Measurement performance of reagent manufacturers by Centers for Disease Control and Prevention/Cholesterol Reference Method Laboratory Network lipid standardization specified for metabolic syndrome-focused health checkups program in Japan.
OBJECTIVE
This study was designed to clarify the current measurement performance of 7 reagent manufacturers for high-density lipoprotein cholesterol (HDLC), low-density lipoprotein cholesterol (LDLC) and triglycerides (TG) specified for the metabolic syndrome (MetS)-focused health checkups program in Japan.


METHODS
Twenty HDLC, 21 LDLC and 9 TG analytical reagent/instrument/calibrator systems (system), and combinations of reagent lots, instrument models and calibrator lots, underwent Centers for Disease Control and Prevention (CDC)/Cholesterol Reference Method Laboratory Network (CRMLN) lipid standardization. Eighty and 100% systems were requested to achieve an accuracy of within +/-1% and +/-2% of the reference value, so that a clinical laboratory can meet the CDC criteria.


RESULTS
The CDC performance criteria of HDLC, LDLC and TG require an accuracy of within +/-5%, +/-4% and +/-5%, respectively. For HDLC, all 20 systems met the criteria. Fourteen (70.0%) and 18 (90.0%) systems were within +/-1% and +/-2%, respectively. For LDLC, 14 (66.7%) of 21 systems met the criteria, but 7 (33.3%) failed. Five (23.8%) and 17 (81.0%) systems were within +/-1% and +/-2%, respectively. For TG, 8 of 9 systems met the criteria. Two (22.2%) and 4 (44.4%) systems were within +/-1% and +/-2%, respectively. The minimum and maximum differences of a specified sample among manufacturers were 1.6 and 11.0 mg/dL for HDLC, 7.8 and 33.0 mg/dL for LDLC, and 2.8 and 27.4 mg/dL for TG, respectively.


CONCLUSIONS
Homogeneous HDLC methods are acceptable for MetS, but further accuracy improvement of homogeneous LDLC and TG methods will be needed because of their poor performance.
Nakamura
Masakazu
M
Osaka Medical Center for Health Science and Promotion, Japan. xnakamura@kenkoukagaku.jp
Koyama
Isao
I
Iso
Hiroyasu
H
Sato
Shinichi
S
Okazaki
Mitsuyo
M
Kiyama
Masahiko
M
Shimamoto
Takashi
T
Konishi
Masamitsu
M
D001774:Blood Chemical Analysis / Q000592:standards; D002138:Calibration / Q000592:standards; D002487:Centers for Disease Control and Prevention, U.S. / Q000592:standards; D002784:Cholesterol / Q000097:blood / Q000592:standards*; D008076:Cholesterol, HDL / Q000097:blood / Q000592:standards*; D006801:Humans; D007564:Japan; D007753:Laboratories / Q000592:standards; D008055:Lipids / Q000737:chemistry; D024821:Metabolic Syndrome / Q000097:blood / Q000175:diagnosis*; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012016:Reference Values; D015203:Reproducibility of Results; D014481:United States
D008076:Cholesterol, HDL; D008055:Lipids; D011933:Reagent Kits, Diagnostic; D002784:Cholesterol