TY - JOUR
T1 - Performance of Nucleic Acid Amplification Tests in Patients with Presumptive Pulmonary Tuberculosis in Taiwan
AU - Huang, Wei Chang
AU - Lin, Chih Bin
AU - Chien, Shun Tien
AU - Wang, Jann Yuan
AU - Lin, Chou Jui
AU - Feng, Jia Yih
AU - Lee, Chih Hsin
AU - Shu, Chin Chung
AU - Yu, Ming Chih
AU - Lee, Jen Jyh
AU - Chiang, Chen Yuan
N1 - Funding Information:
This work was supported by the Ministry of Science and Technology, Taiwan (MOST 108-2314-B-038-122). The Rapid Service Fee was funded by the Taichung Veterans General Hospital, Taichung, Taiwan.
Funding Information:
We thank the participants of the study and Dr. Gwan-Han Shen, who supervised Laboratory No. 114 at Taichung Veterans General Hospital and passed away in 2014. We hold you dear in our memory.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/4
Y1 - 2022/4
N2 - Introduction: Several nucleic acid amplification tests (NAATs) for detection of Mycobacterium tuberculosis (TB) complex (MTBC) are available in Taiwan; however, their performances may differ and have not been extensively evaluated. Therefore, we aimed to explore the accuracy of NAATs overall followed by comparison between platforms commonly used in Taiwan. Methods: This study enrolled presumptive pulmonary TB patients with NAATs throughout Taiwan. The diagnostic performance of smear microscopy and NAATs was assessed using sputum culture as a reference standard. To investigate the performance of NAATs in excluding non-tuberculous mycobacteria (NTM), we quantified the false-positive proportion of NAATs in patients infected with NTM. Results: Of the 4126 enrollees, 860 (20.8%) had positive NAATs. The sensitivity and specificity of NAATs were 83.2% and 96.7%, respectively, compared to 81.5% and 55.3% for smear. There was no significant difference in sensitivity between the NAATs and smear; however, the specificity of smear was significantly lower than that of the NAATs [difference 41.4%, 95% confidence interval (CI) 39.6–43.2%]. There was no significant difference in sensitivity among Roche Cobas Amplicor Mycobacterium tuberculosis assay (Amplicor), Xpert MTB/RIF assay (Xpert) and in-house polymerase chain reaction (in-house PCR) (82.2% versus 83.8% versus 82.4%); however, in-house PCR was significantly less specific than Amplicor (difference 5.3%, 95% CI 2.4–8.2%) and Xpert (difference 5.8%, 95% CI 3.1–8.5%). The sensitivity of NAATs among smear-negative cases was 33.1% (95% CI 26.0–40.3%). In-house PCR had a significantly higher false-positive rate among specimens that were culture positive for NTM than Amplicor (7.7% versus 0.3%; difference 7.4%, 95% CI 3.4–11.5%) and Xpert (7.7% versus 0.7%; difference 7.0%, 95% CI 2.9–11.0%). Conclusion: The NAATs overall had a relatively high sensitivity and specificity in detecting MTBC while Amplicor and Xpert performed better than in-house PCR in excluding NTM. Our findings will be useful for the development of national policy.
AB - Introduction: Several nucleic acid amplification tests (NAATs) for detection of Mycobacterium tuberculosis (TB) complex (MTBC) are available in Taiwan; however, their performances may differ and have not been extensively evaluated. Therefore, we aimed to explore the accuracy of NAATs overall followed by comparison between platforms commonly used in Taiwan. Methods: This study enrolled presumptive pulmonary TB patients with NAATs throughout Taiwan. The diagnostic performance of smear microscopy and NAATs was assessed using sputum culture as a reference standard. To investigate the performance of NAATs in excluding non-tuberculous mycobacteria (NTM), we quantified the false-positive proportion of NAATs in patients infected with NTM. Results: Of the 4126 enrollees, 860 (20.8%) had positive NAATs. The sensitivity and specificity of NAATs were 83.2% and 96.7%, respectively, compared to 81.5% and 55.3% for smear. There was no significant difference in sensitivity between the NAATs and smear; however, the specificity of smear was significantly lower than that of the NAATs [difference 41.4%, 95% confidence interval (CI) 39.6–43.2%]. There was no significant difference in sensitivity among Roche Cobas Amplicor Mycobacterium tuberculosis assay (Amplicor), Xpert MTB/RIF assay (Xpert) and in-house polymerase chain reaction (in-house PCR) (82.2% versus 83.8% versus 82.4%); however, in-house PCR was significantly less specific than Amplicor (difference 5.3%, 95% CI 2.4–8.2%) and Xpert (difference 5.8%, 95% CI 3.1–8.5%). The sensitivity of NAATs among smear-negative cases was 33.1% (95% CI 26.0–40.3%). In-house PCR had a significantly higher false-positive rate among specimens that were culture positive for NTM than Amplicor (7.7% versus 0.3%; difference 7.4%, 95% CI 3.4–11.5%) and Xpert (7.7% versus 0.7%; difference 7.0%, 95% CI 2.9–11.0%). Conclusion: The NAATs overall had a relatively high sensitivity and specificity in detecting MTBC while Amplicor and Xpert performed better than in-house PCR in excluding NTM. Our findings will be useful for the development of national policy.
KW - In-house PCR
KW - Nucleic acid amplification
KW - Performance
KW - Roche Cobas Amplicor Mycobacterium tuberculosis assay
KW - Xpert MTB/RIF assay
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U2 - 10.1007/s40121-022-00610-2
DO - 10.1007/s40121-022-00610-2
M3 - Article
AN - SCOPUS:85125737145
SN - 2193-8229
VL - 11
SP - 871
EP - 885
JO - Infectious Diseases and Therapy
JF - Infectious Diseases and Therapy
IS - 2
ER -
