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- W4381280023 abstract "Abstract Introduction: Light microscopy and rapid diagnostic tests (RDT) have long been the recommended diagnostic methods for malaria. However, in recent years, LAMP techniques have been shown to offer superior diagnostic performance, in particular concerning low-grade parasitaemia, by delivering higher sensitivity and specificity with low laboratory capacity requirements in little more than an hour. In this study we assessed the diagnostic performance of two Loop-mediated Isothermal Amplification (LAMP) kits head-to-head, compared to highly sensitive quantitative real time PCR (qPCR), in a non-endemic setting. Methods: In this retrospective validation study two LAMP kits; Alethia® illumigene Malaria kit and HumaTurb Loopamp™ Malaria Pan Detection (PDT) kit, were evaluated head-to-head for detection of Plasmodium -DNA in 133 biobanked blood samples from suspected malaria cases at the Clinical Microbiology Laboratory of Region Skåne, Sweden to determine their diagnostic performance compared to qPCR. Results: Of the 133 samples tested, qPCR detected Plasmodium DNA in 41 samples (the true positives), and the two LAMP methods detected 41 and 37 of those, respectively. The results from the HumaTurb Loopamp™ Malaria PDT kit were in complete congruence with the qPCR, with a sensitivity of 100% (95% CI 91.40 - 100%) and specificity of 100% (95% CI 96.07 – 100%); and the PPV and NPV were both 100%. The Alethia® illumigene Malaria kit had a sensitivity of 90.24% (95% CI 76.87 – 97.28) and a specificity of 95.65% (95% CI 89.24 – 98.80) as compared to qPCR. The PPV was 90.31% (95% CI 78.06-96.07) and the NPV was 95.62% (95%CI 89.58-98.23) with the malaria positivity rate of 30.8 % in the study material. This performance would give a PPV of 69.75% (95% CI 46.80 – 85.81) and NPV 98.88% (97.20 – 99.56) in a situation where samples tested had a 10% positivity rate, which more accurately resembles the situation in Skåne. Conclusions: This head-to-head comparison showed superior performance of the HumaTurb Loopamp™ Malaria PDT kit compared to the Alethia® illumigene Malaria kit for detection of malaria." @default.
- W4381280023 created "2023-06-21" @default.
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- W4381280023 date "2023-05-30" @default.
- W4381280023 modified "2023-10-02" @default.
- W4381280023 title "Head-to-head comparison of two loop-mediated isothermal amplification (LAMP) kits for diagnosis of malaria in a non-endemic setting" @default.
- W4381280023 doi "https://doi.org/10.21203/rs.3.rs-2984503/v1" @default.
- W4381280023 hasPublicationYear "2023" @default.
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