Abstract

Lateral flow immunochromatographic rapid diagnostic tests (RDTs) are the primary form of medical diagnostic used for malaria in underdeveloped nations. Unfortunately, many of these tests do not detect asymptomatic malaria carriers. In order for eradication of the disease to be achieved, this problem must be solved. In this study, we demonstrate enhancement in the performance of six RDT brands when a simple sample-processing step is added to the front of the diagnostic process. Greater than a 4-fold RDT signal enhancement was observed as a result of the sample processing step. This lowered the limit of detection for RDT brands to submicroscopic parasitemias. For the best performing RDTs the limits of detection were found to be as low as 3 parasites per μL. Finally, through individual donor samples, the correlations between donor source, WHO panel detection scores and RDT signal intensities were explored.

Highlights

  • The advent of point of care (POC) diagnostic tools has changed the face of healthcare in nations affected by the ongoing spread of infectious diseases.[1]

  • As is shown in Electronic supplementary information (ESI) Fig. 1†, the control line was missing on random tests from one lot (Lot #10006) of ICT Pf (IPf) rapid diagnostic tests (RDTs)

  • These differing trends suggest a greater concentration of active antibody on the test line of IPf and ParaHit Total (PTot) RDTs, providing a wider linear range for calculations made through our algorithm

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Summary

Introduction

The advent of point of care (POC) diagnostic tools has changed the face of healthcare in nations affected by the ongoing spread of infectious diseases.[1]. Lateral ow immunochromatographic rapid diagnostic tests (RDTs), which operate much like a commercial pregnancy test, were developed to circumvent these challenges and bring affordable disease diagnosis to low-resource areas.[3,4] Several advantages of RDTs include low-cost, rapid time to result, and ease of use and interpretability.[5] these tests have been widely used in public health programs to aid with patient management, disease surveillance and treatment campaigns.[6] In 2006, over 16 million RDTs were delivered to underdeveloped nations for the detection of malaria alone.[3] These RDTs detect protein biomarkers of the malarial parasite. The predominant RDT biomarker indicative of Plasmodium falciparum infection is Histidine Rich Protein II (pfHRPII), while Plasmodium lactate dehydrogenase (pLDH) serves as a pan-speci c biomarker.[3]

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