TY - JOUR
T1 - Clinical Impact of the Line Probe Assay and Xpert® MTB/RIF Assay in the Presumptive Diagnosis of Drug-Resistant Tuberculosis in Brazil: A Pragmatic Clinical Trial
AU - Kritski, Afranio
AU - Oliveira, Maria Martha
AU - de Almeida, Isabela Neves
AU - Ramalho, Daniela
AU - Andrade, Monica Kramer de Noronha
AU - Carvalho, Monica
AU - Miranda, Pryscila Fernandes Campino
AU - Dalcolmo, Margareth Pretti
AU - Braga, Jose Ueleres
AU - Brígido, Tania
AU - Mesquita, Eliene
AU - Dias, Claudia
AU - Gambirasio, Aglae
AU - Filho, Joao Baptista Souza
AU - Detjen, Anne
AU - Phillips, Patrick Peter John
AU - Langley, Ivor
AU - Fujiwara, Paula
AU - Squire, Bertie
PY - 2022/2/25
Y1 - 2022/2/25
N2 - Background:Rapid molecular methods such as the line probe assay (LPA) and Xpert® MTB/RIF assay (Xpert) have been recommended by the World Health Organization for drug-resistant tuberculosis (DR-TB) diagnosis. We conducted an interventional trial in DR-TB reference centers in Brazil to evaluate the impact of the use of LPA and Xpert.Methods:Patients with DR-TB were eligible if their drug susceptibility testing results were available to the treating physician at the time of consultation. The standard reference MGITTM 960 was compared with Xpert (arm 1) and LPA (arm 2). Effectiveness was considered as the start of the appropriate TB regimen that matched drug susceptibility testing (DST) and the proportions of culture conversion and favorable treatment outcomes after 6 months.Results:A higher rate of empirical treatment was observed with MGIT alone than with the Xpert assay (97.0% vs. 45.0%) and LPA (98.2% vs. 67.5%). Patients started appropriate TB treatment more quickly than those in the MGIT group (median 15.0 vs. 40.5 days; p<0.01) in arm 1. Compared to the MGIT group, culture conversion after 6 months was higher for Xpert in arm 1 (90.9% vs. 79.3%, p=0.39) and LPA in arm 2 (80.0% vs. 83.0%, p=0.81).Conclusions:In the Xpert arm, there was a significant reduction in days to the start of appropriate anti-TB treatment and a trend towards greater culture conversion in the sixth month.
AB - Background:Rapid molecular methods such as the line probe assay (LPA) and Xpert® MTB/RIF assay (Xpert) have been recommended by the World Health Organization for drug-resistant tuberculosis (DR-TB) diagnosis. We conducted an interventional trial in DR-TB reference centers in Brazil to evaluate the impact of the use of LPA and Xpert.Methods:Patients with DR-TB were eligible if their drug susceptibility testing results were available to the treating physician at the time of consultation. The standard reference MGITTM 960 was compared with Xpert (arm 1) and LPA (arm 2). Effectiveness was considered as the start of the appropriate TB regimen that matched drug susceptibility testing (DST) and the proportions of culture conversion and favorable treatment outcomes after 6 months.Results:A higher rate of empirical treatment was observed with MGIT alone than with the Xpert assay (97.0% vs. 45.0%) and LPA (98.2% vs. 67.5%). Patients started appropriate TB treatment more quickly than those in the MGIT group (median 15.0 vs. 40.5 days; p<0.01) in arm 1. Compared to the MGIT group, culture conversion after 6 months was higher for Xpert in arm 1 (90.9% vs. 79.3%, p=0.39) and LPA in arm 2 (80.0% vs. 83.0%, p=0.81).Conclusions:In the Xpert arm, there was a significant reduction in days to the start of appropriate anti-TB treatment and a trend towards greater culture conversion in the sixth month.
KW - Diagnostics
KW - Impact assessment
KW - MDR-TB
KW - Molecular tests
KW - Tuberculosis
U2 - 10.1590/0037-8682-0191-2021
DO - 10.1590/0037-8682-0191-2021
M3 - Article
SN - 0037-8682
VL - 55
SP - e0191-2021
JO - Revista da Sociedade Brasileira de Medicina Tropical
JF - Revista da Sociedade Brasileira de Medicina Tropical
M1 - e0191-2021
ER -
