Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
11
pubmed:dateCreated
2000-11-17
pubmed:abstractText
A nucleic acid sequence-based amplification (NASBA) assay for qualitative detection of human cytomegalovirus (CMV) pp67 mRNA was evaluated in a multicenter study. Negative results were obtained for all specimens from 50 CMV-seronegative and 50 CMV-seropositive low-risk whole-blood donors. No interference with CMV mRNA amplification was observed in the testing of 288 specimens containing various potential interfering substances, nonspecifically reacting substances (including mRNA from other herpesviruses), and three anticoagulants. A total of 95% (50 of 51) of CMV-positive (cell culture- and antigenemia immunofluorescence [AG-IFA]-positive) clinical specimens were positive by the NASBA assay. Results from different operators over multiple testing days were consistent for each of four panel members containing different concentrations of CMV mRNA, indicating the reproducibility of the assay. The estimated 95% reliable upper detection limit of the assay was 600 mRNA copies; the lower limit of detection was less than 25 mRNA copies. The clinical utility of the assay was evaluated with longitudinally collected specimens from solid-organ transplant patients (n = 21). A total of 98% (81 of 83) of the specimens from CMV-negative patients were negative by the NASBA assay, while 90% (10 of 11) of patient specimens that were positive by cell culture or AG-IFA were positive by the NASBA assay. Positive NASBA assay results were obtained earlier than AG-IFA or cell culture results for 55% of the patients and at the same time for the remainder of the patients (45%). The overall agreement between the NASBA assay and current reference tests was 86% when active CMV infection was present. These studies indicate that the CMV pp67 mRNA NASBA assay has reproducible and sensitive performance characteristics that should enable more rapid diagnosis of CMV infection.
pubmed:commentsCorrections
http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-10071460, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-10074499, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-10328539, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-10342321, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-10573068, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-10655353, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-10655383, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-1311365, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-1313313, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-1647559, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-1691208, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-2536831, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-2982911, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-3005633, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-4350775, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-6260871, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-7822457, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-8747770, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-9422409, http://linkedlifedata.com/resource/pubmed/commentcorrection/11060058-9574702
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Nov
pubmed:issn
0095-1137
pubmed:author
pubmed:issnType
Print
pubmed:volume
38
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
3994-9
pubmed:dateRevised
2009-11-18
pubmed:meshHeading
pubmed:year
2000
pubmed:articleTitle
Analytical performance and clinical utility of a nucleic acid sequence-based amplification assay for detection of cytomegalovirus infection.
pubmed:affiliation
Organon Teknika Corporation, Durham, North Carolina 27712, USA. dwitt@orgtek.com
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't, Multicenter Study, Evaluation Studies