Detection of Plasmodium spp. infection by the illumigene® Malaria assay compared to reference microscopy and real-time PCR.

5 years ago

Detection of Plasmodium spp. infection by the illumigene® Malaria assay compared to reference microscopy and real-time PCR.

Chan W, Chow B, Pillai DR, Church D, Rypien C

Malaria is one of the leading causes of infectious disease in returning travelers from the tropics. Diagnosis of malaria is typically performed by examination of Giemsa-stained thick and thin peripheral blood smears, which is time-consuming, labor-intensive and requires high levels of proficiency. Alternatively, loop-mediated isothermal amplification (LAMP) is a new molecular method, which is rapid, sensitive, and requires less capital equipment and technological training. We conducted a retrospective study comparing two formats of a commercial LAMP assay (Meridian illumigene® Malaria [M] and Malaria Plus [MP]) versus reference microscopy on archived blood specimens (n=140) obtained from unique returning travelers suspected of having malaria. Discrepant results were resolved by either repeat testing or a laboratory developed ultra-sensitive real-time PCR method. On initial testing, the Meridian illumigene® M and MP kits had a sensitivity of 97.3% [90.7 - 99.7%]and 100.0% [95.1- 100.0%] and specificity of 93.8% [95% CI; 84.8 - 98.3%] and 91.5% [81.3 - 97.2%], respectively, versus reference microscopy. We project a significant cost reduction in low prevalence non-endemic settings with LAMP-based malaria screening given the excellent negative predictive value achieved with LAMP compared to traditional rapid malaria tests.

Publisher URL: https://www.ncbi.nlm.nih.gov/pubmed/28768730

DOI: PubMed:28768730