Clinical evaluation of the Abbott RealTi me MTB Assay for direct detection of Mycobacterium tuberculosis -complex from respiratory and non-respiratory samples

Hinić, Vladimira; Feuz, Kinga; Turan, Selda; Berini, Andrea; Frei, Reno; Pfeifer, Karin; Goldenberger, Daniel

doi:10.1016/j.tube.2017.03.002

Cited by 16 publications

(11 citation statements)

References 16 publications

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“…The RT-MTB assay identifies both rifampin (RIF) and isoniazid (INH) resistance via the RealTime MTB RIF/INH reflex test (RT-MTB RIF/INH), which targets the rifampin resistance-determining region (RRDR) of rpoB, as well as the katG and upper inhA gene promoter regions. In analytical studies, RT-MTB has a LoD of 32 CFU/ml (13), and in clinical studies, the test sensitivity ranged from 74% in smearnegative specimens (6) to 100% in smear-positive pulmonary specimens (14)(15)(16)(17)(18). However, most of the studies of RT-MTB to date, aside from those by Scott and colleagues (6), did not include specimens from people living with HIV, which may impact the results.…”

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confidence: 99%

Performance of Xpert MTB/RIF, Xpert Ultra, and Abbott RealTi m e MTB for Diagnosis of Pulmonary Tuberculosis in a High-HIV-Burden Setting

et al. 2018

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More sensitive tests are needed for the diagnosis of smear-negative and HIV-associated tuberculosis. This study compares the sensitivities and specificities of three molecular tests, namely, the Xpert MTB/RIF test, the Xpert Ultra (Ultra), and RealTime MTB (RT-MTB), in a high HIV prevalence setting. Symptomatic adults were recruited from three outpatient sites, and each provided 4 sputum specimens. The diagnostic performance of Xpert MTB/RIF, Ultra, and RT-MTB was evaluated, with culture as a reference standard. HIV infection occurred in 62% of patients, with a median CD4 count of 220 cells/l. The Ultra test had the highest sensitivity of 89.3% (95% confidence interval [CI], 78.1 to 96) compared to those of the Xpert MTB/RIF at 82.1% (95% CI, 69.6 to 91.1; P ϭ 0.12) and RT-MTB at 78.6% (95% CI, 65.6 to 88.4; P ϭ 0.68). The specificity was highest with the Xpert MTB/RIF at 100% (95% CI, 98 to 100), followed by RealTime MTB at 96.7% (95% CI, 92.9 to 98.8; P ϭ 0.03) and the Ultra at 95.6% (95% CI, 91.5 to 98.1; P ϭ 0.08). In patients with smear-negative disease, the Ultra was more sensitive than the Xpert MTB/RIF (64.7% [95% CI, 38.3 to 85.8] versus 41.2% [95% CI, 18.4 to 67.1], respectively; P ϭ 0.12), and RT-MTB performed equally to Xpert MTB/RIF. In a comparison of the Ultra and RT-MTB on the same sputum specimen pellets, the Ultra was more sensitive than RT-MTB in the overall cohort (88.9% [95% CI, 77.4 to 95.8] versus 77.8% [95% CI, 64.4 to 88], respectively; P ϭ 0.03) and among people with HIV (87.5% [95% CI, 71 to 96.5] versus 68.6% [95% CI, 50 to 83.9], respectively; P ϭ 0.03). Although these results did not reach statistical significance, they suggest that the Ultra is more sensitive than the Xpert MTB/RIF and RT-MTB, most prominently in smear-negative disease. This was accompanied by a loss of specificity.

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confidence: 99%

Performance of Xpert MTB/RIF, Xpert Ultra, and Abbott RealTi m e MTB for Diagnosis of Pulmonary Tuberculosis in a High-HIV-Burden Setting

et al. 2018

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“…Numerous studies have assessed the use of real-time PCR to detect the MTBC, with probes of around 15 to 20 nucleotides in length (7,(18)(19)(20)(21)(22)(23)(24) (Table 4). In this study, we evaluated for the first time the ability of the multiplex real-time PCR-short TUB assay, which uses LNA probes of around 8 to 9 nucleotides in length (25) in combination with uracil-N-glycosylase (CodUNG) to detect MTBC.…”

Section: Discussionmentioning

confidence: 99%

“…The real-time PCR technique has been used to detect MTBC with different DNA targets and effectiveness (Table 4). The DNA targets most frequently used to detect MTBC are rpoB and IS6110 (7,18,21,23,24), and other DNA targets used include rpnB (22), 16S rRNA and rRNA (rDNA) (20), and the intergenic region SenX3-RegX3 (19). The highest overall sensitivity and specificity of the real-time PCR technique in these studies, which analyzed a large number of clinical samples with low mycobacterium loads, were obtained by Hinic et al (100% and 100%, respectively) (23) and Queipo-Ortuño et al (19) (93.3% and 100%, respectively) ( Table 4).…”

Section: Discussionmentioning

confidence: 99%

Multiplex Real-Time PCR-short _TUB Assay for Detection of the Mycobacterium tuberculosis Complex in Smear-Negative Clinical Samples with Low Mycobacterial Loads

et al. 2019

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Tuberculosis (TB) remains a major health problem worldwide. Control of TB requires rapid, accurate diagnosis of active disease. However, extrapulmonary TB is very difficult to diagnose because the clinical specimens have very low bacterial loads. Several molecular methods involving direct detection of the Mycobacterium tuberculosis complex (MTBC) have emerged in recent years. Real-time PCR amplification simultaneously combines the amplification and detection of candidate sequences by using fluorescent probes (mainly TaqMan or Molecular Beacons) in automated systems. The multiplex real-time PCR-short assay is performed using locked nucleic acid (LNA) probes (length, 8 to 9 nucleotides) in combination with CodUNG to detect multiple pathogens in clinical samples. In this study, we evaluated the performance of this novel multiplex assay for detecting the MTBC in comparison with that of the conventional culture-based method. The multiplex real-time PCR-shortTUB assay targets two genes, whiB3 (redox-responsive transcriptional regulator) and pstS1 (phosphate-specific transporter), yielding limits of detection (LOD) of 10 copies and 100 copies, respectively, and amplification efficiencies of 92% and 99.7%, respectively. A total of 94 extrapulmonary samples and pulmonary samples with low mycobacterial loads (all smear negative; 75 MTBC culture positive) were analyzed using the test, yielding an overall sensitivity of 88% and a specificity of 95%. For pleural fluid and tissues/biopsy specimens, the sensitivity was 83% and 85%, respectively. In summary, this technique could be implemented in routine clinical microbiology testing to reduce the overall turnaround time for MTBC detection and may therefore be a useful tool for the diagnosis of extrapulmonary tuberculosis and diagnosis using pulmonary samples with low mycobacterial loads.

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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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Clinical evaluation of the Abbott RealTi me MTB Assay for direct detection of Mycobacterium tuberculosis -complex from respiratory and non-respiratory samples

Cited by 16 publications

References 16 publications

Performance of Xpert MTB/RIF, Xpert Ultra, and Abbott RealTi m e MTB for Diagnosis of Pulmonary Tuberculosis in a High-HIV-Burden Setting

Performance of Xpert MTB/RIF, Xpert Ultra, and Abbott RealTi m e MTB for Diagnosis of Pulmonary Tuberculosis in a High-HIV-Burden Setting

Multiplex Real-Time PCR-short _TUB Assay for Detection of the Mycobacterium tuberculosis Complex in Smear-Negative Clinical Samples with Low Mycobacterial Loads

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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Clinical evaluation of the Abbott RealTi me MTB Assay for direct detection of Mycobacterium tuberculosis -complex from respiratory and non-respiratory samples

Cited by 16 publications

References 16 publications

Performance of Xpert MTB/RIF, Xpert Ultra, and Abbott RealTi m e MTB for Diagnosis of Pulmonary Tuberculosis in a High-HIV-Burden Setting

Performance of Xpert MTB/RIF, Xpert Ultra, and Abbott RealTi m e MTB for Diagnosis of Pulmonary Tuberculosis in a High-HIV-Burden Setting

Multiplex Real-Time PCR-short TUB Assay for Detection of the Mycobacterium tuberculosis Complex in Smear-Negative Clinical Samples with Low Mycobacterial Loads

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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Product

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Multiplex Real-Time PCR-short _TUB Assay for Detection of the Mycobacterium tuberculosis Complex in Smear-Negative Clinical Samples with Low Mycobacterial Loads