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Comparison of 2 homogeneous high-density lipoprotein cholesterol assays
M P Hoang1, S V Hirany, J Parupia
1Department of Pathology, University of Texas Southwestern Medical Center, Dallas 75235-9072, USA.
Insights
New direct homogeneous methods for measuring high-density lipoprotein cholesterol (HDL-C) offer advantages over traditional precipitation methods. The Liquid N-geneous HDL-C (LN-HDL) assay demonstrates superior accuracy, especially in hypertriglyceridemic patients, meeting clinical guidelines.
Area of Science:
- Clinical Chemistry
- Cardiovascular Disease Biomarkers
- Diagnostic Assays
Background:
- High-density lipoprotein cholesterol (HDL-C) is a key inverse risk factor for coronary artery disease.
- Traditional HDL-C measurement methods are time-consuming, affected by high triglycerides, and not fully automatable.
- Direct homogeneous HDL-C assays offer a more efficient and reliable alternative.
Purpose of the Study:
- To evaluate the performance of two direct homogeneous HDL-C assays: LN-HDL and Boehringer Mannheim HDL Cholesterol (BM-HDL).
- To compare these methods against a modified CDC reference method (MR-HDL).
- To assess assay accuracy and precision in patients with and without hypertriglyceridemia.
Main Methods:
- The study involved 126 patients with normotriglyceridemia and 50 with hypertriglyceridemia.
- Performance of LN-HDL and BM-HDL assays was evaluated against the MR-HDL reference method.
- Assays were assessed for precision, correlation, bias, and total error according to NCEP guidelines.
Main Results:
- Both LN-HDL and BM-HDL showed excellent precision and good correlation with MR-HDL in normotriglyceridemic samples.
- LN-HDL demonstrated better correlation and accuracy than BM-HDL in hypertriglyceridemic samples.
- LN-HDL met NCEP accuracy guidelines (bias < +/-5%) in both patient groups, while BM-HDL did not.
Conclusions:
- Both homogeneous HDL-C assays are precise.
- The LN-HDL assay is superior in accuracy compared to the BM-HDL assay, particularly in hypertriglyceridemic individuals.
- LN-HDL is a reliable method for accurate HDL-C measurement across different triglyceride levels.
Background:
High-density lipoprotein cholesterol (HDL-C) is an independent inverse risk factor for coronary artery disease. Current methodologies for measurement of HDL-C in most clinical laboratories involve chemical precipitation-based methods. However, these methods are time-consuming, affected by high triglycerides, are not suitable for complete automation, and require a large sample size. New direct homogeneous methods are now available that do not have these constraints.
Design:
We evaluated the performance of 2 direct homogeneous methods, Liquid N-geneous HDL-C assay (LN-HDL) and Boehringer Mannheim HDL Cholesterol assay (BM-HDL), and compared these methods against a modified Centers for Disease Control and Prevention reference method (MR-HDL) in 126 patients with normotriglyceridemia (triglycerides < 4.5 mmol/L, range 0.6-4.3 mmol/ L) and 50 patients with hypertriglyceridemia (triglycerides > or =4.5 mmol/L, range 4.5-18.8 mmol/L).
Results:
Excellent precision profiles were exhibited by both homogeneous methods. Both LN-HDL and BM-HDL correlated well with MR-HDL in normotriglyceridemia (r = 0.98, slope = 0.93 and r = 0.97, slope = 1.0, respectively). However, compared with the modified reference method, the LN-HDL correlated better than the BM-HDL in hypertriglyceridemic samples (r = 0.97, slope = 1.0 and r = 0.91, slope = 0.9, respectively). The 1998 National Cholesterol Education Program guidelines for accuracy (bias < +/-5%) were met by LN-HDL in both normotriglyceridemic and hypertriglyceridemic samples (bias = 1.3% and 3.3%, respectively); however, BM-HDL failed to meet the National Cholesterol Education Program accuracy criteria in both triglyceride subgroups (bias = 8.2% and 11.3%, respectively). In addition, the total error for LN-HDL in both normotriglyceridemia (6.6%) and hypertriglyceridemia (8.6%) was well within the National Cholesterol Education Program guidelines for total error (< or =13%); BM-HDL exhibited a higher total error than LN-HDL in normotriglyceridemia (11.9%) and failed to meet the National Cholesterol Education Program guidelines in hypertriglyceridemia (15.0%).
Conclusion:
Although both homogeneous methods are precise, the LN-HDL assay is superior in accuracy to the BM-HDL assay when compared with the modified reference method.