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A field evaluation of the Hardy TB MODS kit™ for the rapid phenotypic diagnosis of tuberculosis and multi-drug resistant tuberculosis

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dc.contributor.author Martin, Laura
dc.contributor.author Coronel, Jorge
dc.contributor.author Faulx, Dunia
dc.contributor.author Valdez, Melissa
dc.contributor.author Metzler, Mutsumi
dc.contributor.author Crudder, Chris
dc.contributor.author Castillo, Edith
dc.contributor.author Caviedes, Luz
dc.contributor.author Grandjean, Louis
dc.contributor.author Rodriguez, Mitzi
dc.contributor.author Friedland, Jon S.
dc.contributor.author Gilman, Robert H.
dc.contributor.author Moore, David A. J.
dc.date.accessioned 2020-06-10T18:12:20Z
dc.date.available 2020-06-10T18:12:20Z
dc.date.issued 2014
dc.identifier.uri https://hdl.handle.net/20.500.12866/8108
dc.description.abstract BACKGROUND: Even though the WHO-endorsed, non-commercial MODS assay offers rapid, reliable TB liquid culture and phenotypic drug susceptibility testing (DST) at lower cost than any other diagnostic, uptake has been patchy. In part this reflects misperceptions about in-house assay quality assurance, but user convenience of one-stop procurement is also important. A commercial MODS kit was developed by Hardy Diagnostics (Santa Maria, CA, USA) with PATH (Seattle, WA, USA) to facilitate procurement, simplify procedures through readymade media, and enhance safety with a sealing silicone plate lid. Here we report the results from a large-scale field evaluation of the MODS kit in a government service laboratory. METHODS & FINDINGS: 2446 sputum samples were cultured in parallel in Lowenstein-Jensen (LJ), conventional MODS and in the MODS kit. MODS kit DST was compared with conventional MODS (direct) DST and proportion method (indirect) DST. 778 samples (31.8%) were Mycobacterium tuberculosis culture-positive. Compared to conventional MODS the sensitivity, specificity, positive, and negative predictive values (95% confidence intervals) of the MODS Kit were 99.3% (98.3-99.8%), 98.3% (97.5-98.8%), 95.8% (94.0-97.1%), and 99.7% (99.3-99.9%). Median (interquartile ranges) time to culture-positivity (and rifampicin and isoniazid DST) was 10 (9-13) days for conventional MODS and 8.5 (7-11) for MODS Kit (p<0.01). Direct rifampicin and isoniazid DST in MODS kit was almost universally concordant with conventional MODS (97.9% agreement, 665/679 evaluable samples) and reference indirect DST (97.9% agreement, 687/702 evaluable samples). CONCLUSIONS: MODS kit delivers performance indistinguishable from conventional MODS and offers a convenient, affordable alternative with enhanced safety from the sealing silicone lid. The availability in the marketplace of this platform, which conforms to European standards (CE-marked), readily repurposed for second-line DST in the near future, provides a fresh opportunity for improving equity of access to TB diagnosis and first and second-line DST in settings where the need is greatest. en_US
dc.language.iso eng
dc.publisher Public Library of Science
dc.relation.ispartof urn:issn:1932-6203
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Mycobacterium tuberculosis/drug effects en_US
dc.subject Reagent Kits, Diagnostic en_US
dc.subject Antitubercular Agents/pharmacology en_US
dc.subject Humans en_US
dc.subject Isoniazid/pharmacology en_US
dc.subject Microbial Sensitivity Tests/methods en_US
dc.subject Peru en_US
dc.subject Reproducibility of Results en_US
dc.subject Rifampin/pharmacology en_US
dc.subject Sensitivity and Specificity en_US
dc.subject Sputum/microbiology en_US
dc.subject Tuberculosis, Multidrug-Resistant/diagnosis en_US
dc.subject Tuberculosis/diagnosis en_US
dc.title A field evaluation of the Hardy TB MODS kit™ for the rapid phenotypic diagnosis of tuberculosis and multi-drug resistant tuberculosis en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1371/journal.pone.0107258
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.00 es_PE

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