Evaluation of a point-of-care molecular detection device for Leishmania spp. and intercurrent fungal and mycobacterial organisms in Peruvian patients with cutaneous ulcers

• Published in: Infection Vol. 49; no. 6; pp. 1203 - 1211
• Main Authors: Kariyawasam, Ruwandi, Valencia, Braulio M., Lau, Rachel, Shao, Eric, Thompson, Courtney A., Stevens, Michael, Kincaid, Leah, Del Castillo, Ana Luz Quispe, Cruz-Arzapalo, Lloysi O., Llanos-Cuentas, Alejandro, Boggild, Andrea K.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.12.2021; Springer Nature B.V
• Subjects: Cutaneous leishmaniasis; Diagnostic systems; Family Medicine; Fungi; General Practice; Infectious Diseases; Inflammation; Internal Medicine; Leishmania; Medical diagnosis; Medicine; Medicine & Public Health; Original Paper; Pathogens; Patients; Phenotypes; Protozoa; Sensitivity; Strains (organisms); Ulcers; Vector-borne diseases; Cutaneous leishmaniasis; Fungi; Point of care diagnostics; Mycobacterium; Peru; Tropical ulcer
• ISSN: 0300-8126; 1439-0973
• DOI: 10.1007/s15010-021-01673-y

Purpose Overlapping clinical features of cutaneous leishmaniasis (CL) with ulcers caused by fungi and mycobacteria necessitate confirmatory diagnostic testing. We evaluated a handheld battery-operated device for detection of CL and common fungal and mycobacterial causes of ulcers. Methods We validated Palm PCR ™ for detection of common ulcerative skin pathogens using ATCC ® reference and clinical strains of Leishmania , mycobacteria, and fungi in the lab and field. Amplified products were Sanger sequenced. Performance characteristics were calculated using conventional PCR as a reference standard. Results Palm PCR ™ detected 100% of ATCC ® strains of Leishmania , fungi, and mycobacteria, with sensitivity and specificity of 90% and 91.7%, respectively. In the field, the sensitivity for detection of Leishmania in patients with suspected CL was 100%. In 61% of CL patients, co-colonization with genera such as Malassezia , Aspergillus , Candida , and Cladosporium was detected. In 50% of CL patients with an inflammatory (secondarily infected) phenotype, detected fungal species had known associations with human cutaneous disease. Conclusions Palm PCR ™ performs comparably to conventional PCR for detection of Leishmania , fungi, and mycobacteria. This work has implications for the diagnostic approach to tropical ulcers, and has the potential to improve field detection of ulcerative pathogens in resource constrained areas.