Clinical accuracy of malaria loop-mediated isothermal amplification assay as a stand-alone screening tool at a non-endemic Northern California regional health system

Cristina Costales, Mora Jana Broadhurst, Indre Budvytiene, Niaz Banaei

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

Malaria is critical to rule out in febrile returned travelers. We evaluated the performance of the Alethia Malaria loop-mediated isothermal amplification (LAMP) assay for rapid one-time malaria screening using nucleic acid amplification testing. Retrospective analysis of 51 archival blood specimens collected from 32 patients with malaria and 25 uninfected controls showed Malaria LAMP assay to have sensitivity of 100% (95% CI 93.0–100) and specificity of 100% (95% CI 86.7–100) using blood smear microscopy as the reference standard. Prospective evaluation of Malaria LAMP as a single screening test in 205 patients identified 4 (1.95%) positives which were all confirmed as Plasmodium falciparum by PCR, with parasitemia quantified as <0.1% (n = 2), 1.0% (n = 1), and 4.6% (n = 1). Alternative diagnoses were found in 129 of 201 (64.2%) of LAMP-negative patients, and no patient was subsequently diagnosed with malaria. The Malaria LAMP offers a sensitive and rapid stand-alone screening alternative in non-endemic settings.

Original languageEnglish (US)
Article number115680
JournalDiagnostic Microbiology and Infectious Disease
Volume103
Issue number2
DOIs
StatePublished - Jun 2022

Keywords

  • Loop-mediated isothermal amplification
  • Malaria diagnosis
  • Nucleic acid amplification testing
  • Plasmodium

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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