J Clin Lab Anal. 2018;32:e22311.
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Evaluation of a newly developed chemiluminescence
immunoassay for detecting cardiac troponin T
| Yizhen Fang
| Peihua Li
| Huayue Lin
| Hongwei Jin
| Shengxiang Ge
| Zhong-Ying Zhang
Center for Clinical Laboratory, Xiamen
Xiamen InnoDx Biotech Co., Ltd., Xiamen,
State Key Laboratory of Molecular
Vaccinology and Molecular
University, Xiamen, China
National Institute of Diagnostics and Vaccine
Development in Infectious Diseases, Xiamen,
Background: To evaluate the performance of a chemiluminescence detection kit for
cardiac troponin T (cTnT).
reagents in vitro” and the Clinical and Laboratory Standards Institute (CLSI) Guidelines,
we assessed the detection limit, linear range, reportable range, accuracy, precision,
cross reactivity, interference factors, and matrix effect of the kit, and compared these
parameters with that of the commercial electrochemiluminescence detection kit for
Results: The minimum detection limit of the kit was 0.01 ng/mL. The linear range was
0.01ng/mL-25ng/mL. The reportable range was from 0.01ng/mL to 100ng/mL.
onstrated that there was no reactivity between cTnT and a variety of troponins. Test
gesting that kit results were not significantly interfered with these factors. Results from
thematrix-effect assessmentrevealed absenceof amatrixeffectinthetestedserum
samples. Correlation study revealed that the performance of the kit was very consistent
withthatoftheRocheelectrochemiluminescencedetectionkit(Kappa = 0.900,P < .001)
with a high correlation (r =.903,P <.001)andatotalmatchingrateof95.00%.
Conclusion: The performance of the evaluated chemiluminescence immunoquantita-
tion kit for cTnT detection was acceptable in all tested parameters, fulfilling require-
ments for clinical applications.
cardiac troponin T, chemiluminescence immunoassay, evaluation, performance, reagent
1 | INTRODUCTION
Troponin (Tn) is an important regulatory protein necessary for stri-
ated muscle contraction. It consists of three subunits: troponin C
(TnC), troponin I (TnI), and troponin T (TnT). TnT is the subunit that
binds to tropomyosin and is classified into three subtypes: a fast
skeletal muscle subtype, a slow skeletal muscle subtype, and a myo-
cardial subtype. Cardiac troponin T (cTnT) is a 37 kD protein that is
expressed with a high tissue specificity in myocardium and is ap-
cTnT is present in the blood 3-4hours after a myocardial infarc-
tion, with levels remaining elevated for about 2 weeks. The unique
medium, provided the original work is properly cited and is not used for commercial purposes.
©2017TheAuthorsJournal of Clinical Laboratory Analysis Published by Wiley Periodicals, Inc.