Accuracy of Xpert MTB/RIF Ultra for the Diagnosis of Pleural TB in a Multicenter Cohort Study

Wang, Guirong; Wang, Shuqi; Yang, Xinting; Sun, Qing; Jiang, Guanglu; Huang, Mailing; Huo, Fengmin; Ma, Yifeng; Chen, Xiaoyou; Huang, Hairong

doi:10.1016/j.chest.2019.07.027

Cited by 56 publications

(54 citation statements)

References 15 publications

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“…She was diagnosed with vertebral TB according to CT-guided needle biopsy 4 years ago and was successfully treated after 12 months of anti-tuberculosis treatment. Similar false-positive Xpert results were also reported in a malignant pleural tumour patient 33 and patients with TB history 34 . Regarding the high TB burden in China, we speculated that this patient might still have latent MTB infection or might have both pericardial tumours and TBP.…”

Section: Diagnostic Testssupporting

confidence: 80%

Diagnostic values of Xpert MTB/RIF, T-SPOT.TB and adenosine deaminase for HIV-negative tuberculous pericarditis in a high burden setting: a prospective observational study

Xing

Wang

et al. 2020

Sci Rep

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The diagnosis of tuberculous pericarditis (TBP) remains challenging. This prospective study evaluated the diagnostic value of Xpert MTB/RIF (Xpert) and T-SPOT.TB and adenosine deaminase (ADA) for TBP in a high burden setting. A total of 123 HIV-negative patients with suspected TBP were enrolled at a tertiary referral hospital in China. Pericardial fluids were collected and subjected to the three rapid tests, and the results were compared with the final confirmed diagnosis. Of 105 patients in the final analysis, 39 (37.1%) were microbiologically, histopathologically or clinically diagnosed with TBP. The sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio and diagnostic odds ratio (DOR) for Xpert were 66.7%, 98.5%, 96.3%, 83.3%, 44.0, 0.338, and 130.0, respectively, compared to 92.3%, 87.9%, 81.8%, 95.1%, 7.6, 0.088, and 87.0, respectively, for T-SPOT.TB, and 82.1%, 92.4%, 86.5%, 89.7%, 10.8, 0.194, and 55.8, respectively, for ADA (≥ 40 U/L). ROC curve analysis revealed a cut-off point of 48.5 spot-forming cells per million pericardial effusion mononuclear cells for T-SPOT.TB, which had a DOR value of 183.8, while a cut-off point of 41.5 U/L for ADA had a DOR value of 70.9. Xpert (Step 1: rule-in) followed by T-SPOT.TB [cut-off point] (Step 2: rule-out) showed the highest DOR value of 252.0, with only 5.7% (6/105) of patients misdiagnosed. The two-step algorithm consisting of Xpert and T-SPOT.TB could offer rapid and accurate diagnosis of TBP.

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Section: Diagnostic Testssupporting

confidence: 80%

Diagnostic values of Xpert MTB/RIF, T-SPOT.TB and adenosine deaminase for HIV-negative tuberculous pericarditis in a high burden setting: a prospective observational study

Xing

Wang

et al. 2020

Sci Rep

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“…Several studies have been published on the diagnostic accuracy of Ultra in extrapulmonary specimens 11,14,15,[17][18][19][20][21][22][23][24][25]28,29 . Most of the studies were performed in TB endemic settings 14,17,[19][20][21][22][23][24][25]28,29 , and only three studies have investigated Ultra test performance in low TB prevalence settings 11,15,18 . However, two of these studies were retrospective and performed on selected sample material.…”

Section: Discussionmentioning

confidence: 99%

“…Most, but not all 28,29 , of the studies that investigate Ultra for the diagnosis of EPTB suggest increased sensitivity of Ultra compared to Xpert in different extrapulmonary specimens 11,14,15,17,[19][20][21][22][23]25 . When culture is used as reference standard, the reported sensitivity of Ultra varies, but is generally high in lymph node specimens (90-94%) 18,24 , FNAs and tissue samples (87-95%) 18,22 , cerebrospinal fluid (80-100%) 17,18,21,25,29 and pus specimens (65-95%) 18,19 , and lower in pleural fluid samples (48-84%) 18,20,22,23 , which is in line with our findings. Several of the studies also show that Ultra can detect MTC in culture negative specimens from clinically diagnosed TB cases 17,[19][20][21][22][23][24][25]28,29 , thus, contributing to improved diagnosis of TB in samples with a very low bacillary load.…”

Section: Discussionmentioning

confidence: 99%

“…The increased sensitivity of Ultra is achieved by incorporation of two new PCR assays targeting the multicopy genes IS6110 and IS1081 for the diagnosis of TB, a larger DNA reaction chamber and transformation from hemi-nested to fully nested PCR reactions 7 . A number of studies report increased sensitivity of Ultra compared to Xpert in smear negative PTB [9][10][11][12][13][14][15][16] , and several studies also show promising results for diagnosing EPTB 11,14,15,[17][18][19][20][21][22][23][24][25] . However, most of the studies that investigate Ultra for diagnosing EPTB have been conducted in low-resource settings with high TB incidence.…”

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confidence: 99%

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Xpert MTB/RIF ultra for rapid diagnosis of extrapulmonary tuberculosis in a high-income low-tuberculosis prevalence setting

Hoel

Syre

Skarstein

et al. 2020

Sci Rep

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the diagnosis of extrapulmonary tuberculosis (eptB) is often challenging due to paucibacillary nature of the disease. Xpert MtB/Rif Ultra (Ultra) has been developed to improve detection of Mycobacterium tuberculosis complex (Mtc) in paucibacillary specimens. the objective of the study was to assess the performance of Ultra for the diagnosis of eptB in a high-income low tB prevalence country. extrapulmonary samples received for tB diagnostics at two hospitals in norway between January 2015 and January 2016 were prospectively and consecutively included. Defrosted samples were subjected to Ultra. Culture and routine PCR tests were used as reference standard. A total of 82 samples, 10 culture and/or routine PCR positive (confirmed TB) samples and 72 culture and routine PCR negative samples were included in analysis. The overall sensitivity and specificity of Ultra were 90% (9/10, 95% CI 56-100) and 99% (71/72, 95% CI 93-100), respectively. Ultra was positive in 6/7 smear negative confirmed TB samples. To conclude, Ultra showed a high sensitivity and specificity in extrapulmonary specimens and may contribute to a rapid diagnosis of eptB in a low tB prevalence setting.

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“…Non-invasive imagologic examinations, such as radiologic examination or ultrasound, are mainstays for bacteriologic-negative TB diagnosis, whereas their specificities are often suboptimal [10,11]. Xpert-Ultra was developed to improve the sensitivity for detection of paucibacillary TB and has been successfully used for different types of clinical specimens [12,13]. Percutaneous biopsy has been used for diagnosis of lung cancer, and its value has been validated in multiple other studies and in this study as well [14].…”

Section: Discussionmentioning

confidence: 78%

Combination of Percutaneous Lung Biopsy and Xpert MTB/RIF Ultra Enhances the Differential Diagnosis of Tuberculosis: A Prospective Cohort Study

Zhou

Zhu

et al. 2020

Infect Dis Ther

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Introduction: To evaluate the value of the combination of computed tomography (CT)guided percutaneous lung biopsy and Xpert MTB/RIF Ultra (Xpert-Ultra) in enhancing the differential diagnosis of tuberculosis. Methods: Patients with lesions in the lungs for whom the differential diagnosis was difficult were prospectively and consecutively enrolled. Specimens collected by percutaneous lung biopsy were subject to Xpert-Ultra and histopathologic examination, respectively. Results: Biopsy was successfully performed for 147 patients who were eligible for analysis, including 65 TB, 55 lung cancer and 27 other chronic infection cases. The sensitivity, specificity, positive predictive value and negative predictive value of Xpert-Ultra for TB diagnosis were 75.38% (49/65) and 95.12% (78/82), 92.45% (49/53) and 82.98% (78/94), respectively. Among patients with strong evidence for TB diagnosis (categorized as confirmed or probable TB cases), the overall positive rate of the Xpert-Ultra assay was 83.63% (46/55), which was much higher than for any reported sample type with negative smear test outcomes to date. Five rifampicin (RIF)-resistant cases were identified using the biopsy tissues. However, ''trace'' positive did not seem reliable for TB diagnosis with lung biopsy specimens; a 25.61% (21/82) ''trace''-positive rate was acquired in the non-TB group. Conclusion: Percutaneous lung biopsy combined with Xpert-Ultra produced high sensitivity for culture-negative pulmonary TB patient diagnosis. ''Trace'' outcome might not be a reliable positive category for lung biopsy specimens. Zhen Zhou, Chenghai Li and Rui Zhu contributed equally to this study.

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Accuracy of Xpert MTB/RIF Ultra for the Diagnosis of Pleural TB in a Multicenter Cohort Study

Cited by 56 publications

References 15 publications

Diagnostic values of Xpert MTB/RIF, T-SPOT.TB and adenosine deaminase for HIV-negative tuberculous pericarditis in a high burden setting: a prospective observational study

Diagnostic values of Xpert MTB/RIF, T-SPOT.TB and adenosine deaminase for HIV-negative tuberculous pericarditis in a high burden setting: a prospective observational study

Xpert MTB/RIF ultra for rapid diagnosis of extrapulmonary tuberculosis in a high-income low-tuberculosis prevalence setting

Combination of Percutaneous Lung Biopsy and Xpert MTB/RIF Ultra Enhances the Differential Diagnosis of Tuberculosis: A Prospective Cohort Study

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