Lin Ya-Hui, Li Yang, Su Bao-Man, Kang Jin-Suo, Zhou Zhou
Center 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.
Center 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.
Clin Chim Acta. 2020 Sep;508:273-276. doi: 10.1016/j.cca.2020.05.036. Epub 2020 May 20.
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.
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.
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%.
The analytical performance of the Pylon hs-cTnI assay with whole blood is comparable to that of a clinical lab instrument.
高敏心肌肌钙蛋白（hs-cTn）检测可实现对心肌损伤的高灵敏度检测。尽管使用全血的检测方法可以缩短周转时间并减少人力，但使用全血样本的hs-cTn检测方法尚属新颖，需要对其分析性能进行表征。
使用全血、血浆和商业质量控制样本评估Pylon hs-cTnI检测的不精密度。确定Pylon hs-cTnI检测中全血样本和血浆的定量限（LOQ）。使用全血样本和血浆评估Pylon hs-cTnI检测与雅培Architect hs-cTnI检测之间的相关性。
合并患者血浆的平均浓度分别为8.3、15.0和396.9 ng/l，而重复性的相应变异系数（CV）和实验室内CV分别计算为7.6%和9.9%、4.3%和4.5%、3.3%和4.5%。血浆中LOQ（20% CV）为1.2 ng/l，全血中为2.0 ng/l。达到10% CV的最低浓度，血浆为4.8 ng/l，全血为9.4 ng/l。全血和相应血浆样本的定量具有相关性，血细胞比容在25%至44%范围内无影响。
Pylon hs-cTnI全血检测的分析性能与临床实验室仪器相当。
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