Chemiluminescence Assay Improves Specificity of Hepatitis C Antibody Detection

Dufour, D. Robert; Talastas, Mageli; Fernandez, Maria D.A.; Harris, Barbara J.

doi:10.1373/49.6.940

Cited by 51 publications

(49 citation statements)

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“…CLIA showed significantly improved specificity, a greater positive predictive value, and a similar sensitivity compared to those of EIA for detecting anti-HCV antibodies (10,15). Although automated CLIAs are gradually replacing the EIA, there are no published studies on the comparative evaluation of automated CLIAs (10,15,16,22,27). We compared the performance of currently marketed anti-HCV automated CLIAs under routine conditions of a hospital laboratory.…”

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confidence: 99%

Clinical Performance Evaluation of Four Automated Chemiluminescence Immunoassays for Hepatitis C Virus Antibody Detection

Kim

Yoon

et al. 2008

J Clin Microbiol

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Various automated chemiluminescence immunoassay (CLIA) analyzers for the detection of antibodies to hepatitis C virus (HCV) are now commercially available in clinical laboratories and are replacing conventional enzyme immunoassays. We investigated the performance of four anti-HCV CLIAs (the Architect Anti-HCV assay on the Architect i2000 system, the Vitros Anti-HCV assay on the Vitros ECiQ Immunodiagnostic System, the Access HCV Ab PLUS assay on the UniCel DxI 800 analyzer, and the newly developed Elecsys Anti-HCV assay on the Cobas e 411 analyzer). The total percent coefficient of variation values of imprecision were 3.5 to 5.7% with positive control materials and 7.2 to 10.2% with negative control materials. The agreement between the results of the Elecsys, Architect, Vitros, and Access CLIAs ranged from 94.5 to 98.1%. The clinical sensitivity of all CLIAs was 100%. Each CLIA showed excellent reproducibility and clinical sensitivity. The Elecsys, Architect, Vitros, and Access CLIAs showed clinical specificities of 98.2, 98.8, 96.5, and 98.2%.Hepatitis C virus (HCV), first identified in 1989, is an enveloped positive-strand RNA virus classified in the Hepacivirus genus in the family Flaviviridae (6). The HCV genome is about 9.5 kb in length and encodes 3,011-to 3,033-amino-acid polypeptides in structural and nonstructural regions (20). The structural region contains the core protein and two envelope proteins (E1 and E2), and nonstructural proteins have been assigned protease (NS2, NS3, and NS4A), helicase (NS3), and RNA-dependent RNA polymerase (NS5B) (21) functions.The first commercially available anti-HCV enzyme immunoassay (EIA) used a single HCV recombinant antigen derived from the nonstructural NS4 protein designated c100-3 (19). The sensitivity of this first-generation EIA was low for a highprevalence population (approximately 80%) and showed a high false-positive rate (up to 70%) in a low-prevalence blood donor group (13). Therefore, a second-generation EIA was developed and approved for use by the Food and Drug Administration (FDA) in 1992 (3). The second-generation EIA, which contained additional HCV antigens from the core (c22-3) and NS3 (c33c) proteins, showed increased sensitivity and specificity and shortened the average seroconversion period from 16 to 10 weeks (1, 3, 13, 18). The third-generation EIA, which added a fourth antigen (NS5), showed significantly improved performance, particularly for high-risk patients (2, 8). However, a residual risk still exists due to the seroconversion period of approximately 56 days, and high false-positive rates were not resolved (12). The Centers for Disease Control and Prevention (CDC) recommended that an anti-HCV screening test positive result be verified by a more specific supplemental assay such as recombinant immunoblot or nucleic acid test (5). To facilitate the use of the supplemental assay, the revised guideline included an option for reflex supplemental testing based on signal-to-cutoff (s/co) ratios (4).Today, automated chemiluminescence immunoassay (...

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confidence: 99%

Clinical Performance Evaluation of Four Automated Chemiluminescence Immunoassays for Hepatitis C Virus Antibody Detection

Kim

Yoon

et al. 2008

J Clin Microbiol

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“…Although tests are usually interpreted as positive or negative, samples with low-positive anti-HCV results are usually falsely positive, whereas Ͼ90% of samples that are high-positive are from patients who test positive for HCV RNA (8,9 ). Recently, the CDC revised guidelines for laboratories, recommending confirmatory testing for samples with low signal-to-cutoff (S/C) ratios (10 ).…”

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confidence: 99%

“…The Pathology and Laboratory Medicine Service maintains a blinded database of all patients with positive anti-HCV results; details of the screening program and the assays used have been reported previously (8,9 ). A total of 13 714 individuals were tested over a 13-month period by a third-generation EIA (Ortho Clinical Diagnostics), with 2140 (15.6%) positive, whereas 19 518 were tested over a 21-month period by CA (Vitros Eci; Ortho Clinical Diagnostics), with 2257 (11.6%) positive (Data are available in supplemental files EIA and CA in the Data Supplement that accompanies the online version of this Technical Brief at http://www.clinchem.org/content/ vol50/issue5/).…”

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confidence: 99%

Lot-to-Lot Variation in Anti-Hepatitis C Signal-to-Cutoff Ratio

Dufour

2004

Clinical Chemistry

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“…However, lower and/or upper cut-off values for the S/Co ratio vary between studies, even for the same assay [6,7,[9][10][11]. This study provides the first results for the Elecsys Anti-HCV II assay, but further studies are necessary to confirm these findings.…”

Section: S/co Ratiomentioning

confidence: 76%

“…Results of the RecomLine HCV strip immunoassay performed in 276 samples with an S/Co ratio ≥ 1. A number of previous studies have reported the threshold S/Co ratios for a variety of anti-HCV IgG assays [6,7,[9][10][11], and the CDC has published a list of S/Co ratios predictive of a true positive result ≥ 95% of the time for six different immunoassays [1,2]. The Elecsys Anti-HCV II immunoassay was reported to have superior performance compared to several other commercially available assays [8,12].…”

Section: Discussionmentioning

confidence: 99%

Reflex threshold of signal-to-cut-off ratios of the Elecsys anti-HCV II assay for hepatitis C virus infection

Pan

et al. 2016

J Infect Dev Ctries

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Introduction: Fast screening tests for hepatitis C virus (HCV) antibody often give false-positive results. Signal-to-cut-off (S/Co) ratios were suggested to be used as reflex confirmation of anti-HCV. The Elecsys Anti-HCV II assay is an effective test for the detection of hepatitis C, but no S/Co cutoff has been reported. The aim of this study was to determine the S/Co ratio threshold of anti-HCV test using Elecsys Anti-HCV II screening and supplemental recombinant immunoblot assay (RIBA) test results as the gold standard. Methodology: A total of 36,341 serum samples were tested for HCV antibody using the Elecsys Anti-HCV II assay and 276 positive samples were then tested with supplemental RIBA (Mikrogen recomLine HCV IgG strip immunoassay). Receiver operation curve (ROC) analysis was used to determine the cutoff, sensitivity, and specificity of the optimal S/Co ratio. Results: The Elecsys Anti-HCV II assay was positive (S/Co ratio ≥ 1) in 288 of the 36,341 samples (0.79%). RIBA testing on 276 of these 288 positive samples showed that all but one of 44 samples with an S/Co ratio of ≥ 1 and < 10 were negative, whereas the vast majority of samples (223/232, 96.1%) with an S/Co ratio ≥ 10 were positive. ROC analysis revealed that an optimal S/Co ratio cut-off value was 12.27. Conclusions: An S/Co ratio of 12.27 obtained with the Elecsys Anti-HCV II assay could be used as reflex confirmation of anti-HCV tests.

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Chemiluminescence Assay Improves Specificity of Hepatitis C Antibody Detection

Abstract: Background: Antibodies to hepatitis C virus (anti-HCV) have typically been detected by enzyme immunoassay (EIA).

Cited by 51 publications

References 24 publications

Clinical Performance Evaluation of Four Automated Chemiluminescence Immunoassays for Hepatitis C Virus Antibody Detection

Clinical Performance Evaluation of Four Automated Chemiluminescence Immunoassays for Hepatitis C Virus Antibody Detection

Lot-to-Lot Variation in Anti-Hepatitis C Signal-to-Cutoff Ratio

Reflex threshold of signal-to-cut-off ratios of the Elecsys anti-HCV II assay for hepatitis C virus infection

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