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Serum triglyceride measurements: the commutability of reference materials and the accuracy of results

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Published/Copyright: February 21, 2017
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 55 Issue 9

Abstract

Background

We aimed to evaluate the commutability of external quality assessment (EQA) materials, aqueous solutions, and commercial reference materials (calibrators and controls), and the accuracy of routine systems for serum triglyceride measurements.

Methods

According to the clinical and laboratory standards institute (CLSI) EP14-A3 protocol, we analyzed 43 fresh patient specimens and 32 processed materials including lyophilized samples, human serum pools, liquid reagents, swine sera and aqueous solutions by 14 routine methods (evaluated methods) and an isotope dilution liquid chromatography tandem mass spectrometry method (ID-LC/MS/MS) (comparative method). The accuracy of the routine method was evaluated by analyzing the absolute bias, relative bias, and the bias at three medical decision levels based on CLSI EP9-A3.

Results

Frozen serum samples and swine sera were commutable for all of the assays. The EQA/PT materials, commercial calibrators and control materials showed matrix effects differently on routine methods. The aqueous glycerol solutions were generally noncommutable for routine method. All except one routine analytical systems met the National Cholesterol Education Program (NCEP) recommended analytical performance guideline analytical quality criteria for total error.

Conclusions

Matrix effects and calibration biases existed in measurements of serum triglyceride. Continued efforts are needed to improve the accuracy and comparability of routine measurements.

Keywords: calibration bias; commutability; mass spectrometry; matrix effect; triglyceride
Corresponding author: Wenxiang Chen, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, PR China; and National Center for Clinical Laboratories, Beijing Hospital, National Center for Gerontology, No. 1 Dahua Road, Dongcheng District, Beijing 100730, P.R. China, Phone: +86-1058115059, Fax: +86-1065132968

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: This study was supported by research grants from the National High Technology Research and Development Program of China (863 Program) (No. 2011AA02A102 and No. 2011AA02A116) and National Natural Science Foundation of China (No. 81171665 and No. 81201337).

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

References

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Supplemental Material:

The online version of this article offers supplementary material (DOI: https://doi.org/10.1515/cclm-2016-0682).

Received: 2016-5-17
Accepted: 2016-12-27
Published Online: 2017-2-21
Published in Print: 2017-8-28

©2017 Walter de Gruyter GmbH, Berlin/Boston

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  2. Editorial
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https://doi.org/10.1515/cclm-2016-0682
Keywords for this article
calibration bias; commutability; mass spectrometry; matrix effect; triglyceride

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Mass spectrometry or immunoassay: est modus in rebus
  4. Reviews
  5. The use of liquid chromatography-tandem mass spectrometry for therapeutic drug monitoring of antibiotics in cancer patients
  6. Tackling serum folate test in European countries within the health technology assessment paradigm: request appropriateness, assays and health outcomes
  7. Genetics and Molecular Diagnostics
  8. Genetic diagnosis of α1-antitrypsin deficiency using DNA from buccal swab and serum samples
  9. General Clinical Chemistry and Laboratory Medicine
  10. Serum triglyceride measurements: the commutability of reference materials and the accuracy of results
  11. Variant peptide detection utilizing mass spectrometry: laying the foundations for proteogenomic identification and validation
  12. Evaluation of two fully automated immunoassay based tests for the measurement of 1α,25-dihydroxyvitamin D in human serum and comparison with LC-MS/MS
  13. Parallel diurnal fluctuation of testosterone, androstenedione, dehydroepiandrosterone and 17OHprogesterone as assessed in serum and saliva: validation of a novel liquid chromatography-tandem mass spectrometry method for salivary steroid profiling
  14. Determination of oxycodone and its major metabolites noroxycodone and oxymorphone by ultra-high-performance liquid chromatography tandem mass spectrometry in plasma and urine: application to real cases
  15. Identification and quantitation of phosphatidylethanols in oral fluid by liquid chromatography-tandem mass spectrometry
  16. Relationship between plasma and salivary melatonin and cortisol investigated by LC-MS/MS
  17. Paramagnetic micro-particles as a tool for rapid quantification of apixaban, dabigatran, edoxaban and rivaroxaban in human plasma by UHPLC-MS/MS
  18. Measurements of serum non-ceruloplasmin copper by a direct fluorescent method specific to Cu(II)
  19. The serum concentrations of leptin and MCP-1 independently predict low back pain duration
  20. Immunoassay screening in urine for synthetic cannabinoids – an evaluation of the diagnostic efficiency
  21. Cancer Diagnostics
  22. Study of kallikrein-related peptidase 6 (KLK6) and its complex with α1-antitrypsin in biological fluids
  23. Cardiovascular Diseases
  24. A candidate liquid chromatography mass spectrometry reference method for the quantification of the cardiac marker 1-32 B-type natriuretic peptide
  25. The natriuretic peptide MR-proANP predicts all-cause mortality and adverse outcome in community patients: a 10-year follow-up study
  26. CASZ1 loss-of-function mutation contributes to familial dilated cardiomyopathy
  27. Diabetes
  28. Evaluating new HbA1c methods for adoption by the IFCC and NGSP reference networks using international quality targets
  29. Infectious Diseases
  30. Analytical and diagnostic performance of two automated fecal calprotectin immunoassays for detection of inflammatory bowel disease
  31. Letters to the Editor
  32. Is fasting necessary for lipid profile determinations? Some considerations from the perspective of the clinical laboratory
  33. Precision of nonfasting lipid profiles should focus on clinical relevance rather than necessarily obtaining the least variation
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  35. Estimation of the reference interval for serum folate measured with assays traceable to the WHO International Standard
  36. Implausible elevation of peripheral thyroid hormones during therapy with a protein supplement
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  38. Usefulness of maternal red cell antibodies to predict hemolytic disease of the fetus and newborn and significant neonatal hyperbilirubinemia: a retrospective study
  39. Improvement of the Sandell-Kolthoff reaction method (ammonium persulfate digestion) for the determination of iodine in urine samples
  40. Clinical use of targeted high-throughput whole-genome sequencing for a dengue virus variant
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