Very low hepatitis C antibody levels predict false‐positive results and avoid supplemental testing

Contreras, Ana María Carmona; Tornero-Romo, Claudia M.; Toribio, José G.; Celis, Alfredo; Orozco-Hernández, Axel; Rivera, Kristian; Méndez, Claudia; Hernández-Lugo, M. Isabel; Olivares, Laura; Alvarado, M

doi:10.1111/j.1537-2995.2008.01886.x

Cited by 45 publications

(63 citation statements)

References 25 publications

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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 Ratiosupporting

confidence: 59%

“…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%

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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: S/co Ratiosupporting

confidence: 59%

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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“…In our current study, we analyzed HCV S/Co ratios by using ROC curves to develop an improved algorithm for HCV testing in our veteran population. Applying ROC curve analyses as previously described by Contreras et al (6 ), we determined that the optimal high S/Co ratio cutoff for confirmation of HCV exposure by RIBA testing is 20.0 (Fig. 3).…”

Section: Discussionmentioning

confidence: 99%

Improved Reflexive Testing Algorithm for Hepatitis C Infection Using Signal-to-Cutoff Ratios of a Hepatitis C Virus Antibody Assay

et al. 2011

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BACKGROUND:Chemiluminescence immunoassay (CIA) is used to detect hepatitis C virus (HCV) antibody status on the basis of signal-to-cutoff (S/Co) ratios. Positive results of antibody to HCV (anti-HCV) are followed by either recombinant immunoblot assay (RIBA) to confirm anti-HCV positivity or reverse transcription (RT)-PCR to detect viremia. We hypothesized that by analyzing S/Co ratios, we could determine a strategy to reduce unnecessary supplementary testing in our population.

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“…Son zamanlarda bu konuda yapılan ça-lışmalarda, anti-HCV S/Co değerinin viremiyi kestirmede önemli olduğu ve yüksek S/Co değerlerinin HVR-RNA ile daha uyumlu olduğu belirtilmekte ve HCV enfeksiyonunu tanısında kullanılabilecek en iyi S/Co değerleri önerilmektedir. [5][6][7][8] Biz de bu çalışmada kullandığımız anti-HCV mikropartikül EIA testinin viremiyi öngörmedeki performansını, ve bu test için duyarlılık ve özgül-lük yönünden en uygun S/Co değerini tespit etmek istedik. Veri analizinde, HCV enfeksiyonu tanısında viremiyi belirleyen HCV-RNA testi altın standart olarak kabul edilerek, anti-HCV testinin viremiyi öngörmedeki performansı ve özgüllük, duyarlılık ve prediktif değerleri SPSS v15.0 istatistik programında hesaplanarak belirlendi.…”

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The Threshold Value of Anti-HCV Test in the Diagnosis of HCV Infection

Ecemiş¹,

Akçalı²,

Dündar³

et al. 2012

Turkiye Klinikleri J Med Sci

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Ö ÖZ ZE ET T A Am ma aç ç: : Hepatit C virüs (HCV) enfeksiyonunun tanısında ilk basamak anti-HCV antikorlarının taranması ve pozitif sonuçların genellikle nükleik asit amplifikasyon testleri ile onaylanması şeklindedir. Son yıllarda yapılan çalışmalarda, anti-HCV enzim immünoassay (EIA) testi için, rutin reaktivite eşiği olan S/Co'nun (signal to cut-off) 1'den büyük değerlerde kullanılmasıyla HCV-RNA testi ile daha uyumlu sonuçların elde edileceği bildirilmektedir. Biz de bu çalışmada anti-HCV EIA testi için, HCV enfeksiyonunu öngören en uygun S/Co değerini tespit etmek istedik. G Ge er re eç ç v ve e Y Yö ön nt te em ml le er r: : Mikropartikül EIA yöntemiyle anti-HCV ve hibridizasyon yöntemiyle HCV-RNA testleri çalışılmış 387 hastanın sonuçları karşılaştırıldı. HCV enfeksiyonu için HCV-RNA testi altın standart olarak kabul edilerek, EIA testinin özgüllük, duyarlılık ve prediktif değerleri belirlendi ve en uygun reaktivite eşiğini tespit etmek amacıyla istatistiksel "receiver operating characteristic" (ROC) analizi uygulandı. B Bu ul lg gu ul la ar r: : EIA sonuçlarına göre; 197 (%49,1) pozitif, 190 (%50,9) negatif sonuç elde edildi ve testin duyarlılığı %94,9, özgüllüğü %60,4 bulundu. Pozitif ve negatif prediktif değerleri sırasıyla %38,1 ve %97,9 olarak hesaplandı. ROC analizine göre en uygun S/Co değeri 5 olarak belirlendi ve bu değere göre duyarlılık %92,4, özgüllük %76,6 bulundu. Pozitif ve negatif prediktif değerleri ise sırasıyla %50,3 ve %97,5 olarak hesaplandı. S So on nu uç ç: : HCV enfeksiyonu tanısında kullanılabilecek en uygun anti-HCV EIA reaktivite değerleri araştırıldı ve S/Co ≥5 bulundu.A An na ah ht ta ar r K Ke el li im me el le er r: : Hepatit C antikorları; immünoenzimatik yöntem; eşik limit değerler

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Very low hepatitis C antibody levels predict false‐positive results and avoid supplemental testing

Abstract: The high prediction rate of false-positive anti-HCV results using very low levels by the Ortho VITROS anti-HCV assay safely avoids the need for supplemental testing.

Cited by 45 publications

References 25 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

Improved Reflexive Testing Algorithm for Hepatitis C Infection Using Signal-to-Cutoff Ratios of a Hepatitis C Virus Antibody Assay

The Threshold Value of Anti-HCV Test in the Diagnosis of HCV Infection

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