Intended Use
The One Step Dengue NS1 Ag Test is a rapid chromatographic immunoassay for the qualitative detection of dengue virus NS1 antigen in Whole Blood /Serum / Plasma to aid in the diagnosis of Dengue viral infection.
 
Summary
Dengue is transmitted by the bite of an Aedes mosquito infected with any one of the four dengue viruses. It occurs in tropical and sub-tropical areas of the world. Symptoms appear 3—14 days after the infective bite. Dengue fever is a febrile illness that affects infants, young children and adults. Dengue haemorrhagic fever (fever, abdominal pain, vomiting, bleeding) is a potentially lethal complication, affecting mainly children. Early clinical diagnosis and careful clinical management by experienced physicians and nurses increase survival of patients. One step Dengue NS1 Ag Test is a simple, visual qualitative test that detects dengue virus NS1 antigen in human Whole Blood/serum/plasma. The test is based on immunochromatography and can give a result within 15 minutes.  
 
Principle
The One Step Dengue NS1 Ag Test is a qualitative membrane strip based immunoassay for the detection of dengue virus NS1 antigen in Whole Blood /Serum / Plasma. In this test procedure, anti-Dengue NS1 antibody is immobilized in the test line region of the device. After a Whole Blood /Serum / Plasma specimen is placed in the specimen well, it reacts with anti-Dengue NS1 antibody coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized anti-Dengue NS1 antibody. If the specimen contains dengue virus NS1 antigen, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain dengue virus NS1 antigen, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred. 

Storage and Stability
·            Store as packaged in the sealed pouch at room temperature or refrigerated (4-30℃ or 40-86℉). The test device is stable through the expiration date printed on the sealed pouch.
·            The test must remain in the sealed pouch until use.
 
Additional Special Equipment
Materials Provided
Ÿ    Test devices                         Ÿ    Disposable specimen droppers   
Ÿ    Buffer (for whole blood only)           Ÿ    Package insert
Materials Required But Not Provided
Ÿ    Timer                                Ÿ    Centrifuge
Ÿ    Specimen collection containers        

25T/kits