中文版 | English
Title

Safety of a Novel ESAT6-CFP10 skin test compared with tuberculin skin test in a double-blind, randomized, controlled study

Author
Corresponding AuthorLi, Shaojie; Lu, Shuihua
Publication Years
2022-10-11
DOI
Source Title
EISSN
1471-2334
Volume22Issue:1
Abstract
Background ESAT6-CFP10 (EC) skin test has been reported accurate and safe in identifying tuberculosis infection. We aimed to demonstrate the safety of EC skin test compared with tuberculin skin test (TST) in university freshmen. Methods: We conducted a double-blind, randomized, controlled clinical study in a university freshmen population with 16,680 participates in China, and finally 14,579 completed the study. About a half received an EC skin test and the others received TST. Adverse reactions were evaluated. Results Out of the 14,579 participants, 48.2% (7029/14,579) were males. The average age was 18.1 +/- 0.8 years and the average BMI was 20.9 +/- 3.1 kg/m(2). 50.4% (7351/14,579) participants received EC skin test and 49.6% (7228/14,579) received TST. The EC group had significantly less adverse reactions compared with the TST group (21.3%, 1565/7351 vs. 34.6%, 2499/7228, P = 0.000). The most common adverse reactions for EC were bleeding (5.63%, 414), dermatodyschroia (4.27%, 314), induration (3.90%, 287), swelling (2.49%, 183), pain (1.59%, 117) and pruritus (1.48%, 109). Bleeding, dermatodyschroia, swelling and erythema were significantly less in EC group (P < 0.05), while others were similar to those of TST. Conclusion the EC skin test was safe in our cohort. And its incidence of total adverse drug reactions (ADRs) is less than that of TST. Most adverse reactions were mild or moderate, lasting less than 48 h and self-limiting. Considering the satisfactory diagnostic accuracy in identifying tuberculosis infection, the cost and safety, the EC skin test might be a potential candidate for replacing TST in high burden countries or those with routine BCG vaccination. Clinical Trials Registration. ChiCTR2000038622, Safety of the EC skin test to screen tuberculosis infection in two universities, compared with the tuberculin skin test: a double-blind, randomized, controlled trial. registered on 26/09/2020 at .
Keywords
URL[Source Record]
Indexed By
Language
English
SUSTech Authorship
Corresponding
Funding Project
Shanghai Clinical key specialist Construction Project (Tuberculosis)[shslczdzk03002] ; National Science Foundation of China[81770014] ; Hunan Provincial Health Commission[20200855] ; Shanghai Public Health Clinical Center[KY-GW-2021-21]
WOS Research Area
Infectious Diseases
WOS Subject
Infectious Diseases
WOS Accession No
WOS:000866134800001
Publisher
ESI Research Field
IMMUNOLOGY
Data Source
Web of Science
Citation statistics
Cited Times [WOS]:1
Document TypeJournal Article
Identifierhttp://kc.sustech.edu.cn/handle/2SGJ60CL/406519
DepartmentSchool of Medicine
南方科技大学第一附属医院
南方科技大学第二附属医院
Affiliation
1.Fudan Univ, Shanghai Publ Hlth Clin Ctr, Shanghai 201508, Peoples R China
2.Cent Hosp Xiangtan, Dept Infect Dis & Publ Hlth, Xiangtan, Hunan, Peoples R China
3.Xiangtan Ctr Dis Control & Prevent, Xiangtan, Hunan, Peoples R China
4.Xiangtan First Peoples Hosp, Dept Gen Surg, Xiangtan, Hunan, Peoples R China
5.Southern Univ Sci & Technol, Natl Clin Res Ctr Infect Dis, Shenzhen Peoples Hosp 3, Dept Pulm Med,Affiliated Hosp 2,Sch Med, Shenzhen 518112, Guangdong, Peoples R China
Corresponding Author AffilicationSchool of Medicine;  The Third People's Hospital of Shenzhen;  Shenzhen People's Hospital
Recommended Citation
GB/T 7714
Yang, Yang,Fang, Zhixiong,Huang, Wei,et al. Safety of a Novel ESAT6-CFP10 skin test compared with tuberculin skin test in a double-blind, randomized, controlled study[J]. BMC INFECTIOUS DISEASES,2022,22(1).
APA
Yang, Yang.,Fang, Zhixiong.,Huang, Wei.,Zhang, Haiming.,Luo, Si.,...&Lu, Shuihua.(2022).Safety of a Novel ESAT6-CFP10 skin test compared with tuberculin skin test in a double-blind, randomized, controlled study.BMC INFECTIOUS DISEASES,22(1).
MLA
Yang, Yang,et al."Safety of a Novel ESAT6-CFP10 skin test compared with tuberculin skin test in a double-blind, randomized, controlled study".BMC INFECTIOUS DISEASES 22.1(2022).
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