Ignite Creation Date:
2024-05-06 @ 9:59 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03137875
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2011-02-22
Brief Title:
Evaluation of PCR Using DNA Extract From Slides and Filter Paper for the Detection of Tuberculosis and MDR-tuberculosis
Sponsor:
Epicentre
Organization:
Epicentre
Study Overview
Official Title:
Evaluation of the PCR Using DNA Extracts From Stained Slides and Sputum Collected on Filter Paper for Identification and Detection of Tuberculosis and Multidrug Resistant MDR Tuberculosis
Status:
COMPLETED
Status Verified Date:
2017-04
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:
Specimen transport from peripheral health structures to the National TB reference laboratory for MDR-TB identification presents a big challenge in term of sample management safety contamination and delays Thus a system that allows specimen to be collected and shipped in a safely manner while reducing the possibilities of contamination the cost of shipment and especially the time for detection of MDR-TB by using molecular methods would be very useful Whereas the some studies show promising results for the development and standardization of simple specimen collection and transportation methods for molecular DST more data is needed before these can be used in routine
The study described here aims at identifying a suitable method in terms of adapted sample support s slide filter paper FTA Genocard and DNA extraction method If one or several methods are found to give satisfying results then a larger patient based evaluation of this these methods for molecular DST will be performed in a second phase The protocol for the second phase will be prepared separately
The study described here aims at identifying a suitable method in terms of adapted sample support s slide filter paper FTA Genocard and DNA extraction method If one or several methods are found to give satisfying results then a larger patient based evaluation of this these methods for molecular DST will be performed in a second phase The protocol for the second phase will be prepared separately
Detailed Description:
The main objective of this study is to evaluate the performance of PCR in identification and detection of tuberculosis using DNA extracts from stained slides Ziehl Neelsen and Fluorescence and Filter paper FTA card and Genocard
The secondary objectives of this study are to assess the MTB extraction yield from smear-negative low and high bacilli load specimens on slides filter paper Genocardand FTA to determine the amount of sample required to make a detectable PCR reaction and to assess the feasibility of storage and extraction methods
The secondary objectives of this study are to assess the MTB extraction yield from smear-negative low and high bacilli load specimens on slides filter paper Genocardand FTA to determine the amount of sample required to make a detectable PCR reaction and to assess the feasibility of storage and extraction methods
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