Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3-4
pubmed:dateCreated
2004-4-12
pubmed:abstractText
Hepatitis B surface antigen is one of the most important serological markers used to diagnose an HBV infection. Improvements in HBsAg assay sensitivity have been achieved constantly over the years since introduction of the first commercial assays. It is generally assumed that diagnostic assay sensitivity includes the ability to detect wild type and viral variants at the same level. Thus it would be expected, as newer HBsAg assays are developed, that viral mutation would be considered in assay design and that assay sensitivity would be equivalent for wild type as well as mutant forms. Two newly launched HBsAg assays (Bayer ADVIA Centaur and Ortho VITROS ECi) were compared to two established HBsAg assays (Abbott AxSYM and Roche Elecsys) in order to test the assumption that assay sensitivity for variants is equivalent to wild type HBsAg. The four assays were challenged with a standard HBsAg sensitivity panel of both ad and ay subtypes as well as a 13 member mutant panel comprised of both recombinant and native HBsAg members. Results demonstrate that the analytical sensitivity for wild type HBsAg is comparable for all assays tested. In contrast, significant differences were observed for detection of mutants. AxSYM HBsAg detected all mutant samples while all other asssays missed 10 out of 13 samples tested. It is noteworthy that the most frequently reported HBsAg mutation, G145 R, remained undetected in three of the assays tested. It is discussed whether the reduced sensitivity for mutants of the most recent assays represents a new risk for the diagnosis of HBV infection.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
1433-6510
pubmed:author
pubmed:issnType
Print
pubmed:volume
50
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
159-62
pubmed:dateRevised
2004-11-17
pubmed:meshHeading
pubmed:year
2004
pubmed:articleTitle
Evaluation of sensitivity for wild type and mutant forms of hepatitis B surface antigen by four commercial HBsAg assays.
pubmed:affiliation
LKO-LMC, Sint-Truiden, Belgium. b.moerman@lkolmc.be
pubmed:publicationType
Journal Article, Evaluation Studies