A preliminary study for the establishment of a reference interval for vitamin B12 in China after performance verification of a second-generation ECLIA kit.
Chinese
Vitamin B12
electrochemiluminescent
performance verification
reference interval
Journal
Journal of clinical laboratory analysis
ISSN: 1098-2825
Titre abrégé: J Clin Lab Anal
Pays: United States
ID NLM: 8801384
Informations de publication
Date de publication:
May 2020
May 2020
Historique:
received:
11
08
2019
revised:
16
11
2019
accepted:
26
11
2019
pubmed:
8
1
2020
medline:
20
5
2021
entrez:
8
1
2020
Statut:
ppublish
Résumé
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. 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. 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. The reference range of vitamin B12 was established, which provided a theoretical basis for the clinical application and monitoring of vitamin B12 detection.
Sections du résumé
BACKGROUND
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
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
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
CONCLUSIONS
The reference range of vitamin B12 was established, which provided a theoretical basis for the clinical application and monitoring of vitamin B12 detection.
Identifiants
pubmed: 31907976
doi: 10.1002/jcla.23165
pmc: PMC7246358
doi:
Substances chimiques
Vitamin B 12
P6YC3EG204
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e23165Informations de copyright
© 2020 The Authors. Journal of Clinical Laboratory Analysis Published by Wiley Periodicals, Inc.
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