A preliminary study for the establishment of a reference interval for vitamin B12 in China after performance verification of a second-generation ECLIA kit.

ABSTRACT:

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

SUBMITTER: Jiang W 

PROVIDER: S-EPMC7246358 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature