Diagnostics to support mycetoma management—Development of two target product profiles

Fongwen, Noah; Asiedu, Kingsley; Bakhiet, Sahar Mubarak; Bonifáz, Alexandro; Cruz, Israel; Argaw, Daniel; Estrada-Chávez, Guadalupe; Fahal, Ahmed Hassan; Litvintseva, Ana; Marks, Michael; Salinas‐Carmona, Mario C.; Sow, Doudou; Sande, Wendy W J van de

doi:10.1111/tmi.13828

Cited by 3 publications

(4 citation statements)

References 22 publications

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“…However, the challenges in resource-limited settings for eumycetoma diagnosis are diagnostic modalities like MRI and molecular techniques are expensive, need expertise and are not readily available except in tertiary and referral centres in developing and endemic countries 6. Current serology tests available are not specific, and point-of-care tests are difficult to develop as there are more than 70 causative agents for mycetoma 7…”

Section: Discussionmentioning

confidence: 99%

Fusarium falciformeeumycetoma: a diagnostic challenge of a neglected tropical disease

Badarol Hisham,

Abdul Rhani,

Mohd Ali

et al. 2024

BMJ Case Rep

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Eumycetoma, a subcutaneous infection caused by various fungi with pathognomonic discharging grain, is rarely reported in Malaysia. This case concerns a eumycetoma infection in an immunocompetent man who presented with progressive left foot swelling complicated with pustules, sinuses and pale grain discharge for the past year after recurrent thorn pricks. Histological findings of the grain and tissue showed foci of septate fungal hyphae. Tissue culture yielded no growth. Amplification and sequencing of the rDNA internal transcribed spacer 1 (ITS1), ITS4 and large subunit regions of the tissue identified the causative agent asFusarium falciforme, highlighting the role of molecular diagnostic method in identifying fungal species in eumycetoma. The patient was treated with surgical excision and oral itraconazole with excellent improvement. However, he presented again with recurrence after defaulting therapy.F. falciformehas been implicated in causing diseases in crops and sea turtles. Therefore, the One Health approach should be adopted to manage this emerging species.

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Section: Discussionmentioning

confidence: 99%

Fusarium falciformeeumycetoma: a diagnostic challenge of a neglected tropical disease

Badarol Hisham,

Abdul Rhani,

Mohd Ali

et al. 2024

BMJ Case Rep

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“…are the most common causative agents of eumycetomas. Due to the challenges in isolating and morphologically identifying Madurella in culture media [ 4 , 9 ], many studies have reported using molecular techniques for diagnosing mycetoma [ 11 , 16 , 18 , 24 ]. Since isothermal DNA amplification techniques are regarded as a promising tool in community-based medical treatment, this study aimed to develop a LAMP method for Madurella spp.. Three primer sets were designed to target three Madurella spp.…”

Section: Discussionmentioning

confidence: 99%

“…is difficult because culture media lacks sporulation and has a slow growth rate [ 8 ]. These circumstances have become a severe diagnostic problem [ 6 , 9 ].…”

Section: Introductionmentioning

confidence: 99%

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Specific and sensitive loop-mediated isothermal amplification (LAMP) method for Madurella strains, eumycetoma filamentous fungi causative agent

Yoshioka,

Mori,

Fahal

et al. 2023

PLoS Negl Trop Dis

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Background Filamentous fungi of the genus Madurella are the primary causative agents of mycetoma, a disease observed in tropical and subtropical regions. Since early diagnostics based on a morphological approach are difficult and have many shortcomings, a molecular diagnostic method suitable for rural settings is required. In this study, we developed the loop-mediated isothermal amplification (LAMP) method to present a foundational technique of the diagnosis of Madurella spp. (M. mycetomatis, M. pseudomycetomatis, M. tropicana, and M. fahalii), the common causative organisms of eumycetoma. Principal findings We successfully designed a primer pair targeting the rDNAs of three Madurella spp. excluding M. fahalii, and detected up to 100 fg of genomic DNA extracted from isolates of M. mycetomatis and 1 pg of M. pseudomycetomatis and M. tropicana, within one hour. Second, a primer pair specific to M. mycetomatis, the most common causative species, or M. fahalii, a drug-resistant species, was constructed, and the detection limit of both primer pairs was 1 pg. The designed primers accurately distinguished 16 strains of the genus Madurella from various fungal species known to cause mycetomas. Conclusion In summary, we established the first model of a LAMP detection method that rapidly and sensitively detects and identifies Madurella isolates for clinical diagnostics. Moreover, the combined designed primer sets could identify mycetoma-causing strains simultaneously.

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Diagnostics to support mycetoma management—Development of two target product profiles

Fongwen

Asiedu

Bakhiet

et al. 2022

Tropical Med Int Health

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Objective Mycetoma is a neglected tropical disease caused by more than 70 different microorganisms and identified by the WHO as one of the high‐priority diseases for developing diagnostic tests. To ensure the production of diagnostic assays for use by clinical staff in endemic regions, target product profiles (TPPs) were designed. Methods We describe the development of two TPPs: one for a diagnostic test able to identify the causative agent of mycetoma and another that would determine when treatment could be stopped. The TPPs were developed by considering product use, design, performance, product configuration and costs. Results Version 1.0 TPPs for two uses were posted by WHO for a 1‐month online public consultation on 25 October 2021, and the final TPP was posted online on 5 May 2022. Conclusion A major difficulty encountered in developing both TPPs was the large number of agents able to cause mycetoma and the lack of specific biomarkers for most of them.

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Diagnostics to support mycetoma management—Development of two target product profiles

Cited by 3 publications

References 22 publications

Fusarium falciformeeumycetoma: a diagnostic challenge of a neglected tropical disease

Fusarium falciformeeumycetoma: a diagnostic challenge of a neglected tropical disease

Specific and sensitive loop-mediated isothermal amplification (LAMP) method for Madurella strains, eumycetoma filamentous fungi causative agent

Diagnostics to support mycetoma management—Development of two target product profiles

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