A field evaluation of the Hardy TB MODS Kit™ for the rapid phenotypic diagnosis of tuberculosis and multi-drug resistant tuberculosis.
<h4>Background</h4>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...
Saved in:
| Main Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2014-01-01
|
| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0107258 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850124913790156800 |
|---|---|
| author | Laura Martin Jorge Coronel Dunia Faulx Melissa Valdez Mutsumi Metzler Chris Crudder Edith Castillo Luz Caviedes Louis Grandjean Mitzi Rodriguez Jon S Friedland Robert H Gilman David A J Moore |
| author_facet | Laura Martin Jorge Coronel Dunia Faulx Melissa Valdez Mutsumi Metzler Chris Crudder Edith Castillo Luz Caviedes Louis Grandjean Mitzi Rodriguez Jon S Friedland Robert H Gilman David A J Moore |
| author_sort | Laura Martin |
| collection | DOAJ |
| description | <h4>Background</h4>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.<h4>Methods & findings</h4>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).<h4>Conclusions</h4>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. |
| format | Article |
| id | doaj-art-1e667b4aee584d418b89d36fc2ad5443 |
| institution | OA Journals |
| issn | 1932-6203 |
| language | English |
| publishDate | 2014-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-1e667b4aee584d418b89d36fc2ad54432025-08-20T02:34:13ZengPublic Library of Science (PLoS)PLoS ONE1932-62032014-01-0199e10725810.1371/journal.pone.0107258A field evaluation of the Hardy TB MODS Kit™ for the rapid phenotypic diagnosis of tuberculosis and multi-drug resistant tuberculosis.Laura MartinJorge CoronelDunia FaulxMelissa ValdezMutsumi MetzlerChris CrudderEdith CastilloLuz CaviedesLouis GrandjeanMitzi RodriguezJon S FriedlandRobert H GilmanDavid A J Moore<h4>Background</h4>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.<h4>Methods & findings</h4>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).<h4>Conclusions</h4>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.https://doi.org/10.1371/journal.pone.0107258 |
| spellingShingle | Laura Martin Jorge Coronel Dunia Faulx Melissa Valdez Mutsumi Metzler Chris Crudder Edith Castillo Luz Caviedes Louis Grandjean Mitzi Rodriguez Jon S Friedland Robert H Gilman David A J Moore A field evaluation of the Hardy TB MODS Kit™ for the rapid phenotypic diagnosis of tuberculosis and multi-drug resistant tuberculosis. PLoS ONE |
| title | A field evaluation of the Hardy TB MODS Kit™ for the rapid phenotypic diagnosis of tuberculosis and multi-drug resistant tuberculosis. |
| title_full | A field evaluation of the Hardy TB MODS Kit™ for the rapid phenotypic diagnosis of tuberculosis and multi-drug resistant tuberculosis. |
| title_fullStr | A field evaluation of the Hardy TB MODS Kit™ for the rapid phenotypic diagnosis of tuberculosis and multi-drug resistant tuberculosis. |
| title_full_unstemmed | A field evaluation of the Hardy TB MODS Kit™ for the rapid phenotypic diagnosis of tuberculosis and multi-drug resistant tuberculosis. |
| title_short | A field evaluation of the Hardy TB MODS Kit™ for the rapid phenotypic diagnosis of tuberculosis and multi-drug resistant tuberculosis. |
| title_sort | field evaluation of the hardy tb mods kit™ for the rapid phenotypic diagnosis of tuberculosis and multi drug resistant tuberculosis |
| url | https://doi.org/10.1371/journal.pone.0107258 |
| work_keys_str_mv | AT lauramartin afieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT jorgecoronel afieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT duniafaulx afieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT melissavaldez afieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT mutsumimetzler afieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT chriscrudder afieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT edithcastillo afieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT luzcaviedes afieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT louisgrandjean afieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT mitzirodriguez afieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT jonsfriedland afieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT roberthgilman afieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT davidajmoore afieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT lauramartin fieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT jorgecoronel fieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT duniafaulx fieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT melissavaldez fieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT mutsumimetzler fieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT chriscrudder fieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT edithcastillo fieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT luzcaviedes fieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT louisgrandjean fieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT mitzirodriguez fieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT jonsfriedland fieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT roberthgilman fieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis AT davidajmoore fieldevaluationofthehardytbmodskitfortherapidphenotypicdiagnosisoftuberculosisandmultidrugresistanttuberculosis |