Age-stratified and gender-specific reference intervals of six tumor markers panel of lung cancer: A geographic-based multicenter study in China

• Main Authors: Chen, Q. (Author), Chen, Y. (Author), Huang, H. (Author), Jiang, L. (Author), Li, G. (Author), Li, M. (Author), Li, X. (Author), Li, Y. (Author), liang Xing, J. (Author), Qu, W. (Author), Wang, S. (Author), Wang, W. (Author), Yang, C. (Author), Zhang, Y. (Author), Zhou, J. (Author)
• Format: Article
• Language: English
• Published: John Wiley and Sons Inc 2021
• Subjects: adolescent; Adolescent; adult; Adult; age; Age Factors; aged; antigen blood level; antigen CYFRA21.1; Antigens, Neoplasm; Article; Biomarkers, Tumor; blood; blood sampling; carcinoembryonic antigen; Carcinoembryonic Antigen; carrier protein; Carrier Proteins; CEACAM5 protein, human; chemoluminescence; China; clinical laboratory standard; clinical trial; clinician; cohort analysis; Cohort Studies; controlled study; cytokeratin 19; cytokeratin 19 fragment; female; Female; gender; geography; Geography; glycosylphosphatidylinositol anchored protein; GPI-Linked Proteins; groups by age; human; human epididymis protein 4; Humans; immunoassay; Immunoassay; Keratin-19; lung cancer; lung neoplasms; Lung Neoplasms; lung tumor; major clinical study; male; Male; middle aged; Middle Aged; multicenter study; neuron specific enolase; NSMCE1 protein, human; observational study; patient care; peptide fragment; Peptide Fragments; population structure; practice guideline; procedures; progastrin releasing peptide; progastrin-releasing peptide; pro-gastrin-releasing peptide (31-98); prognosis; Prognosis; protein blood level; recombinant protein; Recombinant Proteins; reference value; Reference Values; sample size; serine proteinase inhibitor; Serpins; sex factor; Sex Factors; squamous cell carcinoma antigen; squamous cell carcinoma-related antigen; tumor antigen; tumor biomarkers; tumor marker; very elderly; WAP four-disulfide core domain protein 2; WAP Four-Disulfide Core Domain Protein 2; WFDC2 protein, human; young adult; Young Adult
• Online Access: View Fulltext in Publisher

 Background: Serum biomarkers have been widely adopted in clinical practice for assisting lung cancer diagnoses, therapeutic monitoring, and prognostication. The function of a well-performing tumor biomarker depends on a reliable reference interval (RI) with consideration of the study subjects’ age, gender, and geographical location. This study aimed to establish a RI for each of 6 lung cancer biomarkers for use in the whole country of China on Mindray platform. Methods: The levels of serum 6 lung cancer biomarkers—namely progastrin-releasing peptide (ProGRP), neuron-specific enolase (NSE), squamous cell carcinoma antigen (SCC), carcinoembryonic antigen (CEA), cytokeratin-19 fragment (CYFRA21-1), and human epididymis protein 4 (HE4)—were measured utilizing the chemiluminescence immunoassay on the Mindray CL-6000i platform following the laboratory standard operating procedures in apparently healthy Chinese individuals on large cohort, multicenter, and geographical consideration bases. The CLSI EP28-A3C guideline was followed for the enrollment of study subjects. Results: The age-stratified, gender-specific RIs for ProGRP, NSE, SCC, CEA, CYFRA21-1, and HE4 lung cancer biomarkers in the Chinese population have been established as described in the results and discussion in this work. In addition, various levels of the six lung cancer biomarkers among nine geographical locations in China have been observed. Conclusions: The sample volume of study cohort, age, and geographical location should be considered upon establishing a reliable biomarker RI. A RI for each of six lung cancer biomarkers has been established. The results from this study would be helpful for clinical laboratories in interpreting the analytical results and for clinicians in patient management. © 2021 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC