Performance Verification of CardioChek PA Lipid Point-of-care Devices
10.3969/j.issn.1674-9081.2014.03.008
- VernacularTitle:CardioChek PA床旁血脂检测仪的准确性验证
- Author:
Li-An HOU
1
;
Ling QIU
;
Qian DI
;
Xiu-Zhi GUO
;
Hong-Jie XIE
;
Peng-Chang LI
;
Kai WANG
;
Xin-Qi CHENG
;
Li LIU
Author Information
1. 中国医学科学院 北京协和医学院 北京协和医院检验科
- Keywords:
point-of-care testing;
imprecision;
accuracy;
comparison test
- From:
Medical Journal of Peking Union Medical College Hospital
2014;(3):283-289
- CountryChina
- Language:Chinese
-
Abstract:
Objective To validate the accuracy of CardioChek PA lipid point-of-care devices in determi-ning total cholesterol ( TC ) , triglyceride ( TG ) , and high-density lipoprotein cholesterol ( HDL-C ) in whole blood and the comparability with results determined by full-automatic biochemical analyzer .Methods We deter-mined the low, medium, and high levels of TG, TC, and HDL-C in whole blood with single reagent lot number 20 times using 3 different CardioChek PA devices to evaluate inter-run and devices'coefficient of variations ( CVs) , and used single CardioChek PA device with 3 reagent lot number to determine the whole blood 10 times for evaluating inter-run and total CVs .Fifty-four volunteers whose lipid profiles covered up high , medium, and low levels were recruited .Lipids in fasting periphery whole blood and venous serum were collected and deter -mined using 3 different CardioChek PA devices and 4 kinds of full-automatic biochemical analyzers , respectively . Bland-Altman plot was made to analyze the comparability of results from CardioChek PA and the full -automatic bi-ochemical analyzers .Linear regression was analyzed using results of CardioChek PA and full -automatic biochemi-cal analyzers .Bias and percentage bias were determined between CardioChek PA and different automatic bio -chemical analyzers; meanwhile, whether they satisfied the requirements of medical decision levels was deter -mined.Results The total CVs of TC in low , medium, and high levels in 3 different devices were 2.69%, 4.88%, and 3.51%, respectively;for TG, they were 5.51%, 5.27%and 4.96%;and for HDL-C, they were 7.27%, 6.84%and 6.79%.The total CVs of TC , TG, and HDL-C determined with the same device but dif-ferent reagent lot number were 4.70%, 7.66%, and 8.61%, respectively .Comparison of the results from Car-dioChek PA devices and the 4 kinds of full-automatic biochemical analyzers showed lowest deviation for TC with-2.21% 2.56%, and for HDL-C with -1.12% 5.57%;the deviation of TG results of BeckmanDxC 800 was relatively high with 25.85%, but in other 3 systems were -4.55% 13.34%.Deviation of TC , TG, and HDL-C in different medical decision levels were -3.27% 1.96%, -11.05% 13.06%, and -5.86% 11.56%, respectively , all of which could satisfy the requirements of the National Cholesterol Education Program ( NCEP) . Compared with reference methods , the biases of TC in medical decision levels were 1.96% and 0.77%; for HDL-C, they were 2.34%and 4.87%.Conclusion The accuracy of CardioChek PA lipid point-of-care device can satisfy the clinical requirements , and the device can be used in the screening and monitoring of dyslipidemia .
