title: A new liquid homogeneous assay for HDL cholesterol determination evaluated in seven laboratories in Europe and the United States.
abstract: 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.
authors.affiliation: University Hospital Freiburg, Department of Clinical Chemistry, Germany. manauck@med1.ukl.uni-freiburg.de
authors.forename: M
authors.initials: M
authors.lastname: Nauck
authors.forename: M S
authors.initials: MS
authors.lastname: Graziani
authors.forename: J
authors.initials: J
authors.lastname: Jarausch
authors.forename: D
authors.initials: D
authors.lastname: Bruton
authors.forename: C
authors.initials: C
authors.lastname: Cobbaert
authors.forename: T G
authors.initials: TG
authors.lastname: Cole
authors.forename: F
authors.initials: F
authors.lastname: Colella
authors.forename: F
authors.initials: F
authors.lastname: Lefevre
authors.forename: P
authors.initials: P
authors.lastname: Gillery
authors.forename: B
authors.initials: B
authors.lastname: Haas
authors.forename: T
authors.initials: T
authors.lastname: Law
authors.forename: M
authors.initials: M
authors.lastname: König
authors.forename: M
authors.initials: M
authors.lastname: Macke
authors.forename: W
authors.initials: W
authors.lastname: März
authors.forename: C
authors.initials: C
authors.lastname: Meier
authors.forename: W
authors.initials: W
authors.lastname: Riesen
authors.forename: M
authors.initials: M
authors.lastname: van Vliet
authors.forename: H
authors.initials: H
authors.lastname: Wieland
authors.forename: N
authors.initials: N
authors.lastname: Rifai
mesh_terms: 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
chemical_list: D008076:Cholesterol, HDL