Validation of the GenoType<sup>®</sup> MTBDRplus Ver 2.0 assay for detection of rifampicin and isoniazid resistance in Mycobacterium tuberculosis complex isolates at UZCHS-CTRC TB research laboratory

Stephen, Stephen; Muzhizhizhi, Donhodzo; Dhibi, Nicholas; Chidemo, Tinashe; Samaneka, Wadzanai; Matubu, Taguma Allen; Hakim, James; Chirenje, Zvavahera M.

doi:10.4103/ijmy.ijmy_170_18

Cited by 11 publications

(5 citation statements)

References 2 publications

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“…A similar high prevalence (85%) of S531L mutation in rifampicin resistant isolates was reported in a study at Cameroon (Abanda et al, 2017). These findings are also consistent with other reported studies (Buyankhishig et al, 2012;Stephen et al, 2019). The presence of a high frequency of S531L mutation around the globe might be due to low fitness cost which impacts its strong selection in environment and transmissibility (Gagneux, 2009).…”

Section: Discussionsupporting

confidence: 89%

Variations in rifampicin and isoniazid resistance associated genetic mutations among drug naïve and recurrence cases of pulmonary tuberculosis

Kabir

Junaid

Rehman

2021

International Journal of Infectious Diseases

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Background: The resistance to first-line drugs can increase the risk of treatment failure and development of resistance to other anti-TB drugs. In TB endemic settings, a considerable rate of recurrence cases exhibited each, year which adds significant burden to the prevalence of disease worldwide. Methods: A total of 562 sputum samples were collected from presumptive positive clinical cases of MDR tuberculosis. Treatment history and demographic data of the patients were obtained after informed consent. Xpert MTB/RIF assay was performed for simultaneous detection of MTB and rifampicin resistance. The mutation patterns of isoniazid and rifampicin were observed after multiplex PCR and reverse hybridization by Genotype 1 MTBDRplus version 2.0 assay. Results: A total of 73 of 97 cases (75.2%) of treatment failure were found positive for MDR-TB, whereas 79.6% newly diagnosed and 72.9% default cases were MDR in our isolates. The mutation of rpoB S531L was slightly higher in new treatment cases (89.3%) as compared to the default (80.4%) and failure cases (84.8%), whereas rpoB D516V mutation was more prevalent in default cases (19.6%) with complete absence of rpoB 526 mutation, which was observed in the other two types of cases. The mutation pattern of katG resistance differed among drug naïve and recurrence cases. The resistance in newly diagnosed cases was mostly conferred by katG 315 (49.1%) whereas in default (70.8%) and failure cases (63.3%) isoniazid resistance was commonly associated with katG S315T1 mutation. Mutations in inhA promoter region occurred at nucleotide position À8 and À15. In new cases the rate of mutation of C-15T was 3.7% and T-8A was 1.5% while in treatment failure cases the frequency for C-15T and T-8C was 2.5 and 3.8% respectively. However, no inhA promoter region mediated mutations were detected in default treatment cases. Conclusion: Retreated cases are at more risk of developing hot spot mutations. An unusual difference in mutation pattern was determined in naïve and recurrence cases. Some mutations were exclusively associated with the retreatment of 35anti-TB drugs which suggest the increased risk of resistance with poor treatment outcome.

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Section: Discussionsupporting

confidence: 89%

Variations in rifampicin and isoniazid resistance associated genetic mutations among drug naïve and recurrence cases of pulmonary tuberculosis

Kabir

Junaid

Rehman

2021

International Journal of Infectious Diseases

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“…The above documentation of drug-resistant TB was similar to the study of Barnard et al,(86.3% susceptible to both RIF and INH). 28 Our study is in concurrence to susceptibility (95%) and mono resistant (4.2%) to RIF, (91%) susceptibility and (9%) resistant to INH, 7 (2.4%) MDR strains with Stephen et al 24 In the present study, 9 (3%) cases with RIF-WT7 probe was detected and similar to Ritu Singhal et al 21 In INH resistant, 6(2.1%) showed katG gene mutations in the inhA gene promoter region detected by LPA and this resistance pattern was not in concurrence with Sara Siddiqui et al 33 In our study, 51/216 (24%) of the smearnegative sample showed TUB band (LPA). Our study similar to Binit Kumar Singh et al 34 The use of Genotype MTBDRplus LPA (v2.0) directly from the smear-negative samples and susceptibility to RIF (84%), INH(82%) and detection of mono resistant strains to RIF (16%), to INH (18%) and MDR 3 (6%) were similar to Syed Beenish Rufai et al 35 This study supports the use of Genotype MTBDRplus LPA (v2.0) for detection of newer cases and MDR from the directly from pulmonary sample.…”

Section: Discussionsupporting

confidence: 71%

“…The presence of bands suggesting a mutation or the lack of at least one of the wildtype bands indicates that the sample is resistant to the antibiotic tested. 23,24…”

Section: Genotype Mtbdrplus Ver20 Line-probe Assaymentioning

confidence: 99%

A Comparison Study of CBNAAT, Gene Xpert and Line Probe Assays in the Diagnosis of Tuberculosis in smear Negative Specimens

Vijay¹,

Meharaj²,

Jayanthi³

et al. 2022

J. Pure Appl. Microbiol.

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Tuberculosis (TB) is a serious and important public health issue to be addressed in India. Timely diagnosis of the drug resistance in tuberculosis is essential to ensure and initiate appropriate therapy. The detection of drug resistant Mycobacterium tuberculosis (MTB) in cases of smear-negative and clinical diagnosed pulmonary TB. A prospective case-control study was conducted on 473 pulmonary samples received at the tertiary care center from January 2019 to December 2019. All specimens were processed for microscopy and culture. CBNAAT- Gene Xpert and LPA Genotype MTBDRplus (VER 2.0) was used to confirm in smear-negative samples. Among the pulmonary samples, 52% smear-positive, and 48% smear-negative, 183 (43%) were found to be culture-positive by Lowenstein Jensen medium (LJ) and MGIT 960, 267 (63%) were positive CBNAAT and LPA n= 216 (51%) samples positive for the TUB band. The use of CBNAAT-Gene Xpert, Line Probe Assay Genotype MTBDR plus(VER 2.0) can be done from the samples directly and the diagnostic performance are more specific for detecting MTB in smear-negative specimens. This study suggests that LPA also helps in the diagnosis of MDR rapidly and in initiation of earlier treatment.

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“…The NALC/NAOH (N-acetyl-L-cysteine and sodium hydroxide) method was used to prepare the specimens. [ 13 ] The pre-treatment sputum was cultured for mycobacteria using the BACTEC MGIT (mycobacterial growth indicator tubes) 960 system (Becton Dickinson BACTECTM MGITTM 960 System, USA). Mycobacteria species were identified using the SD Bioline TB Ag MPT64 Rapid test.…”

Section: Methodsmentioning

confidence: 99%

Drug susceptibility testing and line probe assay of first-line anti-tuberculosis drugs among presumptive tuberculosis patients attending a secondary care hospital in Bhubaneswar

Singh,

Barik,

Das

et al. 2024

Journal of Family Medicine and Primary Care

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Background: Pyrazinamide (PZA) is important for identification in multi-drug-resistant tuberculosis patients before starting therapy. PZA drug susceptibility testing (DST) is essential for the management of drug-resistant and susceptible TB patients. Aims: The degree of drug resistance among TB patients and discrepancy between DST results of the phenotype and genotype were assessed. Materials and Methods: Socio-demographic and clinical profiles of TB patients recruited in the study were documented. Sputum samples were processed for diagnosis using TrueNat Xpert MTB, TrueNat Xpert MTB Plus, and MGIT culture. Results: Rifampicin (RIF) line probe assay (LPA) showed the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 100%, whereas isoniazid (INH) LPA testing showed a sensitivity of 85.7%, a specificity and PPV of 100%, and NPV of 94.8%. The gene mutation for RIF resistance was between the codon, 530–533 of rpoB gene, and that for INH resistance was at the codon, 315 of katG gene. Conclusion: Our findings demonstrated high prevalence of mono- and poly-drug resistance as well as pyrazinamide resistance.

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Validation of the GenoType^® MTBDRplus Ver 2.0 assay for detection of rifampicin and isoniazid resistance in Mycobacterium tuberculosis complex isolates at UZCHS-CTRC TB research laboratory

Cited by 11 publications

References 2 publications

Variations in rifampicin and isoniazid resistance associated genetic mutations among drug naïve and recurrence cases of pulmonary tuberculosis

Variations in rifampicin and isoniazid resistance associated genetic mutations among drug naïve and recurrence cases of pulmonary tuberculosis

A Comparison Study of CBNAAT, Gene Xpert and Line Probe Assays in the Diagnosis of Tuberculosis in smear Negative Specimens

Drug susceptibility testing and line probe assay of first-line anti-tuberculosis drugs among presumptive tuberculosis patients attending a secondary care hospital in Bhubaneswar

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Validation of the GenoType® MTBDRplus Ver 2.0 assay for detection of rifampicin and isoniazid resistance in Mycobacterium tuberculosis complex isolates at UZCHS-CTRC TB research laboratory

Cited by 11 publications

References 2 publications

Variations in rifampicin and isoniazid resistance associated genetic mutations among drug naïve and recurrence cases of pulmonary tuberculosis

Variations in rifampicin and isoniazid resistance associated genetic mutations among drug naïve and recurrence cases of pulmonary tuberculosis

A Comparison Study of CBNAAT, Gene Xpert and Line Probe Assays in the Diagnosis of Tuberculosis in smear Negative Specimens

Drug susceptibility testing and line probe assay of first-line anti-tuberculosis drugs among presumptive tuberculosis patients attending a secondary care hospital in Bhubaneswar

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Product

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Validation of the GenoType^® MTBDRplus Ver 2.0 assay for detection of rifampicin and isoniazid resistance in Mycobacterium tuberculosis complex isolates at UZCHS-CTRC TB research laboratory