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  4. Alternative antibody for the detection of CA19-9 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access (R) GI Monitor assay on the UniCel (R) Dxl 800 Immunoassay System
Alternative antibody for the detection of CA19-9 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access (R) GI Monitor assay on the UniCel (R) Dxl 800 Immunoassay System

Alternative antibody for the detection of CA19-9 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access (R) GI 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: Gastrointestinal cancer antigen CA19-9 is known as a
valuable marker for the management of patients with pancreatic
cancer. Methods: The analytical and clinical performance of the
Access(R) GI Monitor assay (Beckman Coulter) was evaluated on the
UniCel(R) Dxl 800 Immunoassay System at five different European
sites and compared with a reference method, defined as CA19-9 on
the Elecsys System (Roche Diagnostics). Results: Total imprecision
(%CV) of the GI Monitor ranged between 3.4% and 7.7%, and
inter-laboratory reproducibility between 3.6% and 4.0%. Linearity
upon dilution showed a mean recovery of 97.4% (SD+7.2%). Endogenous
interferents had no influence on GI Monitor levels (mean
recoveries: hemoglobin 103%, bilirubin 106%, triglycerides 106%).
There was no high-dose hook effect up to 115,000 kU/L. Clinical
performance investigated in sera from 1811 individuals showed a
good correlation between the Access' GI Monitor and Elecsys CA19-9
(R = 0.959, slope = 1.004, intercept +0.17). GI Monitor serum
levels were low in healthy individuals (n = 267, median = 6.0 kU/L,
95th percentile = 23.1 kU/L), higher in individuals with various
benign diseases (n = 550, medians = 5.8-13.4 kU/L, 95th percentiles
= 30.1-195.5 kU/L) and even higher in individuals suffering from
various cancers (n = 995, medians = 8.4-233.8 kU/L, 95th
percentiles = 53.7-13,902 kU/L). Optimal diagnostic accuracy for
cancer detection against the relevant benign control group by the
GI Monitor was found for pancreatic cancer {[}area under the curve
(AUC) 0.83]. Results for the reference CA19-9 assay were comparable
(AUC 0.85). Conclusions: The Access(R) GI Monitor provides very
good methodological characteristics and demonstrates an excellent
analytical and clinical correlation with the Elecsys CA19-9. The GI
Monitor shows the best diagnostic accuracy in pancreatic cancer.
Our results also suggest a clinical value of the GI Monitor in
other cancers.

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„Alternative antibody for the detection of CA19-9 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access (R) GI Monitor assay on the UniCel (R) Dxl 800 Immunoassay System“

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