Abstract:
OBJECTIVES:Define performance characteristics of the Stratus CS cardiac troponin I (cTnI) assay in routine practice. METHODS:Imprecision at low cTnI values was assessed according to NCCLS EP5-A. Linearity was assessed by regression analysis; the reference interval was determined in 345 healthy individuals. Minimum detectable concentration (MDC) was assessed with 20 replicates of zero calibrator, and method correlation and bias (n = 77) were by Passing-Bablok regression and Bland-Altman plot. RESULTS:cTnI of 0.06 microg/l corresponded to the 10% CV; the 99th percentile of the reference population was 0.07 microg/l. Linearity extended from 0 to 50.0 microg/l and the MDC was 0.010 microg/l. The method comparison equation was Stratus CS = 1.00 (Dimension RxL)-0.02 microg/l with no bias. CONCLUSIONS:The Stratus CS cTnI assay in routine practice has performance characteristics appropriate for clinical use, including good correlation to a central laboratory cTnI method and imprecision of a high sensitivity troponin method with a CV of <10% at the 99th percentile of the reference population.
journal_name
Clin Biochemjournal_title
Clinical biochemistryauthors
Christenson RH,Cervelli DR,Bauer RS,Gordon Mdoi
10.1016/j.clinbiochem.2004.03.009subject
Has Abstractpub_date
2004-08-01 00:00:00pages
679-83issue
8eissn
0009-9120issn
1873-2933pii
S0009912004000694journal_volume
37pub_type
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journal_title:Clinical biochemistry
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journal_title:Clinical biochemistry
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更新日期:2003-02-01 00:00:00
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pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2005.10.005
更新日期:2006-01-01 00:00:00
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更新日期:2014-04-01 00:00:00
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更新日期:1998-11-01 00:00:00
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pub_type: 杂志文章,meta分析
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更新日期:2014-05-01 00:00:00