The T2 Mycobacterium tuberculosis Genotype, Predominant in Kampala, Uganda, Shows Negative Correlation with Antituberculosis Drug Resistance

ABSTRACTSurveillance of the circulatingMycobacterium tuberculosiscomplex (MTC) strains in a given locality is important for understanding tuberculosis (TB) epidemiology. We performed molecular epidemiological studies on sputum smear-positive isolates that were collected for anti-TB drug resistance surveillance to establish the variability of MTC lineages with anti-TB drug resistance and HIV infection. Spoligotyping was performed to determine MTC phylogenetic lineages. We compared patients' MTC lineages with drug susceptibility testing (DST) patterns and HIV serostatus. Out of the 533 isolates, 497 (93.2%) had complete DST, PCR, and spoligotyping results while 484 (90.1%) participants had results for HIV testing. Overall, the frequency of any resistance was 75/497 (15.1%), highest among the LAM (34.4%; 95% confidence interval [CI], 18.5 to 53.2) and lowest among the T2 (11.5%; 95% CI, 7.6 to 16.3) family members. By multivariate analysis, LAM (adjusted odds ratio [ORadj], 5.0; 95% CI, 2.0 to 11.9;P< 0.001) and CAS (ORadj, 2.9; 95% CI, 1.4.0 to 6.3;P= 0.006) families were more likely to show any resistance than was T2. All other MTC lineages combined were more likely to be resistant to any of the anti-TB drugs than were the T2 strains (ORadj, 1.7; 95% CI, 1.0 to 2.9;P= 0.040). There were no significant associations between multidrug resistance and MTC lineages, but numbers of multidrug-resistant TB strains were small. No association was established between MTC lineages and HIV status. In conclusion, the T2 MTC lineage negatively correlates with anti-TB drug resistance, which might partly explain the reported low levels of anti-TB drug resistance in Kampala, Uganda. Patients' HIV status plays no role with respect to the MTC lineage distribution.

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Disparities in Capreomycin Resistance Levels Associated with therrsA1401G Mutation in Clinical Isolates of Mycobacterium tuberculosis

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.04438-14 ◽

2014 ◽

Vol 59 (1) ◽

pp. 444-449 ◽

Cited By ~ 19

Author(s):

Analise Z. Reeves ◽

Patricia J. Campbell ◽

Melisa J. Willby ◽

James E. Posey

Keyword(s):

Mycobacterium Tuberculosis ◽

Strong Predictor ◽

Critical Concentration ◽

Drug Susceptibility ◽

Multidrug Resistant ◽

Drug Susceptibility Testing ◽

Clinical Isolates ◽

Cross Resistance ◽

Second Line ◽

Content Type

ABSTRACTAs the prevalence of multidrug-resistant and extensively drug-resistant tuberculosis strains continues to rise, so does the need to develop accurate and rapid molecular tests to complement time-consuming growth-based drug susceptibility testing. Performance of molecular methods relies on the association of specific mutations with phenotypic drug resistance and while considerable progress has been made for resistance detection of first-line antituberculosis drugs, rapid detection of resistance for second-line drugs lags behind. TherrsA1401G allele is considered a strong predictor of cross-resistance between the three second-line injectable drugs, capreomycin (CAP), kanamycin, and amikacin. However, discordance is often observed between therrsA1401G mutation and CAP resistance, with up to 40% ofrrsA1401G mutants being classified as CAP susceptible. We measured the MICs to CAP in 53 clinical isolates harboring therrsA1401G mutation and found that the CAP MICs ranged from 8 μg/ml to 40 μg/ml. These results were drastically different from engineered A1401G mutants generated in isogenicMycobacterium tuberculosis, which exclusively exhibited high-level CAP MICs of 40 μg/ml. These data support the results of prior studies, which suggest that the critical concentration of CAP (10 μg/ml) used to determine resistance by indirect agar proportion may be too high to detect all CAP-resistant strains and suggest that a larger percentage of resistant isolates could be identified by lowering the critical concentration. These data also suggest that differences in resistance levels among clinical isolates are possibly due to second site or compensatory mutations located elsewhere in the genome.

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Transmission patterns of rifampicin resistant Mycobacterium tuberculosis complex strains in Cameroon: a genomic epidemiological study

BMC Infectious Diseases ◽

10.1186/s12879-021-06593-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Matthias Merker ◽

Nkongho F. Egbe ◽

Yannick R. Ngangue ◽

Comfort Vuchas ◽

Thomas A. Kohl ◽

...

Keyword(s):

Drug Resistance ◽

Mycobacterium Tuberculosis ◽

Prolonged Exposure ◽

Drug Susceptibility ◽

Multidrug Resistant ◽

Drug Susceptibility Testing ◽

High Dose ◽

Factors Affecting ◽

Recent Transmission ◽

Mdr Tb

Abstract Background Determining factors affecting the transmission of rifampicin (RR) and multidrug-resistant (MDR) Mycobacterium tuberculosis complex strains under standardized tuberculosis (TB) treatment is key to control TB and prevent the evolution of drug resistance. Methods We combined bacterial whole genome sequencing (WGS) and epidemiological investigations for 37% (n = 195) of all RR/MDR-TB patients in Cameroon (2012–2015) to identify factors associated with recent transmission. Results Patients infected with a strain resistant to high-dose isoniazid, and ethambutol had 7.4 (95% CI 2.6–21.4), and 2.4 (95% CI 1.2–4.8) times increased odds of being in a WGS-cluster, a surrogate for recent transmission. Furthermore, age between 30 and 50 was positively correlated with recent transmission (adjusted OR 3.8, 95% CI 1.3–11.4). We found high drug-resistance proportions against three drugs used in the short standardized MDR-TB regimen in Cameroon, i.e. high-dose isoniazid (77.4%), ethambutol (56.9%), and pyrazinamide (43.1%). Virtually all strains were susceptible to fluoroquinolones, kanamycin, and clofazimine, and treatment outcomes were mostly favourable (87.5%). Conclusion Pre-existing resistance to high-dose isoniazid, and ethambutol is associated with recent transmission of RR/MDR strains in our study. A possible contributing factor for this observation is the absence of universal drug susceptibility testing in Cameroon, likely resulting in prolonged exposure of new RR/MDR-TB patients to sub-optimal or failing first-line drug regimens.

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Comparative Utility of Genetic Determinants of Drug Resistance and Phenotypic Drug Susceptibility Profiling in Predicting Clinical Outcomes in Patients With Multidrug-Resistant Mycobacterium tuberculosis

Frontiers in Public Health ◽

10.3389/fpubh.2021.663974 ◽

2021 ◽

Vol 9 ◽

Author(s):

Yang Che ◽

Tianchi Yang ◽

Lv Lin ◽

Yue Xiao ◽

Feng Jiang ◽

...

Keyword(s):

Drug Resistance ◽

Latent Class ◽

Treatment Success ◽

Drug Susceptibility ◽

Multidrug Resistant ◽

Drug Susceptibility Testing ◽

Sputum Smear ◽

Genetic Determinants ◽

Resistant Tuberculosis ◽

Mdr Tb

Setting: Programmatic management of drug-resistant tuberculosis in Ningbo, China.Objective: To assess whether data-driven genetic determinants of drug resistance patterns could outperform phenotypic drug susceptibility testing in predicting clinical meaningful outcomes among patients with multidrug-resistant tuberculosis (MDR-TB).Design: We conducted a prospective cohort study of 104 MDR-TB patients. All MDR-TB isolates underwent drug susceptibility testing and genotyping for mutations that could cause drug resistance. Study outcomes were time to sputum smear conversion and probability of treatment success, as well as time to culture conversion within 6 months. Data were analyzed using latent class analysis, Kaplan–Meier curves, and Cox regression models.Results: We report that latent class analysis of data identified two latent classes that predicted sputum smear conversion with P = 0.001 and area under receiver-operating characteristic curve of 0.73. The predicted latent class memberships were associated with superior capability in predicting sputum culture conversion at 6 months and overall treatment success compared to phenotypic drug susceptibility profiling using boosted logistic regression models.Conclusion: These results suggest that genetic determinants of drug resistance in combination with phenotypic drug-resistant tests could serve as useful biomarkers in predicting treatment prognosis in MDR-TB.

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Tuberculosis outcomes related to the Mycobacterium tuberculosis genotype

Russian Journal of Infection and Immunity ◽

10.15789/2220-7619-2019-3-4-531-538 ◽

2019 ◽

Vol 9 (3-4) ◽

pp. 531-538

Author(s):

O. A. Pasechnik ◽

A. A. Vyazovaya ◽

M. A. Dymova ◽

A. I. Blokh ◽

V. L. Stasenko ◽

...

Keyword(s):

Drug Resistance ◽

Mycobacterium Tuberculosis ◽

Drug Susceptibility ◽

Biological Properties ◽

Drug Susceptibility Testing ◽

Beijing Genotype ◽

Multi Drug Resistance ◽

Co Morbidity ◽

Extensive Drug Resistance ◽

Phylogenetic Lineages

Mycobacterium tuberculosis strains of different phylogenetic lineages and genetic families differ in biological properties that determine, to some extent, epidemiological features and clinical manifestation in tuberculosis (TB) patients.The aim of the study was to assess the risk of an adverse outcome of the disease in TB patients caused by various M. tuberculosis genotypes.Materials and methods. A total of 425 patients with respiratory TB were enrolled in this study. They were registered at phthisiatric facilities in the Omsk region from March 2015 to June 2017 period and included: males — 73.1%, mean age 39.9 years, females — 26.9%, mean age 42.0 years. M. tuberculosis culture and drug susceptibility testing and DNA extraction were performed in accordance with standard methods. Strains were assigned to the M. tuberculosis Beijing genotype and its epidemiologically relevant clusters B0/W148 and 94-32 by PCR based detection of specific markers. Non-Beijing strains were subjected to spoligotyping.Results. We found that 66.5% isolates belonged to the Beijing genotype, 12.8% — to LAM, 10.1% — to T, and 4.7% — to the Ural genotype. Multi-drug resistance (MDR) to anti-TB drugs was observed in 195 M. tuberculosis strains (45.9%). Moreover, Beijing genotype was more often isolated from patients with MDR-TB infection (PR = 2.09 (95% CI 1.6–2.74) and TB infection associated with HIV infection (PR = 1.14 (95% CI 1.01–1.31). Lethal outcome was double higher in patients infected with Beijing vs. non-Beijing strains, 28.6% vs. 14.0% (PR = 2.03; 95% CI 1.3–3.17). The risk factors were identified as follows: young age 18–44 years (RR = 1.7; 95% CI 1.18–2.7), co-morbidity with HIV (RR = 5.0; 95% CI 3.39–7.45), multiple (RR = 1.7; 95% CI 1.14–2.55) and extensive drug resistance (RR = 2.57; 95% CI 1.35–4.92), and association with the Beijing genotype (RR = 2.0, 95% CI 1.3–3.17).Conclusion. M. tuberculosis spread in the Omsk region is characterised by significant prevalence of the Beijing genotype, associated with multiple and extensive drug resistance. A significant association of adverse clinical outcomes and various factors, including association with the Beijing genotype, requires development of new approaches in the fight against tuberculosis.

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Molecular Detection of Mutations Associated with First- and Second-Line Drug Resistance Compared with Conventional Drug Susceptibility Testing of Mycobacterium tuberculosis

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.01550-10 ◽

2011 ◽

Vol 55 (5) ◽

pp. 2032-2041 ◽

Cited By ~ 236

Author(s):

Patricia J. Campbell ◽

Glenn P. Morlock ◽

R. David Sikes ◽

Tracy L. Dalton ◽

Beverly Metchock ◽

...

Keyword(s):

Drug Resistance ◽

Mycobacterium Tuberculosis ◽

Dna Sequencing ◽

Susceptibility Testing ◽

Drug Susceptibility ◽

Drug Susceptibility Testing ◽

Second Line ◽

First Line ◽

Content Type ◽

Line Drug

ABSTRACTThe emergence of multi- and extensively drug-resistant tuberculosis is a significant impediment to the control of this disease because treatment becomes more complex and costly. Reliable and timely drug susceptibility testing is critical to ensure that patients receive effective treatment and become noninfectious. Molecular methods can provide accurate and rapid drug susceptibility results. We used DNA sequencing to detect resistance to the first-line antituberculosis drugs isoniazid (INH), rifampin (RIF), pyrazinamide (PZA), and ethambutol (EMB) and the second-line drugs amikacin (AMK), capreomycin (CAP), kanamycin (KAN), ciprofloxacin (CIP), and ofloxacin (OFX). Nine loci were sequenced:rpoB(for resistance to RIF),katGandinhA(INH),pncA(PZA),embB(EMB),gyrA(CIP and OFX), andrrs,eis, andtlyA(KAN, AMK, and CAP). A total of 314 clinicalMycobacterium tuberculosiscomplex isolates representing a variety of antibiotic resistance patterns, genotypes, and geographical origins were analyzed. The molecular data were compared to the phenotypic data and the accuracy values were calculated. Sensitivity and specificity values for the first-line drug loci were 97.1% and 93.6% forrpoB, 85.4% and 100% forkatG, 16.5% and 100% forinhA, 90.6% and 100% forkatGandinhAtogether, 84.6% and 85.8% forpncA, and 78.6% and 93.1% forembB. The values for the second-line drugs were also calculated. The size and scope of this study, in numbers of loci and isolates examined, and the phenotypic diversity of those isolates support the use of DNA sequencing to detect drug resistance in theM. tuberculosiscomplex. Further, the results can be used to design diagnostic tests utilizing other mutation detection technologies.

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Prevalence of Multi-Drug Resistant Mycobacterium Tuberculosis in Khyber Pakhtunkhwa – A High Tuberculosis Endemic Area of Pakistan

Polish Journal of Microbiology ◽

10.33073/pjm-2020-005 ◽

2020 ◽

Vol 69 (2) ◽

pp. 133-137 ◽

Cited By ~ 1

Author(s):

SAJID ALI ◽

MUHAMMAD TAHIR KHAN ◽

ANWAR SHEED KHAN ◽

NOOR MOHAMMAD ◽

MUHAMMAD MUMTAZ KHAN ◽

...

Keyword(s):

Drug Resistance ◽

Mycobacterium Tuberculosis ◽

Large Scale ◽

Simple Random Sampling ◽

Drug Susceptibility ◽

Multidrug Resistant ◽

Drug Susceptibility Testing ◽

Drug Resistant ◽

Khyber Pakhtunkhwa ◽

Mdr Tb

Anti-tuberculosis therapy involves the combination of drugs to hamper the growth of Mycobacterium tuberculosis (MTB). The emergence of multidrug-resistant tuberculosis (MDR-TB) is a global concern. Pakistan has been ranked 5th position in terms of a high burden of MDR-TB in the world. The aim of the current study was to investigate the prevalence of drug resistance in MTB in Khyber Pakhtunkhwa. Random samples were collected from 25 districts using the simple random sampling formula. All samples were processed in a biosafety level 3 laboratory for culture and drug susceptibility testing. Among 5759 presumptive tuberculosis (TB) cases, 1969 (34%) were positive. The proportion of TB was higher in females (39%) than males (29%), thus it represents a significant association between gender and tuberculosis (p < 0.05). People ages between 25 to 34 years were more likely to be infected with MTB (40%). Drug-resistant profile showed 97 (4.9%) patients were infected with MDR-TB. Streptomycin resistance was the highest and was observed in 173 (9%) isolates followed by isoniazid in 119 (6%) isolates. The lowest resistance was observed to pyrazinamide (3%). The prevalence of MDR-TB (10.4%) among patients that previously received anti-tuberculosis treatment is seemingly high. A large-scale drug resistance survey is required to evaluate the drug resistance for better management of tuberculosis.

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PO 8408 DETECTION OF EXTENSIVELY DRUG-RESISTANT TUBERCULOSIS AMONG MULTIDRUG-RESISTANT MYCOBACTERIUM TUBERCULOSIS CLINICAL ISOLATES IN BOTSWANA

BMJ Global Health ◽

10.1136/bmjgh-2019-edc.85 ◽

2019 ◽

Vol 4 (Suppl 3) ◽

pp. A33.1-A33

Author(s):

Tuelo Mogashoa ◽

Lucy Mupfumi ◽

Thato Iketleng ◽

Pinkie Melamu ◽

Nametso Kelentse ◽

...

Keyword(s):

Drug Resistance ◽

Geographical Location ◽

Drug Susceptibility ◽

Multidrug Resistant ◽

Drug Susceptibility Testing ◽

Drug Resistant ◽

Second Line ◽

Hiv Status ◽

Extensively Drug Resistant ◽

Line Drug

BackgroundThe emergence and transmission of multidrug-resistant (MDR) and extensively drug-resistant (XDR) Mycobacterium tuberculosis (Mtb) strains is a serious threat to tuberculosis control in Botswana. Early detection of drug-resistant isolates is critical to ensure optimal treatment and thereby improve treatment outcomes. The objective of this study was to determine the extent of second-line drug resistance among drug-resistant Mtb-isolates from Botswana.MethodsA total of 60 drug-resistant Mtb isolates received at Botswana National Tuberculosis Reference Laboratory between 2012 and 2013 were analysed. DNA was extracted from BD Mycobacterial Growth Indicator Tubes (MGIT) using GenoLyse DNA isolation kit (Hain Lifescience). Spoligotyping was done using a commercially available spoligotyping kit (Isogen Life Science). The spoligotype patterns were compared with existing patterns in the SITVIT2 Web database. GenoType MTBDRs assay (Hain Lifescience) was used for second-line drug susceptibility testing. Fisher’s exact test was used to test for association between drug resistance patterns and HIV status, lineage and geographical location.ResultsSeventeen distinct spoligotype patterns were detected amongst the 60 drug-resistant isolates. The most predominant lineages were Euro-American (58.3%), East Asian (25%) and Indo-Oceanic (15%). Fifty (83.3%) were MDR, 7 (11.7%) were resistant to fluoroquinolones (Pre-XDR) whereas 3 (5%) were resistant to both fluoroquinolones and second-line injectable drugs (XDR). Drug resistance profiles were significantly associated with Mtb lineage (p<0.001). There was no association between drug resistance profile and HIV status (p=0.057) and geographical location (p=0.372).ConclusionThis study highlights the importance of including second-line drug susceptibility testing in a testing algorithm in Botswana. The detection of XDR isolates among MDR-TB isolates highlights the ongoing evolution of resistance and the need for strengthened treatment regimens to improve treatment outcomes and to prevent the spread of these highly resistant strains. Second-line testing will be essential if the 9 month MDR regimen is used in Botswana.

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Importance of the Genetic Diversity within the Mycobacterium tuberculosis Complex for the Development of Novel Antibiotics and Diagnostic Tests of Drug Resistance

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.01641-12 ◽

2012 ◽

Vol 56 (12) ◽

pp. 6080-6087 ◽

Cited By ~ 40

Author(s):

Claudio U. Köser ◽

Silke Feuerriegel ◽

David K. Summers ◽

John A. C. Archer ◽

Stefan Niemann

Keyword(s):

Genetic Diversity ◽

Drug Resistance ◽

Clinical Trials ◽

Mycobacterium Tuberculosis ◽

Drug Susceptibility ◽

Drug Susceptibility Testing ◽

Resistance Mutations ◽

Content Type ◽

Phenotypic Methods ◽

Multiple Antibiotics

ABSTRACTDespite being genetically monomorphic, the limited genetic diversity within theMycobacterium tuberculosiscomplex (MTBC) has practical consequences for molecular methods for drug susceptibility testing and for the use of current antibiotics and those in clinical trials. It renders some representatives of MTBC intrinsically resistant against one or multiple antibiotics and affects the spectrum and consequences of resistance mutations selected for during treatment. Moreover, neutral or silent changes within genes responsible for drug resistance can cause false-positive results with hybridization-based assays, which have been recently introduced to replace slower phenotypic methods. We discuss the consequences of these findings and propose concrete steps to rigorously assess the genetic diversity of MTBC to support ongoing clinical trials.

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Performance of the New Version (v2.0) of the GenoType MTBDRslTest for Detection of Resistance to Second-Line Drugs in Multidrug-Resistant Mycobacterium tuberculosis Complex Strains

Journal of Clinical Microbiology ◽

10.1128/jcm.00051-16 ◽

2016 ◽

Vol 54 (6) ◽

pp. 1573-1580 ◽

Cited By ~ 29

Author(s):

Florence Brossier ◽

David Guindo ◽

Anne Pham ◽

Florence Reibel ◽

Wladimir Sougakoff ◽

...

Keyword(s):

Mycobacterium Tuberculosis ◽

Dna Sequencing ◽

Drug Susceptibility ◽

Multidrug Resistant ◽

Resistance Mechanisms ◽

Drug Susceptibility Testing ◽

Second Line ◽

Content Type ◽

Injectable Drugs ◽

Resistant Tuberculosis

Detecting resistance to fluoroquinolones (FQ) and second-line injectable drugs (amikacin [AMK], kanamycin [KAN], and capreomycin [CAP]) is crucial given the worldwide increase in the incidence of extensively drug-resistant tuberculosis (XDR-TB). A new version of the GenoType MTBDRsltest (v2.0) has been developed to improve the detection of resistance to FQ (involvinggyrAandgyrBmutations) and to second-line injectable drugs (involvingrrsandeispromoter mutations) inMycobacterium tuberculosis. A collection of 127 multidrug-resistant (MDR)M. tuberculosiscomplex strains was tested using the first (v1) and second (v2.0) versions of the MTBDRsltest, as well as DNA sequencing. The specificities in resistance detection of v1 and v2.0 were similar throughout, whereas the levels of sensitivity of v2.0 were superior for FQ (94.8% versus 89.6%) and KAN (90.5% versus 59.5%) but similar for AMK (91.3%) and CAP (83.0%). The sensitivity and specificity of v2.0 were superior to those of v1 for the detection of pre-XDR strains (83.3% versus 75.0% and 88.6% versus 67.1%, respectively), whereas the sensitivity of v2.0 was superior to that of v1 only for the detection of XDR strains (83.0% versus 49.1%). In conclusion, MTBDRslv2.0 is superior to MTBDRslv1 and efficiently detects the most common mutations involved in resistance to FQ and aminoglycosides/CAP. However, due to mutations not recognized by v2.0 or to the presence of resistance mechanisms not yet characterized (particularly mechanisms related to monoresistance to aminoglycosides or CAP), the results for wild-type strains obtained with MTBDRslv2.0 should be confirmed by further DNA sequencing and phenotypic drug susceptibility testing.

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Multicenter Study of the Accuracy of the BD MAX Multidrug-resistant Tuberculosis Assay for Detection of Mycobacterium tuberculosis Complex and Mutations Associated With Resistance to Rifampin and Isoniazid

Clinical Infectious Diseases ◽

10.1093/cid/ciz932 ◽

2019 ◽

Vol 71 (5) ◽

pp. 1161-1167 ◽

Cited By ~ 5

Author(s):

Maunank Shah ◽

Sonia Paradis ◽

Joshua Betz ◽

Natalie Beylis ◽

Renu Bharadwaj ◽

...

Keyword(s):

Mycobacterium Tuberculosis ◽

Sensitivity And Specificity ◽

High Sensitivity ◽

Drug Susceptibility ◽

Multidrug Resistant ◽

Drug Susceptibility Testing ◽

Sputum Smear ◽

Smear Microscopy ◽

Resistant Tuberculosis ◽

Mdr Tb

Abstract Background Tuberculosis (TB) control is hindered by absence of rapid tests to identify Mycobacterium tuberculosis (MTB) and detect isoniazid (INH) and rifampin (RIF) resistance. We evaluated the accuracy of the BD MAX multidrug-resistant (MDR)-TB assay (BD MAX) in South Africa, Uganda, India, and Peru. Methods Outpatient adults with signs/symptoms of pulmonary TB were prospectively enrolled. Sputum smear microscopy and BD MAX were performed on a single raw sputum, which was then processed for culture and phenotypic drug susceptibility testing (DST), BD MAX, and Xpert MTB/RIF (Xpert). Results 1053 participants with presumptive TB were enrolled (47% female; 32% with human immunodeficiency virus). In patients with confirmed TB, BD MAX sensitivity was 93% (262/282 [95% CI, 89–95%]); specificity was 97% (593/610 [96–98%]) among participants with negative cultures on raw sputa. BD MAX sensitivity was 100% (175/175 [98–100%]) for smear-positive samples (fluorescence microscopy), and 81% (87/107 [73–88%]) in smear-negative samples. Among participants with both BD MAX and Xpert, sensitivity was 91% (249/274 [87–94%]) for BD MAX and 90% (246/274 [86–93%]) for Xpert on processed sputa. Sensitivity and specificity for RIF resistance compared with phenotypic DST were 90% (9/10 [60–98%]) and 95% (211/222 [91–97%]), respectively. Sensitivity and specificity for detection of INH resistance were 82% (22/27 [63–92%]) and 100% (205/205 [98–100%]), respectively. Conclusions The BD MAX MDR-TB assay had high sensitivity and specificity for detection of MTB and RIF and INH drug resistance and may be an important tool for rapid detection of TB and MDR-TB globally.

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