| Format |
Cassette |
Package |
Cartons |
| Specimen |
WB/S/P |
Certificate |
CE ISO 13485 |
| Storage Temperature |
4-30°C |
Pack |
40T |
| Test Time |
15 min |
Shelf life |
2 years |
| Sensitivity |
>99% |
OEM |
Available |
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.
LIMITATIONS
1. Dengue IgG/IgM/NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of Dengue antibodies and NS1 antigen in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in Dengue antibody and NS1 antigen concentration can be determined by this qualitative test.
2. In the early onset of fever, anti-Dengue IgM concentrations may be below detectable levels. For primary infection, an IgM antibody-capture enzyme linked immunosorbent assay(MAC-ELISA) showed that 80% of the Dengue patients tested exhibited detectable levels of IgM antibody by the fifth day after infection, and 99% of the patients tested IgM positive by day 10.lt is recommended that patients be tested within this time. For the secondary Infection, a low molar fraction of anti- Dengue IgM and a high molar fraction of IgG that is broadly reactive to flavivirus characterize the antibodies. 5 The IgM signal may be faint and the cross reaction in the region of IgG line may appear.
3.Serological cross-reactivity across the flavivirus group (Dengue 1,2,3 & 4, St. Louis encephalitis, West Nile virus, Japanese encephalitis and yellow fever viruses) is common.6,7,8 Positive results should be confirmed by other means.
4.The continued presence or absence of antibodies and NS1 antigen cannot be used to determine the success or failure of therapy.
5.As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
6.lf the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of Dengue infection
Audited Supplier 
){kind=link}
){kind=link}