Document Detail


The analytic sensitivity and mutant detection capability of six hepatitis B surface antigen assays.
MedLine Citation:
PMID:  16707377     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Hepatitis B virus surface antigen (HBsAg) mutants occur in clinical specimens. We studied the analytic sensitivity and ability to detect recombinant and native mutants of 6 HBsAg assays. The ARCHITECT, AUSZYME MONOCLONAL and AxSYM assays (Abbott Diagnostics, Abbott Park, IL), the ADVIA Centaur assay (Bayer Diagnostics, Tarrytown, NY), and the Test System 3 and VITROS ECi assays (Ortho Clinical Diagnostics, Raritan, NJ) showed comparable sensitivity with wild-type HBsAg. The ARCHITECT, AUSZYME, and AxSYM assays detected all mutants that were tested. The Test System 3 and VITROS ECi assays failed to detect mutants with amino acid substitutions at positions 143, 144, and 145, which are located in the immunodominant "a" determinant. The ADVIA Centaur failed to detect substitutions at position 145 and showed negative or very low positive results for substitutions at position 143. The inability to detect HBsAg mutants may lead to misdiagnosis of hepatitis B virus infection. Further studies on the prevalence of HBsAg mutants and the ability of commercial assays to detect them are needed.
Authors:
Sonia L La'ulu; William L Roberts
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Publication Detail:
Type:  Evaluation Studies; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American journal of clinical pathology     Volume:  125     ISSN:  0002-9173     ISO Abbreviation:  Am. J. Clin. Pathol.     Publication Date:  2006 May 
Date Detail:
Created Date:  2006-05-18     Completed Date:  2006-05-30     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0370470     Medline TA:  Am J Clin Pathol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  748-51     Citation Subset:  AIM; IM    
Affiliation:
ARUP Institute for Clinical and Experimental Pathology, ARUP Laboratories, 500 Chipeta Way, Salt Lake City, UT 84108, USA.
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MeSH Terms
Descriptor/Qualifier:
DNA, Viral / analysis
Hepatitis B / diagnosis*,  virology
Hepatitis B Surface Antigens / analysis*,  genetics
Hepatitis B virus / genetics,  immunology,  isolation & purification*
Humans
Immunoassay*
Mutation*
Reagent Kits, Diagnostic
Sensitivity and Specificity
Chemical
Reg. No./Substance:
0/DNA, Viral; 0/Hepatitis B Surface Antigens; 0/Reagent Kits, Diagnostic

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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