Development of Tuberculosis Diagnostic Kit
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|ClinicalTrials.gov Identifier: NCT00311207|
Recruitment Status : Unknown
Verified April 2006 by Taichung Veterans General Hospital.
Recruitment status was: Recruiting
First Posted : April 5, 2006
Last Update Posted : April 5, 2006
Pulmonary tuberculosis is one of the most important infectious diseases in human with high mortality.
Early diagnosis followed by antibiotic treatment is the only way for control of the disease. However, most of commercial tuberculosis diagnostic kits are of moderate sensitivity. Oncoprobe Inc. recently developed a tuberculosis diagnostic kit (HR-103) based on detection of antibody against Mycobacterium tuberculosis in serum. The main purpose of this project is to evaluate the sensitivity and specificity of the kit in detection of pulmonary tuberculosis from saliva, urine, pleura and serum samples.Capilia TB assay and another Immunochromatographic assay such as ESAT-6 and CFP-10 based or other PCR based immunochromatographic assay will be tried to detection tuberculous disease.
|Condition or disease||Phase|
|Tuberculosis Lung Cancer Pneumonia||Phase 3|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Observational Model:||Case Control|
|Official Title:||Development of Tuberculosis Diagnostic Kit|
|Study Start Date :||December 2005|
|Estimated Study Completion Date :||November 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311207
|Contact: Shen Gwan Han, MD||886-4-23592525 ext 3217||911B@vghtc.gov.tw|
|Taichung Veterans General Hospital||Recruiting|
|Taichung, Taiwan, 407|
|Contact: Shen Gwan Han, MD 886-4-23592525 ext 3217 911B@vghtc.gov.tw|
|Principal Investigator: Shen Gwan Han, MD|
|Principal Investigator:||Shen Gwan Han, MD||Respiratory and Critical care medicine department of Taichung Veterans General Hospital|