Pathogen Identification via Sequencing and Amplification for Mycobacterium tuberculosis Infection (PISA-MTB)

PISA-MTB is a tNGS product designed for the entire course of tuberculosis（TB）patients. Based on high-multiplex targeted amplification and NGS technology, PISA-MTB© can cover Mycobacterium tuberculosis complex (MTBC), 16 non-tuberculous mycobacteria (NTM), 47 pathogens requiring differential diagnosis or reported MTBC co-infection, and 158 resistance gene mutation types associated with 14 first-line and second-line anti-tuberculosis drugs, and is suitable for the diagnosis of suspected pulmonary TB, extrapulmonary TB (tuberculous meningitis, tuberculous spondylitis, tuberculous peritonitis, thoracic tuberculosis, tuberculous arthritis, urinary tract tuberculosis, etc.), retractable TB, drug-resistant TB, NTM, TB mixed infection, etc. Sample types include but are not limited to bronchoalveolar lavage fluid (BALF), sputum, hydrothorax, ascites, cerebrospinal fluid(CSF), tissue, joint fluid, etc.

1. Detection Scope

2. Clinical Application Scenarios

①Patients with suspected tuberculosis who are negative on routine sputum-related tests or whose diagnosis cannot be confirmed with the addition of balf tests.


②Patients with suspected tuberculous pleurisy who have a typical clinical performance but whose routine tests are negative and no other causes of pleural effusion can be identified.


③Patients with suspected extrapulmonary TB. Clinical samples from this type of patient have low levels of Mycobacterium and are more difficult to diagnose;


④For patients with relapsed TB who have been treated with regular anti-tuberculosis therapy with unsatisfactory results and who routinely test negative and are recommended to detect to clarify drug-resistant status.


⑤Patients with suspected NTM disease, especially those with positive antacid bacillus smears during the same period.


⑥Patients considered to be multi-drug resistant to TB or NTM disease are recommended to be test timely to obtain further evidence of multi-drug resistance, and bacillus-rich clinical specimens or strains are recommended for testing.

3. Dection Workflow

Not for use in diagnostic procedures (except as specifically noted).