International Organization for Standardization (ISO) 15189

Schneider, Frank; Maurer, Caroline; Friedberg, Richard

doi:10.3343/alm.2017.37.5.365

Cited by 119 publications

(80 citation statements)

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“…The main finding of this prospective, noninterventional feasibility study is that UPLC‐MS/MS is suitable for rapid measurement of cefuroxime plasma levels within the therapeutic range of 0.5‐100 mg/L in a heterogeneous cohort of ICU patients. Precision and accuracy were within acceptable limits for clinical application in conformity with ISO 15189 requirements . By using an ultrafiltration device developed for protein filtration, we could detect similar protein‐bound fractions in in vitro spiked cefuroxime plasma samples as reported by the drug manufacturer .…”

Section: Discussionmentioning

confidence: 54%

“…Analysis validation was performed according to the International Standardization Organization (ISO) 15189:2012 guideline chapter 5.5.1.3 . The clinical pharmaceutical laboratory is ISO 15189 accredited.…”

Section: Methodsmentioning

confidence: 99%

“…Total and unbound plasma concentrations of cefuroxime are presented as medians with ranges and IQR and are visually displayed as box plots. Analytical values for in vitro validation of the UPLC‐MS/MS method are expressed as means . Correlation of true in vitro stock sample concentration versus measured concentration by UPLC‐MS/MS was checked using Bland‐Altman analysis.…”

Section: Methodsmentioning

confidence: 99%

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Quantification of total and unbound cefuroxime in plasma by ultra‐performance liquid chromatography tandem mass spectrometry in a cohort of critically ill patients with hypoalbuminemia and renal failure

Raaij

Mabelis

Shudofsky

et al. 2019

Clinical Laboratory Analysis

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Background Pharmacokinetic studies of cefuroxime by ultra‐performance liquid chromatography tandem mass spectrometry (UPLC‐MS/MS) have been limited to measurements of total concentrations. Here, we developed a robust method for quantifying total and unbound cefuroxime concentrations using UPLC‐MS/MS and ultrafiltration in critically ill patients with hypoalbuminemia and renal failure. Methods Method validation included accuracy, linearity, precision, repeatability, recovery, and limit of quantification (LOQ). Feasibility of the method was performed on samples obtained from randomly selected intensive care unit (ICU) patients. Total and unbound cefuroxime concentrations were quantified using UPLC‐MS/MS. Sampling times were categorized as trough (180‐1 min prior to administration), peak (10‐30 min after administration), mid (30‐360 min after administration), and continuous (sampling during administration). Pharmacokinetic/pharmacodynamic (PK/PD) targets were unbound cefuroxime concentrations above 4 times the minimum inhibitory concentration (32 mg/L). Results Intra‐assay and inter‐assay precision was <3%. Recovery was 99.7%‐100.3%, and LOQ was 0.1 mg/L. We included 11 patients (median age 72 years (range 54‐77). Median albumin serum concentrations and eGFR were 19 g/L (range 11‐40 g/L) and 48 mL/min/1.73 m2 (range 7‐115 mL/min/1.73 m2), respectively. Median trough and mid concentrations of total cefuroxime were 22.27 mg/L (range 5.42‐54.03 mg/L) and 71.49 mg/L (range 53.87‐73.86 mg/L), and median unbound fraction was 75.42% (range 27.36%‐99.75%). Median unbound cefuroxime concentrations were 11.94 mg/L (range 3.85‐32.39 mg/L) (trough) and 55.62 mg/L (range 10.03‐62.62 mg/L) (mid). Conclusion The method is precise and accurate according to ISO 15189 and within the clinical range of cefuroxime (0.5‐100 mg/L). The method was applied in ICU patients and is suitable for TDM on unbound cefuroxime concentrations.

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Section: Discussionmentioning

confidence: 54%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Quantification of total and unbound cefuroxime in plasma by ultra‐performance liquid chromatography tandem mass spectrometry in a cohort of critically ill patients with hypoalbuminemia and renal failure

Raaij

Mabelis

Shudofsky

et al. 2019

Clinical Laboratory Analysis

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“…QA is broader in scope and addresses issues related from specimen collection to application of laboratory results. The internationally recognized standard for quality management systems is the International Organization for Standardization (ISO) 15189 . The overall success of the quality management system is determined through a process called quality assessment.…”

Section: Quality Management and The Clinical Laboratorymentioning

confidence: 99%

“…The internationally recognized standard for quality management systems is the International Organization for Standardization (ISO) 15189. 4 The overall success of the quality management system is determined through a process called quality assessment. In countries or regions for which such programs are available, external quality assessment (also called proficiency testing) pools data from a large number of clinical laboratories using identical test specimens to determine the performance of a given laboratory relative to its peers.…”

Section: Qualit Y Manag Ement and The Clinic Al L Abor Atorymentioning

confidence: 99%

Quality management and accreditation in laboratory hematology: Perspectives from India

Pai

Frater

2019

Int J Lab Hematology

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Quality management (QM), including quality assurance and quality control, was developed in clinical laboratories in North America and Western Europe, but must be implemented worldwide to ensure accurate, reproducible, and clinically useful results. India, a middle income country with a population of over 1.34 billion, has limited budget allotted to health care. As yet accreditation for clinical laboratories is not mandatory, which contributes to challenges in implementing good laboratory practice. This review provides a summary of internationally laid down QM principles and their application in a middle income country like India.

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