Measurement uncertainty of β-lactam antibiotics results: estimation and clinical impact on therapeutic drug monitoring
-
Raúl Rigo-Bonnin
,
Francesca Canalias
Abstract
Background
Despite that measurement uncertainty data should facilitate an appropriate interpretation of measured values, there are actually few reported by clinical laboratories. We aimed to estimate the measurement uncertainty of some β-lactam antibiotics (β-LA), and to evaluate the impact of reporting the measurement uncertainty on clinicians’ decisions while guiding antibiotic therapy.
Methods
Measurement uncertainty of β-LA (aztreonam [ATM], cefepime [FEP], ceftazidime [CAZ], and piperacillin [PIP]) values, obtained by an UHPLC-MS/MS based-method, was estimated using the top-down approach called the single laboratory validation approach (EUROLAB guidelines). Main uncertainty sources considered were related to calibrators’ assigned values, the intermediate precision, and the bias. As part of an institutional program, patients with osteoarticular infections are treated with β-LA in continuous infusion and monitored to assure values at least 4 times over the minimal inhibitory concentration (4×MIC). We retrospectively evaluated the impact of two scenarios of laboratory reports on clinicians’ expected decisions while monitoring the treatment: reports containing only the β-LA values, or including the β-LA coverage intervals (β-LA values and their expanded measurement uncertainties).
Results
The relative expanded uncertainties for ATM, FEP, CAZ and PIP were lower than 26.7%, 26.4%, 28.8%, and 25.5%, respectively. Reporting the measurement uncertainty, we identified that clinicians may modify their decision especially in cases where 4×MIC values were within the β-LA coverage intervals.
Conclusions
This study provides a simple method to estimate the measurement uncertainty of β-LA values that can be easily applied in clinical laboratories. Further studies should confirm the potential impact of reporting measurement uncertainty on clinicians’ decision-making while guiding antibiotic therapy.
Author contribution: 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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©2019 Walter de Gruyter GmbH, Berlin/Boston
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Articles in the same Issue
- Frontmatter
- Editorial
- Towards a personalized assessment of vitamin D status
- Reviews
- Circulating tumor DNA and their added value in molecular oncology
- Telomere length determinants in childhood
- Opinion Papers
- Serum or plasma? An old question looking for new answers
- Evaluating sample stability in the clinical laboratory with the help of linear and non-linear regression analysis
- General Clinical Chemistry and Laboratory Medicine
- Simultaneous measurement of 25(OH)-vitamin D and 24,25(OH)2-vitamin D to define cut-offs for CYP24A1 mutation and vitamin D deficiency in a population of 1200 young subjects
- How well do Croatian laboratories adhere to national recommendations for laboratory diagnostics of chronic kidney disease (CKD)?
- Underfilling of vacuum blood collection tubes leads to increased lactate dehydrogenase activity in serum and heparin plasma samples
- Calcium state estimation by total calcium: the evidence to end the never-ending story
- The use of faecal immunochemical testing in the decision-making process for the endoscopic investigation of iron deficiency anaemia
- Measurement uncertainty of β-lactam antibiotics results: estimation and clinical impact on therapeutic drug monitoring
- Practical approach to method verification in plasma and validation in cerebrospinal fluid under accreditation using a flexible scope in molecular virology: setting up the HIV, HBV and HCV Aptima™ Quant Dx assays
- Plasma neurofilament light chain is associated with mortality after spontaneous intracerebral hemorrhage
- Comparison of the diagnostic performance of two automated urine sediment analyzers with manual phase-contrast microscopy
- Development and validation of LC-MS/MS methods to measure tobramycin and lincomycin in plasma, microdialysis fluid and urine: application to a pilot pharmacokinetic research study
- Reference Values and Biological Variations
- Cord blood S100B: reference ranges and interest for early identification of newborns with brain injury
- Hematology and Coagulation
- Validation and standardization of the ETP-based activated protein C resistance test for the clinical investigation of steroid contraceptives in women: an unmet clinical and regulatory need
- Cancer Diagnostics
- Next-generation sequencing for tumor mutation quantification using liquid biopsies
- Cardiovascular Diseases
- Evolution of the slopes of ST2 and galectin-3 during marathon and ultratrail running compared to a control group
- Letters to the Editor
- Biological variation of two serum markers for preeclampsia prediction
- Daily monitoring of a control material with a concentration near the limit of detection improves the measurement accuracy of highly sensitive troponin assays
- Are patients adequately informed about procedures for 24-h urine collection?
- Interferences in free thyroxine concentration using the Roche analytical platform: improvement of the third generation?
- Procedures for the diagnosis of macro-follicle stimulating hormone (FSH) in a patient with high serum FSH concentrations
- False-positive result of immunochromatographic (IC) strip test for the diagnosis of α-thalassemia in samples with autoantibodies
- Sample dilution for soluble interleukin-2 receptor α measurement: comparison of two different matrices
- The growing problem of predatory publishing: a case report
- Cerebrospinal fluid lactate levels according to the site of puncture
