Tuberculosis Clinical Trial
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
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) method(s) for molecular DST will be performed in a second phase. The
protocol for the second phase will be prepared separately.
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.
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