Evaluation of a new automated Abbott RealTime MTB RIF/INH assay for qualitative detection of rifampicin/isoniazid resistance in pulmonary and extra-pulmonary clinical samples of &lt;em&gt;Mycobacterium tuberculosis&lt;/em&gt;

Ruiz, Pilar; Causse, Manuel; Vaquero, Manuel; Gutiérrez, J.; Casal, Manuel

doi:10.2147/idr.s147272

Cited by 13 publications

(6 citation statements)

References 8 publications

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“…But in 3/19 INH resistance specimens, mutation(s) was not detected with the Abbott RealTime MTB RIF/INH assay resulting with 84.2% sensitivity. This proportion is relatively similar to the study conducted by Ruiz P et al (78.8%) [ 20 ] and Tam KK et al (84%) [ 21 ]. Discordant INH resistance pattern between DST and this assay could be as a result of INH resistance is linked with multiple genes and appears more complex [ 22 ].…”

Section: Discussionsupporting

confidence: 90%

Performance of the Abbott RealTime MTB and RIF/INH resistance assays for the detection of Mycobacterium Tuberculosis and resistance markers in sputum specimens

et al. 2021

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Background The Abbott RealTime MTB is an assay for the detection of Mycobacterium tuberculosis (MTB) complex DNA from respiratory specimens in combination with the Abbott RealTime RIF/INH assay for the detection of genetic resistance markers for isoniazid (INH) and rifampicin (RIF) from MTB positive isolates. Hence, this study aimed to evaluate the performance of the Abbott RealTime MTB and RIF/INH assays. Methods A cross-sectional study was conducted on 289 study subjects presumptive to have pulmonary tuberculosis at Nigist Eleni Mohammed Memorial Hospital, South Ethiopia from April 2017 to June 2018. Two morning expectorated sputum specimens were collected from each study participant. One sample was tested directly by Xpert MTB/RIF assay at Nigist Eleni Mohammed Memorial Hospital and the other sample was used for smear microscopy, TB culture, Abbott RealTime MTB, and Abbott RealTime INH/RIF assays at International Clinical Laboratories, Addis Ababa, Ethiopia. The diagnostic performance of the Abbott RealTime MTB and INH/RIF assays were calculated against MGIT liquid culture and phenotypic drug susceptibility testing (DST) as the gold standard. Results For the detection of MTB the Abbott RealTime MTB assay exhibited sensitivity 92.4% (95% CI 83.6–96.9), specificity 95.4% (95% CI 91.1–97.7), PPV 89.0% (95% CI 79.7–94.5) and NPV 96.9% (95% CI 93.0–98.7). For the detection of RIF resistance MTB, Abbott RealTime MTB RIF/INH concurred with phenotypic DST and Xpert MTB/RIF, while for the detection of INH resistance MTB, the sensitivity, specificity, PPV and NPV of the Abbott MTB RIF/INH assay was 84.2% (95% CI 60.4–96.6), 100% (95% CI 89.7–100), 100% and 91.9% (95% CI 80.0–96.9), respectively. Conclusions The Abbott RTMTB and RIF/INH assays revealed high sensitivity and specificity in MTB diagnosis and provided reliable INH and RIF resistance profiles. This assay has a similar diagnostic performance to the Xpert MTB/RIF assay with the advantages of high-throughput.

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Section: Discussionsupporting

confidence: 90%

Performance of the Abbott RealTime MTB and RIF/INH resistance assays for the detection of Mycobacterium Tuberculosis and resistance markers in sputum specimens

et al. 2021

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“…A misdiagnosis for Rif on the RT MTB RIF/INH assay has also been demonstrated previously on H526D, H526R and L533P mutations. 24 , 25 For the 10 discordant isolates, and using sequencing as the reference, the LPA misclassified five isolates for Rif resistance profiling versus 2 on the RT MTB RIF/INH assay. The LPA, therefore, missed three additional Rif resistant isolates as compared to the RT MTB RIF/INH assay.…”

Section: Discussionmentioning

confidence: 99%

<p>The Performance of the Abbott Real Time MTB RIF/INH Compared to the MTBDR<em>plus</em> V2 for the Identification of MDR-TB Among Isolates</p>

David

Singh

Silva

et al. 2020

IDR

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Background: The GenoType MTBDRplus V2 line-probe assay (LPA) is routinely used in clinical patient management to characterise the susceptibility of Mycobacterium tuberculosis complex to rifampicin (Rif) and isoniazid (INH) directly from sputum and cultured isolates. The laboratory workflow requires skill and three separate areas to minimize contamination and banding pattern interpretation requires experienced laboratory personnel. We explored the use of the RT MTB RIF/INH assay performed on the Abbott m2000 platform as an alternative laboratory platform. Methods: Isolates (n=93) consisting of fully susceptible, Rif-or INH-mono-resistant and multi-drug resistant (MDR) strains were tested on both MTBDRplus v2 and RT MTB RIF/ INH assays. Both assays target the rpoB, katG and inhA genes for resistance-detection mutations. Concordance was assessed using percent agreement and the kappa statistic. Those specimens with discordant results were further assessed using Sanger sequencing. Results: A total of 89% (83/93) of cultured isolates generated successful results on the RT MTB/RIF-INH assay and MTBDRplus assays. Of the 10 discordant results, where sequencing was used as the reference method, the RT MTB RIF/INH assays misclassified six resistance isolates, while the LPA misclassified seven. Discussion: Overall, the RT MTB RIF/INH demonstrated good agreement with the LPA, and a better correlation with sequencing on discrepant isolates specifically with mutations occurring in codon 511 of the rpoB gene. The RT MTB RIF/INH therefore can be used to complement existing laboratory algorithms determining Rif and INH resistance profiles, with less emphasis on manual laboratory processing.

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“…The mycobacterial laboratory of the hospital stores aliquots of remaining decontaminated samples and a specificity of 99%. In addition, Abbott RealTime MTB has been used in several studies [8][9][10], showing a sensitivity of around 80%. Another study comparing both methods found equivalent results [11].…”

Section: Methodsmentioning

confidence: 99%

Retrospective diagnosis of lymphatic tuberculosis in frozen samples using two genetic amplification methods, Xpert® MTB/RIF ULTRA and Abbott RealTime MTB Assay

Fernandez-Pittol¹,

Zboromyrska²,

Román³

et al. 2021

Rev Esp Quimioter

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Objectives. The main objective of the present study is to assess the sensitivity and specificity of a retrospective diagnostic of lymphatic tuberculosis (LTB), testing frozen samples using gene amplification PCR methods. The secondary objective was to compare the results of two different commercial tuberculosis gene amplification methods for this purpose. Material and methods. We retrospectively studied 38 frozen samples, previously processed for mycobacterial culture between January 2014 and August 2019. The results of the previous cultures were: 21 samples positive for Mycobacterium tuberculosis complex (MTB) (5 being smear positive), 7 samples culture positive for Mycobacterium avium-intracellulare complex and 10 samples which were mycobacterial culture negative and discarded for LTB diagnosis, used as controls. The samples were processed using two gene amplification methods: Xpert® MTB/RIF Ultra (Cepheid) and Abbott RealTime MTB Assay (Abbott). Results. Compared to initial culture results the sensitivity and specificity of Xpert® MTB/RIF Ultra were 57.1% and 100% and 52.3 % and 92.5%, respectively for the Abbott RealTime MTB assay. The differences were not statiscally significant. In addition, there were no differences according to the period of freezing. Conclusions. Gene amplification of frozen samples confirmed the diagnosis of lymphatic TB in almost 60% of cases, allowing retrospective diagnosis in initially non suspected cases. Both gene amplification techniques tested were equally useful.

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Evaluation of a new automated Abbott RealTime MTB RIF/INH assay for qualitative detection of rifampicin/isoniazid resistance in pulmonary and extra-pulmonary clinical samples of <em>Mycobacterium tuberculosis</em>

Cited by 13 publications

References 8 publications

Performance of the Abbott RealTime MTB and RIF/INH resistance assays for the detection of Mycobacterium Tuberculosis and resistance markers in sputum specimens

Performance of the Abbott RealTime MTB and RIF/INH resistance assays for the detection of Mycobacterium Tuberculosis and resistance markers in sputum specimens

<p>The Performance of the Abbott Real Time MTB RIF/INH Compared to the MTBDR<em>plus</em> V2 for the Identification of MDR-TB Among Isolates</p>

Retrospective diagnosis of lymphatic tuberculosis in frozen samples using two genetic amplification methods, Xpert® MTB/RIF ULTRA and Abbott RealTime MTB Assay

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