title: Clinical evaluation of a loop-mediated amplification kit for diagnosis of imported malaria.
abstract: BACKGROUND
  Diagnosis of malaria relies on parasite detection by microscopy or antigen detection; both fail to detect low-density infections. New tests providing rapid, sensitive diagnosis with minimal need for training would enhance both malaria diagnosis and malaria control activities. We determined the diagnostic accuracy of a new loop-mediated amplification (LAMP) kit in febrile returned travelers.
  
  
  METHODS
  The kit was evaluated in sequential blood samples from returned travelers sent for pathogen testing to a specialist parasitology laboratory. Microscopy was performed, and then malaria LAMP was performed using Plasmodium genus and Plasmodium falciparum-specific tests in parallel. Nested polymerase chain reaction (PCR) was performed on all samples as the reference standard. Primary outcome measures for diagnostic accuracy were sensitivity and specificity of LAMP results, compared with those of nested PCR.
  
  
  RESULTS
  A total of 705 samples were tested in the primary analysis. Sensitivity and specificity were 98.4% and 98.1%, respectively, for the LAMP P. falciparum primers and 97.0% and 99.2%, respectively, for the Plasmodium genus primers. Post hoc repeat PCR analysis of all 15 tests with discrepant results resolved 4 results in favor of LAMP, suggesting that the primary analysis had underestimated diagnostic accuracy.
  
  
  CONCLUSIONS
  Malaria LAMP had a diagnostic accuracy similar to that of nested PCR, with a greatly reduced time to result, and was superior to expert microscopy.
authors: Department of Clinical Parasitology, Walk-in Clinic, Hospital for Tropical Diseases, University London Colleges NHS Foundation Trust, Mortimer Market, London WC1E 6JB, UK.
authors: Spencer D
authors: SD
authors: Polley
authors: Iveth J
authors: IJ
authors: González
authors: Deqa
authors: D
authors: Mohamed
authors: Rosemarie
authors: R
authors: Daly
authors: Kathy
authors: K
authors: Bowers
authors: Julie
authors: J
authors: Watson
authors: Emma
authors: E
authors: Mewse
authors: Margaret
authors: M
authors: Armstrong
authors: Christen
authors: C
authors: Gray
authors: Mark D
authors: MD
authors: Perkins
authors: David
authors: D
authors: Bell
authors: Hidetoshi
authors: H
authors: Kanda
authors: Norihiro
authors: N
authors: Tomita
authors: Yutaka
authors: Y
authors: Kubota
authors: Yasuyoshi
authors: Y
authors: Mori
authors: Peter L
authors: PL
authors: Chiodini
authors: Colin J
authors: CJ
authors: Sutherland
mesh_terms: D000328:Adult; D001769:Blood / Q000469:parasitology; D005260:Female; D006801:Humans; D016778:Malaria, Falciparum / Q000175:diagnosis*; D008297:Male; D008853:Microscopy; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D010274:Parasitology / Q000379:methods*; D010963:Plasmodium falciparum / Q000235:genetics / Q000302:isolation & purification*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D057236:Travel Medicine / Q000379:methods*
chemical_list: D011933:Reagent Kits, Diagnostic
keywords: LAMP; diagnostics; malaria
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