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Multicenter evaluation of the elecsys® anti-HCV II assay for the diagnosis of hepatitis C virus infection
Journal of medical virology, 2013-08, Vol.85 (8), p.1362-1368
Esteban, Juan I.
van Helden, Josef
Alborino, Flora
Bürgisser, Philippe
Cellerai, Cristina
Pantaleo, Giuseppe
Eiras, Adolfo
Rodriguez, Maria I.
Ghisetti, Valeria
Gleich, Michael
Imdahl, Roland
Kaiser, Claudia
Möller, Petra
Wetlitzky, Olaf
Segovia, Manuel
Schennach, Harald
Mühlbacher, Annelies
2013
Details
Autor(en) / Beteiligte
Esteban, Juan I.
van Helden, Josef
Alborino, Flora
Bürgisser, Philippe
Cellerai, Cristina
Pantaleo, Giuseppe
Eiras, Adolfo
Rodriguez, Maria I.
Ghisetti, Valeria
Gleich, Michael
Imdahl, Roland
Kaiser, Claudia
Möller, Petra
Wetlitzky, Olaf
Segovia, Manuel
Schennach, Harald
Mühlbacher, Annelies
Titel
Multicenter evaluation of the elecsys® anti-HCV II assay for the diagnosis of hepatitis C virus infection
Ist Teil von
Journal of medical virology, 2013-08, Vol.85 (8), p.1362-1368
Ort / Verlag
Hoboken, NJ: Blackwell Publishing Ltd
Erscheinungsjahr
2013
Link zum Volltext
Quelle
Wiley Online Library - AutoHoldings Journals
Beschreibungen/Notizen
Routine screening of patients at risk of hepatitis C virus (HCV) infection has become a priority given recent improvements in therapeutic options and the asymptomatic nature of most chronic infections. The aim of this study was to evaluate the performance of the Elecsys® Anti‐HCV II assay, a new qualitative antibody immunoassay, compared with currently available assays, and assess its suitability for routine diagnostic testing. The sensitivity of the Elecsys® Anti‐HCV II, ARCHITECT® Anti‐HCV, AxSYM® HCV 3.0, PRISM® HCV, Vitros® ECi Anti‐HCV, Elecsys® Anti‐HCV, and ADVIA Centaur® HCV assays was compared using commercially available seroconversion panels and samples from patients known to be HCV positive and infected with HCV genotypes 1–6. Specificity was investigated using samples from blood donors, unselected hospitalized patients, and patients with potential cross‐reacting factors or from high‐risk groups. The Elecsys® Anti‐HCV II assay detected more positive bleeds than the comparator assays, was more sensitive in recognizing early HCV infection, and correctly identified all 765 samples known to be HCV positive, regardless of genotype. The overall specificity of the Elecsys® Anti‐HCV II assay was 99.84% (n = 6,850) using blood donor samples, 99.66% (n = 3,922) using samples from unselected hospitalized patients, and 99.66% (n = 2,397) using samples from patients with potentially cross‐reacting factors or from high‐risk groups. The specificity of the Elecsys® Anti‐HCV II assay was superior or equal to the comparator assays. In conclusion, the Elecsys® Anti‐HCV II assay is a sensitive and specific assay suitable for routine use in the reliable detection of anti‐HCV antibodies. J. Med. Virol. 85:1362–1368, 2013. © 2013 Wiley Periodicals, Inc.
Sprache
Englisch
Identifikatoren
ISSN: 0146-6615
eISSN: 1096-9071
DOI: 10.1002/jmv.23536
Titel-ID: cdi_proquest_miscellaneous_1367883757
Format
–
Schlagworte
Biological and medical sciences
,
Clinical Laboratory Techniques - methods
,
diagnosis
,
Female
,
Fundamental and applied biological sciences. Psychology
,
Hepacivirus - immunology
,
Hepatitis C - diagnosis
,
Hepatitis C Antibodies - blood
,
hepatitis C virus
,
Human viral diseases
,
Humans
,
immunoassay
,
Immunoassay - methods
,
Infectious diseases
,
Male
,
Medical sciences
,
Microbiology
,
Miscellaneous
,
Pregnancy
,
qualitative
,
Sensitivity and Specificity
,
Viral diseases
,
Virology
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