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. 2022 Feb 25:55:e0191.
doi: 10.1590/0037-8682-0191-2021. eCollection 2022.

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

Afranio Kritski  1 , Maria Martha Oliveira  1 , Isabela Neves de Almeida  2 , Daniela Ramalho  1 , Monica Kramer de Noronha Andrade  1   3 , Monica Carvalho  3 , Pryscila Fernandes Campino Miranda  1 , Margareth Pretti Dalcolmo  3 , Jose Ueleres Braga  4 , Tania Brígido  5 , Eliene Mesquita  6 , Claudia Dias  7 , Aglae Gambirasio  8 , Joao Baptista Souza Filho  9 , Anne Detjen  10 , Patrick Peter John Phillips  11   12 , Ivor Langley  13 , Paula Fujiwara  12 , Stephen Bertel Squire  13
Affiliations

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

Afranio Kritski et al. Rev Soc Bras Med Trop. .

Abstract

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.

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Conflict of interest statement

Conflict of Interest: The authors declare that there are no conflicts of interest.

Figures

FIGURE 1:
FIGURE 1:. Flow diagram of presumed DR-TB with DST conducted at five reference centers, Brazil.
See this image and copyright information in PMC

References

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    1. World Health Organization (WHO) Global strategy and targets for tuberculosis prevention, care and control after 2015. WHO; Geneva: 2018. [2021 Feb 11]. Available from: https://www.who.int/tb/post_2015_tb_presentation.pdf .

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