PMID- 31907976
OWN - NLM
STAT- MEDLINE
DCOM- 20210519
LR  - 20221207
IS  - 1098-2825 (Electronic)
IS  - 0887-8013 (Print)
IS  - 0887-8013 (Linking)
VI  - 34
IP  - 5
DP  - 2020 May
TI  - A preliminary study for the establishment of a reference interval for vitamin B12 
      in China after performance verification of a second-generation ECLIA kit.
PG  - e23165
LID - 10.1002/jcla.23165 [doi]
LID - e23165
AB  - BACKGROUND: The second-generation electrochemiluminescence immunoassay (ECLIA) 
      kit of vitamin B12 is widely used in clinical laboratories, and the establishment 
      of a reference interval (RI) is essential to provide the basis for clinical 
      monitoring. The purpose of this study was to establish a laboratory RI for 
      vitamin B12 in China and at the same time verify the method performance of the 
      second-generation kit. METHODS: The verification of the method performance was 
      conducted according to the Clinical and Laboratory Standards Institute (CLSI) 
      guidelines. Based on these guidelines, a total of 580 serum samples were 
      collected, and 391 serum samples were used for the establishment of the RI 
      according to CLSI guidelines. The subjects were grouped by sex and age. The age 
      groups were as follows: 21-40, 41-60, and 61-80 years. The RI was defined by 
      nonparametric 2.5th and 97.5th percentile intervals. RESULTS: The performance of 
      the second-generation kit of vitamin B12 from the Roche Cobas E602 system was in 
      compliance with laboratory requirements. Serum vitamin B12 levels conformed to a 
      non-Gaussian distribution. Harris-Boyd's test did not indicate partitioning for 
      different age and gender group. Besides, there was no significant difference 
      between different age groups (P = .07) and gender groups (P = .2002). The RI for 
      healthy Chinese adults (aged 21-80 years) calculated by the nonparametric method 
      was 250.8-957.1 pg/mL. CONCLUSIONS: The reference range of vitamin B12 was 
      established, which provided a theoretical basis for the clinical application and 
      monitoring of vitamin B12 detection.
CI  - (c) 2020 The Authors. Journal of Clinical Laboratory Analysis Published by Wiley 
      Periodicals, Inc.
FAU - Jiang, Wencan
AU  - Jiang W
AD  - Department of Clinical Laboratory Medicine, Chinese People's Liberation Army 
      General Hospital & Postgraduate Medical School, Beijing, China.
FAU - Men, Shasha
AU  - Men S
AD  - Department of Clinical Laboratory Medicine, Chinese People's Liberation Army 
      General Hospital & Postgraduate Medical School, Beijing, China.
FAU - Wen, Xinyu
AU  - Wen X
AD  - Department of Clinical Laboratory Medicine, Chinese People's Liberation Army 
      General Hospital & Postgraduate Medical School, Beijing, China.
FAU - Yuan, Xiaozhou
AU  - Yuan X
AD  - Department of Clinical Laboratory Medicine, Chinese People's Liberation Army 
      General Hospital & Postgraduate Medical School, Beijing, China.
FAU - Pu, Danna
AU  - Pu D
AD  - Department of Clinical Laboratory Medicine, Chinese People's Liberation Army 
      General Hospital & Postgraduate Medical School, Beijing, China.
FAU - Liu, Xiaoting
AU  - Liu X
AD  - Department of Clinical Laboratory Medicine, Chinese People's Liberation Army 
      General Hospital & Postgraduate Medical School, Beijing, China.
FAU - Jia, Xingwang
AU  - Jia X
AD  - Department of Clinical Laboratory Medicine, Chinese People's Liberation Army 
      General Hospital & Postgraduate Medical School, Beijing, China.
FAU - Wang, Chengbin
AU  - Wang C
AUID- ORCID: 0000-0002-6535-5967
AD  - Department of Clinical Laboratory Medicine, Chinese People's Liberation Army 
      General Hospital & Postgraduate Medical School, Beijing, China.
LA  - eng
PT  - Journal Article
DEP - 20200106
PL  - United States
TA  - J Clin Lab Anal
JT  - Journal of clinical laboratory analysis
JID - 8801384
RN  - P6YC3EG204 (Vitamin B 12)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Asian People
MH  - Female
MH  - Humans
MH  - Immunoassay/*methods
MH  - Luminescent Measurements/methods
MH  - Male
MH  - Middle Aged
MH  - Reference Values
MH  - Vitamin B 12/*blood
MH  - Young Adult
PMC - PMC7246358
OTO - NOTNLM
OT  - Chinese
OT  - Vitamin B12
OT  - electrochemiluminescent
OT  - performance verification
OT  - reference interval
COIS- None.
EDAT- 2020/01/08 06:00
MHDA- 2021/05/20 06:00
PMCR- 2020/01/06
CRDT- 2020/01/08 06:00
PHST- 2019/08/11 00:00 [received]
PHST- 2019/11/16 00:00 [revised]
PHST- 2019/11/26 00:00 [accepted]
PHST- 2020/01/08 06:00 [pubmed]
PHST- 2021/05/20 06:00 [medline]
PHST- 2020/01/08 06:00 [entrez]
PHST- 2020/01/06 00:00 [pmc-release]
AID - JCLA23165 [pii]
AID - 10.1002/jcla.23165 [doi]
PST - ppublish
SO  - J Clin Lab Anal. 2020 May;34(5):e23165. doi: 10.1002/jcla.23165. Epub 2020 Jan 6.