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Diagnosis Test of Real-time Polymerase Chain Reaction (RT-PCR) for Pulmonary Tuberculosis

Diagnosis Test of Real-time Polymerase Chain Reaction (RT-PCR) for Pulmonary Tuberculosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06284187
Enrollment
120
Registered
2024-02-28
Start date
2023-01-01
Completion date
2023-12-31
Last updated
2024-02-28

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

Conditions

Pulmonary, Tuberculosis

Keywords

pulmonary tuberculosis, real-time PCR, diagnosis test

Brief summary

BACKGROUND: Pulmonary tuberculosis remains the leading cause of morbidity and mortality in Thailand. The microbiological detection of TB is important because of early and correct diagnosis, drug resistance testing and ensures that the effective treatment can be achieved and in a timely manner. Mycobacterial culture is the gold standard diagnostic test. Currently, a real-time polymerase chain reaction (RT-PCR) assay, such as Allplex™ MTB/MDRe Detection, Seegene is commonly used. OBJECTIVE: To evaluate the diagnosis value of the real-time multiplex PCR by using Allplex™ MTB/MDRe Detection kit to detect MTB from sputum specimens with a gold standard TB culture.

Detailed description

A retrospective study design of adult patients (> 15 years) with suspected pulmonary M. tuberculosis infection was conducted from January 2023 until October 2023, at Khon Kaen Hospital. Sample size was 101 cases. Sensitivity, specificity, accuracy, negative predictive value (NPV), and positive predictive value (PPV) of Allplex™ MTB/MDRe Detection, each with its respective 95% confidence interval (95% CI) were analysed with compared to MTB culture as the gold standard.

Interventions

None listed

Sponsors

Khon Kaen Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum

Inclusion criteria

* Clinical suspected pulmonary M. tuberculosis infection * Aged 15 years and older

Exclusion criteria

* Children under 15 years old * Non-tuberculous mycobacteria (NTM) detection

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with pulmonary TB by Allplex™ MTB/MDReFrom enrollment to the end of diagnosis at 1 weekLaboratory parameter

Countries

Thailand

Outcome results

None listed

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