Performance of the IS6110-TaqMan® assay in the diagnosis of extrapulmonary tuberculosis from different biological samples

Santos, Fabiana Cristina Fulco; Lira, Laís Ariane de Siqueira; Montenegro, Rosana de Albuquerque; Lima, Jaime; Lima, Andrea Santos; Schindler, Haiana Charifker; Montenegro, Lílian Maria Lapa

doi:10.1590/0037-8682-0372-2017

Cited by 5 publications

(5 citation statements)

References 31 publications

(48 reference statements)

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“…This method provides precise and reproducible quantitation of specific microbial nucleic acids via the ongoing detection of the amplification target throughout the full exponential phase of the reaction (Santos et al, 2018). The CapitalBio Mycobacterium real-time PCR detection test is a relatively inexpensive commercial real-time fluorescent PCR-TaqMan assay that amplifies IS6110 for MTB and HSP65 for NTM; as such, this assay can detect both MTB and NTM simultaneously (Shen et al, 2020). IS6110 has been used as a validated MTB target gene with good levels of performance for the diagnosis of TB in several studies (Raj et al, 2016).…”

Section: Discussionmentioning

confidence: 99%

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A comparison of the accuracy of the CapitalBio Mycobacterium real-time polymerase chain reaction and the Xpert MTB/RIF assay for the diagnosis of tuberculous meningitis

Sun¹,

Yao²,

Fu³

et al. 2021

International Journal of Infectious Diseases

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We aimed to compare the efficiency of the CapitalBioMycobacterium real-time polymerase chain reaction (PCR) detection test with the standard Xpert MTB/RIF assay for the diagnosis of tuberculous meningitis (TBM). Methods: We analyzed cerebrospinal fluid (CSF) from 163 patients with suspected TBM that were collected between January 1, 2018, and December 31, 2019. For both tests, we determined the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC). Next, we compared the diagnostic accuracy of the two techniques using clinical diagnosis as a reference standard. Results: The sensitivity, specificity, PPV, NPV, and AUC, of the CapitalBio Mycobacterium detection test were 48.5%, 100%, 100%, 29.6%, and 0.74, respectively, when used for the diagnosis of TBM. In comparison, the Xpert MTB/RIF assay returned values of 47.0%, 100%, 100%, 29.0%, and 0.74, respectively. Our analysis showed that the diagnostic accuracies of the CapitalBio Mycobacterium detection test and the Xpert MTB/ RIF assay were very similar; the accuracy of both tests for detecting mycobacteria was significantly higher than that associated with acidfast staining. Conclusions: The CapitalBio Mycobacterium real-time PCR detection test has moderate sensitivity and very high specificity for TBM; results are very similar to those generated by the Xpert MTB/RIF assay. We recommend that the CapitalBio PCR test should be used as an initial screening method for TB.

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Section: Discussionmentioning

confidence: 99%

“…Amplification was performed using a real-time fluorescence quantification PCR instrument (SLAN-96S Real-Time PCR System ZEESAN Xiamen CN) to detect IS6110 and HSP65 multicopy elements from MTB and NTM, respectively. This test can be performed in 3 h (Shen et al, 2020).…”

Section: The Capitalbio Mycobacterium Real-time Pcr Detection Testmentioning

confidence: 99%

A comparison of the accuracy of the CapitalBio Mycobacterium real-time polymerase chain reaction and the Xpert MTB/RIF assay for the diagnosis of tuberculous meningitis

Sun¹,

Yao²,

Fu³

et al. 2021

International Journal of Infectious Diseases

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“…One such test is fluorescent RT-PCR. Compared with traditional PCR, fluorescent RT-PCR has the advantage of simultaneous amplification and detection of DNA via a fluorescence system (Santos et al, 2018). This method determines values throughout the exponential phase of the reaction, making the quantification of nucleic acids precise and reproducible (Santos et al, 2018).…”

Section: Discussionmentioning

confidence: 99%

“…Compared with traditional PCR, fluorescent RT-PCR has the advantage of simultaneous amplification and detection of DNA via a fluorescence system (Santos et al, 2018). This method determines values throughout the exponential phase of the reaction, making the quantification of nucleic acids precise and reproducible (Santos et al, 2018). Limited research has demonstrated the efficacy of this test in detecting mycobacterial DNA for MTB and NTM infection (Armand et al, 2011;Lira et al, 2013).…”

Section: Discussionmentioning

confidence: 99%

CapitalBio Mycobacterium real-time polymerase chain reaction detection test: Rapid diagnosis of Mycobacterium tuberculosis and nontuberculous mycobacterial infection

Shen¹,

Fang²,

Xu³

et al. 2020

International Journal of Infectious Diseases

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“…The use of polymerase chain reaction (PCR) assays has been proposed in a few studies to increase the sensitivity and specificity of the diagnosis of childhood tuberculosis 6 , 22 . Generally, they have high sensitivities and specificities using clinical samples and produce rapid results 9 , 10 , 23 - 25 . These techniques detect a specific genome DNA region in the microorganism.…”

Section: Introductionmentioning

confidence: 99%

Rapid detection of Mycobacterium tuberculosis in children using blood and urine specimens

Lima

Pimentel

Santos

et al. 2020

Rev. Soc. Bras. Med. Trop.

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Introduction: Laboratory and clinical features of childhood tuberculosis (TB) are non-specific and establishing an accurate diagnosis remains a challenge. This study evaluated a Single tube nested-PCR (STNPCR) to detect genomic DNA of Mycobacterium tuberculosis complex in blood and urine. Methods: Biological samples were obtained from children (<15 years old) with clinical suspicion of pulmonary and extrapulmonary TB at public hospitals in Recife-Pernambuco, Brazil. Cultures yielded negative results in a majority of childhood TB cases, which are generally paucibacillary. A set of clinical, epidemiological, radiological, and laboratory criteria with evident clinical improvement after anti-TB treatment were frequently used to define childhood TB cases. Results: Ninety children with clinical suspicion were enrolled in this study (44 with TB and 46 without TB). The pulmonary TB group had 20 confirmed cases and 46 negative controls, while the extrapulmonary TB group had 24 confirmed cases. The STNPCR showed sensitivities to pulmonary and extrapulmonary TB of 47.4% and 52.2% (blood) and 38.8% and 20% (urine), respectively. Considering the low performance of STNPCR on separate samples, we decided to perform a combined analysis (parallel sensitivity analysis) of the results from blood and urine samples. The parallel sensitivity increased to 65% in blood and 62.5% in urine. The specificity in both samples ranged from 93.5-97.8%. Conclusions: Although STNPCR showed moderate sensitivity, the specificity is high; therefore, the test can be used as an auxiliary tool to diagnose TB in children. It is a rapid test that demonstrated better performance than other diagnostic tests in paucibacillary samples as it does in childhood tuberculosis.

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Performance of the IS6110-TaqMan® assay in the diagnosis of extrapulmonary tuberculosis from different biological samples

Cited by 5 publications

References 31 publications

A comparison of the accuracy of the CapitalBio Mycobacterium real-time polymerase chain reaction and the Xpert MTB/RIF assay for the diagnosis of tuberculous meningitis

A comparison of the accuracy of the CapitalBio Mycobacterium real-time polymerase chain reaction and the Xpert MTB/RIF assay for the diagnosis of tuberculous meningitis

CapitalBio Mycobacterium real-time polymerase chain reaction detection test: Rapid diagnosis of Mycobacterium tuberculosis and nontuberculous mycobacterial infection

Rapid detection of Mycobacterium tuberculosis in children using blood and urine specimens

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