Evaluation of the performance of a highly-sensitive rapid diagnostic test (hsRDT) versus conventional RDT in reactive case detection of malaria infections in Battambang and Paili

The primary objective of this study is to assess the performance of the new hsRDT developed by Alere, compared with PCR as the gold standard, in detecting malaria infections associated with index cases identified through passive surveillance in a low transmission area. There is currently one commercially available hsRDT marketed by Abbott (Alere™ Malaria Ag Pf Ultra-Sensitive test) (“Alere Pf hsRDT”) designed to detect the P. falciparum-specific antigen, HRP2, in a format similar to the current conventional RDTs resulting in a limit of detection (LOD) of HRP2 of about 80 pg/mL compared to conventional RDTs with a LOD of 800-1000 pg/mL. Another HRP2 hsRDT developed by Global Good (“GG Pf hsRDT”) with an even lower LOD of about 10–25pg/mL is also available for external testing. Carestart has also developed a HRP2/pan LDH hsRDT (“Carestart combo hsRDT”) which is 10-fold more sensitive than their current RDT for vivax malaria.

The current tools such as microscopy or cRDT are insufficient in identifying low density malaria infections and missing them may pose a great impediment to achieving malaria elimination. In addition to its higher sensitivity, hsRDTs are a point-of-care test, therefore it is convenient for large-scale testing and feasible to deploy in resource-limited settings. These tools are urgently needed in the current surveillance activities in Cambodia as they prepare for the elimination phase. Findings from the proposed study will also contribute useful data in the development of national SOPs for ACD.

Asymptomatic Reservoir
Diagnostics

Nov 2018 — Aug 2020

$300,000

Cambodia

Highly sensitive point-of-care diagnostics for P. falciparum