{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,13]],"date-time":"2026-04-13T23:35:33Z","timestamp":1776123333532,"version":"3.50.1"},"reference-count":33,"publisher":"Walter de Gruyter GmbH","issue":"12","funder":[{"name":"The Fundamental Research Funds for the Central Universities","award":["226-2023-00153"],"award-info":[{"award-number":["226-2023-00153"]}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82271735"],"award-info":[{"award-number":["82271735"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"name":"The Key R&D Program of Zhejiang Province","award":["2022C03167"],"award-info":[{"award-number":["2022C03167"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,11,26]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec id=\"j_cclm-2024-0334_abs_001\">\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>Spinal muscular atrophy (SMA) is a neuromuscular disorder caused by homozygous deletion and compound heterozygous mutations in survival motor neuron 1 (<jats:italic>SMN1<\/jats:italic>), with severity tied to the copy number of survival motor neuron 2 (<jats:italic>SMN2<\/jats:italic>). This study aimed to develop a rapid and comprehensive method for the diagnosis of SMA.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2024-0334_abs_002\">\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>A total of 292 children with clinically suspected SMA and 394 family members were detected by the amplification refractory mutation system polymerase chain reaction-capillary electrophoresis (ARMS-PCR-CE) method, which targeted 19 reported mutations, and the results were compared with those in multiplex ligation-dependent probe\u00a0amplification (MLPA). Individuals with identified point mutations were further confirmed by <jats:italic>SMN1<\/jats:italic> long-range PCR and Sanger sequencing.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2024-0334_abs_003\">\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 202 children with SMA, 272 carriers, and 212 normal individuals were identified in this study. No\u00a0difference was found in the R-value distribution of exons 7 and 8 in <jats:italic>SMN1<\/jats:italic> and <jats:italic>SMN2<\/jats:italic> among these cohorts, with coefficients of variation consistently below 0.08. To detect exon 7 and 8 copy numbers in <jats:italic>SMN1<\/jats:italic> and <jats:italic>SMN2<\/jats:italic>, the ARMS-PCR-CE results were concordant with those of MLPA. Approximately 4.95\u202f% (10\/202) of the study patients had compound heterozygous mutations.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2024-0334_abs_004\">\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The ARMS-PCR-CE assay is a comprehensive, rapid, and accurate diagnostic method for SMA that simultaneously detects copy numbers of exons 7 and 8 in <jats:italic>SMN1<\/jats:italic>\/<jats:italic>SMN2<\/jats:italic>, as well as 19 point mutations in <jats:italic>SMN1<\/jats:italic> and 2 enhancers in <jats:italic>SMN2<\/jats:italic>. This approach can effectively reduce the\u00a0time frame for diagnosis, facilitating early intervention and preventing birth defects.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1515\/cclm-2024-0334","type":"journal-article","created":{"date-parts":[[2024,6,11]],"date-time":"2024-06-11T16:41:55Z","timestamp":1718124115000},"page":"2405-2414","source":"Crossref","is-referenced-by-count":2,"title":["Analytical validation of the amplification refractory mutation system polymerase chain reaction-capillary electrophoresis assay to diagnose spinal muscular atrophy"],"prefix":"10.1515","volume":"62","author":[{"given":"Mei","family":"Yao","sequence":"first","affiliation":[{"name":"Department of Neurology , Children\u2019s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health , Hangzhou , P.R. China"},{"name":"Department of Infectious Diseases , Children\u2019s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health , Hangzhou , P.R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liya","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Neurology , Children\u2019s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health , Hangzhou , P.R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yue","family":"Yan","sequence":"additional","affiliation":[{"name":"Department of Neurology , Children\u2019s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health , Hangzhou , P.R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yicheng","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Neurology , Children\u2019s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health , Hangzhou , P.R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuwei","family":"Chen","sequence":"additional","affiliation":[{"name":"Xiamen Biofast Biotechnology Co., Ltd. , Xiamen , P.R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaoyi","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Neurology , Children\u2019s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health , Hangzhou , P.R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yijie","family":"Feng","sequence":"additional","affiliation":[{"name":"Department of Neurology , Children\u2019s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health , Hangzhou , P.R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yiqin","family":"Cui","sequence":"additional","affiliation":[{"name":"Department of Neurology , Children\u2019s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health , Hangzhou , P.R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dongming","family":"Zhou","sequence":"additional","affiliation":[{"name":"Children\u2019s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health , Hangzhou , P.R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Feng","family":"Gao","sequence":"additional","affiliation":[{"name":"Department of Neurology , Children\u2019s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health , Hangzhou , P.R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6736-1407","authenticated-orcid":false,"given":"Shanshan","family":"Mao","sequence":"additional","affiliation":[{"name":"Department of Neurology , Children\u2019s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health , Hangzhou , P.R. China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"374","published-online":{"date-parts":[[2024,6,12]]},"reference":[{"key":"2024101207143232146_j_cclm-2024-0334_ref_001","doi-asserted-by":"crossref","unstructured":"Mercuri, E, Sumner, CJ, Muntoni, F, Darras, BT, Finkel, RS. 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Neurology 2019;93:267\u20139. https:\/\/doi.org\/10.1212\/wnl.0000000000007836.","DOI":"10.1212\/WNL.0000000000007836"},{"key":"2024101207143232146_j_cclm-2024-0334_ref_015","doi-asserted-by":"crossref","unstructured":"Qu, YJ, Bai, JL, Cao, YY, Wang, H, Jin, YW, Du, J, et al.. Mutation spectrum of the survival of motor neuron 1 and functional analysis of variants in Chinese spinal muscular atrophy. J Mol Diagn 2016;18:741\u201352. https:\/\/doi.org\/10.1016\/j.jmoldx.2016.05.004.","DOI":"10.1016\/j.jmoldx.2016.05.004"},{"key":"2024101207143232146_j_cclm-2024-0334_ref_016","doi-asserted-by":"crossref","unstructured":"Milligan, JN, Larson, JL, Filipovic-Sadic, S, Laosinchai-Wolf, W, Huang, YW, Ko, TM, et al.. Multisite evaluation and validation of a sensitive diagnostic and screening system for spinal muscular atrophy that reports SMN1 and SMN2 copy number, along with disease modifier and gene duplication variants. 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