Clinical Performance of a Molecular-based Lateral Flow Assay for Rapid and Simultaneous Detection of Tuberculosis and Non-Tuberculous Mycobacteria in Indonesia
DOI:
https://doi.org/10.36497/jri.v46i2.1071Keywords:
nucleic-acid lateral immunoflow assay, rapid molecular test, TB diagnosisAbstract
Background: Diagnostic modalities that can differ Tuberculosis (TB) and Non-Tuberculosis Mycobacteria (NTM) are urgently needed, especially in TB high burden areas, to avoid misdiagnosis. A rapid molecular approach can be utilized to accommodate easy implementation for routine diagnosis in low-resource countries to decrease the turnaround time and increase sensitivity significantly. This study evaluated the diagnostic performance of PaxView® TB/NTM, a rapid multiplex PCR assay that utilizes universal lateral flow technology for the simultaneous detection and visualization of TB and NTM.
Methods: The study was conducted in Bandung, Indonesia, using sputum samples from the outpatient TB clinic in Hasan Sadikin General Hospital. Sputum samples were collected consecutively from each patient. All the eligible samples underwent microbiological work-up and Xpert MTB/RIF testing with different sputum taken previously. The collected sputum was extracted, amplified, and then visualized using the PaxView® TB/NTM MPCR-ULFA kit.
Results: The sensitivity and specificity of the PaxView® MPCR-ULFA were 83.0% and 92.1%, respectively. The positivity rate for MPCR ULFA showed significantly higher results (43.0%) compared to culture (32.8%), smear microscopy (26.3%), and was comparable with the Xpert MTB/RIF assay (43.5%). A total of 23 confirmed NTM-positive cases were found in this study (2.6%).
Conclusion: The PaxView® MPCR-ULFA demonstrated promising performance for MTB and NTM detection. The sensitivity and specificity of this kit are comparable to those of other molecular diagnostic modalities. The simple platform using a test strip and straightforward visualization might be appropriately applied in poorly-equipped laboratories.
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