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Development of Tuberculosis Diagnostic Kit

Phase 3
18 Years
Open (Enrolling)
Tuberculosis, Lung Cancer, Pneumonia

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Trial Information

Development of Tuberculosis Diagnostic Kit

Sputum samples from 200 patients with chest or respiratory problems will be collected.
Presence of M.

tuberculosis in the samples will be checked by acid-fast stain and bacterial culture and
identification methods.

At the same time, saliva, urine, and serum samples from these 200 patients and 50 healthy
volunteers will be collected. The tuberculosis diagnostic kit (HR-103) from Oncoprobe Inc.
or capilia TB assay or another Immunochromatographic assay such as ESAT-6 and CFP-10 based
or other PCR based immunochromatographic assay will be used to detect tuberculosis disease
from these samples. By comparing the results with the stain and identification results of
sputum samples from the 200 patients, the sensitivity and specificity of the kit in
detection of pulmonary tuberculosis from saliva, urine,pleura and serum samples, as well as
from combination of these samples, will be obtained. In addition to pulmonary tuberculosis,
M. tuberculosis causes pleural tuberculosis. Diagnosis of pleural tuberculosis involves
determination of activities of adenosine deaminase and interferon-gamma in pleural effusion,
which is tedious. We also plan to collect pleural effusion samples from 100 patients, and
examined by the tuberculosis diagnostic kit (HR-103) from Oncoprobe Inc. By comparing the
results with the adenosine deaminase and interferon-gamma activities of the same samples,
the sensitivity and specificity of the kit in detection of pleural tuberculosis from pleural
effusion samples will be obtained.

Inclusion Criteria:

clinical suspicious of tuberculosis


Exclusion Criteria:


Type of Study:


Study Design:

Observational Model: Case Control, Primary Purpose: Screening, Time Perspective: Cross-Sectional, Time Perspective: Retrospective/Prospective

Principal Investigator

Shen Gwan Han, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Respiratory and Critical care medicine department of Taichung Veterans General Hospital


Taiwan: Department of Health

Study ID:




Start Date:

December 2005

Completion Date:

November 2006

Related Keywords:

  • Tuberculosis
  • Lung Cancer
  • Pneumonia
  • diagnostic kit
  • immunochromatography test
  • PCR detection kit
  • luminex
  • Lung Neoplasms
  • Pneumonia
  • Tuberculosis