Measurement uncertainty and metrological traceability of whole blood cyclosporin A mass concentration results obtained by UHPLC-MS/MS
-
Raül Rigo-Bonnin
,
Pedro Alía
Abstract
Background:
Traceable and accurate results of cyclosporine A (CsA) mass concentrations in whole blood are required to ensure the monitoring of immunosuppressive therapy in transplant recipients. Metrological traceability and measurement uncertainty can allow ensuring reliability and comparability of these results over time and space. In this study, we provide a practical and detailed example of how the traceability and uncertainty of mass concentration of CsA results, obtained using an ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) procedure, can be described and estimated.
Methods:
Traceability was described mainly according to ISO 17511 and information obtained from certificates facilitated with the manufacturer’s calibrators. Uncertainty estimation was performed using the bottom-up and top-down approaches. For the bottom-up approach, the most relevant sources of uncertainty were identified and later used to estimate the standard, combined and expanded uncertainties. For the top-down approach, expanded uncertainty was estimated directly using intralab quality control data mainly.
Results:
Mass concentration of CsA results was traceable to the manufacturer’s product calibrators used to calibrate the UHPLC-MS/MS procedure. The expanded uncertainties estimated by the bottom-up and top-down approaches were 7.4% and 7.2%, respectively.
Conclusions:
After performing the bottom-up and top-down approaches, we observed that their results were quite similar. This fact would confirm that the top-down approach could be sufficient for estimating uncertainty of CsA mass concentrations in whole blood results in clinical laboratories. Finally, we hope that this study can help and motivate clinical laboratories to describe metrological traceability and to perform measurement uncertainty studies based on the simpler top-down approach.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
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.
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©2018 Walter de Gruyter GmbH, Berlin/Boston
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Articles in the same Issue
- Frontmatter
- Editorials
- Clinical Chemistry and Laboratory Medicine continues to shine brightly in the constellation of laboratory medicine
- The Theranos saga and the consequences
- Innovative approaches in diabetes diagnosis and monitoring: less invasive, less expensive… but less, equally or more efficient?
- Reviews
- Exploring the microbiota to better understand gastrointestinal cancers physiology
- Linking type 2 diabetes and gynecological cancer: an introductory overview
- Mini Reviews
- MicroRNAs as predictive biomarkers of response to tyrosine kinase inhibitor therapy in metastatic renal cell carcinoma
- Salivary biomarkers and cardiovascular disease: a systematic review
- Opinion Paper
- The meteoric rise and dramatic fall of Theranos: lessons learned for the diagnostic industry
- General Clinical Chemistry and Laboratory Medicine
- Uncertainty evaluation in clinical chemistry, immunoassay, hematology and coagulation analytes using only external quality assessment data
- Measurement uncertainty and metrological traceability of whole blood cyclosporin A mass concentration results obtained by UHPLC-MS/MS
- Computer-assisted interventions in the clinical laboratory process improve the diagnosis and treatment of severe vitamin B12 deficiency
- Trueness, precision and stability of the LIAISON 1-84 parathyroid hormone (PTH) third-generation assay: comparison to existing intact PTH assays
- Fibroblast growth factor 23 and renal function among young and healthy individuals
- Optimizing charge state distribution is a prerequisite for accurate protein biomarker quantification with LC-MS/MS, as illustrated by hepcidin measurement
- Quantification of human complement C2 protein using an automated turbidimetric immunoassay
- EE score: an index for simple differentiation of homozygous hemoglobin E and hemoglobin E-β0-thalassemia
- Reference Values and Biological Variations
- Algorithm on age partitioning for estimation of reference intervals using clinical laboratory database exemplified with plasma creatinine
- A simple transformation independent method for outlier definition
- Cancer Diagnostics
- Quantification of vanillylmandelic acid, homovanillic acid and 5-hydroxyindoleacetic acid in urine using a dilute-and-shoot and ultra-high pressure liquid chromatography tandem mass spectrometry method
- Cardiovascular Diseases
- Sialylated isoforms of apolipoprotein C-III and plasma lipids in subjects with coronary artery disease
- Diabetes
- Analysis of protein glycation in human fingernail clippings with near-infrared (NIR) spectroscopy as an alternative technique for the diagnosis of diabetes mellitus
- Letter to the Editor
- Preanalytical errors before and after implementation of an automatic blood tube labeling system in two outpatient phlebotomy centers
- Hemolysis interference studies: freeze method should be used in the preparation of hemolyzed samples
- The curious case of postprandial glucose less than fasting glucose: little things that matter much
- Finding best practice in internal quality control procedures using external quality assurance performance
- Evaluation of the analytical performance of a new ADVIA immunoassay using the Centaur XPT platform system for the measurement of cardiac troponin I
- Reference ranges of the Sebia free light chain ratio in patients with chronic kidney disease
- Antigen excess detection by automated assays for free light chains
- Multiple myeloma and macro creatine kinase type 1: the first case report
- Comparison of five cell-free DNA isolation methods to detect the EGFR T790M mutation in plasma samples of patients with lung cancer
- Can we use a point-of-care blood gas analyzer to measure the lactate concentration in cerebrospinal fluid of patients with suspected meningitis?
- Unstable haemoglobin variant Hb Leiden is detected on Sysmex XN-Series analysers
- Congress Abstracts
- 59th National Congress of the Hungarian Society of Laboratory Medicine
