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Do new concepts for deriving permissible limits for analytical imprecision and bias have any advantages over existing consensus?
-
Per Hyltoft Petersen
,
Sverre Sandberg
Veröffentlicht/Copyright:
11. Februar 2011
Abstract
The Stockholm conference held in 1999 on “Strategies to set global analytical quality specifications (AQS) in laboratory medicine” reached a consensus and advocated the ubiquitous application of a hierarchical structure of approaches to setting AQS. This approach has been widely used over the last decade, although several issues remain unanswered. A number of new suggestions have been recently proposed for setting AQS. One of these recommendations is described by Haeckel and Wosniok in this issue of Clinical Chemistry and Laboratory Medicine. Their concept is to estimate the increase in false-positive results using conventional population-based reference intervals, the delta false-positive rate due to analytical imprecision and bias, and relate the results directly to the current analytical quality attained. Thus, the actual estimates in the laboratory for imprecision and bias are compared to the AQS. These values are classified in a ranking system according to the closeness to the AQS, and this combination is the new idea of the proposal. Other new ideas have been proposed recently. We wait, with great interest, as should others, to see if these newer approaches become widely used and worthy of incorporation into the hierarchy.
Keywords: analytical goals; analytical quality specifications; biological variation; clinical situations; hierarchy of specifications; medical opinions
Received: 2010-11-24
Accepted: 2010-11-24
Published Online: 2011-02-11
Published in Print: 2011-04-01
©2011 by Walter de Gruyter Berlin New York
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Schlagwörter für diesen Artikel
analytical goals;
analytical quality specifications;
biological variation;
clinical situations;
hierarchy of specifications;
medical opinions
Artikel in diesem Heft
- Editorial
- Nuclear and radiation accidents: the next and further challenge for laboratory diagnostics
- Reviews
- Diagnostic, prognostic and therapeutic relevance of B-type natriuretic hormone and related peptides in children with congenital heart diseases
- Miniaturization and globalization of clinical laboratory activities
- Inflammatory markers in childhood asthma
- Age-related macular degeneration: genetic and clinical findings
- Opinion Paper
- Economic evidence in decision-making process in laboratory medicine
- Point
- A new concept to derive permissible limits for analytical imprecision and bias considering diagnostic requirements and technical state-of-the-art
- Counterpoint
- Do new concepts for deriving permissible limits for analytical imprecision and bias have any advantages over existing consensus?
- Genetics and Molecular Diagnostics
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- General Clinical Chemistry and Laboratory Medicine
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- Evaluation of two HbA1c point-of-care analyzers
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- Pseudohypocalcemia caused by perchlorate (Irenat®)
- Serum cholesterol measured by isotope dilution liquid chromatography tandem mass spectrometry
- Confirmation of congenital adrenal hyperplasia by adrenal steroid profiling of filter paper dried blood samples using ultra-performance liquid chromatography-tandem mass spectrometry
- Sensitivity and specificity of the high fluorescent lymphocyte count-gate on the Sysmex XE-5000 hematology analyzer for detection of peripheral plasma cells
- Clauss assay and fibrinogen protein estimated by capillary zone electrophoresis
- High frequency of inadequate test requests for antiphospholipid antibodies in daily clinical practice
- Cancer Diagnostics
- Detection of HOXA9 gene methylation in tumor tissues and induced sputum samples from primary lung cancer patients
- MMP-9 expression in peripheral blood mononuclear cells and the association with clinicopathological features and prognosis of nasopharyngeal carcinoma
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- B-type natriuretic peptide measurement in primary care; magnitude of associations with cardiovascular risk factors and their therapies. Observations from the STOP-HF (St. Vincent’s Screening TO Prevent Heart Failure) study
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