Plasmodium vivax infections during pregnancy contribute to adverse outcomes, such as maternal and neonatal anaemia, as well as low birth weight. These infections are often submicroscopic and asymptomatic. However, diagnostic tools for P. vivax infections in non-reference laboratory settings are limited to light microscopy (LM) and rapid diagnostic tests (RDTs), even though studies using sensitive polymerase-chain reaction (PCR) techniques indicate that at least half of all infections in maternal venous blood are missed by LM or RDTs. As such, the development and validation of new sensitive tools for P. vivax detection remains a high priority.
This study assessed the performance of P. vivax loop-mediated isothermal amplification (LAMP) for the detection of malaria during pregnancy in Papua New Guinea (PNG). 986 pregnant women attending ante-natal care clinics in East New Britain Province were enrolled between August 2018-May 2019. Standard Carestart™ Malaria HRP2/pLDH (Pf/Pan) Combo tests, Pan/Pv loop-mediated isothermal amplification (LAMP), quantitative real-time PCR (qPCR) and ultra-sensitive qPCR (usqPCR) were performed and the performance of LAMP was evaluated, using qPCR and usqPCR as reference standards for all comparisons.
The prevalence of mixed and/or non-Pf Plasmodium spp. infections by RDT was 0.2%, whilst the prevalence of P. vivax infections by qPCR and usqPCR was 7% and 22%, respectively. Compared to qPCR, LAMP detected a much higher prevalence of P. vivax (12%) infections with a sensitivity and specificity of 83% and 93% respectively. Using the usqPCR as the reference, the sensitivity of LAMP decreased to 47%, but specificity remained high (98%). This study provides evidence that there is a high burden of P. vivax malaria infections that remain undetected and untreated in the first and second trimester of pregnancy and that LAMP is a promising field deployable tool for detecting harmful sub-clinical P. vivax malaria during pregnancy in PNG.