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

Yu, Guocan; Wang, Linhua; Shen, Yanqin; Fang, Lingling; Yang, Jun; Ye, Bo; Xu, Kan; Zhong, Fangming

doi:10.2147/idr.s360064

Cited by 9 publications

(11 citation statements)

References 24 publications

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“…With it development, molecular diagnostic technology is now preferably used for the early and rapid diagnosis of TB. 20 However, there may be differences between molecular diagnostic tests, 21 and the efficacy of each molecular test for TB diagnosis should be evaluated separately. In EPTB, Xpert MTB/RIF is widely used for the early diagnosis of the disease, and its diagnostic accuracy is satisfactory; 22 , 23 The loop-mediated isothermal amplification (LAMP) assay is also used for the diagnosis of EPTB, and its performance is also very good.…”

Section: Discussionmentioning

confidence: 99%

“…In EPTB, Xpert MTB/RIF is widely used for the early diagnosis of the disease, and its diagnostic accuracy is satisfactory; 22 , 23 The loop-mediated isothermal amplification (LAMP) assay is also used for the diagnosis of EPTB, and its performance is also very good. 24 Other molecular methods, such as the CapitalBio Mycobacterium real-time polymerase chain reaction (RT-PCR) and mNGS, 21 , 25 , 26 have also been used in EPTB, and they have shown their own characteristics in the diagnosis of the disease. The most widely used clinical tests are molecular diagnostic tests based on MTB-DNA; molecular tests based on MTB-RNA are limited.…”

Section: Discussionmentioning

confidence: 99%

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Application of Mycobacterium tuberculosis RNA for the Rapid Diagnosis of Lymph Node Tuberculosis Using Different Specimens

Ting

et al. 2023

IDR

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Purpose To evaluate the accuracy of Mycobacterium tuberculosis (MTB)-RNA in the rapid diagnosis of lymph node tuberculosis (LNTB). Moreover, the difference in the diagnostic accuracy of MTB-RNA using different specimens was determined. Methods We included patients with suspected LNTB who met the inclusion criteria and retrospectively analyzed their clinical data. The sensitivity, specificity, positive-predictive value (PPV), negative-predictive value (NPV), and area under the curve (AUC) of MTB-RNA and culture were calculated and its diagnostic accuracy for LNTB was evaluated in comparison with the final clinical diagnosis. Results Overall, 285 patients were included in the study. The overall sensitivity, specificity, PPV, NPV, and AUC of MTB-RNA were 40.6%, 100.0%, 100.0%, 17.0%, and 0.70, respectively. These values were 30.8%, 100.0%, 100.0%, 16.0%, and 0.65, respectively, for tissue specimens; 34.2%, 100.0%, 100.0%, 24.6%, and 0.67, respectively, for puncture specimens; and 57.14%, 100.0%, 100.0%, 5.3%, and 0.79, respectively, for pus specimens. These values of culture were 24.4%, 100.0%, 100.0%, 13.9%, and 0.62, respectively, for all specimens; 17.6%, 100.0%, 100.0%, 13.8%, and 0.59, respectively, for tissue specimens; 25.3%, 100.0%, 100.0%, 22.4%, and 0.63, respectively, for puncture specimens; and 31.0%, 100.0%, 100.0%, 3.3%, and 0.65, respectively, for pus specimens. Conclusion The diagnostic efficacy of MTB-RNA for the rapid diagnosis of LNTB was moderate, but its sensitivity was low. The lymph node pus specimens were the most sensitive for MTB-RNA testing, followed by puncture specimens; tissues were the least sensitive. Pus specimens should be preferably obtained in case only this test is to be used for diagnosis.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Application of Mycobacterium tuberculosis RNA for the Rapid Diagnosis of Lymph Node Tuberculosis Using Different Specimens

Ting

et al. 2023

IDR

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“… 19 The microbiological diagnosis remains the most critical aspect of TBP diagnosis, with the AFB smear and MTB culture still being the most classical microbiological tests for TB diagnosis. 19 , 25 Although they have their own advantages, the disadvantages cannot be ignored. The AFB smear plays a limited role in EPTB diagnosis.…”

Section: Discussionmentioning

confidence: 99%

“…This finding is consistent with previous studies that used either pericardial effusion or pericardial tissue testing. 19,25 A study using pericardial effusion to diagnose TBP found that AFB smear were negative in all 40 pericardial effusion specimens. 25 Another study using pericardial tissues observed that AFB smear were positive in only 4 of 19 These findings suggested that the role of AFB smear in TBP diagnosis is limited.…”

Section: Discussionmentioning

confidence: 99%

Clinical Application of the Mycobacterium tuberculosis-RNA Assay of Pericardial Tissue Specimens in the Diagnosis of Tuberculous Pericarditis

Zhang¹,

Bu²,

Yao³

et al. 2023

IDR

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Purpose To assess the accuracy of the Mycobacterium tuberculosis (MTB)-RNA assay using pericardial tissue specimens for tuberculous pericarditis (TBP) diagnosis. Methods MTB culture and MTB-RNA assay were performed for patients with suspected TBP. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) of these two assays were analyzed. Results This study included 79 patients. The sensitivity, specificity, PPV, NPV, and AUC were 28.1% (18/64), 100.0% (15/15), 100.0% (18/18), 24.6% (15/61), and 0.64 for the MTB culture and 37.5% (24/64), 100.0% (15/15), 100.0% (24/24), 27.3% (15/55), and 0.69 for the MTB-RNA assay, respectively. Patients with positive pericardial tissue culture were defined as having definite TBP; in other words, culture was the gold standard for this group of patients and had a sensitivity, specificity, PPV, and NPV of 100% and an AUC of 1.00. However, these values were found to be 72.2% (13/18), 100.0% (15/15), 100.0% (13/13), 75.0% (15/20), and 0.86 for the MTB-RNA assay, respectively. Among patients with probable TBP (culture-negative patients), the sensitivity, specificity, NPV, and AUC of MTB culture were 0.0% (0/46), 100.0% (15/15), 24.6% (15/61), and 0.50, respectively, but the PPV could not be determined. These values were found to be 23.9% (11/46), 100.0% (15/15), 100.0% (11/11), 30.0% (15/50), and 0.62 for the MTB-RNA assay, respectively. Conclusion MTB-RNA assay using pericardial tissues had limited diagnostic efficacy for TBP. In culture-positive TBP, the diagnostic accuracy of MTB-RNA was good. In contrast, in culture-negative TBP, its diagnostic accuracy was unsatisfactory.

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“…11 In recent years, with the development of molecular diagnostics, molecular tests have been widely used for the early and rapid diagnosis of TB, 12 as well as for the rapid diagnosis of PTB. 13 Although most current molecular assays target Mtb DNA, 14,15 research on molecular assays that target Mtb RNA has been limited. 16 Shanghai Rendu Biotechnology Co has developed a TB-RNA detection technology that involves simultaneous amplification and testing for the detection of Mtb RNA by employing isothermal 16S ribosomal RNA (rRNA) amplification.…”

Section: Introductionmentioning

confidence: 99%

Comparing Mycobacterium tuberculosis RNA Accuracy in Various Respiratory Specimens for the Rapid Diagnosis of Pulmonary Tuberculosis

Qiu¹,

Zheng²,

Yang³

et al. 2022

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Objective To evaluate the rapid diagnostic accuracy of Mycobacterium tuberculosis RNA (TB-RNA) for pulmonary tuberculosis (PTB) in a large patient sample and to evaluate the difference in TB-RNA diagnostic accuracy in various respiratory specimens. Methods Patient medical records were retrospectively reviewed to determine the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) of the acid-fast bacillus (AFB) smear and TB-RNA to evaluate their diagnostic accuracy against final clinical diagnosis. Results Of the 2336 patients ultimately included, 1123 provided 1 sputum specimen each and 1213 provided 1 bronchoalveolar lavage fluid (BALF) specimen each. The overall sensitivity, specificity, PPV, NPV, and AUC of the AFB smear were 36.2%, 86.4%, 90.6%, 27.3%, and 0.61, respectively. The overall sensitivity, specificity, PPV, NPV, and AUC of TB-RNA for the rapid detection of PTB were 57.4%, 99.4%, 99.7%, 39.3%, and 0.78, respectively. When sputum and BALF specimens were used for AFB smear testing, the sensitivity, specificity, PPV, NPV, and AUC of the AFB smear were 44.5%, 81.5%, 87.5%, 33.5%, and 0.63; and 29.2%, 92.7%, 94.8%, 22.5%, and 0.61, respectively. The sensitivity, specificity, PPV, NPV, and AUC of TB-RNA for the rapid detection of PTB using sputum were 49.6%, 99.3%, 99.5%, 40.4%, and 0.74, respectively; whereas those of TB-RNA determined using BALF were 63.9%, 99.5%, 99.8%, 38.0%, and 0.82, respectively. Conclusion The diagnostic accuracy of TB-RNA for PTB was moderate and considerably better than that of the AFB smear. The diagnostic accuracy of TB-RNA for various respiratory specimens differed; the diagnostic accuracy of TB-RNA for BALF specimens was substantially better than that for sputum samples, and BALF specimens were more suitable for TB-RNA.

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

Cited by 9 publications

References 24 publications

Application of Mycobacterium tuberculosis RNA for the Rapid Diagnosis of Lymph Node Tuberculosis Using Different Specimens

Application of Mycobacterium tuberculosis RNA for the Rapid Diagnosis of Lymph Node Tuberculosis Using Different Specimens

Clinical Application of the Mycobacterium tuberculosis-RNA Assay of Pericardial Tissue Specimens in the Diagnosis of Tuberculous Pericarditis

Comparing Mycobacterium tuberculosis RNA Accuracy in Various Respiratory Specimens for the Rapid Diagnosis of Pulmonary Tuberculosis

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