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Comparison between Centcor CA 125 and CA 125 II assays
G H Eltabbakh1, M K Gupta, J L Belinson
1Department of Gynecology, Cleveland Clinic Foundation, Ohio, USA.
European Journal of Gynaecological Oncology
|January 1, 1996
Summary
The new Centcor CA 125 II assay shows results similar to the original assay, especially for values under 300 U/ml. This improved assay also reduces false positives caused by human antimouse antibodies.
Area of Science:
- Clinical Chemistry
- Biomarker Analysis
Background:
- The Cancer Antigen 125 (CA 125) assay is a crucial biomarker in gynecologic oncology.
- Second-generation assays are being developed to improve accuracy and reliability over original assays.
Purpose of the Study:
- To compare the performance of the Centcor CA 125 II assay against the original Centcor CA 125 assay.
- To evaluate the clinical utility of the new assay in women with and without gynecologic cancers.
Main Methods:
- A comparative study involving 50 women (34 with gynecologic cancers, 5 with benign conditions, 11 healthy).
- Serum CA 125 levels were measured using both the original Centcor CA 125 assay and the Centcor CA 125 II assay.
- Statistical analysis was performed to assess correlation and differences between the two assays.
Main Results:
- Serum CA 125 values obtained from both assays showed no statistically significant differences.
- A high correlation was observed between the two assays, particularly for values below 300 U/ml.
- Two patients with false-positive CA 125 elevations on the original assay due to human antimouse antibodies showed normal results with the CA 125 II assay.
Conclusions:
- The Centcor CA 125 II assay provides CA 125 serum values that correlate well with the original Centcor CA 125 assay, especially for values < 300 U/ml.
- The CA 125 II assay demonstrates reduced incidence of false-positive results attributed to human antimouse antibodies.