Disease condition and impact on patients: Dengue fever occurs in a broad spectrum of clinical presentations, often with unpredictable clinical evolution and outcome. While most patients recover after a self-limiting, non-severe clinical course, a small proportion progress to severe disease, characterized mainly by plasma leakage with or without haemorrhage. Intravenous rehydration is the therapy of choice and can reduce the case fatality rate to < 1% of severe cases. The characteristics of patients with dengue that progresses from non-severe to severe are difficult to define. This is an important concern, as appropriate treatment may prevent more severe clinical illness. Does the test address a medical need? Efficient, accurate diagnosis of dengue is of primary importance for clinical care (for early detection of severe cases, case confirmation and differential diagnosis from other infectious diseases), surveillance, outbreak control, pathogenesis, academic research, vaccine development and clinical trials. In relation to the EDL, antibody and antigen tests are essential for case management and surveillance. During the early stages of the disease, detection of antigens can be used to diagnose an infection, while, at the end of the acute phase of infection, serology is the method of choice. The choice of the assay for diagnosis depends on the time of sample collection and the purpose of testing (1). As for other Aedes-borne arboviruses, viraemia is present during the acute phase, and 90% of cases of primary and secondary dengue fever can be identified accurately from a single serum specimen collected during the first 10 days of illness, with DENV-1-4 real-time RT-PCR plus IgM ELISA or NS1 antigen ELISA (2, 3). Purpose of testing: In surveillance, testing is used to alert health authorities to the possible emergence of an outbreak. Testing is usually done with high- throughput immunoassays for IgM antibodies. While they are not ideal markers of active infection (which can persist for 5–6 months), they can be used as the basis for an outbreak alert when an increase in IgM-positive cases is reported or unusually high IgM titres are observed. EIA can be used to identify the cause of an outbreak. The tests must be highly sensitive and specific for detecting DENV directly, by isolation of the virus or its nucleic acid or antigen in the acute phase of infection. Infection can also be diagnosed retrospectively from seroconversion of IgM or a fourfold rise in IgG between samples collected in the acute and convalescent stages > 14 days apart. A combination of IgM and either NAAT or antigen detection tests extends the window of detection of acute infection and was effective in a retrospective study of DENV infections. In surveys, EIA can be used to assess the extent of an outbreak, inform control strategies and identify hotspots. High-throughput, ideally highly specific, tests that can be used in various populations are required. In research, the tests are used to assess the impact of control interventions and increase understanding of the pathogen and its pathogenesis. How the test is used: The DENV IVD can be used at three levels of a health system: primary care centres, district centres and reference centres. A single test is sufficient if a sample is taken within the defined time. As dengue fever is easily confused with other illnesses, particularly in non-epidemic situations, the DENV IVD can also be used for differential diagnosis.

Prevalence: Dengue fever is the most rapidly spreading mosquito-borne viral disease in the world. Its incidence has increased by 30 times in the past 50 years, and it is spreading to other countries; during the current decade, it has spread from urban to rural settings. An estimated 50 million cases of dengue infection occur annually among the 2.5 billion people who live in countries endemic for the disease. World Health Assembly resolution WHA55.17 in 2002 urged WHO and its Member States to make a greater commitment to controlling dengue fever. World Health Assembly resolution WHA58.3 on revision of the IHR gives dengue fever as an example of a disease that may constitute a public health emergency of international concern (PHEIC), with implications for health security due to disruption and rapid epidemic spread beyond national borders. Socioeconomic impact The estimated global cost of the prevention and control of dengue fever is at almost US$ 9 billion per year (4), and WHO has estimated that more than 3 billion DALYs are lost due to dengue fever.

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If only a subset of patients is tested during an outbreak or for confirmation in endemic periods, the impact on overall budgets will be small.

Consent is required to obtain a serum sample. Dengue fever predominantly affects populations living in poverty, and access to high-quality diagnostics can reduce the burden and improve equity.