Factors Associated with the Performance of Direct PCR Detection of Mycobacteria in Clinical Specimens: Retrospective Real-world Data
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Background: Tuberculosis caused by Mycobacterium tuberculosis (MTB) remains a major health problem worldwide. Nontuberculous mycobacteria (NTM) infection is the primary cause of pulmonary disease. Currently, for early diagnosis of mycobacterial infection, direct PCR detection in clinical specimens is used. This study aimed to identify factors affecting the direct PCR detection of mycobacteria from clinical specimens. Methods: Records of mycobacterial culture from October 2016 to July 2020 were retrospectively reviewed. Using culture as the reference method, the performance of direct PCR detection was calculated. Differences in analytical performances among mycobacteria species, specimen type, and acid-fast bacillus (AFB) staining were determined using chi-squared or Fisher’s exact test. Results: Of the 27,267 culture datasets, 1,586 datasets were selected. The sensitivity of direct PCR detection for NTM was 27.6% (95% confidence interval [CI], 22.3–33.5) in sputum and 47.8% (95% CI, 37.3–58.5) in bronchial washing fluid (P<0.001). The sensitivity of direct PCR detection showed higher sensitivity in smear-positive AFB than in smear-negative AFB for both MTB (93.8% vs. 51.2%; P<0.001) and NTM (68.3% vs. 26.1%; P<0.001). Conclusions: AFB staining results were related with the direct PCR detection of MTB and NTM, whereas the respiratory specimen type was related with the direct PCR detection of NTM.
Abstract
Background: Tuberculosis caused by Mycobacterium tuberculosis (MTB) remains a major health problem worldwide. Nontuberculous mycobacteria (NTM) infection is the primary cause of pulmonary disease. Currently, for early diagnosis of mycobacterial infection, direct PCR detection in clinical specimens is used. This study aimed to identify factors affecting the direct PCR detection of mycobacteria from clinical specimens. Methods: Records of mycobacterial culture from October 2016 to July 2020 were retrospectively reviewed. Using culture as the reference method, the performance of direct PCR detection was calculated. Differences in analytical performances among mycobacteria species, specimen type, and acid-fast bacillus (AFB) staining were determined using chi-squared or Fisher’s exact test. Results: Of the 27,267 culture datasets, 1,586 datasets were selected. The sensitivity of direct PCR detection for NTM was 27.6% (95% confidence interval [CI], 22.3–33.5) in sputum and 47.8% (95% CI, 37.3–58.5) in bronchial washing fluid (P<0.001). The sensitivity of direct PCR detection showed higher sensitivity in smear-positive AFB than in smear-negative AFB for both MTB (93.8% vs. 51.2%; P<0.001) and NTM (68.3% vs. 26.1%; P<0.001). Conclusions: AFB staining results were related with the direct PCR detection of MTB and NTM, whereas the respiratory specimen type was related with the direct PCR detection of NTM.
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