Large-scale analysis of hepatitis C virus serological typing assay: Effectiveness and limits

The HCV (hepatitis C virus) Serotyping 1–6 Assay™ (Murex Laboratories) was evaluated on 303 French HCV‐infected patients. Serological typing results were compared to the genotypes obtained from sequence analyses of the 5′ noncoding regions of the virus genome from 46 HCV‐infected patients, and assay...

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Published in:	Journal of medical virology Vol. 55; no. 1; pp. 18 - 23
Main Authors:	Leruez-Ville, Marianne, Nguyen, Quang-Tri, Cohen, Pascal, Cocco, Sylvain, Nouyou, Marianne, Ferrière, Françoise, Dény, Paul
Format:	Journal Article
Language:	English
Published:	New York Wiley Subscription Services, Inc., A Wiley Company 01-05-1998 Wiley-Liss
Subjects:	AIDS/HIV Biological and medical sciences Case-Control Studies cryoglobulinemia Cryoglobulinemia - complications Cryoglobulinemia - virology diagnosis Evaluation Studies as Topic Genotype HCV Hepacivirus - classification Hepacivirus - genetics Hepacivirus - immunology Hepatitis C - blood Hepatitis C - immunology Hepatitis C - virology HIV Human viral diseases Humans Infectious diseases Medical sciences Reagent Kits, Diagnostic Sensitivity and Specificity sequence analysis Serotyping - methods serotyping assay Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Viral hepatitis Performance evaluation Human Immunopathology Cryoglobulinemia Prevalence Typing Hepatic disease AIDS Immune deficiency Epidemiology Immunological method Infection Virus Viral disease Digestive diseases Diagnosis Serotype Flaviviridae Hepatitis C virus Hepacivirus Comparative study Viral hepatitis C
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Summary:	The HCV (hepatitis C virus) Serotyping 1–6 Assay™ (Murex Laboratories) was evaluated on 303 French HCV‐infected patients. Serological typing results were compared to the genotypes obtained from sequence analyses of the 5′ noncoding regions of the virus genome from 46 HCV‐infected patients, and assay specificity was found to be high (97.6%). The serological typing assay, run in 257 consecutive HCV‐infected patients, yielded an assay sensitivity lower (70.6%) than that previously reported. This finding was attributed mainly to nonreactive sera from human immunodeficiency virus (HIV)‐positive patients (P < 0.001) and perhaps reflected cryoglobulin positivity in others. No anti‐type 6 reactivity was detected, and the overall serological type distribution values for types 1 to 5 were 67.3, 7.9, 16.4, 6.6, and 0.9%, respectively. A higher prevalence of type 4 was noted among HIV‐infected patients (P < 0.001). In addition, serotype 2 was significantly more frequent in cryoglobulinemia positive than in cryoglobulinemia‐negative patients (P < 0.05). Although an initial high level (7%) of mixed serological typing reactivities was found, after predilution of serum only two mixed infections could be confirmed (0.9%). It is suggested, therefore, that mixed reactivities have to be interpreted carefully and retested with prediluted serum, particularly when the optical density of the reactivity is >2.5 or remains >0.4 after competition with all type‐specific peptides. The high specificity and relatively good sensitivity even in immunocompromised patients obtained with this assay indicate that it can be used routinely. Because response to treatment is linked to HCV type, this assay could be used to identify HCV serotype to guide therapeutic decisions. J. Med. Virol. 55:18–23, 1998. © 1998 Wiley‐Liss, Inc.
Bibliography:	Association pour la Recherche sur le Cancer - No. 2505 ark:/67375/WNG-366ZK46L-2 ArticleID:JMV4 Direction de la Recherche et des Etucles Doctorales - No. UPRES 1622 istex:6DB94348D3D1C9BFBCE4CC1AAAFE51AB50BB8E94 ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Article-1 ObjectType-Feature-2
ISSN:	0146-6615 1096-9071
DOI:	10.1002/(SICI)1096-9071(199805)55:1<18::AID-JMV4>3.0.CO;2-R