Multicenter Testing of a Simple Molecular Diagnostic System for the Diagnosis of Mycobacterium Tuberculosis

Hyo Joo Lee, Nam Hun Kim, Eun Hye Lee, Young Soon Yoon, Yun Jeong Jeong, Byung Chul Lee, Bonhan Koo, Yoon Ok Jang, Sung Han Kim, Young Ae Kang, Sei Won Lee, Yong Shin

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

Mycobacterium tuberculosis (MTB) is a communicable disease and still remains a threat to common health. Thus, early diagnosis and treatment are required to prevent the spread of infection. Despite the recent advances in molecular diagnostic systems, the commonly used MTB diagnostic tools are laboratory-based assays, such as mycobacterial culture, MTB PCR, and Xpert MTB/RIF. To address this limitation, point-of-care testing (POCT)-based molecular diagnostic technologies capable of sensitive and accurate detection even in environments with limited sources are needed. In this study, we propose simple tuberculosis (TB) molecular diagnostic assay by combining sample preparation and DNA-detection steps. The sample preparation is performed using a syringe filter with amine-functionalized diatomaceous earth and homobifunctional imidoester. Subsequently, the target DNA is detected by quantitative PCR (polymerase chain reaction). The results can be obtained within 2 h from samples with large volumes, without any additional instruments. The limit of detection of this system is 10 times higher than those of conventional PCR assays. We validated the clinical utility of the proposed method in 88 sputum samples obtained from four hospitals in the Republic of Korea. Overall, the sensitivity of this system was superior to those of other assays. Therefore, the proposed system can be useful for MTB diagnosis in limited-resource settings.

Original languageEnglish
Article number259
JournalBiosensors
Volume13
Issue number2
DOIs
StatePublished - Feb 2023

Keywords

  • NAs extraction
  • molecular diagnostics
  • sample preparation
  • tuberculosis

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