A Model for Setting Analytical Quality Specifications and Design of Control for Measurements on the Ordinal Scale
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Per Hyltoft Petersen
Abstract
A model for characterization of measurements on the ordinal scale is presented. It is based on transformation of the calculated fractions (fractiles) of positives from measurements on samples with known concentrations to a probit-natural log (probit-ln) scale. Such measurements could be made by other methods on ratio or difference scales but, for convenience (for example for speed or low cost), are measured on the ordinal scale by “simple” methods. The model is examined, and verified, using three examples from published data (haemoglobin, glucose, and leukocytes) and an external quality assessment survey on measurements of streptococcus. We show that it is possible to obtain reliable analytical quality specifications and to establish design of control systems for measurements on the ordinal scale. It is concluded that the presented probit-ln model for the ordinal scale is a tool which can improve and facilitate (i) characterizing methods with measurements on the ordinal scale, (ii) defining analytical quality specifications, (iii) designing external assessment as well as internal control schemes, (iv) validation of methods with measurements on the ordinal scale according to the analytical quality specifications, and further, (v) reduction of the number of samples required for method validation and the number of replicate measurements needed.
Copyright © 2000 by Walter de Gruyter GmbH & Co. KG
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- Integrons: an Antibiotic Resistance Gene Capture and Expression System
- Levels of C-Telopeptide Fragments of Collagen Type I Enable the Monitoring and Early Adjustment of Clodronate Therapy in Patients with Postmenopausal Osteoporosis
- Probable Involvement of Cathepsin D in the Degradation of β2-Microglobulin in Acidic Urine
- Autoantibodies against Oxidized Low-Density Lipoprotein Correlate with Achilles Tendon Xanthomas
- Regulation of the Hepatic Endothelin System in Advanced Biliary Fibrosis in Rats
- Determination of Plasma Methoxyamines
- Stability of Brain Natriuretic Peptide (BNP) in Human Whole Blood and Plasma
- Effect of Short- and Long-Term Storage on Human Serum and Recombinant Apolipoprotein E Concentration
- Comparison of Laboratory Parameters as Risk Factors for the Presence and the Extent of Coronary or Carotid Atherosclerosis: the Significance of Apolipoprotein B to Apolipoprotein AII Ratio
- The Effect of a Gender Difference in the Apolipoprotein E Gene DNA Polymorphism on Serum Lipid Levels in a Serbian Healthy Population
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