Abstract: Objective? To explore the necessity of establishing a unified diagnostic standard for congenital syphilis (CS). Methods The clinical data of 85 newborns admitted for maternal syphilis infection from January 2016 to February 2020 were retrospectively analyzed. The CS diagnosis was evaluated by the Guidelines for the Management of Sexually Transmitted Diseases 2015/Red Book, Infection Association Report 2015 (CDC/AAP guidelines), 2014 European Syphilis Management Guidelines (European guidelines) and 2015 Implementation Plan for Prevention of Mother-to-child Transmission of HIV/AIDS, Syphilis and Hepatitis B (Chinese criterion) respectively. The consistency of the above three criteria in the diagnosis of CS was compared. Results? In the confirmed/highly suspected or suspected cases that were included in CS group, 32 cases were diagnosed by CDC/AAP guidelines, 40 cases were diagnosed by European guidelines and 15 cases were diagnosed by the Chinese criterion. A total of 40 cases were diagnosed according to the three criteria, among which 14 cases met all the three criteria. The cases diagnosed by the CDC/AAP guidelines and the Chinese criterion are in the cases diagnosed by the European guidelines, and the same cases diagnosed by the CDC/AAP guidelines and the Chinese criterion was 14 . Among the 10 children with positive Tp test and abnormal long bone X-rays, 7 were not diagnosed by CDC/AAP guidelines because their mothers received standard treatment before or during pregnancy, while the other 3 cases were diagnosed by CDC/AAP due to irregular treatment during pregnancy. None of the 10 cases were diagnosed by the Chinese criterion. One patient with positive Tp test and positive Tp-IgM was not diagnosed by the CDC/AAP guidelines, but was diagnosed by the other two criteria. Fifteen patients with positive Tp test and negative other indexes and irregular treatment during pregnancy were not diagnosed by the Chinese criterion, but were all diagnosed by the other two criteria. The CDC/AAP guidelines have strong consistency with the European guidelines and the Chinese criterion, with the weighted Kappa of 0 . 611 and 0 . 705 respectively. However, the consistency between the European guidelines and the Chinese criterion was moderate, with a weighted Kappa of 0 . 304 . Conclusion? It is necessary to formulate a unified CS diagnostic criterion in clinical practice.

Key words: syphilis; congenital; diagnosis; neonate