Molecular detection of rifampin and isoniazid resistance to guide chronic TB patient management in Burkina Faso

Miotto, Paolo; Saleri, Nuccia; Dembele, M.; Ouedraogo, Martial; Badoum, G.; Pinsi, G.; Migliori, Giovanni Battista; Matteelli, Alberto; Cirillo, Daniela María

doi:10.1186/1471-2334-9-142

Cited by 25 publications

(20 citation statements)

References 19 publications

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“…Similarly, better performance characteristics were achieved when BACTEC MGIT was used as a reference method, which is in agreement with some previous publications [26]. Contrary to previous studies [22,25], there were no significant differences between pooled sensitivity and specificity values for RIF and INH (95.3% and 95.5%; 89.9 and 87.1%, respectively) whereas overall specificity values for both drugs tended to be lower across all sites.…”

Section: Discussionsupporting

confidence: 86%

“…Recent studies, and a meta-analysis, of the GenoType® MTBDRPlus assay performed directly on specimens in various settings demonstrated good concordance with standard phenotypic DST results [15,[22][23][24][25][26]. Most reported studies, however, were based on smaller collections and/or convenience specimens and performed in research laboratories rather than in routine settings.…”

Section: Discussionmentioning

confidence: 86%

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Performance of the GenoType® MTBDRPlus assay in routine settings: a multicenter study

Mironova

Pimkina

Kontsevaya

et al. 2011

Eur J Clin Microbiol Infect Dis

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Former Soviet Union countries including the Baltic States (Latvia, Lithuania, and Estonia) are hot spots for an emerging epidemic of drug resistant tuberculosis (TB). As a part of the development of a co-ordinated network of centers for diagnostic trials across Eastern Europe we conducted a retrospective multicenter analysis of the performance of the GenoType® MTBDRPlus assay for TB identification and susceptibility to isoniazid (INH) and rifampicin (RIF) in routine settings. A total of 1,045 primary samples, 1045 TB cultures derived from these specimens and 306 separate M. tuberculosis isolates tested in 2007-2010 at four participating sites (Tartu, Estonia; Riga, Latvia; Vilnius, Lithuania; and Samara, Russian Federation) were included in the analysis. The pooled sensitivity and specificity values for RIF and INH were 95.3% and 95.5%, 89.9 and 87.1%, respectively; there were no statistically significant variations in performance across sites. The proportion of multidrug resistant (MDR) strains in the collections ranged from 21.8% (in Estonia) to 55.9% (in Russia). In a routine non-trial context, the assay reliably detected both rifampicin and isoniazid resistance. The absence of statistically significant differences between sites suggested that the comparable performance obtained using these assays has helped demonstrate the formation of a successful diagnostic trial network.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionmentioning

confidence: 86%

Performance of the GenoType® MTBDRPlus assay in routine settings: a multicenter study

Mironova

Pimkina

Kontsevaya

et al. 2011

Eur J Clin Microbiol Infect Dis

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“…The inclusion of a multiplex PCR preamplification step significantly increased the overall sensitivity from 70.9% to 96.7% (P Ͻ 0.05), a sensitivity similar to that reported elsewhere with sputum specimens (78.5% to 100%) (3,8,(13)(14)(15)17). Likewise, performance for the detection of RIF resistance, INH resistance, and MDR was similar to that reported in the literature (1-3, 6, 8, 10, 11, 13, 15, 17) for sputum and/or clinical specimens.…”

Section: Discussionmentioning

confidence: 48%

DNA Extracted from Stained Sputum Smears Can Be Used in the MTBDR plus Assay

et al. 2011

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We examined the feasibility of using DNA extracted from stained sputum smears for the detection of rifampin and isoniazid resistance with the commercial MTBDRplus assay from Hain Lifescience GmbH, Nehren, Germany. Overall sensitivity was initially low (70.0%) but increased to 96.7% when a multiplex PCR preamplification step was added. We then tested stored Mycobacterium tuberculosis-positive stained smears prepared from 297 patients' sputum samples. Species identification and drug susceptibility testing (DST) had been performed at the Institut Pasteur de Madagascar. Overall, the performance of the MTBDRplus assay applied to slide DNA was similar to that obtained in other studies with DNA extracted from clinical specimens. With the ready availability of stained smears in routine diagnostic laboratories and their easy transport and storage at room temperature, this approach should be useful for optimizing the treatment of multidrugresistant tuberculosis and for conducting resistance surveys aimed at identifying hot-spot regions and breaking chains of transmission.Multidrug-resistant tuberculosis (MDR-TB) poses a formidable worldwide challenge for control programs, because of complex diagnostic and treatment issues. Less than 5% of MDR-TB patients are currently being diagnosed, owing to a severe lack of laboratory capacity. Alarming increases in MDR-TB, the emergence of extensively drug resistant TB (XDR-TB), potential institutional transmission, and the rapid progression of HIV-coinfected MDR-TB and XDR-TB patients call for rapid screening methods (25). Novel technologies for rapid detection of anti-TB drug resistance have therefore become a priority in TB research and development, and molecular line-probe assays have already been developed for rapid detection of resistance to rifampin (RIF), isoniazid (INH), fluoroquinolones, and injectable drugs (9, 25).The MTBDRplus assay (Hain Lifescience GmbH, Nehren, Germany) has estimated sensitivities of 91.7% to 100% and 73% to 100% for the detection of RIF and INH resistance, respectively, in clinical strains (1-3, 6, 8, 10, 11, 13, 15, 17). However, because of the need for trained staff, specific equipment, and dedicated infrastructure, such tests are currently restricted to specialized laboratories. Even when these tests are available, detection of resistance in developing countries is often restricted by transport and storage of sputum samples from remote locations.It has been shown that Mycobacterium tuberculosis complex DNA present in Ziehl-Neelsen-or auramine-stained smears can be extracted and used in molecular tests (7,19,(21)(22)(23)(24). In this study, we show that the MTBDRplus assay can be applied to DNA extracted from microscopy-positive stained sputum smears from patients with relapse, treatment failure, and newly diagnosed TB. MATERIALS AND METHODS Stored stained slides.We selected 297 stored smear-positive stained slides prepared from TB patients' sputum samples between January 2003 and March 2010. Species identification and drug susceptibility testing (D...

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“…An additional 116 MTBC culture-negative specimens were included in the analysis. DNA from isolates and specimens was extracted by thermal lysis and sonication as described elsewhere (15). Phenotypic drug susceptibility testing (DST) for rifampin (RIF) and isoniazid (INH) was performed according to international recommendations (16).…”

mentioning

confidence: 99%

Lab-on-Chip-Based Platform for Fast Molecular Diagnosis of Multidrug-Resistant Tuberculosis

et al. 2015

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hWe evaluated the performance of the molecular lab-on-chip-based VerePLEX Biosystem for detection of multidrug-resistant tuberculosis (MDR-TB), obtaining a diagnostic accuracy of more than 97.8% compared to sequencing and MTBDRplus assay for Mycobacterium tuberculosis complex and rifampin and isoniazid resistance detection on clinical isolates and smear-positive specimens. The speed, user-friendly interface, and versatility make it suitable for routine laboratory use. Multidrug-resistant tuberculosis (MDR-TB) requires long and expensive treatment and often results in poor clinical outcome in both low-and high-income countries (1, 2). The World Health Organization (WHO) has endorsed specific molecular diagnostics to improve fast diagnosis of MDR-TB (3-5).However, the genotypic diversity and geographical distribution of Mycobacterium tuberculosis complex (MTBC), together with the inability to provide appropriate interpretation of silent mutations and the limited versatility are some of the restraints undermining the effectiveness of the current tools on a global scale (6-13).In the present study, we evaluated a lab-on-chip (LoC) device, developed by STMicroelectronics (Geneva, Switzerland) and marketed by Veredus Laboratories (Republic of Singapore) as the VerePLEX Biosystem, for the diagnosis of MDR-TB and detection of common nontuberculous mycobacteria (NTM). The molecular assay was evaluated on both clinical isolates and direct specimens in low-and high-burden settings.We tested 91 MTBC isolates (see Table S1 in the supplemental material) harboring different patterns of mutations in rpoB, katG, and inhA genes to evaluate the probes on the array listed in Table 1. Eighty respiratory specimens positive for acid-fast bacilli by smear microscopy and MTBC culture positive were decontaminated according to international guidelines and included in the study (Table S1) (14). An additional 116 MTBC culture-negative specimens were included in the analysis. DNA from isolates and specimens was extracted by thermal lysis and sonication as described elsewhere (15). Phenotypic drug susceptibility testing (DST) for rifampin (RIF) and isoniazid (INH) was performed according to international recommendations (16). Some of the

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Molecular detection of rifampin and isoniazid resistance to guide chronic TB patient management in Burkina Faso

Cited by 25 publications

References 19 publications

Performance of the GenoType® MTBDRPlus assay in routine settings: a multicenter study

Performance of the GenoType® MTBDRPlus assay in routine settings: a multicenter study

DNA Extracted from Stained Sputum Smears Can Be Used in the MTBDR plus Assay

Lab-on-Chip-Based Platform for Fast Molecular Diagnosis of Multidrug-Resistant Tuberculosis

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