① Background
According to the World Health Organization’s tuberculosis statistics, in 2022, 30 high-burden countries accounted for 87% of new tuberculosis cases. Bangladesh, China, the Democratic Republic of the Congo, India, Indonesia, Nigeria, Pakistan, and the Philippines accounted for two-thirds of the total. Drug-resistant tuberculosis remains a public health crisis and a threat to global health security. In 2022, only about two-fifths of people with drug-resistant tuberculosis received treatment. In some cases, if treatment is inadequate, more severe forms of drug-resistant tuberculosis may arise. Pre-XDR-TB and XDR-TB are types of tuberculosis that respond less to available drugs. Traditional microbiological diagnostic methods are the gold standard for clinical Mycobacterium tuberculosis detection. However, they have high false-negative/false-positive rates, low sensitivity and specificity, and cannot distinguish between tuberculosis and nontuberculous mycobacteria, and are time-consuming. Traditional infectious disease diagnostics are challenging, and there is an urgent need for rapid, comprehensive, and accurate methods for pathogen and drug resistance testing.
② Technology
Based on the nano-pore sequencing platform and the super-multiple PCR technology, an independently developed project was established for targeted detection of Mycobacterium tuberculosis complex and non-tuberculous mycobacteria. It can detect Mycobacterium tuberculosis complex, 40 kinds of non-tuberculous mycobacteria (including 17 kinds most often encountered in clinic), 6 drug resistance genes related to 4 first-line tuberculosis drugs, and 13 drug resistance genes related to 11 second-line tuberculosis drugs at the same time.
③ Detection range
A. Mycobacterium tuberculosis complex (MTBC), including Mycobacterium tuberculosis, Mycobacterium africanum, Mycobacterium bovis, etc.
B. 40 species of nontuberculous mycobacteria (NTM), focusing on the 17 species most commonly encountered in the clinical environment.
C. Six resistance genes associated with four first-line tuberculosis drugs. Thirteen resistance genes associated with eleven second-line tuberculosis drugs.
Mycobacterium tuberculosis complex (MTBC) |
Mycobacterium tuberculosis | Mycobacterium bovis | Mycobacterium africanum | Mycobacterium canettii | Mycobacterium caprae |
Mycobacterium microti | Mycobacterium pinnipedii | Mycobacterium mungi | Mycobacterium orygis |
|
Non-tuberculous mycobacteria (NTM) |
Mycobacterium avium complex (MAC) | Mycobacterium kansasii | Mycobacterium abscessus | Mycobacterium fortuitum | Mycobacterium chelonae |
Mycobacterium marinum | Mycobacterium xenopi | Mycobacterium gordonae | Mycobacterium szulgai | Mycobacterium haemophilum |
Mycobacterium scrofulaceum | Mycobacterium malmoense | Mycobacterium simiae | Mycobacterium goodii | Mycobacterium mucogenicum |
Mycobacterium genavense | Mycobacterium peregrinum | Mycobacterium terrae | Mycobacterium triplex | Mycobacterium wolinskyi |
The above table only shows a part of the testing scope.
④ Applicable people
