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- Title
Portable smartphone-based molecular test for rapid detection of Leishmania spp.
- Authors
Kobialka, Rea Maja; Ceruti, Arianna; Roy, Madhurima; Roy, Sutopa; Chowdhury, Rajashree; Ghosh, Prakash; Hossain, Faria; Weidmann, Manfred; Graf, Elena; Bueno Alvarez, Jesus; Moreno, Javier; Truyen, Uwe; Mondal, Dinesh; Chatterjee, Mitali; Abd El Wahed, Ahmed
- Abstract
Purpose: Leishmaniasis, caused by the parasite of the genus Leishmania, is a neglected tropical disease which is endemic in more than 60 countries. In South-East Asia, Brazil, and East Africa, it mainly occurs as kala-azar (visceral leishmaniasis, VL), and subsequently as post kala-azar dermal leishmaniasis (PKDL) in a smaller portion of cases. As stated per WHO roadmap, accessibility to accurate diagnostic methods is an essential step to achieve elimination. This study aimed to test the accuracy of a portable minoo device, a small battery-driven, multi-use fluorimeter operating with isothermal technology for molecular diagnosis of VL and PKDL. Methods: Fluorescence data measured by the device within 20 min are reported back to the mobile application (or app) via Bluetooth and onward via the internet to a backend. This allows anonymous analysis and storage of the test data. The test result is immediately returned to the app displaying it to the user. Results: The limit of detection was 11.2 genome copies (95% CI) as determined by screening a tenfold dilution range of whole Leishmania donovani genomes using isothermal recombinase polymerase amplification (RPA). Pathogens considered for differential diagnosis were tested and no cross-reactivity was observed. For its diagnostic performance, DNA extracted from 170 VL and PKDL cases, comprising peripheral blood samples (VL, n = 96) and skin biopsies (PKDL, n = 74) from India (n = 108) and Bangladesh (n = 62), was screened. Clinical sensitivity and specificity were 88% and 91%, respectively. Conclusion: Minoo devices can offer a convenient, cheaper alternative to other molecular diagnostics. Its easy handling makes it ideal for use in low-resource settings to identify parasite burden.
- Subjects
BANGLADESH; BRAZIL; LEISHMANIASIS diagnosis; MOBILE apps; TROPICAL medicine; SMARTPHONES; DIFFERENTIAL diagnosis; INTERNET; DESCRIPTIVE statistics; LEISHMANIA; NEGLECTED diseases; CONFIDENCE intervals; MOLECULAR diagnosis; GENOMES; SENSITIVITY &; specificity (Statistics); NUCLEIC acid amplification techniques
- Publication
Infection, 2024, Vol 52, Issue 4, p1315
- ISSN
0300-8126
- Publication type
Article
- DOI
10.1007/s15010-024-02179-z