Comparison of the diagnostic efficacy of the CapitalBio Mycobacterium real-time polymerase chain reaction detection test and Xpert MTB/RIF in smear-negative pulmonary tuberculosis

Hong, Zhao; Zhong, Fangming; Yu, Guocan; Shen, Yanqin

doi:10.1007/s10096-020-04113-1

Cited by 17 publications

(25 citation statements)

References 32 publications

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“…CapitalBio Mycobacterium RT-PCR detection assay has a limit of detection (LOD) of 5000 colony forming units (CFU)/mL, whereas Xpert MTB/RIF is 131 CFU/mL. 14 CapitalBio Mycobacterium RT-PCR detection assay can detect both MTB and NTM infections, whereas Xpert MTB/RIF can only detect MTB infections. Pericardial fluid with NTM infection was not detected in this study, so the advantage of simultaneous detection of two types of mycobacteria by the CapitalBio Mycobacterium RT-PCR detection assay was not reflected in this study.…”

Section: Discussionmentioning

confidence: 99%

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Comparison of the Diagnostic Accuracy of Xpert MTB/RIF and CapitalBio Mycobacterium RT-PCR Detection Assay for Tuberculous Pericarditis

Yu¹,

Wang²,

Shen³

et al. 2022

IDR

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Purpose We evaluated CapitalBio Mycobacterium RT-PCR assay diagnosing tuberculous pericarditis (TBP), performed a head-to-head comparison with Xpert MTB/RIF, and assessed the impact of a parallel test (positive result for either of these two tests). Methods We reviewed suspected TBP patients with Xpert MTB/RIF, CapitalBio Mycobacterium RT-PCR assay, and Mycobacterium tuberculosis (MTB) culture. We analyzed sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC). Results Seventy-four patients were included. Overall sensitivity, specificity, PPV, NPV, and AUC of CapitalBio Mycobacterium RT-PCR assay compared with culture were 50%, 91.1%, 64.3%, 85%, and 0.71, respectively. Overall sensitivity, specificity, PPV, NPV, and AUC of Xpert MTB/RIF for TBP were 61.1%, 91.1%, 68.8%, 87.9%, and 0.76. Parallel test values were 72.2%, 91.1%, 72.2%, 91.1%, and 0.82. The diagnostic accuracy of Xpert MTB/RIF was higher than CapitalBio Mycobacterium RT-PCR assay but was not significant ( P > 0.05). The parallel test could improve diagnostic accuracy, but it was not significant compared to single tests ( P > 0.05). Conclusion CapitalBio Mycobacterium RT-PCR assay had a moderate diagnostic accuracy, similar to Xpert MTB/RIF. The parallel test maximized diagnostic efficacy, but differences were not significant. CapitalBio Mycobacterium RT-PCR assay and Xpert MTB/RIF for TBP could be an initial option for early diagnosis.

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Section: Discussionmentioning

confidence: 99%

“… 12 The Xpert MTB/RIF assay is one of the most widely used NAATs for diagnosing TB and has demonstrated good diagnostic performance in PTB and EPTB. 13 , 14 It can obtain test results within 2 hours to meet the need for rapid diagnosis. 15 In TBP, Xpert MTB/RIF also showed relatively good performance with a sensitivity of 63.8%.…”

Section: Introductionmentioning

confidence: 99%

Comparison of the Diagnostic Accuracy of Xpert MTB/RIF and CapitalBio Mycobacterium RT-PCR Detection Assay for Tuberculous Pericarditis

Yu¹,

Wang²,

Shen³

et al. 2022

IDR

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“…16 It should be noted that the diagnostic efficacy of this assay for TB is similar to that of Xpert. 17,18 Studies including a pathological examination of CNB specimens combined with molecular tests as an approach to LNTB diagnosis, and comparing their efficacy with that provided by tissue specimens alone, are limited. The aim of this study was: (i) to evaluate the diagnostic efficacy of pathology when combined with molecular tests for the diagnosis of LNTB in CNB specimens, (ii) to compare that diagnostic efficacy with that deriving from tissue specimens' examination alone, as well as (iii) to explore further diagnostic strategies for LNTB so as to provide clinicians and patients with optimal diagnostic protocols.…”

Section: Introductionmentioning

confidence: 99%

The Role of Core Needle Biopsy Pathology Combined with Molecular Tests in the Diagnosis of Lymph Node Tuberculosis

Shen

Fang

et al. 2022

IDR

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Background: Early lymph node tuberculosis (LNTB) diagnosis is still difficult. The majority of LN specimens require the undertaking of invasive and unpleasant procedures. Purpose: To evaluate the diagnostic efficacy of pathology when combined with molecular tests for the diagnosis of LNTB in core needle biopsy (CNB) specimens and to compare that diagnostic efficacy with that deriving from tissue specimens' examination alone. Methods: We retrospectively analyzed the medical records of LNTB patients who met the inclusion criteria. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) of pathology, molecular tests, and parallel test (positive result for either of these two assays) were calculated to evaluate their diagnostic efficacy compared with a composite reference standard. Results: A total of 289 patients were included in the study.

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“… 14 In PTB and EPTB, the CapitalBio test exhibited similar diagnostic accuracy to Xpert MTB/RIF. 15 , 16 However, the diagnostic accuracy of the CapitalBio test using CNB specimens in TBL is still unknown and requires further investigation. To this end, we conducted a study to evaluate the diagnostic accuracy of the CapitalBio test using CNB specimens for TBL and to compare it with Xpert MTB/RIF to provide clinicians with more information for decision-making.…”

Section: Introductionmentioning

confidence: 99%

Comparison of the Accuracy of Two Different Molecular Tests for the Diagnosis of Tuberculous Lymphadenitis Using Core Needle Biopsy Specimens: A Diagnostic Accuracy Study

Yao¹,

Xu²,

Chen³

et al. 2022

IJGM

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Purpose To evaluate the diagnostic accuracy of the CapitalBio Mycobacterium real-time polymerase chain reaction assay (CapitalBio test) testing of core needle biopsy (CNB) specimens for tuberculous lymphadenitis (TBL) and to compare it with Xpert MTB/RIF. Methods We retrospectively analyzed the medical data on patients with suspected peripheral TBL. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) of the CapitalBio test, Xpert MTB/RIF, and parallel test (positive result for either of these two tests) were calculated to evaluate their diagnostic efficacy compared with the final clinical diagnosis. Results The study included 114 patients. For diagnosing TBL using CNB samples, the sensitivity, specificity, PPV, NPV, and AUC were 65.0%, 100.0%, 100.0%, 28.6%, and 0.83, respectively, for the CapitalBio test; 72.0%, 100.0%, 100.0%, 33.3%, and 0.86, respectively, for Xpert MTB/RIF; and 82.0%, 100.0%, 100.0%, 43.8%, and 0.91, respectively, for the parallel test. Conclusion The accuracy of the CapitalBio test and Xpert MTB/RIF for diagnosing TBL using CNB specimens was moderate, while the sensitivity and NPV of these two tests were relatively low. The diagnostic accuracy of the CapitalBio test was slightly lower than that of Xpert MTB/RIF, but the difference between the two was not statistically significant. Parallel test might improve the diagnostic accuracy but not substantially over a single test.

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Comparison of the diagnostic efficacy of the CapitalBio Mycobacterium real-time polymerase chain reaction detection test and Xpert MTB/RIF in smear-negative pulmonary tuberculosis

Cited by 17 publications

References 32 publications

Comparison of the Diagnostic Accuracy of Xpert MTB/RIF and CapitalBio Mycobacterium RT-PCR Detection Assay for Tuberculous Pericarditis

Comparison of the Diagnostic Accuracy of Xpert MTB/RIF and CapitalBio Mycobacterium RT-PCR Detection Assay for Tuberculous Pericarditis

The Role of Core Needle Biopsy Pathology Combined with Molecular Tests in the Diagnosis of Lymph Node Tuberculosis

Comparison of the Accuracy of Two Different Molecular Tests for the Diagnosis of Tuberculous Lymphadenitis Using Core Needle Biopsy Specimens: A Diagnostic Accuracy Study

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