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

NCT03271567 | Completed

• 1 other identifier: TB Protocol ver.1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Active Tuberculosis; Tuberculosis, Extrapulmonary; Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

• Diagnostic test correlation

  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.

  One year from the date of recruitment

Interventions

Nanodisk-MS assay DIAGNOSTIC_TEST

Nanodisk-MS assay is a recently reported novel assay for quantitative detection of various MTB antigen peptides, using nanotechnology and mass spectrometry that showed remarkable sensitivity and specificity in diagnosing active pulmonary and extrapulmonary TB. This assay detected MTB-specific antigens, CFP-10 and ESAT-6, in patients' serum samples.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the Prince of Wales Hospital and the Alice Ho Miu Ling Nethersole Hospital with suspected pulmonary and extrapulmonary TB will be identified by Infectious Diseases physician and recruited.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator
• Alice Ho Miu Ling Nethersole Hospital: collaborator

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (2)

• Liu C, Zhao Z, Fan J, Lyon CJ, Wu HJ, Nedelkov D, Zelazny AM, Olivier KN, Cazares LH, Holland SM, Graviss EA, Hu Y. Quantification of circulating Mycobacterium tuberculosis antigen peptides allows rapid diagnosis of active disease and treatment monitoring. Proc Natl Acad Sci U S A. 2017 Apr 11;114(15):3969-3974. doi: 10.1073/pnas.1621360114. Epub 2017 Mar 27.

  PMID: 28348223 BACKGROUND

• Lui G, Wong RY, Li F, Lee MK, Lai RW, Li TC, Kam JK, Lee N. High mortality in adults hospitalized for active tuberculosis in a low HIV prevalence setting. PLoS One. 2014 Mar 18;9(3):e92077. doi: 10.1371/journal.pone.0092077. eCollection 2014.

  PMID: 24642794 BACKGROUND

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis, Extrapulmonary; Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chung Yan Grace Lui

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate consultant

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 5, 2017
• Study Start: September 28, 2017
• Primary Completion: July 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

HK (1)