Reliability of polymerase chain reaction for detection of hepatitis C virus

Zaaijer, Hans L.; Cuypers, H. T. M.; Reesink, H. W.; Winkel, I.N.; Gerken, Guido; Lelie, P. N.

doi:10.1016/0140-6736(93)90488-3

Cited by 374 publications

(154 citation statements)

References 7 publications

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“…One of the best ways to assess the performance of individual laboratories is to distribute proficiency panels and to evaluate all the test results. Early proficiency studies on the detection of HCV RNA showed high percentages of laboratories with specificity and sensitivity problems (1,19). Similar problems have been reported for the molecular detection of hepatitis B virus (HBV) (9) and Mycobacterium tuberculosis (8).…”

mentioning

confidence: 66%

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External Quality Assessment Program for Qualitative and Quantitative Detection of Hepatitis C Virus RNA in Diagnostic Virology

Schirm¹,

Loon

Valentine-Thon³

et al. 2002

J Clin Microbiol

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mentioning

confidence: 66%

“…In an early study, performed in conjunction with the European Expert Group on Viral Hepatitis, 10 plasma samples (four positive and six negative) were qualitatively tested for HCV RNA by 31 laboratories (19). Of the 31 reported data sets, no less than 9 (29%) showed false-positive results and 12 (39%) gave false-negative results.…”

Section: Discussionmentioning

confidence: 99%

External Quality Assessment Program for Qualitative and Quantitative Detection of Hepatitis C Virus RNA in Diagnostic Virology

Schirm¹,

Loon

Valentine-Thon³

et al. 2002

J Clin Microbiol

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“…No entanto, devido a problemas de especificidade e precisão, apresentaram porcentagens significativas de erros em estudos duplo-cegos 45 . Outra variante técnica é aquela que, em vez de parte do genoma viral amplificase o sinal de sua presença, conhecida como branched DNA (bDNA), muito mais reprodutíveis, porém menos sensíveis do que a PCR.…”

Section: Diagnósticounclassified

Hepatite C

Strauss

2001

Rev. Soc. Bras. Med. Trop.

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Resumo Estima-se que cerca de 3% da população mundial esteja infectada pelo vírus da hepatite C. Todos os que receberam transfusão de sangue ou seus componentes e os usuários de drogas podem estar infectados. Procedimentos odontológicos, médicos, tatuagem ou acupuntura também constituem fatores de risco. A infecção se cronifica em até 85% dos indivíduos, com evolução assintomática durante anos ou décadas e apresentação clínica variada. Para o diagnóstico, a determinação do anti-VHC revela-se muito sensível e a confirmação se faz pela determinação do RNA-VHC no sangue; o estadiamento da doença e a avaliação da atividade inflamatória pela biópsia hepática. O tratamento objetiva deter a progressão da doença hepática através da inibição da replicação viral. Devido à baixa eficácia terapêutica aliada a importantes efeitos colaterais do interferon e da ribavirina, esses medicamentos encontram indicações e contra-indicações específicas. Vários fatores preditivos de resposta ao tratamento, principalmente a carga viral e o genótipo do VHC, mostramse úteis na avaliação dos pacientes. Palavras-chaves: Hepatite C. RNA-VHC. Interferon. Ribavirina.Abstract It has been estimated that 3% of the world population is infected with the hepatitis C virus. Those who are blood product recipients or have been illicit drug users are at risk. Dental and medical procedures as well as tattooing and acupuncture are also risk factors. Chronic infection occurs in up to 85% of infected cases but they may remain without symptoms during years or even decades, and clinical presentation varies. Determination of anti-HCV in sera is a fairly sensitive tool for the diagnosis, and confirmation requires the identification of HCV-RNA. Staging of the liver disease as well as definition of its present activity can be graded by liver biopsy. The aim of treatment is to stop the progression of the hepatic disease by inhibiting viral replication. Due to the low therapeutic efficacy combined with important side-effects, the administration of interferon and ribavirin have specific indications and contraindications. Predictive factors of therapeutic response, particularly viral load and genotypes of HCV, are useful in the evaluation of patients. Key-words: Hepatitis C. RNA-HCV. Interferon. Ribavirin A hepatite C vem sendo estudada há vários anos, mesmo antes da descoberta do vírus causador da doença -o Vírus da Hepatite C (VHC) -há 10 anos. Nesta última década, entretanto, houve avanços significativos no entendimento de sua epidemiologia, modos de transmissão, patogênese, diagnóstico e terapêutica.Sabemos hoje que, a hepatite C compete com a doença hepática alcoólica como a maior causa de doença crônica do fígado, podendo ser a vencedora em várias áreas geográficas. Estima-se que 3 % da população mundial esteja contaminada, sendo relevante o número de pessoas que desconhece o fato de albergar o vírus. Um estudo populacional na cidade de São Paulo mostrou prevalência de 1 a 4% de anti-VHC, variando com a faixa etária 6 . As altas porcentagens de cronicidade da do...

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“…The plasma standards have been characterized in two collaborative EUROHEP studies. 11,12 The EUROHEP HCV-RNA genotype 1b and 3a plasma standard dilutions were prepared from a pool of plasma units negative for hepatitis B surface antigen, anti-hepatitis B core antibodies (Ab), anti-HCV Ab, anti-human immunodeficiency virus-1 or -2 Ab, anti-human T-lymphotropic virus type 1 Ab, syphilis, HCV RNA, hepatitis B virus DNA, and human immunodeficiency virus RNA. The undiluted plasma samples are not available.…”

Section: Pelicheck Hcv-rna Eurohep Panelmentioning

confidence: 99%

Comparative Evaluation of Hepatitis C Virus Rna Quantitation by Branched Dna, Nasba, and Monitor Assays

et al. 1999

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Since its discovery in 1989, 1 it has been demonstrated that hepatitis C virus (HCV) is a major cause of chronic hepatitis throughout the world. The routine virological diagnosis is based on serological tests detecting antibodies to HCV. However, in the absence of an efficient culture system for HCV, or viral antigen assays, direct detection of HCV is based on nucleic acid amplification and hybridization methods. HCV RNA was principally detected with in-house nested polymerase chain reaction (PCR) methods, but new standardized assays such as Amplicor (Roche Diagnostics Systems, Basel, Switzerland) and nucleic acid sequence-based amplification (NASBA) (Organon Teknika, Boxtel, the Netherlands) have been developed to detect HCV RNA on a routine basis 2,3 or for research purposes. 4,5 Several studies have shown a relation between pretreatment viral load and the response to interferon (IFN) therapy, 6-10 creating a need for standardized HCV-RNA quantification assays. Currently, the most frequently used kit is the branched DNA (bDNA) assay (Quantiplex HCV RNA, Chiron Diagnostics, Emeryville, CA), a well-standardized signalamplification method. Other assays are based on HCV-RNA amplification (Amplicor HCV Monitor, Roche Diagnostics Systems, and NASBA HCV). The aim of this study was to compare the NASBA, bDNA, and Monitor HCV assays in terms of reproducibility, sensitivity, and linearity in various clinical settings and using standardized panels. Two qualitative methods (in-house nested PCR and Amplicor) were used as standards for sensitivity. Specificity was not a focus of this study, because specificity studies were performed by the manufacturers during the test registration procedure, and because we routinely obtain very good specificity in our lab. Moreover, negative samples were included in each series of tests (anti-HCV-and PCR-negative blood donors). MATERIALS AND METHODS Pelicheck HCV-RNA EUROHEP PanelThis panel was used to evaluate the sensitivity and linearity of each assay. It contains two dilution panels of the EUROHEP genotype 1 and 3 plasma standards. The plasma standards have been characterized in two collaborative EUROHEP studies. 11,12 The EUROHEP HCV-RNA genotype 1b and 3a plasma standard dilutions were prepared from a pool of plasma units negative for hepatitis B surface antigen, anti-hepatitis B core antibodies (Ab), anti-HCV Ab, anti-human immunodeficiency virus-1 or -2 Ab, anti-human T-lymphotropic virus type 1 Ab, syphilis, HCV RNA, hepatitis B virus DNA, and human immunodeficiency virus RNA. The undiluted plasma samples are not available. According to the EUROHEP group, the undiluted plasma corresponding to the genotype 1 panel should contain 38 Ϯ 8 ϫ 10 5 genome equivalents per milliliter (eq/mL) in the bDNA 2.0 assay, and 2.8 ϫ 10 5 copies per milliliter (cps/mL) in the HCV RNA Monitor assay. The potency of the

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Reliability of polymerase chain reaction for detection of hepatitis C virus

Cited by 374 publications

References 7 publications

External Quality Assessment Program for Qualitative and Quantitative Detection of Hepatitis C Virus RNA in Diagnostic Virology

External Quality Assessment Program for Qualitative and Quantitative Detection of Hepatitis C Virus RNA in Diagnostic Virology

Hepatite C

Comparative Evaluation of Hepatitis C Virus Rna Quantitation by Branched Dna, Nasba, and Monitor Assays

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