Diagnostic performance and impact of routinely implemented Xpert® MTB/RIF assay in a setting of high incidence of drug-resistant TB in Odessa Oblast, Ukraine

Nikolayevskyy, Vladyslav; Kontsevaya, Irina; Nikolaevskaya, Elena; Суркова, Елена; Samchenko, S.; Esipenko, S.

doi:10.1016/j.cmi.2018.12.013

Cited by 5 publications

(2 citation statements)

References 22 publications

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“…The resistance profiles of the outbreak strains indicate that TB treatment regimens including isoniazid, rifampin, pyrazinamide, ethambutol, kanamycin, amikacin, capreomycin, levofloxacin, moxifloxacin, ethionamide, prothionamide, para-aminosalicylic acid, linezolid, and cycloserine (31) are not sufficient to effectively treat patients infected with these strains. Indeed, the implementation of rapid Xpert MTB/RIF diagnostics (Cepheid) in the Odessa region has not resulted in substantially improved MDR TB treatment outcomes (32). The failing standard MDR TB regimens that include 2-3 active and 2-3 nonactive drugs are still used instead of personalized, laboratory-confirmed treatment (30).…”

Section: Discussionmentioning

confidence: 99%

Multidrug- and Extensively Drug-Resistant Mycobacterium tuberculosis Beijing Clades, Ukraine, 2015

Merker¹,

Nikolaevskaya²,

Kohl³

et al. 2020

Emerg. Infect. Dis.

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E ach year, approximately half a million new cases of multidrug-resistant (MDR) tuberculosis (TB) challenge global health (1,2). MDR TB is caused by Mycobacterium tuberculosis complex (MTBC) strains, resistant to at least isoniazid and rifampin (3). In Europe, Ukraine is a hotspot of drug-resistant TB, with 6,564 laboratory-confirmed MDR and rifampin-resistant cases (2) and the third highest burden of extensively drug-resistant (XDR) TB (1,097 laboratory confirmed cases) globally in 2017 (2). XDR TB is a complicated form of MDR TB with additional resistances to >1 second-line injectable antimicrobial drug and a fluoroquinolone (1). Treatment of XDR TB can take up to 2 years (4), and treatment of a single XDR TB case has been reported to exceed €100,000 (5,6), even though treatment success rates remain ≈30% in the European region of the World Health Organization (40 countries reported) (7). Improvement of MDR/XDR TB prevention, diagnosis, and treatment is one of the core activities prioritized by WHO and the European Respiratory Society to eliminate TB (6). In addition to shortcomings in TB diagnosis and treatment, bacterial genetic factors might play a role in the epidemiologic success of certain MDR strains, especially of lineage 2 (Beijing) in Eurasia (8-11). Beijing MDR outbreak strains were shown to acquire fitness-enhancing mutations (i.e., mutations that increase in vitro growth rates) that may result in higher virulence and increased transmissibility, thus fostering the MDR TB epidemic in Eastern Europe (8-10). In line with this assumption, recent computational models predict that in many high TB incidence countries, person-to-person transmission but not treatment-related acquisition accounts for almost all (95.9%) incident MDR TB cases (12). Whole-genome sequencing (WGS) coupled with a molecular drug resistance prediction has provided insight into MTBC transmission networks and the transmissibility of MDR/XDR MTBC strains (8-10,13-15). We applied a WGS-based molecular epidemiologic approach to identify molecular resistance patterns, dominant strain types, and Multidrug-and Extensively Drug-Resistant Mycobacterium tuberculosis Beijing Clades,

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Section: Discussionmentioning

confidence: 99%

Multidrug- and Extensively Drug-Resistant Mycobacterium tuberculosis Beijing Clades, Ukraine, 2015

Merker¹,

Nikolaevskaya²,

Kohl³

et al. 2020

Emerg. Infect. Dis.

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“…The main method of diagnosis changed from sputum smear microscopy, which is performed at L1 Puskesmas , due to a change in policy to promote use of the Xpert MTB/RIF assay [ 30 ]. This newer technology increases the sensitivity of a TB diagnosis as well as detecting rifampicin resistant TB at the peripheral laboratories [ 31 ]. However, the sputum samples from the non-L2 and non-L3 hospitals had to be shipped to facilities with the Xpert MTB/RIF machines.…”

Section: Discussionmentioning

confidence: 99%

Missing Cases of Bacteriologically Confirmed TB/DR-TB from the National Treatment Registers in West and North Sumatra Provinces, Indonesia

et al. 2023

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This study aimed to assess the percentage of confirmed drug-sensitive (DS) TB and drug-resistant (DR) TB patients who were missing in the national treatment registration in North Sumatra and West Sumatra, where treatment services for DR-TB in North Sumatra are relatively well established compared with West Sumatra, where the system recently started. Confirmed DS/DR-TB records in the laboratory register at 40 government health facilities in 2017 and 2018 were traced to determine whether they were in the treatment register databases. A Jaro–Winkler soundexed string distance analysis enhanced by socio-demographic information matching had sensitivity and specificity over 98% in identifying the same person in the same or different databases. The laboratory data contained 5885 newly diagnosed records of bacteriologically confirmed TB cases. Of the 5885 cases, 1424 of 5353 (26.6%) DS-TB cases and 133 of 532 (25.0%) DR-TB cases were missing in the treatment notification database. The odds of missing treatment for DS-TB was similar for both provinces (AOR = 1.0 (0.9, 1.2), but for DR-TB, North Sumatra had a significantly lower missing odds ratio (AOR = 0.4 (0.2, 0.7). The system must be improved to reduce this missing rate, especially for DR-TB in West Sumatra.

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Xpert MTB/RIF and Xpert Ultra assays for screening for pulmonary tuberculosis and rifampicin resistance in adults, irrespective of signs or symptoms

Shapiro

Ross

Yao

et al. 2021

Cochrane Database of Systematic Reviews

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Background Tuberculosis is a leading cause of infectious disease‐related death and is one of the top 10 causes of death worldwide. The World Health Organization (WHO) recommends the use of specific rapid molecular tests, including Xpert MTB/RIF or Xpert Ultra, as initial diagnostic tests for the detection of tuberculosis and rifampicin resistance in people with signs and symptoms of tuberculosis. However, the WHO estimates that nearly one‐third of all active tuberculosis cases go undiagnosed and unreported. We were interested in whether a single test, Xpert MTB/RIF or Xpert Ultra, could be useful as a screening test to close this diagnostic gap and improve tuberculosis case detection. Objectives To estimate the accuracy of Xpert MTB/RIF and Xpert Ultra for screening for pulmonary tuberculosis in adults, irrespective of signs or symptoms of pulmonary tuberculosis in high‐risk groups and in the general population. Screening "irrespective of signs or symptoms" refers to screening of people who have not been assessed for the presence of tuberculosis symptoms (e.g. cough). To estimate the accuracy of Xpert MTB/RIF and Xpert Ultra for detecting rifampicin resistance in adults screened for tuberculosis, irrespective of signs and symptoms of pulmonary tuberculosis in high‐risk groups and in the general population. Search methods We searched 12 databases including the Cochrane Infectious Diseases Group Specialized Register, MEDLINE and Embase, on 19 March 2020 without language restrictions. We also reviewed reference lists of included articles and related Cochrane Reviews, and contacted researchers in the field to identify additional studies. Selection criteria Cross‐sectional and cohort studies in which adults (15 years and older) in high‐risk groups (e.g. people living with HIV, household contacts of people with tuberculosis) or in the general population were screened for pulmonary tuberculosis using Xpert MTB/RIF or Xpert Ultra. For tuberculosis detection, the reference standard was culture. For rifampicin resistance detection, the reference standards were culture‐based drug susceptibility testing and line probe assays. Data collection and analysis Two review authors independently extracted data using a standardized form and assessed risk of bias and applicability using QUADAS‐2. We used a bivariate random‐effects model to estimate pooled sensitivity and specificity with 95% credible intervals (CrIs) separately for tuberculosis detection and rifampicin resistance detection. We estimated all models using a Bayesian approach. For tuberculosis detection, we first estimated screening accuracy in distinct high‐risk groups, including people living with HIV, household contacts, people residing in prisons, and miners, and then in several high‐risk groups combined. Main results We included a total of 21 studies: 18 studies (13,114 partic...

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Diagnostic performance and impact of routinely implemented Xpert® MTB/RIF assay in a setting of high incidence of drug-resistant TB in Odessa Oblast, Ukraine

Cited by 5 publications

References 22 publications

Multidrug- and Extensively Drug-Resistant Mycobacterium tuberculosis Beijing Clades, Ukraine, 2015

Multidrug- and Extensively Drug-Resistant Mycobacterium tuberculosis Beijing Clades, Ukraine, 2015

Missing Cases of Bacteriologically Confirmed TB/DR-TB from the National Treatment Registers in West and North Sumatra Provinces, Indonesia

Xpert MTB/RIF and Xpert Ultra assays for screening for pulmonary tuberculosis and rifampicin resistance in adults, irrespective of signs or symptoms

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