The emergence and spread of multidrugresistant tuberculosis mdrtb and extensively drugresistant tuberculosis xdrtb are a major medical and. Use of genotype mtbdrplus assay for diagnosis of multidrug. Tb online genotype mtbdrplus assay and innolipa rif. Genomic dna of mycobacterial culture was extracted by incubating the colonies dissolved in 300. Early detection of multidrug resistance and common. The genotype mtbdrplus assay is a promising molecular kit designed for rapid identification of resistance to firstline antituberculosis drugs, isoniazid and rifampicin. Genotype mtbdrsl performance on clinical samples with diverse genetic background. Evaluation of the genotype mtbdrplus and mtbdrsl for. Evaluation of genotype mtbdr plus assay for rapid detection of isoniazid and rifampicinresistance in mycobacterium tuberculosis isolates from diabetes mellitus patients. Sputum samples from 1128 patients at risk for multidrugresistant tuberculosis mdrtb were tested using mtbdrplus v2 and compared with. Genotype mtbdrsl performance on clinical samples with.
We sought to identify the mutations in isolates with such hybridization patterns and determine if the mutations are associated with resistance to rifampicin. Sputum samples from 1128 patients at risk for multidrugresistant tuberculosis mdrtb were tested using mtbdrplus v2 and compared with reference. The genotype mtbdrplus version 2 assay is a pcrbased line probe assay for the detection of the m. In this study, we evaluated the diagnostic performance of the xpert mtbrif and genotype mtbdrplus version 2 assays on smearpositive and smearnegative patient specimens submitted to a highthroughput diagnostic laboratory. A performance evaluation of mtbdrplus version 2 for the. The resistant pattern of 81bp regions of rpob gene by genotype mtbdrplus assay was illutrated in fig. In phase 1, the results for 379 test strains were compared to a composite reference standard that used phenotypic drug susceptibility testing dst and targeted sequencing. Genotype mtbdrplus was developed by hain lifescience, a company in germany. Its sensitivity and specificity for detecting inhresistant m.
These newer lpas aim to improve the sensitivity of mycobacterium tuberculosis complex mtbc detection and to simultaneously detect resistance to rifampicin rif and isoniazid h. Barnard m, gey van pittius nc, van helden pd, et al. Pdf a multicenter noninferiority evaluation of hain. Conclusions this comparative study has established a strong correlation between the genexpert and the mtbdrplus assays for the rapid diagnosis of multidrug resistant tb mdrtb. Full text evaluation of the genotype mtbdrplus and. Subsequently, newer versions of the lpa technology have been developed since 2011, including i the genotype mtbdrplus version 2 referred to as genotype mtbdrplus v2, and ii the. Who recommends use of two alternative line probe assays. Genotype mtbdrplus identified two isolates carrying only mutations to lowlevel isoniazid resistance. The reactional medium for the pcr was composed by a mix of nucleotidic primer and amplification probes in mgcl2, sterile water, and taq polymerase. Genotype mtbdrplus assay for rapid detection of multidrug. Sensitivity, specificity, ppv and npv of genotype mtbdrplus ver 2. All statistical analyses were carried out using the open source epidemiologic statistics for public health version 2. The hain version 2 assay allows for the identification of m. Dear ranjan, from the package insert hain mtbdrplus version 2.
Limit of detection for hain connecting our members with. Mycobacterium tuberculosis isolates that fail to hybridize to at least one rpob wildtype or any mutation probe on the genotype mtbdrplus strip are assumed to be rifampicinresistant. Treatment of hcv genotype 2 this is a pdf version of the following document. Early detection of multidrug resistance and common mutations in mycobacterium tuberculosis isolates from delhi using genotype mtbdrplus assay r singhal 1, vp myneedu 1, j arora 1, n singh 1, m bhalla 1, a verma 1, r sarin 2 1 department of microbiology, national institute of tuberculosis and respiratory diseases, new delhi, india 2 department of tb and chest, national institute of. Genotype mtbdrplus version 2 assay hain lifesciences, nehren. In other settings, the genotype mtbdr plus assay was evaluated for its performance on smearpositive, smearnegative clinical specimens and cultivated samples with other methods such as bactec 460tb, mgit 960 systems, and the. The diagnostic performance of the genotype mtbdrplus. To control multidrug resistant tuberculosis mdrtb, the drug susceptibility profile is needed to guide therapy. Am, cpm and emb using the standard version of the who proportion. Genotype mtbdr assays for the diagnosis of multidrug. Furthermore, the test system offers new features or the detection of resistances to secondline drugs. Pdf the diagnostic performance of the genotype mtbdrplus. An assay is a procedure in biochemistry to detect a substance on a molecular level. Frontiers evaluation of genotype mtbdrplus and mtbdrsl.
Multicenter noninferiority evaluation of hain genotype mtbdrplus version 2 and nipro ntm mdrtb line probe assays for detection of rifampin and isoniazid resistance ruvandhi r. The first version of genotype mtbdrsl can be processed from smearpositive pulmonary or cultivated samples. The diagnostic performance of the genotype mtbdrplus version. Background there is an urgent demand for rapid and accurate drugsusceptibility testing for the detection of multidrugresistant tuberculosis. Evaluation of the genotype mtbdrplus assay for detection. The global extensively drugresistant tuberculosis tb response plan calls for implementation of rapid tests to screen patients at risk of drugresistant tb. The emergence and spread of multidrugresistant tuberculosis mdrtb and extensively drugresistant tuberculosis xdrtb are a major medical and public problem threatening the global health. Oa006 comparative evaluation of genotype mtbdrplus version 2 and gene xpert mtbrif assays to detect mycobacterium tuberculosis and resistance gene patterns in gabon abraham alabi, 1francis foguim, jeyaraj sankarganesh, 2 ellen bruske, 2 arnault mfoumbi, 1chester mevyann, ayola adegnika,1 bertrand lell, katharina kranzer,3 peter kremsner, 2martin grobusch4. Absence of hybridization with the wildtype and mutant. The aim of this metaanalysis was to evaluate the diagnostic accuracy of genotype. A total of 282 consecutive specimens were subjected to the two new molecular assays, and their performance. The patients in all age groups of culture positives were enrolled for genotype mtbdr assay version 2.
Genotype mtbdrsl detection of resistance of mtbc complex. Original article comparison of genotype mtbdrplus results. The diagnostic performance of the genotype mtbdrplus version 2 line probe assay is equivalent to that of the xpert mtb. Genotype mtbdrplus line probe assay for rapid and direct. Tb was developed by a belgium company called innogenetics. Comparison of genotype mtbdrplus results between tb patients with different levels of drug resistance. Once a diagnosis of rifampicinresistant tb rrtb or multidrugresistant tb mdrtb has been. Treatment of chronic hepatitis c infection topic 2. Genotype mtbdrplus line probe assay for rapid and direct detection of rifampicin and isoniazid resistance in mycobacterium tuberculosis complex from sputum samples nitin mohan 1, pappala bala chandrasekhar 2, indugula jyothi padmaja 1, neeraj raizada. Oa006 comparative evaluation of genotype mtbdrplus version 2 and gene xpert mtbrif assays to detect mycobacterium tuberculosis and resistance gene patterns in gabon abraham alabi, 1francis foguim, jeyaraj sankarganesh,2 ellen bruske,2 arnault mfoumbi, 1chester mevyann, ayola adegnika,1 bertrand lell, katharina kranzer,3 peter kremsner, 2martin. The diagnostic performance of the genotype mtbdrplus version 2. Performance of lpa from a total of 197 smear negative direct sputum sample.
Tb online who recommends use of two alternative line. Pdf molecular diagnostics for mycobacterium tuberculosis have recently been endorsed by the world health organization. Multicenter noninferiority evaluation of hain genotype. Pdf abstract background multi drug resistant tuberculosis. Molecular line probe assays for rapid screening of patients at risk of multidrug resistant tuberculosis mdrtb expert group report this report contains the collective views of an international group of experts, and does not necessarily.
Crossrefpubmedpubmedcentral barnard m, gey van pittius nc, van helden pd, bosman m, coetzee g, warren rm. Schumacher,c birte schlueter,b nazir ismail, dshaheed vally omar. Data analysis the performance of mtbdrplus v2 was described. This assay detects both the presence of mtb complex as well as the presence of inh and rif resistance and can be done directly on. A multicenter noninferiority evaluation of hain genotype.
In 2012, version 2 of the mtbdrplus assay was released to address performance issues associated. The results of the evaluation of the performance of the genotype mtbdrplus assay in detecting drug resistance are summarized in table 2. Classical drug susceptibility testing dst may take up to 2 to 4 months. Sequence analysis revealed nonsynonymous mutations in 93. The use of molecular line probe assays for the detection. Genotype mtbdrplus version 2 referred to as genotype mtbdrplus v2, and ii the. Statistical analysis was carried out using spss version 20 software packages. To evaluate the performance of a recently updated rapid molecular diagnostic test, mtbdrplus version 2 v2, designed to detect drug resistance in both acidfast bacilli afb smear negative and positive specimens. Genotype mtbdrplus detection of resistance to rifampicin. Until the present edition of the instructions on hand, the performance of the. The commercially available genotype mtbdrplus assay version 2.
The diagnostic performance of the genotype mtbdrplus version 2 line probe assay is equivalent to that of the xpert mtbrif assay. Once you receive a hepatitis c diagnosis, and before you start treatment, youll need another blood test to determine the genotype of the virus. Online annexes pdf, 791kb world health organization. The second version of genotype mtbdrsl also enables the detection of mutations involved in resistance to injectable drugs as well as the resistance to fluoroquinolones. The sensitivity and specificity of the genotype mtbdrplus assay for the detection of rifresistant m. Line probe assays for drug resistant tuberculosis detection.
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