Clinical impact of direct HDLc and LDLc method bias in hypertriglyceridemia. A simulation study of the EAS-EFLM Collaborative Project Group

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• 作者：Michel R. Langlois ; Olivier S. Descamps ; Arnoud van der Laarse ; Cas Weykamp ; Hannsj枚rg Baum ; Kari Pulkki ; Arnold von Eckardstein ; Dirk De Bacquer ; Jan Bor茅n ; Olov Wiklund ; Pa茂vi Laitinen ; Wytze P. Oosterhuis ; Christa Cobbaert ; for the EAS-EFLM Collaborative Project
• 关键词：HDL-cholesterol ; LDL-cholesterol ; Hypertriglyceridemia ; SCORE ; Risk classification ; Treatment goals
• 刊名：Atherosclerosis
• 出版年：March, 2014
• 年：2014
• 卷：233
• 期：1
• 页码：83-90
• 全文大小：417 K

文摘

Background

Despite international standardization programs for LDLc and HDLc measurements, results vary significantly with methods from different manufacturers. We aimed to simulate the impact of analytical error and hypertriglyceridemia on HDLc- and LDLc-based cardiovascular risk classification.

Methods

From the Dutch National EQA-2012 external quality assessment of 200 clinical laboratories, we examined data from normotriglyceridemic (鈭?聽mmol/l) and hypertriglyceridemic (鈭?聽mmol/l) serum pools with lipid target values assigned by the Lipid Reference Laboratory in Rotterdam. HDLc and LDLc were measured using direct methods of Abbott, Beckman, Siemens, Roche, Olympus, or Ortho Clinical Diagnostics. We simulated risk reclassification using HDL- and sex-specific SCORE multipliers considering two fictitious moderate-risk patients with initial SCORE 4% (man) and 3% (woman). Classification into high-risk treatment groups (LDLc >2.50聽mmol/l) was compared between calculated LDLc and direct LDLc methods.

Results

Overall HDLc measurements in hypertriglyceridemic serum showed negative mean bias of聽鈭?5%. HDL-multipliers falsely reclassified 70% of women and 43% of men to a high-risk (SCORE >5%) in hypertriglyceridemic serum (P聽<聽0.0001 vs. normotriglyceridemic serum) with method-dependent risk reclassifications. Direct LDLc in hypertriglyceridemic serum showed positive mean bias with Abbott (+16%) and Beckman (+14%) and negative mean bias with Roche (鈭?%). In hypertriglyceridemic serum, 57% of direct LDLc measurements were above high-risk treatment goal (2.50聽mmol/l) vs. 29% of direct LDLc (33% of calculated LDLc) in normotriglyceridemic sera.

Conclusion

LDLc and HDLc measurements are unreliable in severe hypertriglyceridemia, and should be applied with caution in SCORE risk classification and therapeutic strategies.