Abstract
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.
Highlights
Lung cancer has been the leading cause of cancer related death worldwide
Serum amyloid A (SAA) is one of the biomarkers that we have reported as a lung cancer serum biomarker [12]
To obtain Serum Amyloid A (SAA) pure protein, SAA coding sequence cDNA was cloned into pPAL7 E. coli expression vector which contains Profinity eXtag sequences right before the multiple cloning sites (MCS) (Figure 1A)
Summary
Compared to other type of cancers, lung cancer still shows the low survival rate. According to the cancer statistics, 2012, lung cancer shows little increase in 5-year survival rate among all types of cancers along with pancreatic and stomach cancer [1]. This is largely due to the low diagnostic rate of lung cancer in the early stages. Diagnosis or prognosis of lung cancer largely depends on imaging tools. Such as X-rays, Magnetic resonance imaging (MRI) and computed tomography (CT) scans are commonly used methods [2]. 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
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