A Systematic Review on the Safety of Mycobacterium tuberculosis-Specific Antigen-Based Skin Tests for Tuberculosis Infection Compared With Tuberculin Skin Tests

Yohhei Hamada*, Irina Kontsevaya, Elena Surkova, Ting Ting Wang, Liu Wan-Hsin, Aleksandr Matveev, Liliya Eugenevna Ziganshina, Claudia M. Denkinger, Alexei Korobitsyn, Nazir Ismail, Ibrahim Abubakar, Molebogeng X. Rangaka*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

5 Citations (Scopus)

Abstract

Background: A systematic review showed that the accuracy of Mycobacterium tuberculosis antigen-based skin tests (TBSTs) for tuberculosis is similar to that of interferon γrelease assay, but the safety of TBSTs has not been systematically reviewed. Methods: We searched for studies reporting injection site reactions (ISRs) and systemic adverse events associated with TBSTs. We searched Medline, Embase, e-library, the Chinese Biomedical Literature Database, and the China National Knowledge Infrastructure database for studies through 30 July 2021, and the database search was updated until 22 November 2022. Results: We identified 7 studies for Cy-Tb (Serum Institute of India), 7 (including 2 found through the updated search) for C-TST (Anhui Zhifei Longcom), and 11 for Diaskintest (Generium). The pooled risk of any injection site reactions (ISRs) due to Cy-Tb (n = 2931; 5 studies) did not differ significantly from that for tuberculin skin tests (TSTs; risk ratio, 1.05 [95% confidence interval,. 70-1.58]). More than 95% of ISRs were reported as mild or moderate; common ISRs included pain, itching, and rash. In 1 randomized controlled study, 49 of 153 participants (37.6%) given Cy-Tb experience any systemic adverse event (eg, fever and headache), compared with 56 of 149 participants (37.6%) given TST (risk ratio, 0.85 [95% confidence interval,. 6-1.2]). In a randomized controlled study in China (n = 14 579), the frequency of systemic adverse events in participants given C-TST was similar to that for TST, and the frequency of ISRs was similar to or lower than that for TST. Reporting of the safety data on Diaskintest was not standardized, precluding meta-analysis. Conclusion: The safety profile of TBSTs appears similar to that of TSTs and is associated with mostly mild ISRs.

Original languageEnglish
Article numberofad228
JournalOpen Forum Infectious Diseases
Volume10
Issue number5
DOIs
Publication statusPublished - 1 May 2023
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2023 The Author(s). Published by Oxford University Press on behalf of Infectious Diseases Society of America.

Keywords

  • IGRA
  • LTBI
  • TST
  • diagnostics classification description
  • skin tests

Fingerprint

Dive into the research topics of 'A Systematic Review on the Safety of Mycobacterium tuberculosis-Specific Antigen-Based Skin Tests for Tuberculosis Infection Compared With Tuberculin Skin Tests'. Together they form a unique fingerprint.

Cite this