Comparison of the Japan Society of Clinical Chemistry reference method and CDC method for HDL and LDL cholesterol measurements using fresh sera

Yuzo Kayamori; Masakazu Nakamura; Koji Kishi; Takashi Miida; Kunihiro Nishimura; Tomonori Okamura; Satoshi Hirayama; Hirotoshi Ohmura; Hiroshi Yoshida; Masumi Ai; Akira Tanaka; Hiroyuki Sumino; Masami Murakami; Ikuo Inoue; Tamio Teramoto; Shinji Yokoyama

doi:10.1016/j.plabm.2021.e00228

Comparison of the Japan Society of Clinical Chemistry reference method and CDC method for HDL and LDL cholesterol measurements using fresh sera

Pract Lab Med. 2021 Apr 23:25:e00228. doi: 10.1016/j.plabm.2021.e00228. eCollection 2021 May.

Authors

Yuzo Kayamori¹, Masakazu Nakamura², Koji Kishi³, Takashi Miida⁴, Kunihiro Nishimura⁵, Tomonori Okamura⁶, Satoshi Hirayama⁴, Hirotoshi Ohmura⁷, Hiroshi Yoshida⁸, Masumi Ai⁹, Akira Tanaka¹⁰, Hiroyuki Sumino¹¹, Masami Murakami¹¹, Ikuo Inoue¹², Tamio Teramoto¹³, Shinji Yokoyama¹⁴

Affiliations

¹ Department of Health Sciences, Faculty of Medical Sciences, Kyushu University, 3-1-1, Maidashi, Higashi-ku, Fukuoka City, Fukuoka, 812-8582, Japan.
² Department of Preventive Cardiology, Lipid Reference Laboratory, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka, 564-8565, Japan (retired in 2018).
³ Bio-Reagent Material Development, Bio-Diagnostic Reagent Technology Center, Sysmex Corporation, 1-1-2, Murotani, Nishi-ku, Kobe, 651-2241, Japan.
⁴ Department of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.
⁵ Department of Preventive Medicine and Epidemiologic Informatics, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka, 564-8565, Japan.
⁶ Department of Preventive Medicine and Public Health, Keio University Graduate School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
⁷ Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.
⁸ Department of Laboratory Medicine, The Jikei University Kashiwa Hospital, 161-1 Kashiwashita, Kashiwa City, Ciba, 277-8567, Japan.
⁹ Tokyo Medical and Dental University, Medical Hospital, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan.
¹⁰ Nutrition Clinic, Kagawa Nutrition University, 3-9-21 Chiyoda, Sakado City, Saitama, 350-0288, Japan.
¹¹ Department of Clinical Laboratory Medicine, Gunma University Graduate School of Medicine, 3-39-22 Showa-machi, Maebashi, Gunma, 371-8511, Japan.
¹² Department of Endocrinology and Diabetes, Saitama Medical University, 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan.
¹³ Teikyo Academic Research Center, Teikyo University, 2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605, Japan.
¹⁴ Department of Food and Nutritional Sciences, Practice Center for Registered Dietitian, Chubu University, 1200 Matsumoto-cho, Kasugai, Aichi, 487-8501, Japan.

Abstract

Objectives: In 2009, the Japan Society of Clinical Chemistry (JSCC) recommended a reference method for the measurement of serum high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) levels. This automated method uses cholesterol esterase-cholesterol dehydrogenase to measure cholesterol levels in fractions obtained after ultracentrifugation and dextran sulfate/magnesium chloride precipitation. In the present study, using fresh samples, we compared the LDL-C and HDL-C levels measured using this method with those measured using the traditional Centers for Disease Control and Prevention (CDC)-beta-quantification (BQ) method.

Design: and methods: Using both the JSCC and CDC-BQ methods, LDL-C/HDL-C levels were measured in 47 non-diseased and 126 diseased subjects, whose triglyceride levels were lower than 11.29 mmol/L (1000 mg/dL).

Results: For LDL-C, the equation of the line representing the correlation between the two methods was y = 0.991x + 0.009 mmol/L; r = 0.999; and Sy/x = 0.025 mmol/L, where x is the mean LDL-C level measured using the CDC-BQ method. Similarly, for HDL-C, the equation of the line representing the correlation between the two methods was y = 0.988x + 0.041 mmol/L, r = 0.999, and Sy/x = 0.019 mmol/L, where x is the mean HDL-C level measured using the CDC-BQ method.

Conclusions: The JSCC method agreed with the CDC-BQ method in cases of both non-diseased and diseased subjects, including those with dyslipidemia.

Keywords: AK, Abell-Kendall; BFr-C, bottom fraction-cholesterol; BQ, beta-quantification; Beta-quantification; CD, cholesterol dehydrogenase; CDC, Centers for Disease Control and Prevention; CHE, cholesterol esterase; Cholesterol dehydrogenase; DM, n-dodecyl-β-maltopyranoside; EDDA, ethylenediamine-N,N′-diacetic acid; EDTA·2Na, ethylenediamine-N,N′,N′,N′-tetraacetic acid, disodium salt, dihydrate; HDL-C, high-density lipoprotein-cholesterol; HDL-cholesterol; HEPES, 2-[4-(2-hydroxyethyl)-1-piperazinyl] ethanesulfonic acid; Homogeneous assay; LB, Liebermann-Burchard; LDL-C, low-density lipoprotein-cholesterol; LDL-cholesterol; NIST, National Institute of Standards and Technology; Reference method; SRM, Standard Reference Material; Syx, standard deviation of the regression line; TC, total cholesterol; TG, triglycerides; apo, apolipoprotein.