Abstract：
BACKGROUND:The association between increases in cardiac troponin and adverse cardiac outcomes is well established. There is a growing interest in exploring routine cardiac troponin monitoring as a potential early indicator of adverse heart health trends. Prognostic use of cardiac troponin measurements requires an assay with very high sensitivity and outstanding analytical performance. We report development and preliminary validation of an investigational assay meeting these requirements and demonstrate its applicability to cohorts of healthy individuals and patients with heart failure. METHODS:On the basis of single molecule array technology, we developed a 45-min immunoassay for cardiac troponin I (cTnI) for use on a novel, fully automated digital analyzer. We characterized its analytical performance and measured cTnI in healthy individuals and heart failure patients in a preliminary study of assay analytical efficacy. RESULTS:The assay exhibited a limit of detection of 0.01 ng/L, a limit of quantification of 0.08 ng/L, and a total CV of 10% at 2.0 ng/L. cTnI concentrations were well above the assay limit of detection for all samples tested, including samples from healthy individuals. cTnI was significantly higher in heart failure patients, and exhibited increasing median and interquartile concentrations with increasing New York Heart Association classification of heart failure severity. CONCLUSIONS:The robust 2-log increase in sensitivity relative to contemporary high-sensitivity cardiac troponin immunoassays, combined with full automation, make this assay suitable for exploring cTnI concentrations in cohorts of healthy individuals and for the potential prognostic application of serial cardiac troponin measurements in both apparently healthy and diseased individuals.
journal_name
Clin Chemjournal_title
Clinical chemistryauthors
Jarolim P,Patel PP,Conrad MJ,Chang L,Melenovsky V,Wilson DHdoi
10.1373/clinchem.2015.242081subject
Has Abstractpub_date
2015-10-01 00:00:00pages
1283-91issue
10eissn
0009-9147issn
1530-8561pii
clinchem.2015.242081journal_volume
61pub_type
杂志文章abstract：:Kappa Bence Jones proteinuria was found by immunoelectrophoretic techniques in a patient with plasma cell leukemia, who presented with no M-proteins either in serum or urine. However, a significant decrease in normal immunoglobulins was observed. On microscopic examination of kidney sections obtained a autopsy, protei...
journal_title：Clinical chemistry
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doi：
更新日期：1975-10-01 00:00:00
abstract：:Serum specimens from patients on primidone therapy were assayed by two currently available procedures: a commercially available enzyme immunoassay (EMIT) and a published gas-chromatographic procedure. Both procedures were done with commercially available materials and equipment. Results by the two procedures agreed we...
journal_title：Clinical chemistry
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abstract：:In galactosemia, prevention of mental retardation depends on early recognition of the disorder and institution of dietary restriction of galactose. We describe an automated fluorometric micromethod for galactose in whole blood spotted on filter paper. Galactose is oxidized by galactose oxidase to D-galacto-hexadialdos...
journal_title：Clinical chemistry
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doi：
更新日期：1977-06-01 00:00:00
abstract：:We describe a procedure for determining thiocyanate in plasma with a Technicon AutoAnalyzer I, modified with a 50-mm tubular flow cell to increase the sensitivity of thiocyanate detection. The procedure is suitable for distinguishing cigarette smokers from non-smokers, the mean for smokers being 151 (SD 43) micromol/L...
journal_title：Clinical chemistry
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更新日期：1980-03-01 00:00:00
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journal_title：Clinical chemistry
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doi：10.1373/49.8.1337
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journal_title：Clinical chemistry
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doi：
更新日期：1979-10-01 00:00:00
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doi：
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journal_title：Clinical chemistry
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journal_title：Clinical chemistry
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doi：
更新日期：1979-03-01 00:00:00
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journal_title：Clinical chemistry
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doi：
更新日期：1990-07-01 00:00:00
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doi：
更新日期：2002-01-01 00:00:00
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journal_title：Clinical chemistry
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doi：10.1373/clinchem.2012.193060
更新日期：2013-01-01 00:00:00
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pub_type： 杂志文章
doi：
更新日期：1984-04-01 00:00:00
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journal_title：Clinical chemistry
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doi：10.1373/49.6.861
更新日期：2003-06-01 00:00:00
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journal_title：Clinical chemistry
pub_type： 杂志文章
doi：
更新日期：1994-01-01 00:00:00
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pub_type： 杂志文章,评审
doi：
更新日期：1999-08-01 00:00:00
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journal_title：Clinical chemistry
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doi：
更新日期：1992-09-01 00:00:00
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doi：10.1093/clinchem/hvaa187
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doi：10.1093/clinchem/hvaa158
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journal_title：Clinical chemistry
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journal_title：Clinical chemistry
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doi：
更新日期：1985-10-01 00:00:00
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更新日期：1977-11-01 00:00:00
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journal_title：Clinical chemistry
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doi：
更新日期：1979-10-01 00:00:00
abstract：BACKGROUND:Prostate-specific antigen (PSA) occurs in serum both free and in complex with protease inhibitors. The complex with alpha1-antichymotrypsin (ACT) is the major form in serum, and the proportion of PSA-ACT is higher in prostate cancer (PCa) than in benign prostatic hyperplasia (BPH). PSA also forms a complex w...
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pub_type： 临床试验,杂志文章
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更新日期：1999-06-01 00:00:00
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