-
Something wrong with this record ?
Fully automated ultrasensitive digital immunoassay for cardiac troponin I based on single molecule array technology
P. Jarolim, PP. Patel, MJ. Conrad, L. Chang, V. Melenovsky, DH. Wilson,
Language English Country United States
Document type Journal Article, Research Support, Non-U.S. Gov't
NLK
ProQuest Central
from 2002-12-01 to 2022-04-30
Open Access Digital Library
from 1955-02-01
Medline Complete (EBSCOhost)
from 2010-01-01 to 1 year ago
Nursing & Allied Health Database (ProQuest)
from 2002-12-01 to 2022-04-30
Health & Medicine (ProQuest)
from 2002-12-01 to 2022-04-30
Public Health Database (ProQuest)
from 2002-12-01 to 2022-04-30
- MeSH
- Protein Array Analysis economics methods MeSH
- Adult MeSH
- Immunoassay economics methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Limit of Detection MeSH
- Young Adult MeSH
- Heart Failure blood diagnosis MeSH
- Troponin I analysis blood MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
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.
Brigham and Women's Hospital and
Brigham and Women's Hospital and Harvard Medical School Boston MA
Institute for Clinical and Experimental Medicine Prague Czech Republic
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc16009997
- 003
- CZ-PrNML
- 005
- 20160413094110.0
- 007
- ta
- 008
- 160408s2015 xxu f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1373/clinchem.2015.242081 $2 doi
- 024 7_
- $a 10.1373/clinchem.2015.242081 $2 doi
- 035 __
- $a (PubMed)26283690
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxu
- 100 1_
- $a Jarolim, Petr $u Brigham and Women's Hospital and Harvard Medical School, Boston, MA;
- 245 10
- $a Fully automated ultrasensitive digital immunoassay for cardiac troponin I based on single molecule array technology / $c P. Jarolim, PP. Patel, MJ. Conrad, L. Chang, V. Melenovsky, DH. Wilson,
- 520 9_
- $a 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.
- 650 _2
- $a dospělí $7 D000328
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a srdeční selhání $x krev $x diagnóza $7 D006333
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a imunoanalýza $x ekonomika $x metody $7 D007118
- 650 _2
- $a limita detekce $7 D057230
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a čipová analýza proteinů $x ekonomika $x metody $7 D040081
- 650 _2
- $a troponin I $x analýza $x krev $7 D019210
- 650 _2
- $a mladý dospělý $7 D055815
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a práce podpořená grantem $7 D013485
- 700 1_
- $a Patel, Purvish P $u Quanterix Corporation, Lexington, MA;
- 700 1_
- $a Conrad, Michael J $u Brigham and Women's Hospital and.
- 700 1_
- $a Chang, Lei $u Quanterix Corporation, Lexington, MA;
- 700 1_
- $a Melenovsky, Vojtech $u Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
- 700 1_
- $a Wilson, David H $u Quanterix Corporation, Lexington, MA; dwilson@quanterix.com.
- 773 0_
- $w MED00001129 $t Clinical chemistry $x 1530-8561 $g Roč. 61, č. 10 (2015), s. 1283-91
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/26283690 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y a $z 0
- 990 __
- $a 20160408 $b ABA008
- 991 __
- $a 20160413094153 $b ABA008
- 999 __
- $a ok $b bmc $g 1113426 $s 934365
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2015 $b 61 $c 10 $d 1283-91 $e 20150817 $i 1530-8561 $m Clinical chemistry $n Clin Chem $x MED00001129
- LZP __
- $a Pubmed-20160408
