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Xpert MTB/XDR for detection of pulmonary tuberculosis and resistance to isoniazid, fluoroquinolones, ethionamide, and amikacin

Pillay, Samantha, Davies, Geraint G, Chaplin, Marty, De Vos, Margaretha, Schumacher, Samuel G, Warren, Rob, Steingart, Karen and Theron, Grant (2021) 'Xpert MTB/XDR for detection of pulmonary tuberculosis and resistance to isoniazid, fluoroquinolones, ethionamide, and amikacin'. Cochrane Database of Systematic Reviews, Vol 2021, Issue 6, : CD014841.

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Abstract

Objectives
This is a protocol for a Cochrane Review (diagnostic). The objectives are as follows:

To estimate the diagnostic accuracy of Xpert MTB/XDR for the detection of pulmonary tuberculosis in people with signs and symptoms of pulmonary tuberculosis.

To estimate the diagnostic accuracy of Xpert MTB/XDR for resistance to isoniazid, fluoroquinolones, ethionamide, and amikacin in people irrespective of rifampicin resistance and people with detected rifampicin resistance. In these populations, pulmonary tuberculosis will have been detected by Xpert MTB/XDR (as it is a reflex test). Such populations typically will have received prior testing verifying tuberculosis with another WHO‐approved test.

Secondary objectives
To compare the diagnostic accuracy of Xpert MTB/XDR by direct testing versus indirect testing (whereby Xpert MTB/XDR is performed on a Mycobacterium tuberculosis isolate grown from culture).

To investigate the effects of potential sources of heterogeneity on test accuracy.

For pulmonary tuberculosis, potential sources include HIV status, smear status, history of tuberculosis, treatment status (no treatment or currently on treatment), and treatment response status (culture conversion, yes or no).

For drug resistance, potential sources include the type of reference standard and history of tuberculosis treatment. In addition, for fluoroquinolone resistance, a potential source of heterogeneity is the specific drug (e.g. ofloxacin or moxifloxacin) used in the phenotypic culture‐based DST (pDST) reference standard. We will also consider whether the WHO‐recommended critical drug concentration was used for the pDST reference standard (WHO Critical Concentrations 2018; WHO Critical Concentrations 2021).

Regarding previously treated people, these investigations are important questions for clinical practice. For tuberculosis detection, studies have highlighted the challenges in interpreting Xpert MTB/RIF‐positive and Xpert Ultra‐positive results in previously treated people (Mishra 2020; Theron 2016a). As mentioned, for detection of drug resistance, previous treatment may increase the likelihood of having drug resistance.

Item Type: Article
Subjects: QV Pharmacology > Anti-Inflammatory Agents. Anti-Infective Agents. Antineoplastic Agents > QV 250 Anti-infective agents (General)
QV Pharmacology > Anti-Inflammatory Agents. Anti-Infective Agents. Antineoplastic Agents > QV 268 Antitubercular agents. Antitubercular antibiotics
WF Respiratory System > Tuberculosis > WF 200 Tuberculosis (General)
WF Respiratory System > Tuberculosis > WF 220 Diagnosis. Prognosis
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI): https://doi.org/10.1002/14651858.CD014841
Depositing User: Christianne Esparza
Date Deposited: 01 Jul 2021 11:01
Last Modified: 01 Jul 2021 11:01
URI: https://archive.lstmed.ac.uk/id/eprint/18141

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