External quality assessment for laboratory testing of HLA-B*15:02 allele in relation to carbamazepine therapy.

ABSTRACT:

Background

Due to the significant risk of developing Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), the use of carbamazepine is not recommended in patients carrying the human leukocyte antigen B (HLA-B) *15:02 allele. In an effort to guarantee reliable community-based HLA-B*15:02 testing throughout China, a HLA-B*15:02 genotyping external quality assessment (EQA) program was set up.

Methods

In 2016, 10 genomic DNA samples with known HLA-B*15:02 allele status were sent to 37 laboratories from 16 provinces with a request for routine HLA-B*15:02 screening. The samples were validated using Sanger sequencing by a reference laboratory. Both genotyping results and clinical written reports were evaluated.

Results

Thirty-six of the participating laborator

SUBMITTER: Lin G 

PROVIDER: S-EPMC6817111 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature