Abstract: Background：There are few clinical studies on newborn screening for Duchenne Muscular Dystrophy（DMD） with creatine kinase（CK） or creatine kinase isoenzymeMM（CKMM）, and the diagnostic accuracy is not clear. Objective：To systematically evaluate the accuracy of creatine kinase or creatine kinaseMM in newborn screening for DMD. Design：Systematic review and metaanalysis． Methods：Literature was searched in databases of Embase, Cochrane Library, Web of Science, Scopus, China National Knowledge Infrastructure (CNKI), China Biomedical Literature Database (CBM), Wanfang database and Chinese Journal Fulltext Database (VIP) from Jan 1, 1975 to Oct 5, 2022, and in database of Medline（PubMed） from Jan 1, 1975 to Nov 5, 2022，in order to collect the studies related to neonatal screening of DMD using CK or CKMM. The QUADAS2 scale was used to evaluate the risk of bias and clinical applicability of the included literature. Data were extracted and then metaanalysis was performed using Stata15 and MetaDisc1.4 software. The sensitivity, specificity, positive likelihood ratio（PLR）, negative likelihood ratio（NLR）and diagnostic odds ratio (DOR) were pooled. Summary receiver operating characteristic curve (SROC) was made and the area under the curve (AUC) and Q index was calculated. Main outcome measures：Sensitivity and specificity. Results：Eleven studies were included in newborn screening for DMD using CK with a total of 1 351 953 neonatal samples. Metaanalysis showed that pooled sensitivity, specificity,PLR,NLR and DOR were 97%(95%CI:88%99%),100%(95%CI:100%100%),1 131(95%CI:3703 455),0.01(95%CI:0.000.19),16 476(95%CI:4 11565 963), respectively. The AUC and Q index were 0.995 4 and 0.974 0, respectively. Deeks test（P=0.12）indicating a small possibility of publication bias. Five studies were included in newborn screening for DMD using CKMM with a total of 156 547 neonatal samples.Metaanalysis showed pooled sensitivity, specificity, PLR,NLR and DOR were 100%（95%CI:100%100%）、100%（95%CI:100%100%），3 925（95%CI: 3 9253 925），0.00（95%CI:0.000.00）and 23 094(95%CI:5 77392 384).The AUC and Q index were 0.925 2 and 0.859 4, respectively. Conclusion：The application of serum CK or CKMM in screening neonatal DMD has high accuracy, which is helpful for early diagnosis of DMD.

Key words: Duchenne muscular dystrophy, Creatine kinase, Creatine kinase isoenzyme MM, Newborn screening, Meta-analysis