Tuberculosis
Conditions
Interventions
cobas MTB v2 assay
Sponsors
Roche Molecular Systems Roche Diagnostics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Prospectively Enrolled Patients: a) Participant is adult (=18 years old) and is able/willing to provide written informed consent. Enrolled participant may meet inclusion criterion for either (b) or (c): b) Participant endorses having at least one TB-related symptom – fever, night sweats, weight loss, hemoptysis, or cough for = 2 weeks, or participant has pulmonary chest xray concerning for possible pulmonary TB disease. *OR* c) Participant recruited based on having a prior confirmed MTB diagnosis of pulmonary TB disease.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Prospectively Enrolled Patients a) Participants who were treated for previously diagnosed TB within the 12 months prior to study enrollment and/or prospective sample collection.* b) Participants who are currently participating in a TB-related clinical trial with a pharmacological therapeutic intervention or experimental vaccination *Specimens may be obtained from TB patients (based on TB PCR and/or culture positive result and/ or related symptoms and pulmonary chest x-ray diagnosed in the 2 weeks prior to enrollment) who have not received treatment for more than 3 days prior.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this clinical performance study is: To evaluate the diagnostic accuracy (sensitivity and specificity) of cobas® MTB v2 on raw sputum and sputum sediment samples from individuals who have an indication for pulmonary TB testing, when compared to a sputum sample-based microbiological reference standard (MRS). Sediment samples may also include: bronchoalveolar lavage (BAL), and/or tracheobronchial secretion (TBS). NOTE: MRS is defined as at least one positive test result from sputum culture (MTB growth via solid or liquid culture) or NAAT (e.g. Cepheid Xpert® MTB/RIF Ultra, with a semiquantitative result of ‘very low’ or higher). | — |
Secondary
| Measure | Time frame |
|---|---|
| The exploratory objectives 1 to 4 are not listed according to their priority. The feasibility of pursuing the exploratory objectives will depend on the availability of the required samples and resources. 1. To evaluate the diagnostic accuracy of tongue swabs tested on cobas® MTB v2 among individuals who have an indication for pulmonary TB testing, when compared to solid or liquid culture, a NAAT, or a MRS. 2. To evaluate the diagnostic accuracy of cobas® MTB v2 on raw sputum, sputum/BAL/TBS sediment, and tongue swab samples from individuals who have an indication for pulmonary TB testing, when compared to a clinical reference standard (CRS). NOTE: CRS is defined as meeting the MRS definition and/or receiving/initiating TB treatment within 2 months of study enrollment and specimen collection. 3. To assess whether cobas® MTB v2 Ct (cycle threshold) values on raw sputum, sputum/BAL/TBS sediment, and tongue swab samples are associated with MTB bacillary load, as measured by Cepheid Xpert® MTB/RIF Ultra Ct values, time to culture positivity, AFB microscopy, and clinical disease severity (based on the observed radiologic abnormalities). 4. To evaluate the yield* of tongue swabs for MTB diagnosis versus expectorated sputum tested on cobas® MTB v2 obtained from individuals producing sufficient spontaneous sputum and those unable to produce sufficient spontaneous sputum (i.e., requiring induced sputum and/or BAL/TBS specimens). *Diagnostic yield is defined as the proportion of diagnostic tests that successfullyidentify a disease or condition within a population, calculated by dividing the number of positive results (true positives) by the total number of tests performed. Additional analyses may be performed which will be described in the statistical analysis plan. | — |
Countries
South Africa
Contacts
Public ContactSamantha Aucock
Study Manager
Outcome results
None listed