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View article: Two-sample fecal immunochemical testing as a tool to avert colonoscopy in symptomatic patients: a prospective multicenter cohort study
Two-sample fecal immunochemical testing as a tool to avert colonoscopy in symptomatic patients: a prospective multicenter cohort study Open
In most colonoscopies performed for bowel symptoms, no significant lesions are found. To decrease the number of unnecessary colonoscopies, we evaluated the performance of two-sample fecal immunochemical testing (FIT) in ruling out signific…
View article: Clinical Decision-Making Suffers from Inequivalent Measurement Results and Inadequate Reference Intervals
Clinical Decision-Making Suffers from Inequivalent Measurement Results and Inadequate Reference Intervals Open
Background Appropriate clinical decision-making relies on the interpretation of equivalent measurement results in the context of valid clinical decision limits. Besides guideline-based decision limits, reference intervals (RIs) are commonl…
View article: Investigating the Current Harmonization Status of Tumor Markers Using Global External Quality Assessment Programs: A Feasibility Study
Investigating the Current Harmonization Status of Tumor Markers Using Global External Quality Assessment Programs: A Feasibility Study Open
Background The harmonization status of most tumor markers (TMs) is unknown. We report a feasibility study performed to determine whether external quality assessment (EQA) programs can be used to obtain insights into the current harmonizati…
View article: When bias becomes part of imprecision: how to use analytical performance specifications to determine acceptability of lot-lot variation and other sources of possibly unacceptable bias
When bias becomes part of imprecision: how to use analytical performance specifications to determine acceptability of lot-lot variation and other sources of possibly unacceptable bias Open
ISO 15189 requires laboratories to estimate the uncertainty of their quantitative measurements and to maintain them within relevant performance specifications. Furthermore, it refers to ISO TS 20914 for instructions on how to estimate the …
View article: To rule-in, or not to falsely rule-out, that is the question: evaluation of hs-cTnT EQA performance in light of the ESC-2020 guideline
To rule-in, or not to falsely rule-out, that is the question: evaluation of hs-cTnT EQA performance in light of the ESC-2020 guideline Open
Objectives To accurately evaluate non-ST-elevated acute cardiac syndrome (NSTE-ACS), the quality of high-sensitive cardiac troponin (hs-cTn) assays is of vital importance. The 2020 revision of the NSTE-ACS guideline includes clinical decis…
View article: On the applicability of the Maxwell Garnett effective medium model to media with a high density of cylindrical pores
On the applicability of the Maxwell Garnett effective medium model to media with a high density of cylindrical pores Open
The optical properties of dielectric materials with subwavelength cylindrical pores are commonly described by effective medium models. We compare the Maxwell Garnett and the Bruggeman effective medium models for porous silicon with simulat…
View article: EFLM Working Group Accreditation and ISO/CEN standards on dealing with ISO 15189 demands for retention of documents and examination objects
EFLM Working Group Accreditation and ISO/CEN standards on dealing with ISO 15189 demands for retention of documents and examination objects Open
Many aspects of the activity of a medical laboratory have to be documented so as to facilitate the maintenance of the ongoing quality of service. As a consequence, many documents, forms and reports are generated. The retention time for eac…
View article: APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data
APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data Open
Objectives According to ISO 15189:2022, analytical performance specifications (APS) should relate to intended clinical use and impact on patient care. Therefore, we aimed to develop a web application for laboratory professionals to calcula…
View article: Albumin determined by bromocresol green leads to erroneous results in routine evaluation of patients with chronic kidney disease
Albumin determined by bromocresol green leads to erroneous results in routine evaluation of patients with chronic kidney disease Open
Objectives Measurement of plasma albumin is pivotal for clinical decision-making in patients with chronic kidney disease (CKD). Routinely used methods as bromocresol green (BCG) and bromocresol purple (BCP) can suffer from aselectivity, bu…
View article: ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European <i>In-Vitro</i>-Diagnostics Regulation
ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European <i>In-Vitro</i>-Diagnostics Regulation Open
The EU In-Vitro Diagnostic Device Regulation (IVDR) aims for transparent risk-and purpose-based validation of diagnostic devices, traceability of results to uniquely identified devices, and post-market surveillance. The IVDR regulates desi…
View article: Protocol for a randomized study assessing the feasibility of home-based albuminuria screening among the general population: The THOMAS study
Protocol for a randomized study assessing the feasibility of home-based albuminuria screening among the general population: The THOMAS study Open
Background Chronic kidney disease (CKD) is a rising public health problem that may progress to kidney failure, requiring kidney replacement therapy. It is also associated with an increased incidence of cardiovascular disease (CVD). Because…
View article: Indirect determination of biochemistry reference intervals using outpatient data
Indirect determination of biochemistry reference intervals using outpatient data Open
The aim of this study was to determine reference intervals in an outpatient population from Vall d’Hebron laboratory using an indirect approach previously described in a Dutch population (NUMBER project). We used anonymized test results fr…
View article: (In)direct chloride ISE measurements, room for improvement
(In)direct chloride ISE measurements, room for improvement Open
Contains fulltext : 251596.pdf (Publisher’s version ) (Open Access)
View article: An approach for determining allowable between reagent lot variation
An approach for determining allowable between reagent lot variation Open
Clinicians trust medical laboratories to provide reliable results on which they rely for clinical decisions. Laboratories fulfil their responsibility for accurate and consistent results by utilizing an arsenal of approaches, ranging from v…
View article: External quality assessment providers’ services appear to more impact the immunohaematology performance of laboratories than national regulatory and economic conditions
External quality assessment providers’ services appear to more impact the immunohaematology performance of laboratories than national regulatory and economic conditions Open
Objectives Medical laboratories may, at their own discretion, exceed but not undercut regulatory quality requirements. Available economic resources, however, may drive or hinder eagerness to exceed minimum requirements. Depending on the re…
View article: Harmonization status of procalcitonin measurements: what do comparison studies and EQA schemes tell us?
Harmonization status of procalcitonin measurements: what do comparison studies and EQA schemes tell us? Open
Sepsis represents a global health priority because of its high mortality and morbidity. The key to improving prognosis remains an early diagnosis to initiate appropriate antibiotic treatment. Procalcitonin (PCT) is a recognized biomarker f…
View article: The impact of measurement uncertainty on the uncertainty of ordinal medical scores based on continuous quantitative laboratory results
The impact of measurement uncertainty on the uncertainty of ordinal medical scores based on continuous quantitative laboratory results Open
Article The impact of measurement uncertainty on the uncertainty of ordinal medical scores based on continuous quantitative laboratory results was published on July 1, 2021 in the journal Clinical Chemistry and Laboratory Medicine (CCLM) (…