Ignite Creation Date:
2024-05-06 @ 1:31 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04048018
Status:
COMPLETED
Last Update Posted:
2021-07-16
First Post:
2019-08-02
Brief Title:
Performance Evaluation of the VIDAS TB-IGRA Assay
Sponsor:
BioMérieux
Organization:
BioMérieux
Study Overview
Official Title:
Performance Evaluation of the VIDAS TB-IGRA Assay
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
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:
This study will evaluate the performance of the VIDAS Interferon Gamma IFN-γ Release Assay TB-IGRA assay which is intended for use as an aid in the diagnosis of tuberculosis infection This study is designed to assess 1 the sensitivity of this assay 2 its percent agreement with other diagnostic tests 3 its measurement precision and 4 any potential interference of the presence of other non-tuberculosis mycobacterial bacterial infections with this assay
Detailed Description:
Tuberculosis TB infection is one of the top 10 causes of death in the world and the leading cause of death due to a single infectious agent Millions of people are infected with TB each year which can pose significant economic and health care burdens on the global population
TB can infected the lungs pulmonary TB or other organs such as the brain and kidneys extra-pulmonary TB When a person with pulmonary TB coughs or sneezes water droplets containing M tuberculosis are expelled into the air Persons can become infected with TB when they inhale air containing these water droplets however not everyone infected with Mycobacterium tuberculosis Mtb becomes ill Therefore two TB-related conditions exist latent TB infection LTBI and TB disease
People with latent TB infection are not ill and do not present TB symptoms or have TB disease The only sign of TB infection is a positive reaction to the tuberculin skin test or TB blood tests such as IGRA tests People with latent TB infection are not contagious and cannot spread TB infection to others
Identification and treatment of LTBI can substantially reduce the risk of developing active disease However there is no diagnostic gold standard for LTBI Two types of test are currently available for the identification of LTBI the tuberculin skin test TST and the TB Interferon Gamma IFN-γ Release Assay TB-IGRA Evidence suggests that both TST and TB-IGRA are acceptable but not perfect because they detect indirect markers of Mtb exposure and indicate a cellular immune response to M tuberculosis TB-IGRAs have a number of advantages compared to TST which promote their progressive adoption in the clinical practice and in guidelines
TB can infected the lungs pulmonary TB or other organs such as the brain and kidneys extra-pulmonary TB When a person with pulmonary TB coughs or sneezes water droplets containing M tuberculosis are expelled into the air Persons can become infected with TB when they inhale air containing these water droplets however not everyone infected with Mycobacterium tuberculosis Mtb becomes ill Therefore two TB-related conditions exist latent TB infection LTBI and TB disease
People with latent TB infection are not ill and do not present TB symptoms or have TB disease The only sign of TB infection is a positive reaction to the tuberculin skin test or TB blood tests such as IGRA tests People with latent TB infection are not contagious and cannot spread TB infection to others
Identification and treatment of LTBI can substantially reduce the risk of developing active disease However there is no diagnostic gold standard for LTBI Two types of test are currently available for the identification of LTBI the tuberculin skin test TST and the TB Interferon Gamma IFN-γ Release Assay TB-IGRA Evidence suggests that both TST and TB-IGRA are acceptable but not perfect because they detect indirect markers of Mtb exposure and indicate a cellular immune response to M tuberculosis TB-IGRAs have a number of advantages compared to TST which promote their progressive adoption in the clinical practice and in guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None