Evaluation of the Truenat™MTB Plus/COVID-19 Test for TB (Tuberculosis) and COVID-19 (SARS-CoV2) (Truenat COMBO)

Performance Evaluation of the Molbio Diagnostics Truenat™MTB Plus/COVID-19for TB and COVID-19case Detection Using Prospectively Collected NP (Nasopharyngeal) Swabs and Sputum Samples From Participants With Symptoms Suggestive of TB

This is a prospective, multicentre study in which the accuracy of the Molbio Diagnostics Truenat™ MTB (Mycobacterium tuberculosis) Plus/COVID-19multiplex will be assessed for TB and COVID-19 case detection using prospectively collected NP swabs and sputum samples from patients with symptoms suggestive of TB.

The overall study period is of 24 months which includes telephonic follow-up of the baseline COVID-19negative patients at 2 weeks and of all participants at 2 months.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19; TB
• Intervention / Treatment: Device: Truenat™ MTB Plus/COVID-19

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 1480

Contacts and Locations

• Study Contact: Name: Rita Szekely, Phd; Phone Number: +41 22 749 29 32; Email: Rita.Szekely@finddx.org
• Study Contact Backup: Name: Adam Penn-Nicholson, Phd; Phone Number: +41 22 749 29 46; Email: Adam.Penn-Nicholson@finddx.org

Study Locations

• Uganda
  • Kampala, Uganda
    • Makarere University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study focuses on adults with presumptive TB. Study sites are selected to maximize the generalizability of evidence generated based on the following criteria: 1) TB incidence ≥100 per 100,000 population; 2) HIV prevalence; 3) ongoing community transmission of COVID-19; and 4) laboratory and clinical study infrastructure to support participant recruitment.

Location: the study will take place in 4different countries: South Africa, Uganda, Peru, India Prospective approval of protocol deviations to recruitment and enrolment criteria, also known as protocol waivers or exemptions, are not permitted.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19	Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19, with 95% confidence intervals, using the defined TB MRS	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19, with 95% confidence intervals, using a country-approved RT-PCR COVID-19	Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19, with 95% confidence intervals, using a country-approved RT-PCR ( real time polymerase chain reaction) COVID-19	2 days
Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19multiplex for TB detection compared to Xpert Ultra among presumptive TB patients using a MRS	Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19multiplex for TB detection compared to Xpert Ultra among presumptive TB patients using a MRS	2 days
Estimate of the proportion of presumptive TB patients with COVID-19	Estimate of the proportion of presumptive TB patients with COVID-19 confirmed by country-approved RT-PCR Covid-19 assay) (expressed as a percentage)	2 days
Estimate of the proportion of TB patients (confirmed by MRS) with COVID-19	Estimate of the proportion of TB patients (confirmed by MRS) with COVID-19(confirmed by country-approved RT-PCR Covid-19 assay) (expressed as a percentage)	2 days
Analysis of survey responses using proportions and Linkert scale averages	Analysis of survey responses using proportions and Linkert scale averages	2 days

Collaborators and Investigators

• Sponsor: Foundation for Innovative New Diagnostics, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: TB050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No