Nanodisk-MS Assay for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients

Completed

• Conditions: Active Tuberculosis; Tuberculosis, Extrapulmonary; Tuberculosis, Pulmonary

• Registration Number: NCT03271567
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Diagnosis and treatment of tuberculosis are often delayed in hospitalized patients, leading to worse outcomes. Rapid diagnosis of tuberculosis currently relies on microscopy and molecular techniques, which have limitations including low sensitivity and high cost.Highly sensitive diagnostic technique is needed for more accurate rapid diagnosis of tuberculosis to aid earlier initiation of antituberculous therapy. Detection of Mycobacterium tuberculosis (MTB) antigens in the bloodstream can potentially allow early diagnosis of tuberculosis. This study aims to evaluate the diagnostic performance of a novel assay using nanotechnology to detect MTB antigens in patients admitted to hospital with suspected pulmonary and/or extrapulmonary tuberculosis. Blood will be taken from eligible patients, and will be sent to the School of Biological and Health Systems Engineering, Arizona State University, for detection of 10-kDa culture filtrate protein (CFP-10) and the 6 kDa early secretory antigenic target (ESAT-6), two antigens specific for MTB, using the Nanodisk-MS assay. Investigations, including microscopy, culture, MTB polymerase chain reaction (PCR), and imaging, will be performed for diagnosis of tuberculosis. The diagnostic performance of Nanodisk-mass spectrometry (MS) assay will be evaluated.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-01
• Study First Submitted QC: 2017-09-01
• Study First Posted: 2017-09-05
• Study Start: 2017-09-28
• Primary Completion: 2019-07-31
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adult patients aged 18 or above,
• Assessed by an Infectious Diseases physician to have clinical and/or radiological suspicion of pulmonary and/or extrapulmonary TB.

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Exclusion Criteria

• Refusal to consent from patients or next of kins for incompetent patients.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic test correlation	One year from the date of recruitment	Sensitivity, specificity, positive predictive value, and negative predictive value, will be calculated to determine accuracy of Nanodisk-MS assay, in diagnosing "culture-positive" and "culture-negative" pulmonary and/or extrapulmonary TB.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Sha Tin, Hong Kong