Accurately Diagnose Severe Dengue

Problem Statement

Currently no early method of detecting dengue in patients

Currently, only accurate early diagnosis of knowing if you have dengue is using blood samples to be analyzed at the labs. The usual scenario is waiting for days not knowing if the patient has dengue. Day 2 slight temperature, patients will see a doctor and most cases paracetamol will be prescribed. Day 3-4 significant increased temperature, patients will see a doctor again and most probably blood samples sent to labs. Day 5-6 blood palette count dropped significantly, by then patients are in a critical stage and to be rushed to the hospital. Hence the challenge is to detect the presence of dengue in patients as early as Day 4 rather than wait 3-4 later.
 

Currently, severe dengue diagnosis relies on careful clinical assessment for timely and appropriate management to prevent fatalities. Continuous patient monitoring often leads to prolonged hospitalisation which increases the cost of hospitalisation and insufficient hospital beds during outbreaks. The annual economic burden due to dengue in Malaysia is ~USD128 million and a high disease burden at 8324 disability-adjusted life-years (DALYs). Globally, 3.6 billion people at risk for dengue. In Malaysia, 80,615 dengue cases and 147 fatalities were reported in 2018 and with a continuous rise this year, the severe dengue test kit marketability is high. Unnecessary hospitalisation, fatalities and socioeconomic burden from loss of productivity and high hospitalisation costs.

Solution Statement

SDen-Detect, severe dengue diagnostic kit.

Our solution is UM patented SDen-Detect. SDen-Detect is a severe dengue in vitro diagnostic kit. It is an enzyme-linked immunoassay that quantitatively measures the level of a macrophage scavenger receptor in serum.  This measurement level will show significant elevation in severe dengue patients compared to dengue fever (Patent No. MY168633). The biomarker levels are significantly elevated in severe dengue patients compared to dengue fever including dengue with and without warning signs.
 

SDen-Detect has been awarded with ISO13485 certification in 2019. This certification is expected to facilitate licensing approval by Medical Device Authority. Features:
 

• First and only severe dengue diagnostic kit
• Tested to differentiate severe dengue from dengue through a multicenter trial in Malaysia (AUC value=0.781, p<0.001)
• Sensitivity is 72% and specificity is 80%
• Early detection of severe dengue - from day 4 of fever onset
• Diagnostic threshold and interpretation are provided
• Complete ready to use kit
• Colorimetric detection