Authors' objectives: The objective of this technology review was to assess the effectiveness, safety, and economic implications of ultra-portable digital X-ray for TB screening.

Authors' results and conclusions: Search results A total of 134 records were identified through the Ovid interface, Pubmed and other sources. After screening, 12 articles were assessed for eligibility and 122 records were excluded. After reading, appraising, and applying the inclusion and exclusion criteria to the 12 full-text articles, five were included while the other seven were excluded since the studies had irrelevant populations and few were narrative reviews. All full-text articles finally selected for this review were four cross-sectional studies and one qualitative study. Effectiveness There was limited retrievable evidence showing that an ultraportable digital x-ray system with AI-enhanced interpretations demonstrated variable sensitivity ranging from 89.4% to 95.3% and variable specificity ranging from 29.8% to 62.8%. The combination of chest X-ray (CXR) and symptoms reported higher sensitivity (97.7%) in detecting TB in remote settings. Limited retrievable evidence suggested that while the ultra-portable system met operational standards, it exhibited slightly lower image quality than conventional systems, yet yielded comparable TB detection rates. Limited retrievable evidence suggested high agreement between ultra-portable digital x-ray device and conventional methods. Safety There was very limited retrievable evidence showing that radiation levels from the ultra-portable X-ray system for participants and health workers remained below international safety limits. Despite this, additional precautions were taken by the National Lung Hospital in Vietnam, such as technicians being positioned away from sites and protective gear being worn. Notably, limited evidence on the safety of such ultraportable X-ray systems was available in medical databases. However, certain products, had received CE/USFDA certification, while others were in the certification process. The Philippines' FDA approved the use of these machines in TB screening, and in Malaysia, Fuji Xair was classified as a Class C Medical Device by the MDA. Organisational Healthcare providers’ perspective Limited evidence on the experiences of healthcare providers from six pilot sites, including countries like Nigeria, Vietnam, and Zambia, using ultraportable digital xray systems with DXR-CAD software for TB screening highlighted its potential to decentralize TB screening, emphasizing its portability and integration capabilities. However, challenges such as battery limitations, image quality concerns, and data integration complexities were also identified. Guidelines In 2021, the WHO and International Atomic Energy Agency (IAEA) set technical specifications for ultra-portable X-ray systems, emphasizing their use in remote areas when transferring patients to hospital radiology departments is unfeasible. The Stop TB partnership, backed by USAID and Global Affairs Canada, introduced guidelines for TB screening using CAD technology and ultra-portable X-ray systems. These guidelines address the challenges of system weight, battery reliance, radiation safety, and emphasize the need for proper training and compliance with safety standards. Economic implication There was no retrievable evidence on the cost or cost-effectiveness of an ultraportable X-ray system for TB. Conclusion Based on the review, limited retrievable evidence suggests that ultraportable X-ray systems, coupled with AI and computer-aided detection, have the potential to enhance TB screening in remote settings. Its performance is moderate in sensitivity ranging from 89.4% to 95.3%, and specificity ranging from 29.8% to 62.8%, better compared to symptom screening alone. Limited retrievable evidence also indicates that these systems appeared safe with exposure and leakage doses below the recommended limits for TB screening. However, economic implications remain unclear, and organizational challenges include integration complexities, limited capacity in implementing computer-aided detection, lack of radiation safety guidance, and the dual need for data protection and sharing, demanding comprehensive support, despite being perceived as valuable for TB screening decentralisation in a programmatic setting.

Authors' methods: A systematic search was conducted on the following databases without any restriction on publication language and publication status. The Ovid interface: Ovid MEDLINE(R) and Epub Ahead of Print, In-Process, In-Data-Review & Other Non Indexed Citations and Daily 1946 to Dec 1st, 2023. Searches were also run in PubMed and INAHTA databases. Google was used to search for additional webbased materials and information. Additional articles were identified by reviewing the references of retrieved articles. The last search was conducted on 1st December 2023.

Project Status: Completed

URL for project: https://www.moh.gov.my/index.php/database_stores/store_view_page/30/411

Year Published: 2023

URL for published report: https://www.moh.gov.my/index.php/database_stores/store_view_page/30/411

Requestor: Disease Control Division

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Malaysia

Organisation Name: Malaysian Health Technology Assessment

Contact Address: Malaysian Health Technology Assessment Section, Ministry of Health Malaysia, Federal Government Administrative Centre, Level 4, Block E1, Parcel E, 62590 Putrajaya Malaysia Tel: +603 8883 1229

Contact Name: htamalaysia@moh.gov.my

Contact Email: htamalaysia@moh.gov.my

Copyright: Malaysian Health Technology Assessment Section (MaHTAS)