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The only test available for in vivo diagnosis of tuberculosis is the intradermal injection of tuberculin according to the Mantoux method (also named tuberculosis skin test or PPD skin test).
The tuberculin skin test is based on a delayed-type hypersensitivity skin reaction However, this test needs to be performed by trained personnel, presents problem of reproducibility, and its interpretation is not well standardized (measure in millimeters of skin induration 48 to 72 hours after the PPD skin test).
The new generation BD micro needle used in this study should solve the technical difficulties; intradermal administration of tuberculin could then be made by any personnel.
A non-invasive and objective instrumental method of reading the test will be also tested .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical device : micro-needle BD 1.5 mm 30G | Experimental |
| |
| Manthoux method: lance 26G X 16mm | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical device : micro-needle BD 1.5 mm 30G drug:Tubertest® : tuberculin (purified protein derivative) | Device | 2 intradermal injections are performed on each arm/bottom of the subject:
|
| Measure | Description | Time Frame |
|---|---|---|
| hypersensitivity reaction to tuberculin measured in millimeters of skin induration by comparing two methods of intradermal injection (Mantoux and BD micro-needle). [Phase 1] | 72 h |
| Measure | Description | Time Frame |
|---|---|---|
| spectroscopy instrumentation(non-invasive and objective method)to measure the PPD reaction | 72 h | |
| define changes in the cutaneous immune system at various times (7h, 24h and 48 h), induced by intradermal microinjection of tuberculin, by histological, immunohistochemical and molecular analysis |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine GOUJON, MD | Centre Hospitalier Lyon Sud -Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité de Recherche Clinique en Immunologie Lyon Sud (URCI-LS) et Service d'Immunologie clinique et allergologie-Centre Hospitalier Lyon Sud -Hospices Civils de Lyon | Pierre-Bénite | 69495 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Diffuse Reflectance Spectroscopy: A clinical study of tuberculin skin tests reading Anne Koenig, Sophie Grande, Karima Dahel, Anne Planat-Chrétien, Vincent Poher, Catherine Goujon, Jean- Marc Dinten. Biomedical Applications of Light Scattering VII, 85920S (21 February 2013) |
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| ID | Term |
|---|---|
| D014374 | Tuberculin Test |
| ID | Term |
|---|---|
| D012882 | Skin Tests |
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| medical device: lance 26G X 16mm drug: Tubertest® : tuberculin (purified protein derivative) | Device | 2 intradermal injections are performed on each arm/bottom of the subject:
|
|
| 48 h |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |