A new concept to derive permissible limits for analytical imprecision and bias considering diagnostic requirements and technical state-of-the-art
-
Rainer Haeckel
and
Werner Wosniok
Abstract
Background: Permissible limits of analytical imprecision and bias are usually derived either from biological variability or from the state of the art. Both concepts require information from external sources which often lack transparency and are difficult to integrate in medical decision-making. Additionally, physicians may be interested in knowing the probability of decision errors due to analytical uncertainty. Therefore, an approach was developed which combines all three concepts.
Methods: The empirical (observed) biological variation was derived from reference ranges used by the laboratory (CVE). CVE was corrected to get the biological variation in the theoretical absence of analytical imprecision (CVC). Relatively simple equations were derived from the relationship between biological variation and the analytical imprecision (CVA) to calculate permissible imprecision and bias. Five quality classes are proposed for the various analytes reflecting the false-positive error rates (FPR). These classes characterize analytical procedures according to their theoretical specificity (FPR). Thus, the new approach combines the theoretical base of biological variation with the technical state-of-the-art.
Results and conclusions: As practical examples, the permissible imprecision and bias limits were estimated for a selection of quantities. The limits found were more realistic than present proposals based on Cotlove’s rule (fixed fraction of biological variation), but slightly more stringent than national consensus values based on the state-of-the-art. Imprecision and bias do not affect FPR equally, and, therefore, should be assessed separately. It is proposed to insert monthly imprecision and bias results calculated after each control cycle in a table with five quality classes. This table provides a simple overview of the analytical quality performance of the entire laboratory with one glance and can be handled on the Excel platform.
©2011 by Walter de Gruyter Berlin New York
Articles in the same Issue
- 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
- Non-invasive prenatal diagnosis of trisomy 21 by reverse transcriptase multiplex ligation-dependent probe amplification
- General Clinical Chemistry and Laboratory Medicine
- Evaluation of the Menarini/ARKRAY ADAMS A1c HA-8180V analyser for HbA1c
- Evaluation of two HbA1c point-of-care analyzers
- Indirect reference intervals of plasma and serum thyrotropin (TSH) concentrations from intra-laboratory data bases from several German and Italian medical centres
- 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
- A comparative evaluation of Golgi protein-73, fucosylated hemopexin, α-fetoprotein, and PIVKA-II in the serum of patients with chronic hepatitis, cirrhosis, and hepatocellular carcinoma
- Cardiovascular Diseases
- 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
- Elevated concentrations of Nɛ-homocysteinyl-lysine isopeptide in acute myocardial infarction: links with ADMA formation
- Letters to the Editor
- More on preanalytical variables affecting platelet function testing using light transmittance aggregometry
- Relationship of hepatic steatosis and alanine aminotransferase with coronary calcification
- Why do different EQA schemes have apparently different limits of acceptability?
- Prevalence of antithyroid antibodies and thyroid-stimulating hormone concentration in young people
- Evaluation of multiplex PCR using dual-priming oligonucleotide for the detection of vanA and vanB in vancomycin-resistant enterococci
- The IFCC Task Force for Young Scientists
Articles in the same Issue
- 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
- Non-invasive prenatal diagnosis of trisomy 21 by reverse transcriptase multiplex ligation-dependent probe amplification
- General Clinical Chemistry and Laboratory Medicine
- Evaluation of the Menarini/ARKRAY ADAMS A1c HA-8180V analyser for HbA1c
- Evaluation of two HbA1c point-of-care analyzers
- Indirect reference intervals of plasma and serum thyrotropin (TSH) concentrations from intra-laboratory data bases from several German and Italian medical centres
- 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
- A comparative evaluation of Golgi protein-73, fucosylated hemopexin, α-fetoprotein, and PIVKA-II in the serum of patients with chronic hepatitis, cirrhosis, and hepatocellular carcinoma
- Cardiovascular Diseases
- 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
- Elevated concentrations of Nɛ-homocysteinyl-lysine isopeptide in acute myocardial infarction: links with ADMA formation
- Letters to the Editor
- More on preanalytical variables affecting platelet function testing using light transmittance aggregometry
- Relationship of hepatic steatosis and alanine aminotransferase with coronary calcification
- Why do different EQA schemes have apparently different limits of acceptability?
- Prevalence of antithyroid antibodies and thyroid-stimulating hormone concentration in young people
- Evaluation of multiplex PCR using dual-priming oligonucleotide for the detection of vanA and vanB in vancomycin-resistant enterococci
- The IFCC Task Force for Young Scientists
