Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311207
Status:
UNKNOWN
Last Update Posted:
2006-04-05
First Post:
2006-03-24
Brief Title:
Development of Tuberculosis Diagnostic Kit
Sponsor:
Taichung Veterans General Hospital
Organization:
Taichung Veterans General Hospital
Study Overview
Official Title:
Development of Tuberculosis Diagnostic Kit
Status:
UNKNOWN
Status Verified Date:
2006-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 samplesCapilia 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
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 samplesCapilia 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
Detailed Description:
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 urinepleura 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
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 urinepleura 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None