Comparative studies of the new Access® Toxo IgG assay
Abstract number: P940
Bouniort F., Flecheux O., Clement A., Stoia C., Margotteau F., Duhamel D., Poropane J., Falcou R., Walton C.
Objectives: A new quantitative Access Toxo IgG assay, restandardised by Beckman Coulter to the WHO 3rd International Standard (TOXM), was studied in order to determine concordance between the new assay and the AxSYM** Toxo IgG assay. Relative specificity and sensitivity were calculated within the tested populations as compared to a reference method.
Methods: The concordance studies were performed with samples from non-selected blood donors (n = 700), non-selected hospitalised patients (n = 3824) and non-selected pregnant women (n = 358). The comparative device used for these studies was the Abbott AxSYM Toxo IgG assay and a percentage of agreement between the methods was calculated. Specificity and sensitivity were calculated based on a final interpretation of the results (defined as a reference method) obtained with the current Access Toxo IgG, the AxSYM Toxo IgG and the bioMérieux VIDAS Toxo IgG assays.
Blood donors: The agreement between the new Access Toxo IgG and the AxSYM Toxo IgG assays was 97.57% (683/700). According to the reference methods, the new Access Toxo IgG assay displayed specificity and sensitivity of 99.53% and 99.37%, respectively.
Non selected hospitalised patients: The agreement between the new Toxo IgG and the AxSYM Toxo IgG assays was 97.64% (1781/1824). According to the reference methods, the new Access Toxo IgG assay displayed a relative specificity and sensitivity of 98.89% and 99.70%, respectively.
Pregnant women: The agreement between the new Toxo IgG and the AxSYM Toxo IgG assays was 98.92% (552/558). According to a reference method, the new Access Toxo IgG assay displayed specificity and sensitivity of 100% and 100%, respectively.
Conclusion: The new Access Toxo IgG assay provides good agreement in comparison with the AxSYM Toxo IgG assay. The new Access Toxo IgG assay displays excellent relative specificity and sensitivity results compared to reference Toxo IgG methods. The new Access Toxo IgG assay can be used either with the Access® Immunoassay System or with the high-throughput UniCel® DxI 800 Access Immunoassay System.
|Session name:||18th European Congress of Clinical Microbiology and Infectious Diseases|
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