Clinical Evaluation of a Loop-Mediated Amplification Kit for Diagnosis of Imported Malaria

摘要: (See the major article by Hopkins et al on pages 645–57.) Since 1880s, standard diagnostic test for malaria has been microscopic examination of peripheral blood smears [1–3]. The development rapid antigen-detection tests (RDTs) in early 1990s improved diagnosis Plasmodium infection malaria-endemic countries and targeting treatment [4, 5]. In where is not endemic, imported cases travelers can be mistaken nonspecific viral illness [6, 7], causing delay some progression to severe death [8–11], RDTs have capacity nonspecialist health workers [12–15]. While expert microscopy are considered adequate case management populations [16], there growing interest “improvements point-of-care management, new capable identifying very low parasite densities asymptomatic individuals field settings mass screening treatment” [17]. Polymerase chain reaction (PCR), its most sensitive form, a limit detection as 50 parasites per milliliter [18, 19], although results take 10–16 hours, whereas less but routinely produces 60 minutes. Real-time quantitative PCR (qPCR) reliably detect DNA within 3–5 hours sample receipt also than nested [20]. Recent studies show that loop-mediated amplification (LAMP) assays malaria, which deploy isothermal molecular closed system with visual readout, deliver PCR-level accuracy little more 1 hour, lower laboratory requirements [21–23]. To date, LAMP available format suited routine clinic. A clinically validated, CE-marked assay would an attractive alternative RDT or endemic. A kit developed test, after CE marking it was released commercially mid-2012. This comprises disposable extraction device tubes containing vacuum-dried temperature-stable components. We investigated this study sequential samples from suspected received specialist parasitology London, United Kingdom, over first 7 months 2011. Primary films. An established deployed reference [18]. Diagnostic superior similar additional benefits reduced time ease operation.