PMID- 33982344
OWN - NLM
STAT- MEDLINE
DCOM- 20211207
LR  - 20211214
IS  - 1098-2825 (Electronic)
IS  - 0887-8013 (Print)
IS  - 0887-8013 (Linking)
VI  - 35
IP  - 6
DP  - 2021 Jun
TI  - Age-stratified and gender-specific reference intervals of six tumor markers panel 
      of lung cancer: A geographic-based multicenter study in China.
PG  - e23816
LID - 10.1002/jcla.23816 [doi]
LID - e23816
AB  - 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.
CI  - (c) 2021 The Authors. Journal of Clinical Laboratory Analysis published by Wiley 
      Periodicals LLC.
FAU - Li, Yan
AU  - Li Y
AD  - Department of Laboratory Medicine, Renmin Hospital of Wuhan University, Wuhan, 
      China.
FAU - Li, Ming
AU  - Li M
AUID- ORCID: 0000-0002-2893-3780
AD  - Department of Laboratory Medicine, The First Affiliated Hospital of University of 
      Science and Technology of China, Hefei, China.
FAU - Zhang, Yi
AU  - Zhang Y
AD  - Department of Laboratory Medicine, Qilu Hospital of Shandong University, Jinan, 
      China.
FAU - Zhou, Jianping
AU  - Zhou J
AD  - Department of Radio Immunoassay Center, Shaanxi Provincial People's Hospital, 
      Xi'an, China.
FAU - Jiang, Li
AU  - Jiang L
AD  - Department of Laboratory Medicine, Sichuan Academy of Medical Sciences & Sichuan 
      Provincial People's Hospital, Chengdou, China.
FAU - Yang, Chen
AU  - Yang C
AD  - Department of Laboratory Medicine, Suzhou Municipal Hospital, Suzhou, China.
FAU - Li, Gang
AU  - Li G
AD  - Department of Laboratory Medicine, Henan Provincial People's Hospital, Zhengzhou, 
      China.
FAU - Qu, Wei
AU  - Qu W
AD  - Department of Nuclear Medicine, Nanjing First Hospital, Nanjing Medical 
      University, Nanjing, China.
FAU - Li, Xinhui
AU  - Li X
AD  - Department of Nuclear Medicine, Xiangya Hospital, Central South University, 
      Changsha, China.
FAU - Chen, Yong
AU  - Chen Y
AD  - Division of in vitro Diagnostics, Shenzhen Mindray Bio-Medical Electronics 
      Corporation, Shenzhen, China.
FAU - Chen, Qing
AU  - Chen Q
AD  - Division of in vitro Diagnostics, Shenzhen Mindray Bio-Medical Electronics 
      Corporation, Shenzhen, China.
FAU - Wang, Wei
AU  - Wang W
AD  - Division of in vitro Diagnostics, Shenzhen Mindray Bio-Medical Electronics 
      Corporation, Shenzhen, China.
FAU - Wang, Shukui
AU  - Wang S
AUID- ORCID: 0000-0001-6972-2587
AD  - Department of Nuclear Medicine, Nanjing First Hospital, Nanjing Medical 
      University, Nanjing, China.
FAU - Liang Xing, Jin
AU  - Liang Xing J
AD  - State Key Laboratory of Cancer Biology and Department of Physiology and 
      Pathophysiology, Fourth Military Medical University, Xi'an, China.
FAU - Huang, Huayi
AU  - Huang H
AUID- ORCID: 0000-0002-7272-0838
AD  - Division of in vitro Diagnostics, Shenzhen Mindray Bio-Medical Electronics 
      Corporation, Shenzhen, China.
AD  - Department of Surgical Oncology, Roswell Park Comprehensive Cancer Center, 
      Buffalo, NY, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20210512
PL  - United States
TA  - J Clin Lab Anal
JT  - Journal of clinical laboratory analysis
JID - 8801384
RN  - 0 (Antigens, Neoplasm)
RN  - 0 (Biomarkers, Tumor)
RN  - 0 (CEACAM5 protein, human)
RN  - 0 (Carcinoembryonic Antigen)
RN  - 0 (Carrier Proteins)
RN  - 0 (GPI-Linked Proteins)
RN  - 0 (Keratin-19)
RN  - 0 (NSMCE1 protein, human)
RN  - 0 (Peptide Fragments)
RN  - 0 (Recombinant Proteins)
RN  - 0 (Serpins)
RN  - 0 (WAP Four-Disulfide Core Domain Protein 2)
RN  - 0 (WFDC2 protein, human)
RN  - 0 (antigen CYFRA21.1)
RN  - 0 (pro-gastrin-releasing peptide (31-98))
RN  - 0 (squamous cell carcinoma-related antigen)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Age Factors
MH  - Antigens, Neoplasm/blood
MH  - Biomarkers, Tumor/*blood
MH  - Carcinoembryonic Antigen/blood
MH  - Carrier Proteins/blood
MH  - China
MH  - Cohort Studies
MH  - Female
MH  - GPI-Linked Proteins/blood
MH  - Geography
MH  - Humans
MH  - Immunoassay/*methods
MH  - Keratin-19/blood
MH  - Lung Neoplasms/blood/*diagnosis
MH  - Male
MH  - Middle Aged
MH  - Peptide Fragments/blood
MH  - Prognosis
MH  - Recombinant Proteins/blood
MH  - Reference Values
MH  - Serpins/blood
MH  - Sex Factors
MH  - WAP Four-Disulfide Core Domain Protein 2/analysis
MH  - Young Adult
PMC - PMC8183943
OTO - NOTNLM
OT  - carcinoembryonic antigen
OT  - human epididymis protein 4
OT  - lung neoplasms
OT  - progastrin-releasing peptide
OT  - tumor biomarkers
COIS- Mindray Corporation provided the chemiluminescence immunoassay analyzer and 
      reagents to the participating hospitals. A proportion of intellectual property 
      right will be shared by Mindray Corporation and the participating hospitals.
EDAT- 2021/05/14 06:00
MHDA- 2021/12/15 06:00
PMCR- 2021/05/12
CRDT- 2021/05/13 06:47
PHST- 2021/04/12 00:00 [revised]
PHST- 2021/01/19 00:00 [received]
PHST- 2021/04/14 00:00 [accepted]
PHST- 2021/05/14 06:00 [pubmed]
PHST- 2021/12/15 06:00 [medline]
PHST- 2021/05/13 06:47 [entrez]
PHST- 2021/05/12 00:00 [pmc-release]
AID - JCLA23816 [pii]
AID - 10.1002/jcla.23816 [doi]
PST - ppublish
SO  - J Clin Lab Anal. 2021 Jun;35(6):e23816. doi: 10.1002/jcla.23816. Epub 2021 May 
      12.