Diagnosis of Active Tuberculosis by ELISPOT

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
First received: September 13, 2005
Last updated: NA
Last verified: July 2005
History: No changes posted
Recent studies revealed that the ex vivo enzyme-linked immunospot (ELISPOT) assay for gamma interferon is a specific method for contact tracing of Mycobacterium tuberculosis infection. However, its use in endemic area and bacillus Calmette-Guérin (BCG)-vaccinated hosts has not been proved. We hypothesize that the TB-ELISPOT assay can be a rapid and accurate diagnostic tool for active tuberculosis in clinical suspects in Taiwan.


Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Diagnosis of Active Tuberculosis in Endemic Area by Using Enzyme-Linked Immunospot Assay for Gamma-Interferon

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 200
Study Start Date: August 2005
Estimated Study Completion Date: December 2006

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who present with fever or respiratory symptoms (cough, dyspnea, or hemoptysis) lasting for ≥ 2 weeks and have compatible radiographic findings were considered clinical suspects of TB.

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174083

Contact: Jann-Yuan Wang, MD 886-2-23562905 jywang@ntu.edu.tw

National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Jann-Yuan Wang, MD    886-2-23562905    jywang@ntu.edu.tw   
Contact: Li-Na Lee, PhD    886-2-23563905    linalee@ntu.edu.tw   
Principal Investigator: Jann-Yuan Wang, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Jann-Yuan Wang, MD physician
  More Information


ClinicalTrials.gov Identifier: NCT00174083     History of Changes
Other Study ID Numbers: 9461700717 
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Tuberculosis, TB-ELISPOT, active tuberculosis latent infection interferon

Additional relevant MeSH terms:
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections

ClinicalTrials.gov processed this record on May 02, 2016