Ten-year evaluation of homogeneous low-density lipoprotein cholesterol methods developed by japanese manufacturers, application of the centers for disease control and prevention/cholesterol reference method laboratory network lipid standardization protocol

Masakazu Nakamura, Isao Koyama, Hiroyasu Iso, Shinichi Sato, Mitsuyo Okazaki, Yuzo Kayamori, Masahiko Kiyama, Akihiko Kitamura, Takashi Shimamoto, Yoshinori Ishikawa

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Aim: The risk index for atherosclerotic cardiovascular diseases in the Japanese metabolic syndrome-focused health checkup program was changed from total cholesterol (TC) to low-density lipoprotein cholesterol (LDL-C). We discuss the validity of this change with respect to standardization. Methods: The beta-quantification procedure of the Centers for Disease Control and Prevention (CDC) uses the LDL-C reference value as a target. Clinical laboratories and commercial manufacturers use homogeneous LDL-C methods for standardization. (A) For clinical laboratories, LDL-C in 648 samples requested from 108 hospitals was analyzed. (B) Manufacturers participated in the CDC/ Cholesterol Reference Method Laboratory Network LDL-C standardization protocol. The standardization was conducted with a performance follow-up for the 10-year period from 1998 to 2008 at 2-year intervals, 6 times. Results: (A) In clinical laboratories, acceptable LDL-C levels within ± 4% of the CDC s criteria remained 70.4%, 456 of 648 subjects. Negative maximum bias deviating from the LDL-C target value was - 35.8%, - 52.5 mg/dL, and positive maximum bias was + 24.5%, + 32.3 mg/dL. (B) For manufacturers, the standardization achievement rate of the analytical reagent/instrument/calibrator system in the last four standardizations from 2002 to 2008 remained on average 66.6%, far lower than the level required. Conclusions: The standardization achievement rate of homogeneous LDL-C methods was much lower than that of TC. TC should still be used as a risk index for atherosclerotic cardiovascular diseases. The standardization achievement rate of homogeneous LDL-C should be maintained at 100%, at least using samples with normal lipoprotein profiles. The accuracy and specificity of LDL-C should be further improved before practical and clinical use.

Original languageEnglish
Pages (from-to)1275-1281
Number of pages7
JournalJournal of atherosclerosis and thrombosis
Volume17
Issue number12
DOIs
Publication statusPublished - Jan 1 2010

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Disease control
Centers for Disease Control and Prevention (U.S.)
LDL Cholesterol
Standardization
Cholesterol
Lipids
Clinical laboratories
Cardiovascular Diseases
Lipoproteins
Reference Values
Health

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Cardiology and Cardiovascular Medicine
  • Biochemistry, medical

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Ten-year evaluation of homogeneous low-density lipoprotein cholesterol methods developed by japanese manufacturers, application of the centers for disease control and prevention/cholesterol reference method laboratory network lipid standardization protocol. / Nakamura, Masakazu; Koyama, Isao; Iso, Hiroyasu; Sato, Shinichi; Okazaki, Mitsuyo; Kayamori, Yuzo; Kiyama, Masahiko; Kitamura, Akihiko; Shimamoto, Takashi; Ishikawa, Yoshinori.

In: Journal of atherosclerosis and thrombosis, Vol. 17, No. 12, 01.01.2010, p. 1275-1281.

Research output: Contribution to journalArticle

Nakamura, Masakazu ; Koyama, Isao ; Iso, Hiroyasu ; Sato, Shinichi ; Okazaki, Mitsuyo ; Kayamori, Yuzo ; Kiyama, Masahiko ; Kitamura, Akihiko ; Shimamoto, Takashi ; Ishikawa, Yoshinori. / Ten-year evaluation of homogeneous low-density lipoprotein cholesterol methods developed by japanese manufacturers, application of the centers for disease control and prevention/cholesterol reference method laboratory network lipid standardization protocol. In: Journal of atherosclerosis and thrombosis. 2010 ; Vol. 17, No. 12. pp. 1275-1281.
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abstract = "Aim: The risk index for atherosclerotic cardiovascular diseases in the Japanese metabolic syndrome-focused health checkup program was changed from total cholesterol (TC) to low-density lipoprotein cholesterol (LDL-C). We discuss the validity of this change with respect to standardization. Methods: The beta-quantification procedure of the Centers for Disease Control and Prevention (CDC) uses the LDL-C reference value as a target. Clinical laboratories and commercial manufacturers use homogeneous LDL-C methods for standardization. (A) For clinical laboratories, LDL-C in 648 samples requested from 108 hospitals was analyzed. (B) Manufacturers participated in the CDC/ Cholesterol Reference Method Laboratory Network LDL-C standardization protocol. The standardization was conducted with a performance follow-up for the 10-year period from 1998 to 2008 at 2-year intervals, 6 times. Results: (A) In clinical laboratories, acceptable LDL-C levels within ± 4{\%} of the CDC s criteria remained 70.4{\%}, 456 of 648 subjects. Negative maximum bias deviating from the LDL-C target value was - 35.8{\%}, - 52.5 mg/dL, and positive maximum bias was + 24.5{\%}, + 32.3 mg/dL. (B) For manufacturers, the standardization achievement rate of the analytical reagent/instrument/calibrator system in the last four standardizations from 2002 to 2008 remained on average 66.6{\%}, far lower than the level required. Conclusions: The standardization achievement rate of homogeneous LDL-C methods was much lower than that of TC. TC should still be used as a risk index for atherosclerotic cardiovascular diseases. The standardization achievement rate of homogeneous LDL-C should be maintained at 100{\%}, at least using samples with normal lipoprotein profiles. The accuracy and specificity of LDL-C should be further improved before practical and clinical use.",
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AU - Koyama, Isao

AU - Iso, Hiroyasu

AU - Sato, Shinichi

AU - Okazaki, Mitsuyo

AU - Kayamori, Yuzo

AU - Kiyama, Masahiko

AU - Kitamura, Akihiko

AU - Shimamoto, Takashi

AU - Ishikawa, Yoshinori

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N2 - Aim: The risk index for atherosclerotic cardiovascular diseases in the Japanese metabolic syndrome-focused health checkup program was changed from total cholesterol (TC) to low-density lipoprotein cholesterol (LDL-C). We discuss the validity of this change with respect to standardization. Methods: The beta-quantification procedure of the Centers for Disease Control and Prevention (CDC) uses the LDL-C reference value as a target. Clinical laboratories and commercial manufacturers use homogeneous LDL-C methods for standardization. (A) For clinical laboratories, LDL-C in 648 samples requested from 108 hospitals was analyzed. (B) Manufacturers participated in the CDC/ Cholesterol Reference Method Laboratory Network LDL-C standardization protocol. The standardization was conducted with a performance follow-up for the 10-year period from 1998 to 2008 at 2-year intervals, 6 times. Results: (A) In clinical laboratories, acceptable LDL-C levels within ± 4% of the CDC s criteria remained 70.4%, 456 of 648 subjects. Negative maximum bias deviating from the LDL-C target value was - 35.8%, - 52.5 mg/dL, and positive maximum bias was + 24.5%, + 32.3 mg/dL. (B) For manufacturers, the standardization achievement rate of the analytical reagent/instrument/calibrator system in the last four standardizations from 2002 to 2008 remained on average 66.6%, far lower than the level required. Conclusions: The standardization achievement rate of homogeneous LDL-C methods was much lower than that of TC. TC should still be used as a risk index for atherosclerotic cardiovascular diseases. The standardization achievement rate of homogeneous LDL-C should be maintained at 100%, at least using samples with normal lipoprotein profiles. The accuracy and specificity of LDL-C should be further improved before practical and clinical use.

AB - Aim: The risk index for atherosclerotic cardiovascular diseases in the Japanese metabolic syndrome-focused health checkup program was changed from total cholesterol (TC) to low-density lipoprotein cholesterol (LDL-C). We discuss the validity of this change with respect to standardization. Methods: The beta-quantification procedure of the Centers for Disease Control and Prevention (CDC) uses the LDL-C reference value as a target. Clinical laboratories and commercial manufacturers use homogeneous LDL-C methods for standardization. (A) For clinical laboratories, LDL-C in 648 samples requested from 108 hospitals was analyzed. (B) Manufacturers participated in the CDC/ Cholesterol Reference Method Laboratory Network LDL-C standardization protocol. The standardization was conducted with a performance follow-up for the 10-year period from 1998 to 2008 at 2-year intervals, 6 times. Results: (A) In clinical laboratories, acceptable LDL-C levels within ± 4% of the CDC s criteria remained 70.4%, 456 of 648 subjects. Negative maximum bias deviating from the LDL-C target value was - 35.8%, - 52.5 mg/dL, and positive maximum bias was + 24.5%, + 32.3 mg/dL. (B) For manufacturers, the standardization achievement rate of the analytical reagent/instrument/calibrator system in the last four standardizations from 2002 to 2008 remained on average 66.6%, far lower than the level required. Conclusions: The standardization achievement rate of homogeneous LDL-C methods was much lower than that of TC. TC should still be used as a risk index for atherosclerotic cardiovascular diseases. The standardization achievement rate of homogeneous LDL-C should be maintained at 100%, at least using samples with normal lipoprotein profiles. The accuracy and specificity of LDL-C should be further improved before practical and clinical use.

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