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A multicenter study on the precision and accuracy of homogeneous assays for LDL-cholesterol: comparison with a
Takashi Miida1, Kunihiro Nishimura, Tomonori Okamura
1Department of Clinical Laboratory Medicine, Juntendo University Graduate School of Medicine, Tokyo, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan. tmiida@juntendo.ac.jp
Insights
Homogeneous assays for low-density lipoprotein-cholesterol (LDL-C) show good agreement with beta-quantification in non-diseased individuals. However, some assays exhibit positive bias in diseased subjects with hypertriglyceridemia.
Area of Science:
- Clinical Chemistry
- Biomarker Analysis
- Diagnostic Accuracy
Background:
- Homogeneous assays for LDL-C offer precision and convenience.
- Concerns exist regarding their accuracy, particularly in diseased populations.
- Verification against gold-standard methods is crucial for clinical application.
Purpose of the Study:
- To assess the agreement between homogeneous LDL-C assays and beta-quantification.
- To evaluate assay performance in both non-diseased and diseased subjects.
- To identify potential biases in specific patient cohorts.
Main Methods:
- Simultaneous determination of LDL-C using 12 homogeneous assays and beta-quantification.
- Analysis of fresh clinical samples from 49 non-diseased and 124 diseased subjects.
- Inclusion of subjects with triglyceride levels < 11.29 mmol/L.
Main Results:
- High precision (CVs ≤ 1.8%) was observed across homogeneous assays.
- Most reagents met NCEP error requirements for non-diseased subjects.
- Some reagents showed positive bias for LDL-C in diseased subjects with hypertriglyceridemia.
Conclusions:
- Homogeneous LDL-C assays generally agree with beta-quantification in non-diseased individuals.
- Certain homogeneous assays demonstrate positive bias in diseased subjects with hypertriglyceridemia.
- Assay selection requires careful consideration for patients with elevated triglycerides.
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.
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