Xpert MTB/RIF and Xpert Ultra assays for screening for pulmonary tuberculosis and rifampicin resistance in adults, irrespective of signs or symptoms

Abstract

Background Tuberculosis is a leading cause of infectious disease‐related death and is one of the top 10 causes of death worldwide. The World Health Organization (WHO) recommends the use of specific rapid molecular tests, including Xpert MTB/RIF or Xpert Ultra, as initial diagnostic tests for the detection of tuberculosis and rifampicin resistance in people with signs and symptoms of tuberculosis. However, the WHO estimates that nearly one‐third of all active tuberculosis cases go undiagnosed and unreported. We were interested in whether a single test, Xpert MTB/RIF or Xpert Ultra, could be useful as a screening test to close this diagnostic gap and improve tuberculosis case detection. Objectives To estimate the accuracy of Xpert MTB/RIF and Xpert Ultra for screening for pulmonary tuberculosis in adults, irrespective of signs or symptoms of pulmonary tuberculosis in high‐risk groups and in the general population. Screening "irrespective of signs or symptoms" refers to screening of people who have not been assessed for the presence of tuberculosis symptoms (e.g. cough). To estimate the accuracy of Xpert MTB/RIF and Xpert Ultra for detecting rifampicin resistance in adults screened for tuberculosis, irrespective of signs and symptoms of pulmonary tuberculosis in high‐risk groups and in the general population. Search methods We searched 12 databases including the Cochrane Infectious Diseases Group Specialized Register, MEDLINE and Embase, on 19 March 2020 without language restrictions. We also reviewed reference lists of included articles and related Cochrane Reviews, and contacted researchers in the field to identify additional studies. Selection criteria Cross‐sectional and cohort studies in which adults (15 years and older) in high‐risk groups (e.g. people living with HIV, household contacts of people with tuberculosis) or in the general population were screened for pulmonary tuberculosis using Xpert MTB/RIF or Xpert Ultra. For tuberculosis detection, the reference standard was culture. For rifampicin resistance detection, the reference standards were culture‐based drug susceptibility testing and line probe assays. Data collection and analysis Two review authors independently extracted data using a standardized form and assessed risk of bias and applicability using QUADAS‐2. We used a bivariate random‐effects model to estimate pooled sensitivity and specificity with 95% credible intervals (CrIs) separately for tuberculosis detection and rifampicin resistance detection. We estimated all models using a Bayesian approach. For tuberculosis detection, we first estimated screening accuracy in distinct high‐risk groups, including people living with HIV, household contacts, people residing in prisons, and miners, and then in several high‐risk groups combined. Main results We included a total of 21 studies: 18 studies (13,114 partic...

Screening tests for active pulmonary tuberculosis in children

“…One systematic review of symptom screening and CXR for tuberculosis in adults was discussed above (see 'Chest radiography screening for pulmonary tuberculosis;' van't Hoog 2013). A Cochrane Review of Xpert MTB/RIF and Xpert Ultra for pulmonary tuberculosis in adults irrespective of signs or symptoms of pulmonary tuberculosis is similar to our assessment of Xpert MTB/RIF as a screening strategy (Shapiro 2021). However, especially for younger children, comparisons between paediatric and adult pulmonary tuberculosis are challenging because the diseases are so di erent.…”

Impact of diagnostic strategies for tuberculosis using lateral flow urine lipoarabinomannan assay in people living with HIV

“…The same or similar text appears in the Background section in several other Cochrane protocols and reviews on tests for diagnosing tuberculosis (Bjerrum 2019;Kay 2020;Kohli 2021;Shapiro 2021).…”

Clinical Evaluation of a Line-Probe Assay for Tuberculosis Detection and Drug-Resistance Prediction in Namibia

“…For GenID RIF/INH, we used Xpert MTB/RIF resistance detection as reference standard for RIF and AST for INH. This decision was taken (1) based on data from a meta-analysis ( 17 , 18 ), and (2) as it is known from later, yet unpublished work, that Xpert MTB/RIF predicted RIF resistance more accurately in this study than AST using a critical concentration of 1.0 mg/L for RIF instead of the later adopted 0.5 mg/L ( 19 ). Unfortunately, it was not possible neither to verify phenotypic AST results with genome sequencing of the specimens in question nor to increase sample size due to logistic and funding limitations.…”