Tingting Li1,2, Wei Wang1, Haijian Zhao1, Falin He1, Kun Zhong1, Shuai Yuan1, Zhiguo Wang1. 1. National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing, China. 2. Graduate School, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.
Abstract
BACKGROUND: This study aimed to investigate the status of internal quality control (IQC) for cardiac biomarkers from 2011 to 2016 so that we can have overall knowledge of the precision level of measurements in China and set appropriate precision specifications. METHODS: Internal quality control data of cardiac biomarkers, including creatinine kinase MB (CK-MB) (μg/L), CK-MB(U/L), myoglobin (Mb), cardiac troponin I (cTnI), cardiac troponin T (cTnT), and homocysteines (HCY), were collected by a web-based external quality assessment (EQA) system. Percentages of laboratories meeting five precision quality specifications for current coefficient of variations (CVs) were calculated. Then, appropriate precision specifications were chosen for these six analytes. Finally, the CVs and IQC practice were further analyzed with different grouping methods. RESULTS: The current CVs remained nearly constant for 6 years. cTnT had the highest pass rates every year against five specifications, whereas HCY had the lowest pass rates. Overall, most analytes had a satisfactory performance (pass rates >80%), except for HCY, if one-third TEa or the minimum specification were employed. When the optimal specification was applied, the performance of most analytes was frustrating (pass rates < 60%) except for cTnT. The appropriate precision specifications of Mb, cTnI, cTnT and HCY were set as current CVs less than 9.20%, 9.90%, 7.50%, 10.54%, 7.63%, and 6.67%, respectively. The data of IQC practices indicated wide variation and substantial progress. CONCLUSION: The precision performance of cTnT was already satisfying, while the other five analytes, especially HCY, were still frustrating; thus, ongoing investigation and continuous improvement for IQC are still needed.
BACKGROUND: This study aimed to investigate the status of internal quality control (IQC) for cardiac biomarkers from 2011 to 2016 so that we can have overall knowledge of the precision level of measurements in China and set appropriate precision specifications. METHODS: Internal quality control data of cardiac biomarkers, including creatinine kinase MB (CK-MB) (μg/L), CK-MB(U/L), myoglobin (Mb), cardiac troponin I (cTnI), cardiac troponin T (cTnT), and homocysteines (HCY), were collected by a web-based external quality assessment (EQA) system. Percentages of laboratories meeting five precision quality specifications for current coefficient of variations (CVs) were calculated. Then, appropriate precision specifications were chosen for these six analytes. Finally, the CVs and IQC practice were further analyzed with different grouping methods. RESULTS: The current CVs remained nearly constant for 6 years. cTnT had the highest pass rates every year against five specifications, whereas HCY had the lowest pass rates. Overall, most analytes had a satisfactory performance (pass rates >80%), except for HCY, if one-third TEa or the minimum specification were employed. When the optimal specification was applied, the performance of most analytes was frustrating (pass rates < 60%) except for cTnT. The appropriate precision specifications of Mb, cTnI, cTnT and HCY were set as current CVs less than 9.20%, 9.90%, 7.50%, 10.54%, 7.63%, and 6.67%, respectively. The data of IQC practices indicated wide variation and substantial progress. CONCLUSION: The precision performance of cTnT was already satisfying, while the other five analytes, especially HCY, were still frustrating; thus, ongoing investigation and continuous improvement for IQC are still needed.
Authors: Sverre Sandberg; Callum G Fraser; Andrea Rita Horvath; Rob Jansen; Graham Jones; Wytze Oosterhuis; Per Hyltoft Petersen; Heinz Schimmel; Ken Sikaris; Mauro Panteghini Journal: Clin Chem Lab Med Date: 2015-05 Impact factor: 3.694
Authors: Kristian Thygesen; Joseph S Alpert; Allan S Jaffe; Maarten L Simoons; Bernard R Chaitman; Harvey D White; Hugo A Katus; Bertil Lindahl; David A Morrow; Peter M Clemmensen; Per Johanson; Hanoch Hod; Richard Underwood; Jeroen J Bax; Robert O Bonow; Fausto Pinto; Raymond J Gibbons; Keith A Fox; Dan Atar; L Kristin Newby; Marcello Galvani; Christian W Hamm; Barry F Uretsky; Ph Gabriel Steg; William Wijns; Jean-Pierre Bassand; Phillippe Menasché; Jan Ravkilde; E Magnus Ohman; Elliott M Antman; Lars C Wallentin; Paul W Armstrong; Maarten L Simoons; James L Januzzi; Markku S Nieminen; Mihai Gheorghiade; Gerasimos Filippatos; Russell V Luepker; Stephen P Fortmann; Wayne D Rosamond; Dan Levy; David Wood; Sidney C Smith; Dayi Hu; José-Luis Lopez-Sendon; Rose Marie Robertson; Douglas Weaver; Michal Tendera; Alfred A Bove; Alexander N Parkhomenko; Elena J Vasilieva; Shanti Mendis Journal: Circulation Date: 2012-08-24 Impact factor: 29.690
Authors: Eva Schernhammer; Brian Wolpin; Nader Rifai; Barbara Cochrane; Jo Ann Manson; Jing Ma; Ed Giovannucci; Cynthia Thomson; Meir J Stampfer; Charles Fuchs Journal: Cancer Res Date: 2007-06-01 Impact factor: 12.701