Poster Presentation First Malaria World Congress 2018

The Search for a Thermostable Rapid Diagnostic Test (RDT) Positive Control for Military and Clinical Trial Use in Malaria Endemic Countries (#447)

Patricia Lee 1 , Susan Leed , Lisa Read , David Donkin , Margarita Vidal , Eric Kim , Sophia Kish , Richard Sciotti , Daniel Erwin , Jangwoo Lee , Scott Seronello , Chad Black , Mara Kreishman-Deitrick , Mark Hickman
  1. Walter Reed Army Institute of Research, Silver Spring, MD, United States

In 2016, malaria was responsible for 212 million infections resulting in 429 thousand deaths. Malaria rapid diagnostic tests (RDTs) have become a readily available method to diagnose malaria blood stage infections and are comparable to microscopy when test kits are functioning properly as determined by quality controls. Most malaria endemic countries have annual temperatures that can reach up to 40°C and 90% humidity, and currently available RDT controls can become compromised when stored under these austere conditions. BinaxNOW, the only RDT that is FDA approved for use in the United States, uses a positive control that requires cold chain storage. For Soldiers who are deployed to malaria endemic countries, or for clinical trials taking place in these locations, limited electricity and refrigeration renders this positive control unusable. There is a great need to create a reliable, thermostable positive control to accurately diagnose malaria in field conditions. In this study, two approaches were used to generate a positive control that is stable under high humidity and temperature conditions. Samples were first created using parasitized blood matrix (pBM) in combination with preservatives and differing drying techniques. The second approach relied upon malarial proteins in combination with stabilizing agents to prepare samples. For both tests, samples were stored long term, under extreme temperature and humidity conditions, and were reconstituted for testing on BinaxNOW and SD Bioline RDTs. Results from the pBM test were unreliable, as issues arose with reconstituting the samples within three months of long term storage. In contrast, results from the stabilized malarial protein study proved to be very promising for use as a thermostable positive control. A thermostable positive control that can be used in field settings will increase the utility of currently available RDT kits and may ultimately eliminate the dependence on microscopy to confirm malaria diagnostic results.