This is a prospective, multicentre study in which the accuracy of the Molbio DiagnosticsTruenat™ MTB (Mycobacterium tuberculosis) Plus/COVID-19multiplex will be assessed for TBand COVID-19 case detection using prospectively collected NP swabs and sputum samplesfrom patients with symptoms suggestive of TB.The overall study period is of 24 months which includes telephonic follow-up of thebaseline COVID-19negative patients at 2 weeks and of all participants at 2 months.
Adult patient with presumptive TB will be screened for inclusion at 4 geographically
diverse participating centres in high TB burden countries. This will be the first large
scale evaluation on prospectively collected fresh samples.
Telephonic follow-up visits at 2 weeks (for baseline COVID-19 negative patients) and 2
months (for all participants) after enrolment will help overcome the challenges of using
MRS only. Follow-up will be conducted telephonically two weeks post-enrolment for
participants who tested negative for COVID-19at enrolment to determine any change in
status -this is intended to account for participants who may have tested 'early' for
COVID-19at enrolment (false negative) but subsequently developed symptoms or tested
COVID-19positive. Similarly, investigators will conduct a telephonic follow-up two months
post-enrolment among all participants to determine if: 1) participants diagnosed with
confirmed TB at enrolment were linked to treatment; and 2) assess if any new TB diagnoses
were made.
This multi-center study will evaluate the performance of the Truenat™ MTB (Mycobacterium
tuberculosis) Plus/COVID-19multiplex test using prospectively collected NP swabs and
sputum samples from patients with symptoms suggestive of TB and collect alternative
tongue swab samples for further research use. The data gathered from this study, will
form part of the dossier to be submitted to WHO (world health organization) for review.
Device: Truenat™ MTB Plus/COVID-19
Truenat™ MTB Plus/COVID-19is a disposable, room temperature stable, chip-based Real Time
duplex PCR test, along with freeze dried PCR reagents provided in microtube for
performing Real Time PCR for infectious disease and runs on the Truelab® Real Time
micro-PCR Analyzer.
Inclusion Criteria:
- Adult (≥18 years); and
- Able to provide written informed consent in their chosen language; and
- Self-report at least one or more symptoms suggestive of pulmonary TB*; and
- Willing to return for a day 2 visit
- Willing to provide oral swab samples for biobanking * cough ≥2 weeks, fever, night
sweats or unintended weight-loss
Exclusion Criteria:
- Any tuberculosis preventive therapy (TPT) within 6 months prior to enrolment
- Any anti-TB treatment within 60 days prior to enrolment (not current episode)
- Unable to provide 3ml of sputum, nasopharyngeal and tongue swabs on Day1
- Unable to provide all study samples before starting the 3rddose of anti-TB
treatment.
Makarere University
Kampala, Uganda
Not Provided