Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 208-215 |
| Number of pages | 8 |
| Journal | Atherosclerosis |
| Volume | 225 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2012 Nov |
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Keywords
- Beta-quantification
- Direct LDL-C assay
- Friedewald equation
- Hypertriglyceridemia
- Lipoprotein assay
- Standardization
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
Cite this
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. / 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. 225, No. 1, 11.2012, p. 208-215.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A multicenter study on the precision and accuracy of homogeneous assays for LDL-cholesterol
T2 - Comparison with a beta-quantification method using fresh serum obtained from non-diseased 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 - 2012/11
Y1 - 2012/11
N2 - 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.
AB - 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.
KW - Beta-quantification
KW - Direct LDL-C assay
KW - Friedewald equation
KW - Hypertriglyceridemia
KW - Lipoprotein assay
KW - Standardization
UR - http://www.scopus.com/inward/record.url?scp=84867858479&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84867858479&partnerID=8YFLogxK
U2 - 10.1016/j.atherosclerosis.2012.08.022
DO - 10.1016/j.atherosclerosis.2012.08.022
M3 - Article
VL - 225
SP - 208
EP - 215
JO - Atherosclerosis
JF - Atherosclerosis
SN - 0021-9150
IS - 1
ER -