Multiplex PCR -Microarray-based Assay in the Detection of Mycobacterium

Performance of a Multiplex PCR -Microarray-based Assay in the Detection of Mycobacterium Tuberculosis and Non-tuberculous Mycobacterium Species in Smear-positive Pulmonary Clinical Specimens

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03794284

Enrollment

Registered

2019-01-07

Start date

2019-02-28

Completion date

2022-07-31

Last updated

2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Tuberculous Mycobacterial Pneumonia, Tuberculosis

Brief summary

The study will use the VereMTB tool for rapid diagnosis of TB or non-tuberculous mycobacterium (NTM) pulmonary infections in hospitalised patients, with positive results in acid-fast bacilli smears, which are emerging in many regions of the world.

Detailed description

Delay in diagnosis and treatment of tuberculosis was common in hospitalised patients all around the world, and was associated with poorer outcomes, including respiratory failure and mortality. Rapid and accurate tools for diagnosis of TB is of great importance in initial treatment and for better treatment outcomes. Other than TB, non-tuberculous mycobacterium (NTM) pulmonary infections are emerging in many regions of the world. These bacterium are more common to be found in respiratory specimens than MTB. With similar clinical presentation of NTM pulmonary infections and pulmonary TB, misdiagnosis of NTM pulmonary infections to pulmonary TB would lead to unnecessary intake of anti-TB medications and delay of the initiation of corresponding treatment. This test aims to detect MTB as well differentiate the NTM species involved in pulmonary infections simultaneously using VereMTB.

Interventions

DIAGNOSTIC_TESTVereMTB

At least 2 mL of patient's expectorated or induced sputum would be collected for VereMTB assay and their clinical data would be retrieved for analysis use.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age 18 or older 2. One or more symptoms compatible with mycobacterial pulmonary infections, including fever, cough, sputum production,hemoptysis dyspnea, chest pain and weight loss 3. One or more sputum samples with positive AFB smear

Exclusion criteria

1. Receiving anti-mycobacterial treatment for more than one week 2. Refusal to consent

Design outcomes

Primary

Measure	Time frame	Description
diagnostic test correlation	6 months from the date of first recruitment	Sensitivity, specificity, positive predictive value, and negative predictive value, will be calculated to determine accuracy of VereMTB, in diagnosing MTB and NTM

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026