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

NCT05405296 | Unknown

• 1 other identifier: TB050
• Study Type: observational
• Target: 1,480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

TB; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19, with 95% confidence intervals, using a country-approved RT-PCR 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

  2 days

• Estimate of the proportion of presumptive TB patients with COVID-19

  2 days

• Estimate of the proportion of TB patients (confirmed by MRS) with COVID-19

  2 days

• Analysis of survey responses using proportions and Linkert scale averages

  2 days

Interventions

Truenat™ MTB Plus/COVID-19 DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead

Study Sites (1)

Makarere University

Kampala, Uganda

Location

Related Publications (1)

• Inbaraj LR, Daniel J, Sathya Narayanan MK, Srinivasalu VA, Bhaskar A, Scandrett K, Rajendran P, Kirubakaran R, Shewade HD, Malaisamy M, Padmapriyadarsini C, Takwoingi Y. Truenat MTB assays for pulmonary tuberculosis and rifampicin resistance in adults and adolescents. Cochrane Database Syst Rev. 2025 Mar 24;3(3):CD015543. doi: 10.1002/14651858.CD015543.pub2.

  PMID: 40122135 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tongue swabs

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 6, 2022
• Study Start: August 30, 2022
• Primary Completion: April 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)