Linked Life Data

8914760

Source:http://linkedlifedata.com/resource/pubmed/id/8914760

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
1997-2-18
pubmed:abstractText
Acellular pertussis vaccines are being evaluated in multiple clinical studies, and human immunogenicity data will likely be pivotal in the appraisal of vaccine responses between populations and the responses to different vaccine combinations. Antibody response to pertussis antigens is also used in the diagnosis of pertussis. An international study was designed to assess the comparability of data generated in different laboratories by enzyme-linked immunosorbent assays (ELISAs). Thirty-three participating laboratories were asked to quantitate specific antibody to pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN), or fimbrial proteins (FIM) in 21 samples. Samples were to be assayed in triplicate in five independent assays by each ELISA routinely performed in the laboratory to assess intra-assay, interassay, and population variability. The mean sample values were used to compare quantitative results among the laboratories. Thirteen of the 32 laboratories which submitted evaluable data for an assay to measure antibodies to PT, 12 of 30 laboratories with assays for FHA, 10 of 17 laboratories with assays for PRN, and 6 of 13 laboratories with assays for FIM maintained a coefficient of variation below 20% for 75% of the samples tested. Assays that measure antibodies to FIM appear to be less precise than the other assays. Precision varied among laboratories that used similar methods. The relative values of intra- and interassay variabilities were not consistent for a given assay within a laboratory, indicating that the sources of these variability components may be unrelated. Precision and agreement appeared less reliable for samples with low antibody levels. Ranking and regression analyses suggest that some laboratories generated comparable quantitative results, although direct comparison or combination of results from different laboratories remains difficult to support. Calibration to the U.S. Reference Pertussis Antisera appears to have been successful at standardizing the results in some laboratories. Statistical analyses are affected by assay precision and are not necessarily reliable sole predictors of biologically relevant differences in quantitative results. If results from different laboratories must be compared, appropriate studies of precision and quantitative agreement should be conducted to support the specific comparisons.
pubmed:commentsCorrections
http://linkedlifedata.com/resource/pubmed/commentcorrection/8914760-1554832, http://linkedlifedata.com/resource/pubmed/commentcorrection/8914760-1734048, http://linkedlifedata.com/resource/pubmed/commentcorrection/8914760-2019753, http://linkedlifedata.com/resource/pubmed/commentcorrection/8914760-7602150, http://linkedlifedata.com/resource/pubmed/commentcorrection/8914760-7659475, http://linkedlifedata.com/resource/pubmed/commentcorrection/8914760-7659476, http://linkedlifedata.com/resource/pubmed/commentcorrection/8914760-7659478, http://linkedlifedata.com/resource/pubmed/commentcorrection/8914760-7675047, http://linkedlifedata.com/resource/pubmed/commentcorrection/8914760-7769311, http://linkedlifedata.com/resource/pubmed/commentcorrection/8914760-7814480, http://linkedlifedata.com/resource/pubmed/commentcorrection/8914760-8531284, http://linkedlifedata.com/resource/pubmed/commentcorrection/8914760-8538704, http://linkedlifedata.com/resource/pubmed/commentcorrection/8914760-8538705, http://linkedlifedata.com/resource/pubmed/commentcorrection/8914760-8770509
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Nov
pubmed:issn
1071-412X
pubmed:author
pubmed:issnType
Print
pubmed:volume
3
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
689-700
pubmed:dateRevised
2009-11-18
pubmed:meshHeading
pubmed:year
1996
pubmed:articleTitle
Collaborative study for the evaluation of enzyme-linked immunosorbent assays used to measure human antibodies to Bordetella pertussis antigens.
pubmed:affiliation
Laboratory of Pertussis, Food and Drug Administration, Rockville, Maryland 20852, USA. lynn@a1.cber.fda.gov.
pubmed:publicationType
Journal Article, Clinical Trial, Multicenter Study