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Published on: September 10, 2017
[Evaluation of the analytical performance of the ImmunoCap 250 (Sweden Diagnostics)]
E Cavalier1, A Carlisi, J-P Chapelle
1Service de chimie médicale, CHU de Liège, Belgique. etienne.cavalier@chu.ulg.ac.be
Insights
The new ImmunoCap 250 automated system demonstrates excellent analytical performance for determining specific and total immunoglobulin E (IgE) levels. It shows high precision, sensitivity, and linearity, correlating well with the Unicap 100 system.
Area of Science:
- Clinical chemistry
- Immunology
- Diagnostic assay development
Background:
- Accurate measurement of specific and total immunoglobulin E (IgE) is crucial for diagnosing allergic diseases.
- Existing automated systems require continuous evaluation for analytical performance and clinical utility.
Purpose of the Study:
- To evaluate the analytical performance of the new ImmunoCap 250 automated system for IgE determination.
- To compare the ImmunoCap 250 results with those obtained from the established Unicap 100 system.
Main Methods:
- Analytical performance assessment including intra- and inter-assay precision, linearity, recovery, and sensitivity.
- Comparison of results using 149 samples positive for 12 allergens and 30 samples with varying total IgE concentrations.
- Correlation analysis between ImmunoCap 250 and Unicap 100.
Main Results:
- Intra- and inter-assay precision were below 10% for most specific and total IgE assays, meeting NCCLS guidelines.
- High sensitivity was observed: 0.01 kU(A)/L for specific IgE and 0.35 kU/L for total IgE.
- Excellent correlation coefficients (0.9866 for specific IgE, 0.9984 for total IgE) were found between ImmunoCap 250 and Unicap 100.
Conclusions:
- The ImmunoCap 250 system exhibits robust analytical performance, making it a reliable solution for IgE quantification.
- Its high accuracy and strong correlation with the Unicap 100 system support its suitability for high-throughput laboratories.
- The ImmunoCap 250 is a viable alternative for laboratories performing 20,000–30,000 IgE determinations annually.
Abstract:
A new automate, ImmunoCap 250 has recently been released by Sweden Diagnostics for the determination of specific and total IgE. We have evaluated its analytical performances (intra- and inter-assay precision, linearity, recovery and sensibility) and compared the results obtained by Unicap 100 on 149 samples positive for 12 different allergens and 30 samples containing different concentrations of total IgE. Intra- and inter-assay precision are less than 10% excepted for the specific IgE of one allergen (i3, common wasp), but still in accordance with the NCCLS guidelines. The sensibility is 0.01 kU(A)/L for specific and 0.35 kU/L for total IgE. The method is linear up to 5000 kU/L for total and at least 80 kU(A)/L for specific IgE. The recovery test showed a recovery of the International standard WHO 75/502 between 85 and 115%, with a mean of 103%. The correlation coefficient between the ImmunoCap 250 and Unicap 100 is 0.9866 and 0.9984 for specific and total IgE respectively. ImmunoCap 250 is a good solution for laboratories that perform twenty to thirty thousand determinations.
