Importance of Validation of Immunoassays for Intact Proinsulin
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Stephen D. Luzio
Abstract
The aim of this study was to compare results obtained from two commercially available immunoassay kits for intact proinsulin. Fasting and post-prandial samples were obtained from both healthy subjects and patients with type 2 diabetes mellitus and assays were carried out according to the manufacturers' instructions. Coefficient of variation of the duplicates in both assays was acceptable with the MLT Intact Proinsulin assay giving slightly better overall precision. Regression analysis indicated a good correlation between the assays (r=0.97), however, a procedure better designed to compare analytical methods demonstrated a considerable lack of agreement for some samples. Dilution of samples in the Dako assay greatly affected the results when compared to samples assayed undiluted, whereas in the MLT assay, dilution of samples produced the expected results. Repeat comparison, assaying samples neat in the MLT assay and diluted 1:5 in the Dako assay, resulted in a considerable improvement in the agreement between the Dako and MLT assays. This study underlines the importance of the use of validation procedures which demonstrate quantitative analytical recoveries from a variety of specimens over the working range of the assay method in question.
Copyright © 2001 by Walter de Gruyter GmbH & Co. KG
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Articles in the same Issue
- The Impact of Cardiac Natriuretic Peptide Determination on the Diagnosis and Management of Heart Failure
- Models for Combining Random and Systematic Errors. Assumptions and Consequences for different Models
- Nucleosomes in Serum as a Marker for Cell Death
- Comparative Nuclear Magnetic Resonance Studies of Water Permeability of Red Blood Cells from Maternal Venous Blood and Newborn Umbilical Cord Blood
- Optimization of Single-Stranded Conformation Polymorphism (SSCP) Analysis for Screening for the Estrogen Receptor-α Gene Polymorphism P325P
- Serum Total Renin after Tubal Sterilization
- Oxidative Stress and Male IGF-1, Gonadotropin and Related Hormones in Diabetic Patients
- New PCR-Based Method for the Sp1 Site Polymorphism in the COL1A1 Gene
- Comparability of Serum and Plasma Concentrations of Haemostasis Activation Markers
- Importance of Validation of Immunoassays for Intact Proinsulin
- Plant Sterol-Enriched Margarine Lowers Plasma LDL in Hyperlipidemic Subjects with low Cholesterol Intake: Effect of Fibrate Treatment
- Menopause, Coronary Artery Disease and Antioxidants
- Arterial Tissue of Arsenic, Selenium and Iron in Blackfoot Disease Patients
- Evaluation of Aution Max AX-4280 Automated Urine Test-Strip Analyser
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