Tuberculosis and non tuberculosis mycobacterial diseases
Conditions
Interventions
Gold Standard:Phenotypic drug resistance testing (liquid culture method):The drug resistance of Mycobacterium tuberculosis to certain drugs is evaluated by culturing the bacteria and performing growth
Index test:PTseqTM-TB Mycobacterium Targeted High-Throughput Sequencing Product Based on tNGS Technology
Sponsors
Henan Provincial Chest Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study 1 a) Resuscitable clinical strains (MTB and NTM) are available; b) Have phenotypic resistance test results or molecular test results. Study 2 Inclusion criteria for the drug-resistant TB group: Prior to enrollment, there must be clear evidence of drug resistance or suspected drug-resistant TB (criteria a-c must meet at least one item, and d and e must meet all conditions). a) Positive sputum Xpert MTB/RIF (Ultra) test or other molecular test results for TB and drug resistance; b) Failure of anti-tuberculosis therapy after >=3 months of standard TB treatment, with positive sputum smear or culture; c) Diagnosis of RR-TB/MDR-TB, with positive sputum smear or culture=3 months after receiving anti-TB therapy and treatment failure; d) Availability of clinical samples; e) Signed informed consent (or consent signed by a guardian). Inclusion criteria for the sensitive TB group (all of the following must be met): a) Positive sputum Xpert MTB/RIF (Ultra) test or other molecular detection results for TB, with negative drug resistance results prior to enrollment; b) Current evidence excludes drug-resistant tuberculosis; c) Has not received any form of anti-TB therapy, or has received anti-TB therapy for less than 1 month; d) No close contact with known drug-resistant TB cases; e) Availability of clinical samples; f) Signed informed consent (or consent signed by a guardian). Study 3 a) Suspected mycobacterial infection or clinically diagnosed mycobacteriosis, confirmed by chest X-ray, clinical symptoms or signs, immunological diagnosis, or etiological/pathological examination; b) After enrollment, subjects must undergo mycobacterium culture, with those showing positive mycobacterium culture required to undergo phenotypic drug resistance testing. At least one molecular test, other than tNGS, is available or accepted after enrollment; c) Can provide sputum or bronchoalveolar lavage fluid (BALF) and other types of clinical specimens; d) Signed informed consent (or consent signed by a guardian).
Exclusion criteria
Exclusion criteria: Study 1 a) Phenotypic resistance test results are unclear, or molecular test results are unavailable. Study 2 a) The sample size is insufficient for simultaneous phenotypic resistance testing and PTseqTM-TB testing (sample volume is less than 1.3 mL); b) Clinical information is incomplete; c) Withdrawal of informed consent. Study 3 a) The sample size is insufficient for simultaneous phenotypic resistance testing and PTseqTM-TB testing (sample volume is less than 1.3 mL); b) Clinical information is incomplete; c) Withdrawal of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity and specificity of PTseqTM-TB and their 95% confidence interval.;The readout of PTseqTM-TB for the target genes and the proportion of SNPs with related drug-resistant mutations.;PTseqTM-TB for the MIC50 of each target drug phenotype susceptibility test.;Diagnostic sensitivity and specificity estimates of PTseqTM-TB for each target drug, along with their 95% confidence intervals.;The differences in diagnostic performance and drug resistance prediction performance of PTseqTM-TB across different sub-centers; | — |
Secondary
| Measure | Time frame |
|---|---|
| Turnaround time for TB diagnosis by different methods;Turnaround time for diagnosing drug resistance by different methods;Diagnostic performance of PTseqTM-TB for different clinical specimens;Detection success/failure rate of PTseqTM-TB; | — |
Countries
China
Contacts
Public ContactLiang Ruixia
Henan Provincial Chest Hospital
Outcome results
None listed