it still worth to be further studied.

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Section: Discussionmentioning

confidence: 93%

Multicenter evaluation of EIAs and CLIAs in the detection of hepatitis C virus antibody among blood donors in China

Chang

Guo

et al. 2021

Preprint

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“…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%

“…Numerous methods have been developed to detect HCV antibodies, including ELISA, chemiluminescence, and electrochemiluminescence assays. [5][6][7][8] Though with high sensitivity and accuracy, these methods exist certain disadvantages. For example, ELISA is time-consuming and laborious, and all the above immunoassays also require several washing steps as well as solid-phase immobilization of antibodies.…”

Section: Introductionmentioning

confidence: 99%

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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

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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.

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“…However, no specific anti-HCV profile was observed in the confirmatory tests. The sensitivity and specificity of currently available automated CLIAs for anti-HCV range from 98.0 to 100% and from 96.5 to 100%, respectively [ 19 20 21 22 23 ]. In terms of detection of different HBV and HCV genotypes, the AFIAS tests detected all samples consisting of different genotypes and did not exhibit cross-reactivity with other virus infections.…”

Section: Discussionmentioning

confidence: 99%

Development of a Rapid Automated Fluorescent Lateral Flow Immunoassay to Detect Hepatitis B Surface Antigen (HBsAg), Antibody to HBsAg, and Antibody to Hepatitis C

et al. 2018

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BackgroundAccurate, rapid, and cost-effective screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV) infection may be useful in laboratories that cannot afford automated chemiluminescent immunoassays (CLIAs). We evaluated the diagnostic performance of a novel rapid automated fluorescent lateral flow immunoassay (LFIA).MethodsA fluorescent LFIA using a small bench-top fluorescence reader, Automated Fluorescent Immunoassay System (AFIAS; Boditech Med Inc., Chuncheon, Korea), was developed for qualitative detection of hepatitis B surface antigen (HBsAg), antibody to HBsAg (anti-HBs), and antibody to HCV (anti-HCV) within 20 minutes. We compared the diagnostic performance of AFIAS with that of automated CLIAs—Elecsys (Roche Diagnostics GmbH, Penzberg, Germany) and ARCHITECT (Abbott Laboratories, Abbott Park, IL, USA)—using 20 seroconversion panels and 3,500 clinical serum samples.ResultsEvaluation with the seroconversion panels demonstrated that AFIAS had adequate sensitivity for HBsAg and anti-HCV detection. From the clinical samples, AFIAS sensitivity and specificity were 99.8% and 99.3% for the HBsAg test, 100.0% and 100.0% for the anti-HBs test, and 98.8% and 99.1% for the anti-HCV test, respectively. Its agreement rates with the Elecsys HBsAg, anti-HBs, and anti-HCV detection assays were 99.4%, 100.0%, and 99.0%, respectively. AFIAS detected all samples with HBsAg genotypes A-F and H and anti-HCV genotypes 1, 1a, 1b, 2a, 2b, 4, and 6. Cross-reactivity with other infections was not observed.ConclusionsThe AFIAS HBsAg, anti-HBs, and anti-HCV tests demonstrated diagnostic performance equivalent to current automated CLIAs. AFIAS could be used for a large-scale HBV or HCV screening in low-resource laboratories or low-to middle-income areas.

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Evaluation of the VIDAS Anti-HCV Assay for Detection of Hepatitis C Virus Infection

Cited by 8 publications

References 12 publications

Multicenter evaluation of EIAs and CLIAs in the detection of hepatitis C virus antibody among blood donors in China

Multicenter evaluation of EIAs and CLIAs in the detection of hepatitis C virus antibody among blood donors in China

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

Development of a Rapid Automated Fluorescent Lateral Flow Immunoassay to Detect Hepatitis B Surface Antigen (HBsAg), Antibody to HBsAg, and Antibody to Hepatitis C

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