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 journalArticlepeer-review

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 2014

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

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