Comprehensive Multicenter Evaluation of a New Line Probe Assay Kit for Identification of Mycobacterium Species and Detection of Drug-Resistant Mycobacterium tuberculosis

Mitarai, Satoshi; Kato, Seiya; Ogata, Hideo; Ando, Akio; Chikamatsu, Kinuyo; Mizuno, Kazue; Toyota, Emiko; Sejimo, Akiko; Suzuki, Katsuhiro; Yoshida, Shiomi; Saito, Takefumi; Moriya, Ataru; Fujita, Akira; Sato, Shuko; Matsumoto, Tomoshige; Ano, Hiromi; Suetake, Toshinori; Kondo, Yuji; Kirikae, Teruo; Mori, Toru

doi:10.1128/jcm.05638-11

Cited by 53 publications

(47 citation statements)

References 43 publications

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“…There are currently two commercially available solid phase reverse hybridization assays for the rapid detection of drug resistance in MTB: the line probe assay (LiPA) (INNO-LiPA Rif TB Assay, Innogenetics, Ghent, Belgium) for detecting resistance to rifampicin and the GenoType MTBDR Plus (Hain Lifesciences, Nehren, Germany) for the simultaneous detection of resistance to rifampicin and isoniazid. Recently, the LiPA assay has been evaluated for its identification of MTB species and detection of mutation related to drug resistance in MTB [34]. The results of LiPA identification of Mycobacterium species in clinical isolates were almost identical to those of conventional methods; this assay also was used to directly test sputum specimens with a sensitivity of 85.6%.…”

Section: Therapy and Susceptibility Testingmentioning

confidence: 78%

“…Compared with standard DST for the clinical isolates, LiPA showed a good sensitivity and specificity for detecting rifampin, isoniazid, pyrazinamide, and levofloxacin resistance of clinical isolates with a rate of 89.7% and 100%, respectively. Its sensitivity and specificity for detecting rifampin-, isoniazid-, and levofloxacin-resistant isolates in the sputum were both 100%, and those for detecting isoniazid-resistant isolates were 75% and 92.2%, respectively [34]. A meta-analysis carried out to assess the accuracy of GenoType MTBDR indicates that its sensitivity and specificity for rifampicin resistance were 98.1% and 98.7%, respectively; however, while specificity is excellent for isoniazid resistance (99.5%), sensitivity estimates were modest and variable.…”

Section: Therapy and Susceptibility Testingmentioning

confidence: 95%

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Cost-effectiveness in the diagnosis of tuberculosis: choices in developing countries

Molicotti

Bua

Zanetti

2014

J Infect Dev Ctries

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Tuberculosis remains one of the major causes of global death from a single infectious agent. This situation is worsened by the HIV/AIDS pandemic because one-third of HIV/AIDS patients are co-infected with Mycobacterium tuberculosis. Failure to control the spread of tuberculosis is largely due to our inability to detect and treat all infectious cases of pulmonary tuberculosis in a timely manner, allowing continued M. tuberculosis transmission within communities. Diagnosis of tuberculosis can be made using indirect and direct methods. The indirect tests, such as interferon-gamma release assays, provide a new diagnostic method for M. tuberculosis infection, but do not discriminate between infection and active disease. The most common direct method for diagnosing TB worldwide is sputum smear microscopy (developed more than 100 years ago), where bacteria are observed in sputum samples examined under a microscope. In countries with more developed laboratory capacities, cases of tuberculosis may also be diagnosed using culture methods (the current gold standard) or, increasingly, using rapid molecular tests. In this review, we discuss the traditional methods for the diagnosis of tuberculosis. We also discuss other inexpensive assays that can be used to detect the presence of M. tuberculosis.

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Section: Therapy and Susceptibility Testingmentioning

confidence: 78%

Section: Therapy and Susceptibility Testingmentioning

confidence: 95%

Cost-effectiveness in the diagnosis of tuberculosis: choices in developing countries

Molicotti

Bua

Zanetti

2014

J Infect Dev Ctries

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“…The results of this assay therefore have to be analyzed with caution, particularly since RIF resistance has been used as a surrogate for INH (and hence multidrug) resistance, despite not being always appropriate (147,157). Another synonymous mutation in rpoB (D516D) has the same effect with the aforementioned assay by Nipro Corp. (108), and Q510Q causes false-positive results with the Cepheid Xpert MTB/RIF (168) and, presumably, the other three assays discussed (36,39,71,138). Consequently, the limitation of these tests appears to be confined to some strains of this genotype, but the precise frequency of this double mutation both among Uganda strains and the wider MTBC diversity has to be determined further.…”

Section: Known Impact Of Genetic Diversitymentioning

confidence: 99%

“…Given that these hybridization-based assays interrogate the DNA rather than the amino acid sequence, they detect both synonymous and nonsynonymous mutations, unless the genetic diversity in the target regions was taken into consideration for the design of the respective probes (4,12,24,83,155). For example, additional probes had to be included for the assay manufactured by Nipro Corp. to cover several neutral or silent mutations in pncA (13,108,144). This included the S65S mutation, which is shared by most but not all Delhi/CAS strains (151).…”

Section: Known Impact Of Genetic Diversitymentioning

confidence: 99%

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

Köser

Feuerriegel

Summers

et al. 2012

Antimicrob Agents Chemother

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e Despite being genetically monomorphic, the limited genetic diversity within the Mycobacterium tuberculosis complex (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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“…Unfortunately, at present, there is no reliable commercial molecular tool for the rapid prediction of PZA resistance available. Attempts have been made to develop line probe assay-based tests, but so far there is no convincing published evidence on their performance characteristics on direct specimen testing (20). In addition, molecular prediction of PZA resistance is hampered by the fact that mutations are scattered in relatively large genes.…”

Section: (Iii) Is There a Need For A Rapid Screening Test For Pyrazinmentioning

confidence: 99%

Commentary: The Race Is On To Shorten the Turnaround Time for Diagnosis of Multidrug-Resistant Tuberculosis

Somoskövi

2015

J Clin Microbiol

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A ccording to the World Health Organization (WHO), there are many hot spots of multidrug-resistant tuberculosis (MDR-TB), defined as resistance to rifampin (RIF) and isoniazid (INH), in the world. In one of the hot spots, the Russian Federation, a total of 142,500 TB cases, including an estimated 41,000 MDR-TB pulmonary cases in 2013, were reported. Of all new TB cases, 19% were MDR-TB, and among retreated cases, 49% were MDR-TB cases (1). In contrast, the U.S. Centers for Disease Control and Prevention (CDC) reported 9,582 TB cases, including 96 MDR-TB cases in 2014, resulting in 1.3% of all TB cases with available antimicrobial susceptibility test (AST) results (2). The time has come to screen all TB cases in the United States for MDR-TB either at the time a sputum specimen tests positive with a nucleic acid amplification test (NAAT) or when the culture yields a positive result for Mycobacterium tuberculosis complex.The faster turnaround time for diagnosing MDR-TB, enabled by current molecular assays which yield results within hours compared to weeks and months with conventional testing, is needed in order to make up for lost time because of patient and/or health care system delays. An earlier diagnosis of MDR-TB facilitates earlier prescription of an adequate regimen benefiting patients and public health. However, in addition to screening all patients rapidly for MDR-TB, additional information is necessary from molecular assays for the successful management of MDR-TB patients.Besides the presence or absence of M. tuberculosis, the next additional answer from a routine rapid molecular test is whether the patient's specimen contains MDR-TB. In cases where MDR-TB is confirmed, the second question that such an assay will need to rapidly confirm is the presence of extensively drug-resistant tuberculosis (XDR-TB), which is defined as MDR-TB plus resistance to quinolones and second-line injectable drugs. IS RAPID CONFIRMATION OF THE FACT THAT THE PATIENT HAS MDR-OR XDR-TB ENOUGH OR DO WE NEED TO GO BEYOND WITH RAPID MOLECULAR SCREENING?In light of the accumulating evidence on the meaning of molecular mechanisms of different first-and second-line antituberculosis drugs, by appropriate characterization of known and newly identified resistance-associated mutations with quantitative phenotypic susceptibility testing, it is time to raise the question " is rapid detection of MDR and XDR-TB alone enough to successfully win the war on TB or MDR-TB?" Can we extract and utilize more meaningful diagnostic information from currently used molecular tests for our patients?In order to settle this question, we need to keep in mind that molecular markers cannot only rapidly confirm the presence of MDR-TB, they may also provide additional valuable information that can help to predict the level of phenotypic resistance or even cross-resistance to certain first-and second-line antituberculosis drugs. These molecular markers may provide such important additional information as to significantly influence the care of the patient and ultim...

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Comprehensive Multicenter Evaluation of a New Line Probe Assay Kit for Identification of Mycobacterium Species and Detection of Drug-Resistant Mycobacterium tuberculosis

Cited by 53 publications

References 43 publications

Cost-effectiveness in the diagnosis of tuberculosis: choices in developing countries

Cost-effectiveness in the diagnosis of tuberculosis: choices in developing countries

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

Commentary: The Race Is On To Shorten the Turnaround Time for Diagnosis of Multidrug-Resistant Tuberculosis

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