Cochrane · systematic review · CD014841

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

Pillay, S, Steingart, KR, Davies, GR, et al. · Cochrane Database of Systematic Reviews · 2022 · Cochrane Library

Infectious DiseasesAMSTAR 2: not assessed
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
25
current version
GRADE rated
20
No studies
5
Included studies
NR
No studies 5 · 20%Ungraded 0 · 0%Very low 8 · 32%Low 2 · 8%Moderate 6 · 24%High 4 · 16%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Questions and results

Summary of findings table, Xpert MTB/XDR for pulmonary tuberculosis

Population: people with presumptive pulmonary tuberculosisRole: an initial testIndex test: Xpert MTB/XDRThreshold for index test: an automated result is providedReference standard: solid or liquid cultureStudies: cross‐sectional
5 questions
OutcomeEffectEvidenceStatus / GRADE
Test result
no estimate extractedNRNo studies
True positivespeople with pulmonary tuberculosis
no estimate extracted2 studies · 799 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency, indirectness
False negativespeople incorrectly classified as not having pulmonary tuberculosis
no estimate extracted2 studies · 799 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency, indirectness
True negativespeople without pulmonary tuberculosis
no estimate extracted2 studies · 429 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency, indirectness
False positivespeople incorrectly classified as having pulmonary tuberculosis
no estimate extracted2 studies · 429 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency, indirectness

Summary of findings table, Xpert MTB/XDR for isoniazid resistance

Population: adults with pulmonary tuberculosis irrespective of rifampicin resistance (i.e. whether or not their rifampicin resistance status was known), detected as tuberculosis positive by Xpert MTB/XDR Index test: Xpert MTB/XDR Role: an initial test Xpert MTB/XDR must first detect tuberculosis (even if the patient is already tuberculosis‐positive by another test) before it can detect a resistant or susceptible resultThreshold for index test: an automated result is providedPrior tests: before receiving Xpert MTB/XDR, people typically will have received testing with another WHO‐recommended rapid diagnostic test to confirm tuberculosis Reference standard: culture‐based phenotypic drug susceptibility testingStudies: cross‐sectional
5 questions
OutcomeEffectEvidenceStatus / GRADE
Test result
no estimate extractedNRNo studies
True positivespeople with isoniazid resistance
no estimate extracted2 studies · 756 participantsModerate
Downgraded: inconsistency, indirectness
False negativespeople incorrectly classified as not having isoniazid resistance
no estimate extracted2 studies · 756 participantsModerate
Downgraded: inconsistency, indirectness
True negativespeople without isoniazid resistance
no estimate extracted2 studies · 327 participantsModerate
Downgraded: inconsistency, indirectness
False positivespeople incorrectly classified as having isoniazid resistance
no estimate extracted2 studies · 327 participantsModerate
Downgraded: inconsistency, indirectness

Summary of findings table, Xpert MTB/XDR for fluoroquinolone resistance

Population: adults with pulmonary tuberculosis irrespective of rifampicin resistance (i.e. whether or not their rifampicin resistance status was known), detected as tuberculosis positive by Xpert MTB/XDR Index test: Xpert MTB/XDR Role: an initial test Xpert MTB/XDR must first detect tuberculosis (even if the patient is already tuberculosis‐positive by another test) before it can detect a resistant or susceptible resultThreshold for index test: an automated result is providedPrior tests: before receiving Xpert MTB/XDR, people typically will have received testing with another WHO‐recommended rapid diagnostic test to confirm tuberculosis Reference standard: culture‐based phenotypic drug susceptibility testingStudy design: cross‐sectional
5 questions
OutcomeEffectEvidenceStatus / GRADE
Test result
no estimate extractedNRNo studies
True positivespeople with fluoroquinolone resistance
no estimate extracted2 studies · 381 participantsHigh
False negativespeople incorrectly classified as not having fluoroquinolone resistance
no estimate extracted2 studies · 381 participantsHigh
True negativespeople without fluoroquinolone resistance
no estimate extracted2 studies · 640 participantsModerate
Downgraded: inconsistency, indirectness
False positivespeople incorrectly classified as having fluoroquinolone resistance
no estimate extracted2 studies · 640 participantsModerate
Downgraded: inconsistency, indirectness

Summary of findings table, Xpert MTB/XDR for ethionamide resistance

Population: adults with pulmonary tuberculosis with known rifampicin resistance, detected as tuberculosis positive by Xpert MTB/XDRRole: an initial testIndex test: Xpert MTB/XDR Xpert MTB/XDR must first detect tuberculosis (even if the patient is already tuberculosis‐positive by another test) before it can detect a resistant or susceptible resultThreshold for index test: an automated result is providedPrior tests: before receiving Xpert MTB/XDR, people typically will have received testing with another WHO‐recommended rapid diagnostic test to confirm tuberculosis Reference standard: genotypic drug susceptibility testingStudy design: cross‐sectional
5 questions
OutcomeEffectEvidenceStatus / GRADE
Test result
no estimate extractedNRNo studies
True positivespeople with ethionamide resistance
no estimate extracted1 study · 167 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency
False negativespeople incorrectly classified as not having ethionamide resistance
no estimate extracted1 study · 167 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency
True negativespeople without ethionamide resistance
no estimate extracted1 study · 267 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency
False positivespeople incorrectly classified as having ethionamide resistance
no estimate extracted1 study · 267 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency

Summary of findings table, Xpert MTB/XDR for amikacin resistance

Population: adults with pulmonary tuberculosis with known rifampicin resistance, detected as tuberculosis‐positive by Xpert MTB/XDR Index test: Xpert MTB/XDR Role: an initial test Xpert MTB/XDR must first detect tuberculosis (even if the patient is already tuberculosis‐positive by another test) before it can detect a resistant or susceptible resultThreshold for index test: an automated result is providedPrior tests: before receiving Xpert MTB/XDR, people typically will have received testing with another WHO‐recommended rapid diagnostic test to confirm tuberculosis Reference standard: culture‐based phenotypic drug susceptibility testingStudies: cross‐sectional
5 questions
OutcomeEffectEvidenceStatus / GRADE
Test result
no estimate extractedNRNo studies
True positivespeople with amikacin resistance
no estimate extracted1 study · 65 participantsLow
Downgraded: imprecision, inconsistency
False negativespeople incorrectly classified as not having amikacin resistance
no estimate extracted1 study · 65 participantsLow
Downgraded: imprecision, inconsistency
True negativespeople without amikacin resistance
no estimate extracted1 study · 425 participantsHigh
False positivespeople incorrectly classified as having amikacin resistance
no estimate extracted1 study · 425 participantsHigh