Alternative antibody for the detection of CA125 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access (R) OV Monitor assay on the UniCel (R) Dxl 800 Immunoassay System
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vor 16 Jahren
Background: Cancer antigen CA125 is known as a valuable marker for
the management of ovarian cancer. Methods: The analytical and
clinical performance of the Access OV Monitor Immunoassay System
(Beckman Coulter) was evaluated at five different European sites
and compared with a reference system, defined as CA125 on the
Elecsys System (Roche Diagnostics). Results: Total imprecision
(%CV) of the OV Monitor ranged between 3.1% and 8.8%, and
inter-laboratory reproducibility between 4.7% and 5.0%. Linearity
upon dilution showed a mean recovery of 100% (SD+8.1%). Endogenous
interferents had no influence on OV Monitor levels (mean
recoveries: hemoglobin 107%, bilirubin 103%, triglycericles 103%).
There was no high-dose hook effect up to 27,193 kU/L. Clinical
performance investigated in sera from 1811 individuals showed a
good correlation between the Access OV Monitor and Elecsys CA125 (R
= 0.982, slope = 0.921, intercept = + 1.951). OV Monitor serum
levels were low in healthy individuals (n = 267, median = 9.7 kU/L,
95th percentile = 30.8 kU/L), higher in individuals with various
benign diseases (n = 549, medians = 10.9-16.4 kU/L, 95th
percentiles = 44.2-355 kU/L) and even higher in individuals
suffering from various cancers (n = 995, medians= 12.4-445 kU/L;
95th percentiles = 53.4-4664 kU/L). Optimal diagnostic accuracy for
cancer detection against the relevant benign control group by the
OV Monitor was found for ovarian cancer {[}area under the curve
(AUC) 0.898]. Results for the reference CA125 assay were comparable
(AUC 0.899). Conclusions: The Access OV Monitor provides very good
methodological characteristics and demonstrates an excellent
analytical and clinical correlation with Elecsys CA125. The best
diagnostic accuracy for the OV Monitor was found in ovarian cancer.
Our results also suggest a clinical value of the OV Monitor in
other cancers.
the management of ovarian cancer. Methods: The analytical and
clinical performance of the Access OV Monitor Immunoassay System
(Beckman Coulter) was evaluated at five different European sites
and compared with a reference system, defined as CA125 on the
Elecsys System (Roche Diagnostics). Results: Total imprecision
(%CV) of the OV Monitor ranged between 3.1% and 8.8%, and
inter-laboratory reproducibility between 4.7% and 5.0%. Linearity
upon dilution showed a mean recovery of 100% (SD+8.1%). Endogenous
interferents had no influence on OV Monitor levels (mean
recoveries: hemoglobin 107%, bilirubin 103%, triglycericles 103%).
There was no high-dose hook effect up to 27,193 kU/L. Clinical
performance investigated in sera from 1811 individuals showed a
good correlation between the Access OV Monitor and Elecsys CA125 (R
= 0.982, slope = 0.921, intercept = + 1.951). OV Monitor serum
levels were low in healthy individuals (n = 267, median = 9.7 kU/L,
95th percentile = 30.8 kU/L), higher in individuals with various
benign diseases (n = 549, medians = 10.9-16.4 kU/L, 95th
percentiles = 44.2-355 kU/L) and even higher in individuals
suffering from various cancers (n = 995, medians= 12.4-445 kU/L;
95th percentiles = 53.4-4664 kU/L). Optimal diagnostic accuracy for
cancer detection against the relevant benign control group by the
OV Monitor was found for ovarian cancer {[}area under the curve
(AUC) 0.898]. Results for the reference CA125 assay were comparable
(AUC 0.899). Conclusions: The Access OV Monitor provides very good
methodological characteristics and demonstrates an excellent
analytical and clinical correlation with Elecsys CA125. The best
diagnostic accuracy for the OV Monitor was found in ovarian cancer.
Our results also suggest a clinical value of the OV Monitor in
other cancers.
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