02872nas a2200373   4500000000100000008004100001260001200042653002900054653002400083653003200107653002300139653004000162653002700202100001500229700001300244700001000257700001000267700001600277700001200293700001400305700001500319700001100334700001400345700001300359700001300372700001300385700001700398700001200415245008400427856007300511300000900584520189100593022001402484       2024                            d  c02/202410aIsothermal amplification10aLeishmania donovani10aNeglected Tropical Diseases10aPoint-of-need test10aPost kala-azar dermal leishmaniasis10aVisceral Leishmaniasis1 aKobialka R1 aCeruti A1 aRoy M1 aRoy S1 aChowdhury R1 aGhosh P1 aHossain F1 aWeidmann M1 aGraf E1 aAlvarez J1 aMoreno J1 aTruyen U1 aMondal D1 aChatterjee M1 aWahed A00aPortable smartphone-based molecular test for rapid detection of Leishmania spp.  uhttps://link.springer.com/content/pdf/10.1007/s15010-024-02179-z.pdf  a1-103 a<p><strong>Purpose: </strong>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.</p>

<p><strong>Methods: </strong>Fluorescence data measured by the device within 20&nbsp;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.</p>

<p><strong>Results: </strong>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.</p>

<p><strong>Conclusion: </strong>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.</p>
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