Abstract
The global incidence of dengue has increased significantly in recent decades, resulting in a large public health burden in tropical and subtropical countries. Dengue rapid diagnostic tests (RDTs) can provide accurate, rapid accessible diagnosis for patient management and may be easily used by health workers in rural areas. However, in dengue-endemic areas, ambient temperatures are often higher than manufacturer's recommendation. We therefore evaluated the effect of high temperature over time on the performance of one commonly used dengue RDT, the Standard Diagnostics Bioline Dengue Duo. RDTs were kept in five different conditions (at 4°C, 35°C, 45°C, 60°C, and at fluctuant ambient temperatures in a free-standing hut) for between 2 days and 2 years in the Lao People's Democratic Republic (PDR). RDTs were tested with four control sera (negative, dengue nonstructural protein 1 [NS1], anti-dengue immunoglobulin [Ig] M, and anti-dengue IgG positive). The RDTs had 100% consistency over the 2-year study, despite high temperatures, including in the hut in which temperatures exceeded the manufacturer's recommendations for 29% of time points. These data suggest that the diagnostic accuracy of the SD Bioline Dengue Duo RDT remains stable even after long-term storage at high temperatures. Therefore, use at such ambient temperatures in tropical areas should not jeopardize the dengue diagnostic outcome.
Highlights
The global incidence of dengue has increased significantly in recent decades
The test is easy to perform —three drops and 10 mL of sample are applied into the two small wells on nonstructural protein 1 (NS1) and Ab cassettes, respectively
To prepare IgG control serum, 1/2 dilution of an anti-dengue IgG was tested by rapid diagnostic tests (RDTs) and the results presented in Figure 3C showed that the dilution 1/2 was negative by RDT, which means that the non-diluted serum was already at limit of detection so was directly used as IgG control serum
Summary
Over 2.5 billion people, nearly half of the world’s population, are at risk for contracting dengue, and 70% of those live in southeast Asia and the western Pacific.[1] World Health Organization (WHO) estimates there may be 50–100 million dengue infections worldwide every year with an estimated 500,000 people requiring hospitalization with a 2.5% mortality.[1] Using a cartographic approach, Bhatt and others[2] estimated 390 million dengue infections per year, with only 96 million being symptomatic. The pathogen has spread to new areas and is endemic in more than 100 countries in Africa, the Americas, the eastern Mediterranean, southeast Asia, and the western Pacific.[1] The presentation of the infection ranges from asymptomatic or flu-like illness to, occasionally, severe dengue and even death
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