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Performance evaluation of a new chemiluminescent cardiac troponin I assay
Author(s) -
Dasgupta Amitava,
Chow Loretta,
Nazareno Lupe,
Tso Gretie,
Datta Pradip
Publication year - 2000
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/1098-2825(2000)14:5<224::aid-jcla5>3.0.co;2-w
Subject(s) - chemiluminescence , immunoassay , chemistry , correlation coefficient , troponin , detection limit , troponin i , chromatography , chemiluminescent immunoassay , medicine , immunology , mathematics , statistics , antibody , myocardial infarction
Cardiac troponin I is a marker for diagnosis of myocardial damage. Several immunoassays are currently available for determination of concentrations of troponin I in serum. We evaluated a chemiluminescent assay for troponin I using ACS:180 automated analyzer (Bayer Diagnostics). We compared our results with two other immunoassays using the OPUS Magnum (OPUS troponin I assay, Dade Behring) and AxSYM (microparticle enzyme immunoassay, Abbott) analyzers. The within‐run and between‐run CVs were less than 5% for all three levels of controls. The chemiluminescent assay for troponin I was linear up to a serum troponin I concentration of 50 ng/mL and the detection limit was 0.1 ng/mL of troponin. A good correlation between troponin I concentration measured by the chemiluminescent assay ( y axis) and the microparticle enzyme immunoassay (MEIA) ( x axis) was observed, although the concentrations of troponin I in individual specimens were approximately four times higher, when measured by the MEIA assay, than those measured by chemiluminescent assay. The correlation coefficient was 0.98 with the regression equation y = 0.22x + 1.125. We also observed a good correlation in troponin I concentrations obtained by the chemiluminescent assay ( y axis) and OPUS troponin I assay ( x axis). The correlation coefficient was 0.96 and the regression equation was y = 0.79x – 0.52. The correlation coefficient was 0.93 when we compared troponin I concentrations obtained by the OPUS assay ( x axis) with the corresponding concentrations obtained by the MEIA assay ( y axis). The corresponding regression equation was y = 0.25x + 3.5. We conclude that the chemiluminescent troponin I assay showed good analytical performance. J. Clin. Lab. Anal. 14:224–229, 2000. © 2000 Wiley‐Liss, Inc.

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