Abstract
Purpose: Tuberculosis (TB) is mainly caused by Mycobacterium tuberculosis, which is a pathogenic mycobacterial species grouped under Mycobacterium tuberculosis complex (MTBC) with four other pathogenic mycobacterial species. The mycobacteria not included in MTBC are known as nontuberculous mycobacteria (NTM), and cause several pulmonary diseases including pneumonia. Currently, NTM occurrences in TB-suspected respiratory specimens have increased, due to which, precise detection of MTBC and NTM is considered critical for the diagnosis and vaccination of TB. Among the various methods available, real-time PCR is frequently adopted for MTBC/NTM detection due to its rapidness, accuracy, and ease of handling. In this study, we evaluated a new real-time PCR kit for analytical and clinical performance on sputum, bronchial washing, and culture specimens. Materials and Methods: For assessing its analytical performance, limit of detection (LOD), reactivity, and repeatability test were performed using DNA samples. To evaluate clinical performance, 612 samples were collected and clinically tested at a tertiary hospital. Results: LOD was confirmed as 0.584 copies/μL for MTBC and 47.836 copies/μL for NTM by probit analysis (95% positive). For the reactivity test, all intended strains were detected and, in the repeatability test, stable and steady results were confirmed with coefficient of variation ranging from 0.36 to 1.59. For the clinical test, sensitivity and specificity were 98.6%-100% and 98.8%-100% for MTBC and NTM, respectively. Conclusion: The results proved the usefulness of the kit in TB diagnosis. Furthermore, it could be adopted for the assessment of vaccine efficacy.
Original language | English |
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Pages (from-to) | 111-118 |
Number of pages | 8 |
Journal | Clinical and Experimental Vaccine Research |
Volume | 7 |
Issue number | 2 |
DOIs | |
Publication status | Published - 2018 Jul |
Externally published | Yes |
Bibliographical note
Funding Information:This study was supported by Genetree Research.
Funding Information:
This study was supported by the Ministry of Health & Welfare, Republic of Korea (HI15C2955) and Basic Science Research Program through the NRF funded by the Ministry of Science, ICT & Future Planning (NRF-2015M3A9B5030157).
Publisher Copyright:
© Korean Vaccine Society.
Keywords
- BCG vaccine
- Mycobacterium tuberculosis complex
- Nontuberculous mycobacteria
- Real-time polymerase chain reaction
- Tuberculosis
ASJC Scopus subject areas
- Immunology and Allergy
- Pharmacology
- Public Health, Environmental and Occupational Health
- Infectious Diseases