The Chembio DPP® Dengue NS1 Antigen Assay System is a single-use immunochromatographic test for the rapid detection of dengue virus non-structural protein 1 (NS1) antigen in human fingerstick whole blood, venous whole blood, serum, or plasma samples. The Chembio Dengue NS1 Ag Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with dengue virus (DENV) only in patients with clinical symptoms consistent with either dengue fever or dengue hemorrhagic fever. This test is intended to provide a preliminary result. Positive results must be confirmed by Plaque Reduction Neutralization Test (PRNT), isolation of virus, antigen detection in fixed tissues, RT-PCR, serological test-like haemaggulatination-inhibition test, or by using the current CDC guidelines for diagnosis of this disease.