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Technical performance of the Elecsys CA 72-4 test--development and field study.
X Filella1, S Friese, H J Roth
1Laboratorio de Biochimica, Hospital Clinic Provinciac del Barcelona, Barcelona, Spain.
Anticancer Research
|May 1, 2001
Summary
Tumor-associated glycoprotein 72 (TAG72) is a key biomarker for gastric cancer. The Elecsys CA72-4 assay shows reliable performance for TAG72 determination, aiding in cancer management.
Area of Science:
- Oncology
- Biochemistry
- Clinical Diagnostics
Background:
- Tumor-associated glycoprotein 72 (TAG72) is a high molecular weight mucin-like protein.
- Elevated serum TAG72 levels are indicative of gastric cancer.
- TAG72 determination may assist in managing mucinous ovarian cancer, especially when CA125 sensitivity is low.
Purpose of the Study:
- To evaluate the performance of the new Elecsys CA72-4 assay for measuring TAG72.
- To assess the assay's suitability for routine clinical use in cancer diagnostics.
Main Methods:
- Evaluation of the Elecsys CA72-4 assay on Elecsys 2010 and 1010 platforms.
- Determination of assay precision (intra-assay, inter-assay, inter-instrument).
- Method comparison with Enzymun-Test CA72-4 and a commercial RIA; assessment of hook effect and HAMA interference.
Main Results:
- The Elecsys CA72-4 assay offers a wide measuring range (0.5-300 U/ml) and high precision (intra-assay 2%, inter-assay 4%, inter-instrument 6%).
- Strong correlation observed with Enzymun-Test CA72-4 (0.91-0.96) and moderate correlation with RIA (0.8).
- No hook effect up to 20,000 U/ml and no HAMA interference were detected.
Conclusions:
- The Elecsys CA72-4 assay demonstrates robust performance characteristics, including precision and wide measuring range.
- The assay is suitable for routine clinical use in the determination of TAG72.
- This assay can be a valuable tool for managing gastric and ovarian cancers.