Zeitschrift für Proteomik und Bioinformatik
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Clinically Applicable Diagnostics Assay Development for Lung Cancer Biomarker, SAA

Hye-Jin Sung, Sang-Su Na, Keyung-Jo Seul, Hyo-Sung Jeon, Jae Yong Park and Je-Yoel Cho

Background: Serum Amyloid A (SAA) is an acute phase protein and has been reported as a lung cancer biomarker. Many cancer protein biomarkers have been reported but few are currently in clinical application. This is due to the obstacles in the process from biomarker discovery to biomarker application: validation in large scale clinical samples and paired antibody production for the development of immunoassay-based diagnostics.

Methods: To develop immunoassay-based diagnostics of SAA, we produced anti-SAA monoclonal antibodies after bacterial production of pure SAA whole protein immunogen. Using two SAA specific monoclonal antibody clones, we developed two types of diagnostics; ELISA and rapid tester diagnostics. Hundreds of clinical samples were tested using the immunoassay diagnostics developed.

Results: The diagnostic or differential diagnostic ability of lung cancer from healthy control or respiratory diseases was tested by developed ELISA or rapid tester kits using hundreds of clinical samples. Developed ELISA kit turned out to measure SAA precisely and clinical sample tests showed that, as previously reported, SAA level is significantly higher in lung cancer groups compared with healthy controls or lung diseases (p<0.05). The test results of secondly developed rapid tester kit also showed lung cancer specific positive signals (p<0.05).

Conclusion: Both types of immunoassays showed significant diagnostic capability of SAA. This study demonstrated the potential of developed immunoassays for the clinical lung cancer diagnostics.