[Study on the reliability of CardioChek PA for measuring lipid profile].
OBJECTIVE
To evaluate the clinical correlation between the CardioChek PA analyzer (CCPA) and a clinical laboratory reference method to use for screening program purposes.


METHODS
Fasting blood samples were collected on 325 patients (age: 23-86 years). One venous sample was collected using a serum tube for the evaluation on a Beckman reference analyzer. A second venous sample was collected in a lithium heparin tube and was evaluated on the CCPA analyzer. Linear regression analyses and Bland-Altman method were performed for each measured analyte: total cholesterol (TC), high density lipoprotein-cholesterol (HDL-C), triglycerides (TG) and low density lipoprotein-cholesterol (LDL-C).


RESULTS
Our results demonstrated a good clinical agreement for TC, HDL-C, TG and LDL-C(97.0%, 92.9%, 92.4% and 83.7%)in comparison with the CCPA to the reference analyzer. The correlation coefficients were 0.875, 0.813, 0.910, 0.864, respectively. P values all < 0.001. There was no significant difference in the detection rate of hyperlipidemia in TC, HDL-C and LDL-C.


CONCLUSIONS
We have identified the pre-analytic phase as an important step to guarantee the quality of results and indicated that the CCPA is a reliable lipid point-of-care testing system that can be used for the application of clinical screening anywhere.
Department of Dyslipidemia and Cardiovascular Disease, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100037, China.
Y
Y
Gao
Department of Dyslipidemia and Cardiovascular Disease, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100037, China.
C G
CG
Zhu
Department of Dyslipidemia and Cardiovascular Disease, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100037, China.
N Q
NQ
Wu
Department of Dyslipidemia and Cardiovascular Disease, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100037, China.
Y L
YL
Guo
Department of Dyslipidemia and Cardiovascular Disease, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100037, China.
G
G
Liu
Department of Dyslipidemia and Cardiovascular Disease, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100037, China.
Q
Q
Dong
Department of Dyslipidemia and Cardiovascular Disease, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100037, China.
J J
JJ
Li
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001774:Blood Chemical Analysis / Q000295:instrumentation*; D008076:Cholesterol, HDL / Q000097:blood*; D008078:Cholesterol, LDL / Q000097:blood*; D006801:Humans; D006949:Hyperlipidemias / Q000175:diagnosis; D008875:Middle Aged; D000067716:Point-of-Care Testing; D015203:Reproducibility of Results; D014280:Triglycerides / Q000097:blood*; D055815:Young Adult
D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D014280:Triglycerides