Validation of a strategy for HCV antibody testing with two enzyme immunoassays in a routine clinical laboratory

Vermeersch, Pieter; Ranst, Marc Van; Lagrou, Katrien

doi:10.1016/j.jcv.2008.02.015

Cited by 34 publications

(30 citation statements)

References 20 publications

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“…This finding highlights a potential problem with using an inferior †Adjusted for verification bias. 32 serological reference test as a confirmatory test 18,20 when screening the general population for HCV infection. Our assessment of the body of evidence using GRADE methodology led us to focus on a single "least-biased" study, 26 in which the sensitivity of the ELISA version 3.0 compared with nucleic acid amplification testing was 81.8% (95% CI 59.0%-100%) and the specificity 99.7% (95% CI 99.6%-99.8%).…”

Section: Discussionmentioning

confidence: 99%

Systematic review of the accuracy of antibody tests used to screen asymptomatic adults for hepatitis C infection

Cadieux

Campbell

Dendukuri³

2016

CMAJ Open

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Section: Discussionmentioning

confidence: 99%

Systematic review of the accuracy of antibody tests used to screen asymptomatic adults for hepatitis C infection

Cadieux

Campbell

Dendukuri³

2016

CMAJ Open

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“…Yanlış negatiflikte immün yetmezlik daha önemli bir neden olabileceği belirtilmektedir. 12 Çalışmamızın yukarıda söz edilen çalışmalar-dan önemli bir farkı istatistiksel analiz yöntemi-dir. İkili sınıflandırma sistemlerinde, ayrım eşik değerinin farklılık gösterdiği durumlarda, eşik değerinin en iyi noktasını tespit edilebilen yöntem olan ROC analizi yapıldı.…”

Section: Discussionunclassified

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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“…The United Kingdom Health Protection Agency has recommended the use of a second anti-HCV antibody EIA for the confirmation of positive samples in the National Standard Method Minimum Testing Algorithm for the investigation of HCV infection (14). This algorithm is more cost effective and could reduce the number of samples in the problematic immunoblot-indeterminate group when following the CDC guidelines (17,26). Among the discordant samples, the number of cases in which only one of the four CLIAs gave a positive result was 10 (63%).…”

Section: Discussionmentioning

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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Validation of a strategy for HCV antibody testing with two enzyme immunoassays in a routine clinical laboratory

Cited by 34 publications

References 20 publications

Systematic review of the accuracy of antibody tests used to screen asymptomatic adults for hepatitis C infection

Systematic review of the accuracy of antibody tests used to screen asymptomatic adults for hepatitis C infection

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

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

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