A new liquid homogeneous assay for HDL cholesterol determination evaluated in seven laboratories in Europe and the United States.
We evaluated a new liquid homogeneous assay for the direct measurement of high density lipoprotein cholesterol (HDL-C Plus) in seven laboratories. The assay includes two reagents which can be readily used in most available clinical chemistry analyzers. The total CVs of the new method were below 4.6% and the bias in relation to the designated comparison method was below 3.9%. The total error ranged between 4 to 7%. HDL-C values determined by this method were in good agreement with those obtained by the old homogeneous assay using lyophilized reagents, and other homogeneous and precipitation assays (0.944 < r < 0.996). The assay was linear up to at least 3.89 mmol/l HDL-C. Hemoglobin did not interfere, whereas in icteric samples slight deviations were observed. Lipemia up to 11.3 to 22.6 mmol/l triglycerides did not interfere with this homogeneous HDL-C assay. In samples of patients with paraproteinemia, discrepant results were seen. This liquid homogeneous HDL-C assay was easy to handle and produced similar results in all laboratories participating in this study. This method will enable clinical laboratories to reliably measure HDL-C for risk assessment of coronary heart disease.
Nauck
M
M
University Hospital Freiburg, Department of Clinical Chemistry, Germany. manauck@med1.ukl.uni-freiburg.de
Graziani
M S
MS
Jarausch
J
J
Bruton
D
D
Cobbaert
C
C
Cole
T G
TG
Colella
F
F
Lefevre
F
F
Gillery
P
P
Haas
B
B
Law
T
T
König
M
M
Macke
M
M
März
W
W
Meier
C
C
Riesen
W
W
van Vliet
M
M
Wieland
H
H
Rifai
N
N
D016477:Artifacts; D008076:Cholesterol, HDL / Q000097:blood*; D019963:Clinical Chemistry Tests / Q000379:methods* / Q000592:standards; D005060:Europe; D006801:Humans; D007753:Laboratories; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014481:United States
D008076:Cholesterol, HDL