PMID- 36863950 OWN - NLM STAT- MEDLINE DCOM- 20230314 LR - 20230314 IS - 1880-0920 (Electronic) IS - 1347-4367 (Linking) VI - 49 DP - 2023 Apr TI - Validation of a genotyping technique for a surrogate marker of HLA-B( *)58:01 for allopurinol-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in the Japanese population. PG - 100495 LID - S1347-4367(23)00007-1 [pii] LID - 10.1016/j.dmpk.2023.100495 [doi] AB - Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN) are rare but severe cutaneous adverse drug reactions. Certain human leukocyte antigen (HLA) types have been associated with SJS/TEN onset, e.g., HLA-B( *)58:01 with allopurinol-induced SJS/TEN, but HLA typing is time-consuming and expensive; thus, it is not commonly used in clinical situations. In the previous work, we demonstrated that the single-nucleotide polymorphisms (SNP) rs9263726 was in absolute linkage disequilibrium with HLA-B( *)58:01 in the Japanese population, and can be used as a surrogate marker for the HLA. Here, we developed a new genotyping method for the surrogate SNP using the single-stranded tag hybridization chromatographic printed-array strip (STH-PAS) technique and performed an analytical validation. The results of genotyping rs9263726 using STH-PAS correlated well with those obtained using the TaqMan SNP Genotyping Assay for 15 HLA-B( *)58:01-positive and 13 HLA-B( *)58:01-negative patients (analytical sensitivity and specificity were both 100%). Additionally, at least 1.11 ng of genomic DNA was sufficient to digitally and manually detect positive signals on the strip. Robustness studies showed that the annealing temperature (66 degrees C) was the most important condition related to reliable results. Collectively, we developed an STH-PAS method that can rapidly and easily detect rs9263726 for predicting SJS/TEN onset. CI - Copyright (c) 2023 The Japanese Society for the Study of Xenobiotics. Published by Elsevier Ltd. All rights reserved. FAU - Tsukagoshi, Eri AU - Tsukagoshi E AD - Division of Medicinal Safety Science, National Institute of Health Sciences, Kawasaki, 210-9501, Japan. FAU - Nakamura, Ryosuke AU - Nakamura R AD - Division of Medicinal Safety Science, National Institute of Health Sciences, Kawasaki, 210-9501, Japan. Electronic address: ryosnak@nihs.go.jp. FAU - Tanaka, Yoichi AU - Tanaka Y AD - Division of Medicinal Safety Science, National Institute of Health Sciences, Kawasaki, 210-9501, Japan. FAU - Maekawa, Keiko AU - Maekawa K AD - Department of Analytical Chemistry, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, 610-0395, Japan. FAU - Hiratsuka, Masahiro AU - Hiratsuka M AD - Laboratory of Pharmacotherapy of Life-Style Related Diseases, Graduate School of Pharmaceutical Sciences, Tohoku University, Sendai, 980-8578, Japan; Research Center for Innovations in Next-Generation Medicine, Tohoku University, Sendai, 980-8573, Japan; Tohoku Medical Megabank Organization, Tohoku University, Sendai, 980-8573, Japan; Department of Pharmaceutical Sciences, Tohoku University Hospital, Sendai, 980-8574, Japan. FAU - Asada, Hideo AU - Asada H AD - Department of Dermatology, School of Medicine, Nara Medical University, Kashihara, 634-8522, Japan. FAU - Saito, Yoshiro AU - Saito Y AD - Division of Medicinal Safety Science, National Institute of Health Sciences, Kawasaki, 210-9501, Japan. LA - eng PT - Journal Article DEP - 20230208 PL - England TA - Drug Metab Pharmacokinet JT - Drug metabolism and pharmacokinetics JID - 101164773 RN - 63CZ7GJN5I (Allopurinol) RN - 0 (HLA-B Antigens) RN - 0 (Biomarkers) SB - IM MH - Humans MH - *Allopurinol MH - *Stevens-Johnson Syndrome/genetics MH - Genotyping Techniques MH - Genotype MH - East Asian People MH - HLA-B Antigens/genetics MH - Biomarkers OTO - NOTNLM OT - Allopurinol OT - Human leukocyte antigen OT - Screening test OT - Single-nucleotide polymorphism OT - Stevens-Johnson syndrome OT - Toxic epidermal necrolysis COIS- Declaration of competing interest The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2023/03/03 06:00 MHDA- 2023/03/15 06:00 CRDT- 2023/03/02 22:05 PHST- 2022/11/18 00:00 [received] PHST- 2023/02/02 00:00 [revised] PHST- 2023/02/06 00:00 [accepted] PHST- 2023/03/03 06:00 [pubmed] PHST- 2023/03/15 06:00 [medline] PHST- 2023/03/02 22:05 [entrez] AID - S1347-4367(23)00007-1 [pii] AID - 10.1016/j.dmpk.2023.100495 [doi] PST - ppublish SO - Drug Metab Pharmacokinet. 2023 Apr;49:100495. doi: 10.1016/j.dmpk.2023.100495. Epub 2023 Feb 8.