Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis

Zifodya, Jerry S; Kreniske, Jonah Susser; Schiller, Ian; Kohli, Mikashmi; Dendukuri, Nandini; Schumacher, Samuel G; Ochodo, Eleanor; Haraka, Frederick; Zwerling, Alice; Pai, Madhukar; Steingart, Karen R; Horne, David

doi:10.1002/14651858.cd009593.pub5

Cited by 95 publications

(95 citation statements)

References 299 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…These observed high sensitivity of Xpert Ultra is in line with a meta-analyses, where 87.2% of TB culture positive patients were positive on Xpert Ultra test [12] and an overall estimated pooled sensitivity of 90.9% (95% credible interval 86.2 to 94.7) [25]. Similar to other studies, we also observed potentially false positive Xpert Ultra results, as 4 cases were Xpert Ultra positive by culture negative.…”

Section: Discussionsupporting

confidence: 91%

The Value of Lateral Flow Urine Lipoarabinomannan Assay and Empirical Treatment in the Xpert MTB/RIF Ultra Era: a Prospective Cohort Study

Kebede

Abebe

Gudina

et al. 2021

Preprint

View full text Add to dashboard Cite

Introduction: The value of Lateral Flow urine Lipoarabinomannan (LF-LAM) assay and the role of empiric tuberculosis (TB) treatment in the era of the highly sensitive Xpert MTB/RIF Ultra (Xpert Ultra) assay is unclear. This study aimed to assess the additional yield of Xpert Ultra compared to Xpert MTB/RIF, the yield of LF-LAM assay when used in combination with Xpert Ultra, and the role of empiric TB treatment in the Xpert Ultra era among patients with symptoms of TB admitted to a tertiary hospital in Ethiopia. Methods: We performed a secondary analysis of a cohort of hospitalized Xpert MTB/RIF-negative patients. Sputum samples were examined for Mycobacterium tuberculosis by culture and Xpert Ultra. In HIV positive and severely ill patients, a urine sample was collected for the LF-LAM assay. Treatment outcome was assessed six months after enrollment. Logistic regression was used to identify factors predictive of deaths among Xpert Ultra negative patients. Results: Of the 250 hospitalized Xpert MTB/RIF-negative patients, 35 (14.0%) had culture-confirmed TB. The Xpert Ultra assay diagnosed 31 of the 35 culture positive cases that had been missed by Xpert MTB/RIF. The LF-LAM assay did not identify any case that was not detected by Xpert Ultra. Empiric treatment did not improve survival among Xpert Ultra negative patients (OR 1.28, 95% CI: 0.3-5.3). Low body mass index (< 18.5kg/m2) was the only significant predictor of death in Xpert Ultra negative patients (OR 4.0, 95% CI: 1.12-16.5).Conclusions: In this prospective cohort, we observed that LF-LAM did not improve the diagnostic yield when used in combination with Xpert Ultra and did not find a survival benefit of empiric treatment among Xpert Ultra negative individuals. Research is needed to determine the optimal management of patients with presumptive TB and a negative Xpert Ultra assay in high TB burden settings.

show abstract

Section: Discussionsupporting

confidence: 91%

The Value of Lateral Flow Urine Lipoarabinomannan Assay and Empirical Treatment in the Xpert MTB/RIF Ultra Era: a Prospective Cohort Study

Kebede

Abebe

Gudina

et al. 2021

Preprint

View full text Add to dashboard Cite

show abstract

“…Although the Xpert assay also has suboptimal sensitivity in smear-negative specimens, recent studies have shown that the Gene Xpert platform is evolving further. The Xpert Ultra assay has significantly improved sensitivity for TB detection 21 , and the Xpert MTB/XDR assay has extended the detection of resistance to more key drugs 22 . Moreover, our study showed that the Xpert assay had a high diagnostic accuracy for diagnosing rifampin resistance.…”

Section: Discussionmentioning

confidence: 99%

Head-to-Head Comparison between Xpert MTB/RIF Assay and Real-Time Polymerase Chain Reaction Assay Using Bronchial Washing Specimens for Tuberculosis Diagnosis

et al. 2022

View full text Add to dashboard Cite

Background: With the introduction of Xpert MTB/RIF assay (Xpert), its incorporation into tuberculosis (TB) diagnostic algorithm has become an important issue. The aim of this study was to evaluate the performance of the Xpert assay in comparison with a commercial polymerase chain reaction (PCR) assay.Methods: Medical records of patients having results of both Xpert and AdvanSure TB/NTM real-time PCR (AdvanSure) assays using the same bronchial washing specimens were retrospectively reviewed.Results: Of the 1,297 patients included in this study, 205 (15.8%) were diagnosed with pulmonary TB. Using mycobacterial culture as the reference method, sensitivity of the Xpert assay using smear-positive specimens was 97.5%, which was comparable to that of the AdvanSure assay (96.3%, p=0.193). However, the sensitivity of the Xpert assay using smear-negative specimens was 70.6%, which was significantly higher than that of the AdvanSure assay (52.9%, p=0.018). Usng phenotypic drug susceptibility testing as the reference method, sensitivity and specificity for detecting rifampicin resistance were 100% and 99.1%, respectively. Moreover, a median turnaround time of the Xpert assay was 1 day, which was significantly shorter than 3 days of the AdvanSure assay (p<0.001).Conclusion: In comparison with the AdvanSure assay, the Xpert assay had a higher sensitivity using smear-negative specimens, a shorter turnaround time, and could reliably predict rifampin resistance. Therefore, the Xpert assay might be preferentially recommended over TB-PCR in Korean TB diagnostic algorithm.

show abstract

“…In this cartridge, the detection of RIF resistance is based on the interpretation of the melting curves of molecular probes [21]. However, recent studies showed that for detection of RIF resistance, GeneXpert Ultra and GeneXpert® MTB/RIF had similar sensitivity and speci city [22,23], and post-implementation population based studies are still to be performed. Another cause for the discrepant results could be the presence of minority rpoB mutant populations in the processed samples that were less t to grow in culture, as was previously described for 'borderline' rpoB mutants [24].…”

Section: Discussionmentioning

confidence: 99%

Spot Specimen Testing With GeneXpert® MTB/RIF Results In More Complete TB Diagnostic Results Than Morning Specimens

Massou

Fandohan

Wachinou

et al. 2021

Preprint

View full text Add to dashboard Cite

Background: The diagnosis of Tuberculosis (TB) using smear microscopy has been based on testing 2 specimens: one spot and one early morning sputum. Recently, the World Health Organization (WHO) recommended to replace, whenever possible, microscopy with GeneXpert® MTB/RIF performed on a single specimen. However, as the bacterial load is higher in early morning specimens than in spot specimens, one could expect lower sensitivity of GeneXpert® MTB/RIF performed only on spot specimens. In this study, we compared results of GeneXpert® MTB/RIF on spot specimens versus early morning specimens, under programmatic conditions in Cotonou, Benin. Methods: From June to September 2018, all sputa received from presumptive TB patients at the Supranational Reference Laboratory for Tuberculosis of Cotonou were included in the study. From each patient, two specimens were collected (one spot and one early morning) and GeneXpert® MTB/RIF was performed on both specimens. Results: In total, 886 participants were included in the study, of whom 737 provided both sputa and 149 (16.8%) gave only the spot specimen. For the 737 participants who provided both sputa, GeneXpert® MTB/RIF was positive for both specimens in 152 participants; for three participants GeneXpert® MTB/RIF was positive on spot specimen but negative on morning specimen while for another three, the test was positive on morning specimen but negative on spot specimen. The overall percentage of agreement was excellent (99.2%) with a very positive and negative percent agreement greater than 98%.Conclusions: For TB diagnosis under programmatic conditions in Cotonou, GeneXpert® MTB/RIF in spot specimens gave similar results with the test in morning specimens. Performing GeneXpert® MTB/RIF in both specimens did not significantly increase the number of cases detected. To avoid losing patients from the diagnostic cascade, it is preferable to test sputa produced at the time of visit.

show abstract

Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis

Abstract: Editorial group: Cochrane Infectious Diseases Group. Publication status and date: New search for studies and content updated (conclusions changed), published in Issue 2, 2021.

Cited by 95 publications

References 299 publications

The Value of Lateral Flow Urine Lipoarabinomannan Assay and Empirical Treatment in the Xpert MTB/RIF Ultra Era: a Prospective Cohort Study

The Value of Lateral Flow Urine Lipoarabinomannan Assay and Empirical Treatment in the Xpert MTB/RIF Ultra Era: a Prospective Cohort Study

Head-to-Head Comparison between Xpert MTB/RIF Assay and Real-Time Polymerase Chain Reaction Assay Using Bronchial Washing Specimens for Tuberculosis Diagnosis

Spot Specimen Testing With GeneXpert® MTB/RIF Results In More Complete TB Diagnostic Results Than Morning Specimens

Contact Info

Product

Resources

About