title: Validation of homogeneous assays for HDL-cholesterol using fresh samples from healthy and diseased subjects.
abstract: BACKGROUND
  High-density lipoprotein-cholesterol (HDL-C) is a negative risk factor for cardiovascular events. Although several homogeneous HDL-C assays are available, their accuracy has not been validated, particularly in subjects with disease. We aimed to clarify whether HDL-C concentrations measured by homogeneous assays [HDL-C (H)] agree with those determined by the reference measurement procedures [HDL-C (RMP)] using ultracentrifugation and precipitation with heparin-manganese reagent in fresh clinical samples.
  
  
  METHODS
  HDL-C concentrations in samples from 48 healthy subjects and 119 subjects with disease were determined using 12 homogeneous assays and RMPs.
  
  
  RESULTS
  All reagents showed excellent intra- and inter-assay CVs (<2.23%) for two pooled sera. Furthermore, the mean bias was within ± 1.0% in nine reagents using samples from healthy subjects and in eight reagents using samples from subjects with disease. In a single HDL-C (H) determination, the total error requirement of the National Cholesterol Education Program (95% of results < 13%) was fulfilled in nine reagents using samples from healthy subjects and six reagents in those from subjects with disease. Error component analysis revealed that only one reagent exceeded ± 10% total error in samples from healthy subjects, whereas four reagents exceeded this error in samples from subjects with disease. Correlations between HDL-C (H) and HDL-C (RMP) revealed that the slopes were within 1.00 ± 0.06 in six reagents in healthy subjects, and eight reagents in subjects with disease.
  
  
  CONCLUSIONS
  Except for three reagents, HDL-C (H) agrees well with HDL-C (RMP) in subjects with common disease, but not in those with extremely low HDL-C or abnormal HDL composition.
authors: Department of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan. Electronic address: tmiida@juntendo.ac.jp.
authors: Takashi
authors: T
authors: Miida
authors: National Cerebral and Cardiovascular Center, 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan.
authors: Kunihiro
authors: K
authors: Nishimura
authors: Department of Preventive Medicine and Public Health, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
authors: Tomonori
authors: T
authors: Okamura
authors: Department of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan.
authors: Satoshi
authors: S
authors: Hirayama
authors: Department of Cardiology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan.
authors: Hirotoshi
authors: H
authors: Ohmura
authors: Department of Laboratory Medicine, Jikei University Kashiwa Hospital, 163-1 Kashiwashita, Kashiwa, Chiba 277-8567, Japan.
authors: Hiroshi
authors: H
authors: Yoshida
authors: Center of Diabetes, Endocrine and Metabolism, Toho University Sakura Hospital Medical Center, 564-1 Shimoshizu, Sakura, Chiba 285-0841, Japan.
authors: Yoh
authors: Y
authors: Miyashita
authors: Department of Insured Medical Care Management, Tokyo Medical and Dental University Hospital, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan.
authors: Masumi
authors: M
authors: Ai
authors: Laboratory of Clinical Nutrition and Medicine, Kagawa Nutrition University, 3-9-21 Chiyoda, Sakado, Saitama 350-0288, Japan.
authors: Akira
authors: A
authors: Tanaka
authors: Department of Clinical Laboratory Medicine, Gunma University Graduate School of Medicine, 3-39-22 Showa, Maebashi, Gunma 371-8511, Japan.
authors: Hiroyuki
authors: H
authors: Sumino
authors: Department of Clinical Laboratory Medicine, Gunma University Graduate School of Medicine, 3-39-22 Showa, Maebashi, Gunma 371-8511, Japan.
authors: Masami
authors: M
authors: Murakami
authors: Department of Endcrinology and Diabetics, Saitama Medical University, 38 Morohongo Moroyama-machi, Iruma-gun, Saitama 350-0495, Japan.
authors: Ikuo
authors: I
authors: Inoue
authors: Department of Health Sciences, Faculty of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan.
authors: Yuzo
authors: Y
authors: Kayamori
authors: National Cerebral and Cardiovascular Center, 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan.
authors: Masakazu
authors: M
authors: Nakamura
authors: Department of Molecular and Laboratory Medicine, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie 514-8507 Japan.
authors: Tsutomu
authors: T
authors: Nobori
authors: Department of Laboratory Science, Faculty of Medical Technology, Teikyo University, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan.
authors: Yukihisa
authors: Y
authors: Miyazawa
authors: Department of Internal Medicine, Teikyo University, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan.
authors: Tamio
authors: T
authors: Teramoto
authors: Nutritional Health Science Research Center and Department of Food and Nutritional Sciences, Chubu University, 1200 Matsumoto-cho, Kasugai, Aichi 487-8501, Japan.
authors: Shinji
authors: S
authors: Yokoyama
mesh_terms: D015982:Bias; D001774:Blood Chemical Analysis / Q000592:standards; D008076:Cholesterol, HDL / Q000097:blood*; D004194:Disease; D006801:Humans; D007202:Indicators and Reagents / Q000592:standards*; D015203:Reproducibility of Results; D014461:Ultracentrifugation
chemical_list: D008076:Cholesterol, HDL; D007202:Indicators and Reagents
keywords: Designated comparison method; Direct HDL-C assay; Standardization