Development of Tuberculosis Diagnostic Kit
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 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.
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, 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 Design
Observational Model: Case Control, Primary Purpose: Screening, Time Perspective: Cross-Sectional, Time Perspective: Retrospective/Prospective
Conditions
Tuberculosis
Location
Taichung Veterans General Hospital
Taichung
Taiwan
407
Status
Recruiting
Source
Taichung Veterans General Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00311207
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Latent Tuberculosis
The dormant form of TUBERCULOSIS where the person shows no obvious symptoms and no sign of the causative agent (Mycobacterium tuberculosis) in the SPUTUM despite being positive for tuberculosis infection skin test.
Tuberculosis, Central Nervous System
Tuberculosis of the brain, spinal cord, or meninges (TUBERCULOSIS, MENINGEAL), most often caused by MYCOBACTERIUM TUBERCULOSIS and rarely by MYCOBACTERIUM BOVIS. The infection may be limited to the nervous system or coexist in other organs (e.g., TUBERCULOSIS, PULMONARY). The organism tends to seed the meninges causing a diffuse meningitis and leads to the formation of TUBERCULOMA, which may occur within the brain, spinal cord, or perimeningeal spaces. Tuberculous involvement of the vertebral column (TUBERCULOSIS, SPINAL) may result in nerve root or spinal cord compression. (From Adams et al., Principles of Neurology, 6th ed, pp717-20)
Tuberculosis, Cardiovascular
Pathological conditions of the CARDIOVASCULAR SYSTEM caused by infection of MYCOBACTERIUM TUBERCULOSIS. Tuberculosis involvement may include the HEART; the BLOOD VESSELS; or the PERICARDIUM.
Tuberculosis, Gastrointestinal
TUBERCULOSIS that involves any region of the GASTROINTESTINAL TRACT, mostly in the distal ILEUM and the CECUM. In most cases, MYCOBACTERIUM TUBERCULOSIS is the pathogen. Clinical features include ABDOMINAL PAIN; FEVER; and palpable mass in the ileocecal area.
Tuberculosis, Oral
Tuberculosis of the mouth, tongue, and salivary glands.
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PubMed Articles
Multidrug-resistant tuberculosis.
To the Editor: The study by Gler et al. (June 7 issue)(1) provides a needed reminder regarding the development pipeline for drugs for tuberculosis and multidrug-resistant (MDR) tuberculosis.(2) Delama...
Multidrug-resistant tuberculosis.
To the Editor: The study by Gler et al. (June 7 issue)(1) provides a needed reminder regarding the development pipeline for drugs for tuberculosis and multidrug-resistant (MDR) tuberculosis.(2) Delama...
Multidrug-resistant tuberculosis.
To the Editor: The study by Gler et al. (June 7 issue)(1) provides a needed reminder regarding the development pipeline for drugs for tuberculosis and multidrug-resistant (MDR) tuberculosis.(2) Delama...
Multidrug-resistant tuberculosis.
To the Editor: The study by Gler et al. (June 7 issue)(1) provides a needed reminder regarding the development pipeline for drugs for tuberculosis and multidrug-resistant (MDR) tuberculosis.(2) Delama...
Diagnostic serum proteomic analysis in patients with active tuberculosis.
The diagnosis for smear-negative pulmonary tuberculosis (TB) is very difficult. Proteomic fingerprinting of sera is a potentially useful tool.
