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

Dufour, D. Robert

doi:10.1373/clinchem.2003.031039

Cited by 23 publications

(16 citation statements)

References 10 publications

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“…We also showed that of the 409 samples tested for HCV RNA with S/Co ratios ≥20.0, based on CIA, 374 were positive for HCV RNA (91.4%). The RNA positivity rate was different from that reported in previous studies: 81% [9], 90% [14], 93% [10], 81% [4], and >60% [15]. Of the 34 samples with S/Co ratios ≥20.0 and with negative HCV RNA, 33 samples were RIBA positive and 1 sample was RIBA indeterminate.…”

Section: Discussioncontrasting

confidence: 66%

Is Anti-Hepatitis C Virus Antibody Level an Appropriate Marker to Preclude the Need for Supplemental Testing?

Zhang¹,

Wang²,

Lin³

et al. 2015

Intervirology

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Objectives: In the present study, we aimed to determine whether signal-to-cutoff (S/Co) ratios of reactive anti-HCV samples could be used as a basis for avoiding the need for supplemental testing in our study population. Methods: We analyzed 901 anti-HCV-positive sera from 8 institutions in China. The Ortho VITROS anti-HCV assay and Monolisa Plus anti-HCV version 2 were used as screening assays to detect anti-HCV antibodies. Recombinant immunoblot assay (RIBA) and quantitative tests for HCV RNA were performed to validate confirmed HCV infection status. Results: Receiver operating characteristic curve analyses demonstrated that 41.5% (114/275) of true-positive samples with S/Co ratios ≤3.0 would be missed and the negative predictive value was 63.9 and 87.06%, using real-time polymerase chain reaction (RT-PCR) and RIBA as supplemental testing, respectively. 29.8% (90/302) of those who tested positive by RIBA samples were missed when only RT-PCR was used as supplemental testing. Conclusions: We determined that very low anti-HCV levels (S/Co ≤3.0), as determined by chemiluminescence immunoassay, was not an appropriate marker to preclude the need for supplemental testing in our study population. A screening strategy employing a secondary HCV antibody assay using different HCV antigens from the first assay as the supplemental testing method should be studied further. The immunoblot assay, as a supplemental testing method, is still necessary.

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Section: Discussioncontrasting

confidence: 66%

Is Anti-Hepatitis C Virus Antibody Level an Appropriate Marker to Preclude the Need for Supplemental Testing?

Zhang¹,

Wang²,

Lin³

et al. 2015

Intervirology

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“…Interestingly, in Chen and Kaplan's study, a third lot from the same manufacturer had much lower rates of weakly positive and falsely positive results. We have shown similar lot-to-lot variability in anti-HCV reagents (9 ), which suggests that assignment of optimal cutoff values is an area that could be improved.…”

Section: Falsely Positive Hbsag Results and Neutralization Assaysmentioning

confidence: 69%

Hepatitis B Surface Antigen (HBsAg) Assays—Are They Good Enough for Their Current Uses?

Dufour

2006

Clinical Chemistry

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“…In Turkey this rate varies from 0.3% to 1.8% [2]. Hepatitis C is the leading cause for end-stage liver complications, including hepatocellular carcinoma and the need for liver transplantation; the frequency of these is expected to increase two-to threefold by 2030 [3]. Accurate diagnosis of active HCV infection is important not only because of the associated morbidity and mortality but also because of the possibility of spontaneous or pharmacology-induced sustained virologic cure [4].…”

Section: Introductionmentioning

confidence: 99%

Threshold value of the anti-HCV test in the diagnosis of HCV infection

Kirişçi¹,

Çalışkan

2019

J Infect Dev Ctries

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Introduction: In the diagnosis of hepatitis C virus (HCV) infection, the first step is screening for anti-HCV antibodies, and positive results are generally confirmed with nucleic acid amplification tests. Recent studies have reported that more compatible results have been obtained with the HCV RNA test using signal to cut-off (S/Co) values >1, which are the routine reactivity threshold for the anti-HCV enzyme immunoassay (EIA) test. The aim of this study was to determine the most appropriate S/Co value for the anti-HCV test, predicting HCV infection. Methodology: Comparisons were made between results of 559 patients who underwent anti-HCV with ECLIA method and HCV RNA tests with real-time polymerase chain reaction (PCR) method. By accepting the HCV-RNA test as the gold standard for HCV infection, the sensitivity, specificity and predictive values of the ECLIA test were determined and statistical "receiver operating characteristic" (ROC) analysis was applied to determine the most appropriate threshold. Results: Between January 2013 and April 2018, a total of 81,203 serum samples were examined. Of 559 anti-HCV positive patients, HCV RNA positivity was determined in 214 (38.2%). According to the ROC analysis results, the most appropriate S/Co value was determined as 12.27, at which sensitivity was 94.4 %, and specificity 97.4%. The positive and negative predictive values were calculated at the high rate of 95.7% and 96.6% respectively. Conclusions: The results of this study investigating the anti-HCV reactivity values which could be used in the diagnosis of HCV infection determined the most appropriate value to be 12.27.

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

Cited by 23 publications

References 10 publications

Is Anti-Hepatitis C Virus Antibody Level an Appropriate Marker to Preclude the Need for Supplemental Testing?

Is Anti-Hepatitis C Virus Antibody Level an Appropriate Marker to Preclude the Need for Supplemental Testing?

Hepatitis B Surface Antigen (HBsAg) Assays—Are They Good Enough for Their Current Uses?

Threshold value of the anti-HCV test in the diagnosis of HCV infection

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