Capacity of Abbott RealTime MTB RIF/INH to detect rifampicin- and isoniazid-resistant tuberculosis

Hofmann-Thiel, Sabine; Molodtsov, Nikolay; Duffner, Clara; Kadyrov, Abdylat; Kalmambetova, Gulmira; Kabirov, Olim; Rajabov, Asliddin; Parpieva, Nargiza; Sayfutdinov, Zayniddin; Vogel, Monica; Vogel, Henry J.; Antonenka, Uladzimir; Hoffmann, Harald

doi:10.5588/ijtld.18.0615

Cited by 9 publications

(14 citation statements)

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“…Additionally, at such low concentrations XP-Ultra flags Rif resistance markers as 'indeterminate'. In our recent evaluation of the ABBOTT RealTime MTB INH/RIF, we observed a high rate of indeterminate resistance markers for both Rif and Inh, when smear microscopy was scanty or negative [17]. Zimmermann et al observed 8.9% of indeterminate Rif/Inh results with BD-MAX in 518 clinical samples [15] which is in line with the before mentioned publications on Xpert MTB/RIF [14] and Abbott RealTime MTB RIF/ INH [17].…”

Section: Discussionsupporting

confidence: 87%

“…In our recent evaluation of the ABBOTT RealTime MTB INH/RIF, we observed a high rate of indeterminate resistance markers for both Rif and Inh, when smear microscopy was scanty or negative [17]. Zimmermann et al observed 8.9% of indeterminate Rif/Inh results with BD-MAX in 518 clinical samples [15] which is in line with the before mentioned publications on Xpert MTB/RIF [14] and Abbott RealTime MTB RIF/ INH [17]. This confirms that molecular resistance profiling is less sensitive compared to MTBC detection and coincides with our findings that XP-Ultra's and BD-MAX's LoD 95 HR were higher than its LoD 95 TB , especially when saline or MUCAS were used albeit not being approved by the manufacturer.…”

Section: Discussionmentioning

confidence: 96%

“…The cartridge-based XP-MTB additionally identifies Rif-resistance as a marker of MDR-TB [11] and has significantly ameliorated notification of TB and MDR-TB worldwide [12,13]. Now, with the launch of Abbott RealTime MTB and MTB INH/RIF (Abbott, USA), BD MAX™ MDR-TB (BD-MAX, Beckton Dickinson, USA), and Xpert MTB/Rif Ultra (XP-Ultra, Cepheid, USA) (Rif only), a new generation of closed and virtually fully automated qPCR assays detecting DNA of TB bacteria as well as Rif and/or Inh resistance markers are available which, according to the manufacturers', have sensitivities nearing that of culture [14][15][16][17].…”

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confidence: 99%

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A pre-clinical validation plan to evaluate analytical sensitivities of molecular diagnostics such as BD MAX MDR-TB, Xpert MTB/Rif Ultra and FluoroType MTB

Beutler¹,

Plesnik²,

Mihalic³

et al. 2020

PLoS ONE

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Rapid diagnosis of tuberculosis (TB) and antibiotic resistances are imperative to initiate effective treatment and to stop transmission of the disease. A new generation of more sensitive, automated molecular TB diagnostic tests has been recently launched giving microbiologists more choice between several assays with the potential to detect resistance markers for rifampicin and isoniazid. In this study, we determined analytical sensitivities as 95% limits of detection (LoD 95 ) for Xpert MTB/Rif Ultra (XP-Ultra) and BD-MAX MDR-TB (BD-MAX) as two representatives of the new test generation, in comparison to the conventional Fluoro-Type MTB (FT-MTB). Test matrices used were physiological saline solution, human and a mucin-based artificial sputum (MUCAS) each spiked with Mycobacterium tuberculosis in declining culture-and qPCR-controlled concentrations. With BD-MAX, XP-Ultra, and FT-MTB, we measured LoD 95 TB values of 2.1 cfu/ml (CI 95% : 0.9-23.3), 3.1 cfu/ml (CI 95% : 1.2-88.9), and 52.1 cfu/ml (CI 95% : 16.7-664.4) in human sputum; of 6.3 cfu/ml (CI 95% : 2.9-31.8), 1.5 cfu/ml (CI 95% : 0.7-5.0), and 30.4 cfu/ml (CI 95% : 17.4-60.7) in MUCAS; and of 2.3 cfu/ml (CI 95% : 1.1-12.0), 11.5 cfu/ml (CI 95% : 5.6-47.3), and 129.1 cfu/ml (CI 95% : 82.8-273.8) in saline solution, respectively. LoD 95 of resistance markers were 9 to 48 times higher compared to LoD 95 TB . BD-MAX and XP-Ultra have an equal and significantly increased analytical sensitivity compared to conventional tests. MUCAS resembled human sputum, while both yielded significantly different results than normal saline. MUCAS proved to be suitable for quality control of PCR assays for TB diagnostics.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionmentioning

confidence: 96%

mentioning

confidence: 99%

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A pre-clinical validation plan to evaluate analytical sensitivities of molecular diagnostics such as BD MAX MDR-TB, Xpert MTB/Rif Ultra and FluoroType MTB

Beutler¹,

Plesnik²,

Mihalic³

et al. 2020

PLoS ONE

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“…The WHO still regards INH and RFP to be irreplaceable first-line anti-TB drugs [12,13]. INH inhibits the synthesis of mycolic acid, which is specific to Mycobacterium tuberculosis cells, and such inhibition causes the bacteria to die due to loss of acid resistance, hydrophobicity, and proliferation [13].…”

Section: Introductionmentioning

confidence: 99%

Antituberculosis Drugs (Rifampicin and Isoniazid) Induce Liver Injury by Regulating NLRP3 Inflammasomes

Kuang

Wei-yi

et al. 2021

Mediators of Inflammation

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Patients being treated for pulmonary tuberculosis often suffer liver injury due to the effects of anti-TB drugs, and the underlying mechanisms for those injuries need to be clarified. In this study, rats and hepatic cells were administrated isoniazid (INH) and rifampin (RIF) and then treated with NLRP3-inflammasome inhibitors (INF39 and CP-456773) or NLRP3 siRNA. Histopathological changes that occurred in liver tissue were examined by H&E staining. Additionally, the levels IL-33, IL-18, IL-1β, NLRP3, ASC, and cleaved-caspase 1 expression in the liver tissues were also determined. NAT2 and CYP2E1 expression were identified by QRT-PCR analysis. Finally, in vitro assays were performed to examine the effects of siRNA targeting NLRP3. Treatment with the antituberculosis drugs caused significant liver injuries, induced inflammatory responses and oxidative stress (OS), activated NLRP3 inflammasomes, reduced the activity of drug-metabolizing enzymes, and altered the antioxidant defense system in rats and hepatic cells. The NLRP3 inflammasome was required for INH- and RIF-induced liver injuries that were produced by inflammatory responses, OS, the antioxidant defense system, and drug-metabolizing enzymes. This study indicated that the NLRP3 inflammasome is involved in antituberculosis drug-induced liver injuries (ATLIs) and suggests NLRP3 as a potential target for attenuating the inflammation response in ATLIs.

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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%

The Performance of the Abbott Real Time MTB RIF/INH Compared to the MTBDRplus V2 for the Identification of MDR-TB Among Isolates

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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Capacity of Abbott RealTime MTB RIF/INH to detect rifampicin- and isoniazid-resistant tuberculosis

Cited by 9 publications

References 0 publications

A pre-clinical validation plan to evaluate analytical sensitivities of molecular diagnostics such as BD MAX MDR-TB, Xpert MTB/Rif Ultra and FluoroType MTB

A pre-clinical validation plan to evaluate analytical sensitivities of molecular diagnostics such as BD MAX MDR-TB, Xpert MTB/Rif Ultra and FluoroType MTB

Antituberculosis Drugs (Rifampicin and Isoniazid) Induce Liver Injury by Regulating NLRP3 Inflammasomes

<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>

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