Analytical and Clinical Performance of an Automated Immunoassay System (Immulite®) for Estradiol in Serum
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Abstract
The analytical and clinical performance of a commercial automated immunoassay system (Immulite®) for estradiol (E2) in serum was evaluated. The functional sensitivity for E2 was 0.07 nmol/l, and analytical imprecision (<13 %, <9 % and <7 % at 0.22, 0.51 and 1.51 nmol/l, respectively) for concentrations above this detection limit met published analytical goals. The assay recovery was good and the assay was linear over a wide concentration range. No sample carryover was found, and interferences from common substances present in serum were observed only at very high concentrations. Most of samples from men and postmenopausal women showed E2 concentrations below the detection limit. Longitudinal estradiol profiles from 11 healthy menstruating women showed characteristic menstrual cycle patterns (12 samples per subject obtained during a 30-day period). Longitudinal studies on women during induction of ovulation showed that E2 concentrations are highly correlated with the total number of follicles. Our results demonstrate the reliability of this system for routine use in the clinical laboratory.
Copyright © 1999 by Walter de Gruyter GmbH & Co. KG
Articles in the same Issue
- Author Index
- Contents
- Subject Index
- Polymorphisms of Coagulation Factor Genes a Review
- Urinalysis-Challenges by New Medical Needs and Advanced Technologies
- The Automation of Sediment Urinalysis Using a New Urine Flow Cytometer (UF-100™)
- Urinary Microscopy as Seen by Nephrologists
- Measurement of Urine Relative Density Using Refractometer and Reagent Strips
- Dry Chemistry Urinalysis of Pathological Proteinuria
- Physiopathology of Proteinuria and Laboratory Diagnostic Strategy Based on Single Protein Analysis
- Microalbuminuria in Diabetes
- European Multicentre Evaluation of the Super Aution SA-4220 Urinalysis Analyser
- Optimized Detection of DNA Point Mutations by Double Gradient Denaturing Gradient Gel
- Is the Association of Serum Lipase with β2-Microglobulin or C-Reactive Protein Useful for Establishing the Diagnosis and Prognosis of Patients with Acute Pancreatitis?
- Analytical and Clinical Performance of an Automated Immunoassay System (Immulite®) for Estradiol in Serum
- Evaluation of the Activated Partial Thrombo-plastin Time (APTT) Sensitivity to Heparin Using Five Commercial Reagents: Implications for Therapeutic Monitoring
- An Alternative Analysis for Crossover Studies that Accounts for Between-Group Disparities in Drug Response
Articles in the same Issue
- Author Index
- Contents
- Subject Index
- Polymorphisms of Coagulation Factor Genes a Review
- Urinalysis-Challenges by New Medical Needs and Advanced Technologies
- The Automation of Sediment Urinalysis Using a New Urine Flow Cytometer (UF-100™)
- Urinary Microscopy as Seen by Nephrologists
- Measurement of Urine Relative Density Using Refractometer and Reagent Strips
- Dry Chemistry Urinalysis of Pathological Proteinuria
- Physiopathology of Proteinuria and Laboratory Diagnostic Strategy Based on Single Protein Analysis
- Microalbuminuria in Diabetes
- European Multicentre Evaluation of the Super Aution SA-4220 Urinalysis Analyser
- Optimized Detection of DNA Point Mutations by Double Gradient Denaturing Gradient Gel
- Is the Association of Serum Lipase with β2-Microglobulin or C-Reactive Protein Useful for Establishing the Diagnosis and Prognosis of Patients with Acute Pancreatitis?
- Analytical and Clinical Performance of an Automated Immunoassay System (Immulite®) for Estradiol in Serum
- Evaluation of the Activated Partial Thrombo-plastin Time (APTT) Sensitivity to Heparin Using Five Commercial Reagents: Implications for Therapeutic Monitoring
- An Alternative Analysis for Crossover Studies that Accounts for Between-Group Disparities in Drug Response