A multicenter study on the precision and accuracy of homogeneous assays for LDL-cholesterol: Comparison with a beta-quantification method using fresh serum obtained from non-diseased and diseased subjects

详细信息    查看全文

• 作者：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
• 关键词：Direct LDL-C assay ; Beta-quantification ; Friedewald equation ; Hypertriglyceridemia ; Standardization ; Lipoprotein assay
• 刊名：Atherosclerosis
• 出版年：2012
• 出版时间：November, 2012
• 年：2012
• 卷：225
• 期：1
• 页码：208-215
• 全文大小：1101 K

文摘

Background

Homogeneous assays for low-density lipoprotein-cholesterol (LDL-C) have good precision and are pretreatment-free procedures. However, their accuracies have been questioned, especially in diseased subjects. In this study, we aimed to verify whether LDL-C levels determined by homogeneous assays [LDL-C (H)] agree with those determined by a beta-quantification method [LDL-C (BQ)] in fresh clinical samples.

Methods

We determined LDL-C levels in 49 non-diseased and 124 diseased subjects whose triglyceride (TG) levels were less than 11.29?mmol/L (1000?mg/dL) using 12 homogeneous assays and a BQ method simultaneously.

Results

In total, 30.6 % of non-diseased subjects and 46.0 % of diseased subjects were in the postprandial state. The maximum inter- and intra-assay CVs were 1.8 % and 1.5 % , and 8 reagents had a CV of 1.0 % or less. The mean bias ranged from??0.5 % to 1.8 % for non-diseased subjects and from??0.7 % to 1.6 % for diseased subjects. For non-diseased subjects, all but one reagent achieved the National Cholesterol Education Program (NCEP) total error requirement in more than 90 % of samples. However, for diseased subjects, the number of reagents that met this requirement was low. With some reagents, LDL-C (H) was higher than LDL-C (BQ), especially in subjects with hypertriglyceridemia. While for other reagents, the difference between the two methods was not associated with hypertriglyceridemia except for type I (n?=?2) and type III hyperlipidemia (n?=?1). Postprandial sampling was not the main factor for discordant results.

Conclusions

LDL-C (H) agrees with LDL-C (BQ) in non-diseased subjects, but exhibits positive bias for subjects with hypertriglyceridemia in diseased subjects for some reagents.