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

NCT ID: NCT06284187

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

Tuberculosis; Pulmonary

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khon Kaen Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kriengsak Vacharanukulkieti

Director of Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kriengsak Vacharanukulkieti, Medicine

Role: PRINCIPAL_INVESTIGATOR

Khon Kaen Hospital

Locations

Thananit Sangkomkamhang

Khon Kaen, , Thailand

Countries

Thailand

Other Identifiers

KhonKaenH

Identifier Type: -

Identifier Source: org_study_id