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  4. Alternative antibody for the detection of CA15-3 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access (R) BR Monitor assay on the UniCel (R) Dxl 800 Immunoassay System
Alternative antibody for the detection of CA15-3 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access (R) BR Monitor assay on the UniCel (R) Dxl 800 Immunoassay System

Alternative antibody for the detection of CA15-3 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access (R) BR Monitor assay on the UniCel (R) Dxl 800 Immunoassay System

Medizin - Open Access LMU - Teil 15/22 vor 18 Jahren
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Background: Cancer antigen CA15-3 antigen is known as a valuable
marker for the management of breast cancer. Methods: The analytical
and clinical performance of the Access' BR Monitor Immunoassay
System (Beckman Coulter) was evaluated at five different European
sites and compared with a reference system, defined as CA15-3 on
the Elecsys(R) System (Roche Diagnostics). Results: Total
imprecision (%CV) of the BR Monitor ranged between 5.5% and 11.7%,
and inter-laboratory reproducibility between 3.4% and 5.1%.
Linearity upon dilution showed a mean recovery of 98.5%
(SD+/-9.1%). Endogenous interferents had no influence on BR Monitor
levels (mean recoveries: hemoglobin 112%, bilirubin 111%,
triglycerides 108%). There was no high-dose hook effect up to
13,540 kU/L. Clinical performance investigated in sera from 1811
individuals showed a general correlation between the Access BR
Monitor and Elecsys CA15-3 (R = 0.797), with a slope of 1.383.
CA15-3 serum levels, as measured by the BR Monitor, were low in
healthy individuals (n = 267, median = 11.9 kU/L, 95th percentile =
23.5 kU/L), higher in individuals with various benign diseases (n =
549, medians = 11.3-15.6 kU/L, 95th percentiles = 21.6-54.6 kU/L)
and even higher in individuals suffering from various cancers (n =
995, medians = 11.2-22.8 kU/L, 95th percentiles = 30.0-429.7 kU/L).
Best diagnostic accuracy for cancer detection against the relevant
benign control group by the BR Monitor was found for locoregional
and metastatic breast cancer, as well as for ovarian cancer {[}area
under the curve (AUC) 0.619, 0.897 and 0.774]. Results for the
reference CA15-3 assay were comparable (AUC 0.611, 0.887 and
0.818). Conclusions: The Access BR Monitor provides accurate
methodological characteristics and demonstrates an analytical and
clinical correlation with Elecsys CA15-3. Best diagnostic accuracy
for the BR Monitor was found in breast and ovarian cancer. Our
results also suggest a clinical value of the BR Monitor in other
cancers.

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„Alternative antibody for the detection of CA15-3 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access (R) BR Monitor assay on the UniCel (R) Dxl 800 Immunoassay System“

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