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Published on: December 13, 2017
Evaluation of a novel high sensitivity cardiac troponin I assay with whole blood
Ya-Hui Lin1, Yang Li1, Bao-Man Su1
1Center of Laboratory Medicine, Beijing, Key Laboratory for Molecular Diagnostics of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100037 China.
Background:
High-sensitivity cardiac troponin (hs-cTn) assays provide high sensitivity detection of myocardial injury. Although an assay using whole blood can reduce turn-around-time and labour, hs-cTn assays using whole blood samples are novel requiring characterization of their analytical performance.
Methods:
The imprecision of Pylon hs-cTnI assay was evaluated with whole blood, plasma and commercial quality control samples. The limit of quantitation (LOQ) of whole blood samples and plasma were determined for the Pylon hs-cTnI assay. The correlation between the Pylon hs-cTnI assay and the Abbott Architect hs-cTnI assay was evaluated using whole blood samples and plasma.
Results:
The average concentrations of pooled patient plasma were 8.3, 15.0 and 396.9 ng/l, while the corresponding CVs of repeatability and within-laboratory CVs were calculated respectively as 7.6% and 9.9%, 4.3% and 4.5%, and 3.3% and 4.5%. LOQ (20% CV) was 1.2 ng/l in plasma and 2.0 ng/l in whole blood. The lowest concentrations to reach 10% CV were 4.8 ng/l with plasma and 9.4 ng/l with whole blood. Quantification of whole blood and corresponding plasma samples correlated with no effect by hematocrits ranging from 25 to 44%.
Conclusion:
The analytical performance of the Pylon hs-cTnI assay with whole blood is comparable to that of a clinical lab instrument.
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