Multicenter evaluation of the elecsys® anti‐HCV II assay for the diagnosis of hepatitis C virus infection

Esteban, Juan Ignacio; Helden, Josef van; Alborino, F.; Bürgisser, Philippe; Cellerai, Cristina; Pantaleo, Giuseppe; Eiras, A.; Rodríguez, María I.; Ghisetti, Valeria; Gleich, Michael; Imdahl, Roland; Kaiser, Claudia; Möller, Petra; Wetlitzky, O.; Segovia, Manuel; Schennach, Harald; Mühlbacher, Annelies

doi:10.1002/jmv.23536

Cited by 23 publications

(22 citation statements)

References 16 publications

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“…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]. A previous study has shown that the Elecsys Anti-HCV II immunoassay was sensible, specific, and suitable for the detection of anti-HCV antibodies [8].…”

Section: Discussionmentioning

confidence: 99%

“…The Elecsys Anti-HCV II immunoassay was reported to have superior performance compared to several other commercially available assays [8,12]. A previous study has shown that the Elecsys Anti-HCV II immunoassay was sensible, specific, and suitable for the detection of anti-HCV antibodies [8]. The high sensitivity of the assay makes it suitable for the screening of blood donors [13].…”

Section: Discussionmentioning

confidence: 99%

“…The Roche Elecsys Anti-HCV II immunoassay is a new anti-HCV test system that has been reported to have superior sensitivity and similar or superior specificity for detecting early HCV infection compared to available assays [8].…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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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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“…HBs Ag and HCV Ab+ were detected by NIBSC 00/588; WHO 2nd International Standard for HBsAg, subtype adw2, genotype A; UI/mL with 99.9% specificity and 99.8% sensitivity (Muhlbacher et al, 2008) and hepatitis C antibody (Anti-HCV) by cobas e 411 analyzer, Elecsys® 2010 analyzer: 4.2 -5.2 % with100.0% sensitivity and 99.6% hospitalized patients clinical specificity (Esteban, 2013 ) …”

Section: Laboratory Methodsmentioning

confidence: 99%

The associated factors of HBV and/or HCV with HIV co-infection among men who have sex with men (MSM) in the Northern region of Thailand, 2015

Wongwichit¹,

Singharachai²,

Suwanaporn³

et al. 2017

jmms

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Men who have sex with men (MSM) are at higher risk for co-infection with hepatitis B virus (HBV), hepatitis C virus (HCV) than the general population. The co-infection accelerates disease progressionreciprocally. This study purposed to investigate the prevalence and the associated factors with HBV and/or HCV co-infection with HIV among MSM in Northern region Thailand in 2015. A case-control study design was conducted by a hospital-based in anti-retroviral (ARV) clinic. 31 of 51 hospitals in the Phayao, Chiang Mai and Chiang Rai province were recruited in this study. The result was found 374 total participants who were registered patients in ARV clinic inPhayao84 cases (22.5 %), Chiang Mai 170 (45.5%) and Chiang Rai120 (32.1%). The participants were 30-43 year old (47.1%), followed by 16-29 years old (29.9%), and 44-57 years old (19.8%). The majority of occupational were employee (50.0%), follow by merchant (24.9%) and agriculturist (9.4%).The univariate analysis with a significant α level of 0.05were found six factors had significantly association with HBV and/or HCV with HIV co-infection including (1) age range (2) smoking behavior (3) tongue piercing, (4) Stavudine drug taking, (5) Tenofivir drug taking and (6) Nevirapine drug taking. Moreover, the binary logistic regression at a significant α level of 0.05, after controlling for all possible confounding factors, were found four factors significantly association with co-infection including (1) age between 30-43 year old had the risk of co-infection 2.42 times [odds ratio (OR) = 2.42, 95% confidence interval (CI) = 1.14-5.14] higher than those who had age range 16-29 year old, (2) smoking behavior in the participants had the risk of co-infection 2.05 times (OR = 2.05, 95% CI = 1.12-3.76) higher than no smoking behavior. (3)Tongue piercing in the participants had the risk of co-infection 6.82 times (OR = 6.70, 95% CI = 1.12-40.19) higher than no tongue piercing and (4) Tenofivir drug taking had the risk of co-infection 4.30 (OR = 4.30, 95% CI = 2.37-7.84) more than no taking drug. Therefore, enhancing the surveillance and targeted prevention of viral hepatitis including improved disease prevention, vaccination coverage, sanitation and food safety, safer sex and efficiency healthcare delivery,

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“…The initial test to screen for HCV infection is based on the use of third-generation enzyme immunoassays (EIA) to detect anti-HCV antibodies against recombinant HCV proteins of the Core, NS3, NS4, and NS5 regions (7) in plasma or serum. Serologic assays cannot discriminate acute from chronic or resolved infection (8), so that EIA positives require the detection of HCV RNA to define active HCV infection.…”

Section: Introductionmentioning

confidence: 99%

Hepatitis C Virus Seroprevalence in Mongolian Women Assessed by a Novel Multiplex Antibody Detection Assay

Dondog

Schnitzler

Michael

et al. 2015

Cancer Epidemiology, Biomarkers &Amp; Prevention

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Background: Hepatitis C virus (HCV) infection causes hepatocellular carcinoma and is an important cause of mortality in both industrialized and developing countries. We developed a single-step high-throughput multiplex serology assay for HCV antibody detection and determined HCV prevalence in a highly endemic country.Methods: Five proteins (Core, NS3, NS4A, NS5A, NS5B) each from the three most common subtypes of HCV (1a, 1b, 2a) were recombinantly expressed and used as antigens in a multiplexed antibody detection assay. Multiplex HCV serology was validated with 432 reference sera whose HCV status was established by commercial ELISA, Western blot, and RNA assays. HCV antibodies were determined in 1,023 sera representative for the adult female population of Mongolia.Results: In reference sera, detection of HCV (mostly Core and NS3) antibodies by multiplex serology showed 100% sensitivity

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Multicenter evaluation of the elecsys® anti‐HCV II assay for the diagnosis of hepatitis C virus infection

Cited by 23 publications

References 16 publications

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

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

The associated factors of HBV and/or HCV with HIV co-infection among men who have sex with men (MSM) in the Northern region of Thailand, 2015

Hepatitis C Virus Seroprevalence in Mongolian Women Assessed by a Novel Multiplex Antibody Detection Assay

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