Validation of homogeneous assays for HDL-cholesterol using fresh samples from healthy and diseased subjects

Takashi Miida, Kunihiro Nishimura, Tomonori Okamura, Satoshi Hirayama, Hirotoshi Ohmura, Hiroshi Yoshida, Yoh Miyashita, Masumi Ai, Akira Tanaka, Hiroyuki Sumino, Masami Murakami, Ikuo Inoue, Yuzo Kayamori, Masakazu Nakamura, Tsutomu Nobori, Yukihisa Miyazawa, Tamio Teramoto, Shinji Yokoyama

Research output: Contribution to journalArticle

20 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)253-259
Number of pages7
JournalAtherosclerosis
Volume233
Issue number1
DOIs
Publication statusPublished - Mar 1 2014

Fingerprint

HDL Cholesterol
Healthy Volunteers
Ultracentrifugation
Manganese
LDL Cholesterol
Heparin
Cholesterol
Education

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Miida, T., Nishimura, K., Okamura, T., Hirayama, S., Ohmura, H., Yoshida, H., ... Yokoyama, S. (2014). Validation of homogeneous assays for HDL-cholesterol using fresh samples from healthy and diseased subjects. Atherosclerosis, 233(1), 253-259. https://doi.org/10.1016/j.atherosclerosis.2013.12.033

Validation of homogeneous assays for HDL-cholesterol using fresh samples from healthy and diseased subjects. / Miida, Takashi; Nishimura, Kunihiro; Okamura, Tomonori; Hirayama, Satoshi; Ohmura, Hirotoshi; Yoshida, Hiroshi; Miyashita, Yoh; Ai, Masumi; Tanaka, Akira; Sumino, Hiroyuki; Murakami, Masami; Inoue, Ikuo; Kayamori, Yuzo; Nakamura, Masakazu; Nobori, Tsutomu; Miyazawa, Yukihisa; Teramoto, Tamio; Yokoyama, Shinji.

In: Atherosclerosis, Vol. 233, No. 1, 01.03.2014, p. 253-259.

Research output: Contribution to journalArticle

Miida, T, Nishimura, K, Okamura, T, Hirayama, S, Ohmura, H, Yoshida, H, Miyashita, Y, Ai, M, Tanaka, A, Sumino, H, Murakami, M, Inoue, I, Kayamori, Y, Nakamura, M, Nobori, T, Miyazawa, Y, Teramoto, T & Yokoyama, S 2014, 'Validation of homogeneous assays for HDL-cholesterol using fresh samples from healthy and diseased subjects', Atherosclerosis, vol. 233, no. 1, pp. 253-259. https://doi.org/10.1016/j.atherosclerosis.2013.12.033
Miida, Takashi ; Nishimura, Kunihiro ; Okamura, Tomonori ; Hirayama, Satoshi ; Ohmura, Hirotoshi ; Yoshida, Hiroshi ; Miyashita, Yoh ; Ai, Masumi ; Tanaka, Akira ; Sumino, Hiroyuki ; Murakami, Masami ; Inoue, Ikuo ; Kayamori, Yuzo ; Nakamura, Masakazu ; Nobori, Tsutomu ; Miyazawa, Yukihisa ; Teramoto, Tamio ; Yokoyama, Shinji. / Validation of homogeneous assays for HDL-cholesterol using fresh samples from healthy and diseased subjects. In: Atherosclerosis. 2014 ; Vol. 233, No. 1. pp. 253-259.
@article{36898277925e4140b45ec20c37616491,
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.",
author = "Takashi Miida and Kunihiro Nishimura and Tomonori Okamura and Satoshi Hirayama and Hirotoshi Ohmura and Hiroshi Yoshida and Yoh Miyashita and Masumi Ai and Akira Tanaka and Hiroyuki Sumino and Masami Murakami and Ikuo Inoue and Yuzo Kayamori and Masakazu Nakamura and Tsutomu Nobori and Yukihisa Miyazawa and Tamio Teramoto and Shinji Yokoyama",
year = "2014",
month = "3",
day = "1",
doi = "10.1016/j.atherosclerosis.2013.12.033",
language = "English",
volume = "233",
pages = "253--259",
journal = "Atherosclerosis",
issn = "0021-9150",
publisher = "Elsevier Ireland Ltd",
number = "1",

}

TY - JOUR

T1 - Validation of homogeneous assays for HDL-cholesterol using fresh samples from healthy and diseased subjects

AU - Miida, Takashi

AU - Nishimura, Kunihiro

AU - Okamura, Tomonori

AU - Hirayama, Satoshi

AU - Ohmura, Hirotoshi

AU - Yoshida, Hiroshi

AU - Miyashita, Yoh

AU - Ai, Masumi

AU - Tanaka, Akira

AU - Sumino, Hiroyuki

AU - Murakami, Masami

AU - Inoue, Ikuo

AU - Kayamori, Yuzo

AU - Nakamura, Masakazu

AU - Nobori, Tsutomu

AU - Miyazawa, Yukihisa

AU - Teramoto, Tamio

AU - Yokoyama, Shinji

PY - 2014/3/1

Y1 - 2014/3/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84893866474&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84893866474&partnerID=8YFLogxK

U2 - 10.1016/j.atherosclerosis.2013.12.033

DO - 10.1016/j.atherosclerosis.2013.12.033

M3 - Article

VL - 233

SP - 253

EP - 259

JO - Atherosclerosis

JF - Atherosclerosis

SN - 0021-9150

IS - 1

ER -