External quality assessment for laboratory testing of HLA‐B*15:02 allele in relation to carbamazepine therapy. Issue 2 (25th April 2017)

• Record Type: Journal Article
• Authors: Lin, Guigao; Zhang, Kuo; Han, Yanxi; Xie, Jiehong; Li, Jinming
• Is Part Of: Journal of clinical laboratory analysis. Volume 32:Issue 2(2018)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2017-04-25
• Subjects: carbamazepine -- genetic testing -- HLA‐B*15:02 -- quality assurance -- Stevens‐Johnson syndrome -- toxic epidermal necrolysis; Diagnosis, Laboratory -- Periodicals; Medical laboratory technology -- Periodicals; 616
• DOI: 10.1002/jcla.22242
• Languages: English
• ISSNs: 0887-8013

Abstract

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 laboratories correctly identified the HLA‐B*15:02 allele status for all EQA samples. However, one lab failed to identify any positive challenges. The overall analytical sensitivity was 97.3% (180/185 challenges; 95% confidence interval: 93.8%‐99.1%) and the analytic specificity was 100% (185/185; 95% confidence interval: 98.0%‐100%). A review of the written reports showed that the clinical reporting for HLA‐B*15:02 detection should be improved. Some essential information was missing, most notably laboratory information/contact, therapeutic recommendations, and methodology. Conclusion: External quality assessment is valuable in assessing and improving the quality of laboratory testing of HLA‐B*15:02 allele.