Evaluation of the Abbott RealTi
            <i>m</i>
            e MTB and RealTi
            <i>m</i>
            e MTB INH/RIF Assays for Direct Detection of Mycobacterium tuberculosis Complex and Resistance Markers in Respiratory and Extrapulmonary Specimens

Hofmann-Thiel, Sabine; Molodtsov, Nikolay; Antonenka, Uladzimir; Hoffmann, Harald

doi:10.1128/jcm.01144-16

Cited by 42 publications

(40 citation statements)

References 22 publications

(29 reference statements)

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“…The upgraded version 2.0 software is now available for the RT MTB assay and is recommended for use in conjunction with the RT MTB RIF/INH resistance assay (version 1.0). Recently published studies used the updated software and the direct reflex protocol, and a greater sensitivity was attained (21,22).…”

Section: Discussionmentioning

confidence: 99%

Performance of the Abbott RealTi m e MTB and MTB RIF/INH Assays in a Setting of High Tuberculosis and HIV Coinfection in South Africa

et al. 2017

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South Africa is a country with a high incidence of tuberculosis (TB), complicated by coinfection with human immunodeficiency virus (HIV). The Xpert MTB/RIF (Cepheid, Sunnyvale, CA, USA) is used in South Africa as the test for the initial diagnosis of TB, and other molecular platforms such as the m2000 (Abbott Molecular, Des Plaines, IL, USA) are widely used for molecular monitoring of HIV load. The latter platform is now also equipped with the RealTime (RT) MTB and RealTime MTB RIF/INH assays for TB and first-line drug resistance screening but has not been evaluated in settings of HIV and TB coinfection. A prospective clinical validation study was conducted at a community health center in Johannesburg, South Africa, and consenting individuals with presumptive pulmonary TB were enrolled. The performance of the Abbott assays was compared with those of the Xpert MTB/RIF, liquid culture, drug susceptibility testing, and clinical case definitions. A statistical analysis was performed on 206 individuals (73% were HIV positive). The sensitivity and specificity of the RT MTB were 82.5% (confidence interval [CI], 67.2 to 92.7) and 93.1% (CI, 86.2 to 97.2) on raw sputum and 77.5% (CI, 61.5 to 89.2) and 95.1% (CI, 88.9 to 98.4) on concentrated sputum, respectively, compared with those from liquid culture. The RT MTB correctly identified 17/35 more smear-negative culture-positive specimens than the Xpert MTB/RIF. Both the RT MTB and the Xpert MTB/RIF displayed sensitivities Ͼ70% and specificities Ͼ90% in HIV-positive individuals. The available drug resistance results concurred with MTBDRplus and drug susceptibility profiles. The RT MTB assay has similar diagnostic performance to the Xpert MTB/RIF and is suited to testing presumptive TB patients coinfected with HIV. The existing laboratory information system connectivity, training, and technical support make this a viable polyvalent option to scale up TB alongside HIV laboratory testing services in South Africa.

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Section: Discussionmentioning

confidence: 99%

Performance of the Abbott RealTi m e MTB and MTB RIF/INH Assays in a Setting of High Tuberculosis and HIV Coinfection in South Africa

et al. 2017

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“…A second‐LPA used for the detection of resistance to anti‐TB drugs includes probes to detect resistance to the class of fluoroquinolones drugs , and the WHO recommended it use to detect resistance in patients diagnosed with resistance to RIF or for the diagnosis of extensively drug‐resistant . Another important molecular technology is the Abbott RealTime MTB RIF/INH resistance, an assay for the detection of RIF and INH resistant MTB in pulmonary specimens which is under evaluation . The main limitations of these assays are that laboratory‐trained staff in PCR, and appropriate laboratory infrastructure is required.…”

Section: Challenges and Future Directions For Improving The Diagnosismentioning

confidence: 99%

Diagnosis of Tuberculosis in HIV Co‐infected Individuals: Current Status, Challenges and Opportunities for the Future

Méndez-Samperio¹

2017

Scand J Immunol

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Tuberculosis (TB) remains one of the most important causes of death among people co-infected with human immunodeficiency virus (HIV). The diagnosis of TB remains challenging in HIV co-infected individuals, due to a high frequency of smear-negative disease and high rates of extrapulmonary TB. Accurate, ease of use and rapid diagnosis of active TB are critical to the World Health Organization (WHO) End TB Strategy by 2050. Traditional laboratory techniques do not provide rapid and accurate results to effectively manage HIV co-infected patients. Over the last decade, molecular methods have provided significant steps in the fight against TB. However, many HIV co-infected patients do not have access to these molecular diagnostic tests. Given the costs closely related with confirming a TB diagnosis in HIV patients, an overtreatment for TB is used in this patient population. Nowadays, an estimated US $8 billion a year is required to provide TB treatment, which is very high compared with making an important strategy to improve the current diagnostic tests. This review focuses on current advances in diagnosing active TB with an emphasis on the diagnosis of HIV-associated TB. Also discussed are the main challenges that need to be overcome for improving an adequate initial diagnosis of active TB in HIV-positive patients.

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“…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].…”

mentioning

confidence: 99%

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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Evaluation of the Abbott RealTi m e MTB and RealTi m e MTB INH/RIF Assays for Direct Detection of Mycobacterium tuberculosis Complex and Resistance Markers in Respiratory and Extrapulmonary Specimens

Cited by 42 publications

References 22 publications

Performance of the Abbott RealTi m e MTB and MTB RIF/INH Assays in a Setting of High Tuberculosis and HIV Coinfection in South Africa

Performance of the Abbott RealTi m e MTB and MTB RIF/INH Assays in a Setting of High Tuberculosis and HIV Coinfection in South Africa

Diagnosis of Tuberculosis in HIV Co‐infected Individuals: Current Status, Challenges and Opportunities for the Future

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

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