Description
item | value |
Place of Origin | China |
Brand Name | testsealabs |
Model Number | Dengue Ag NS1 Test Cassette IgM/IgG test |
Power Source | Manual |
Warranty | 2 years |
After-sale Service | Online technical support |
Power Supply Mode | Plug-in |
Material | Plastic |
Shelf Life | 2 years |
Quality Certification | ISO9001/ ISO13485 CE |
Instrument classification | Class II |
Safety standard | GB15979-2002 |
Intended Use
The One Step Dengue IgG/IgM Test is a rapid chromatographic immunoassay for the qualitative
detection of antibodies (IgG and IgM) to dengue virus in serum or plasma to aid in the diagnosis
of Dengue viral infection
Detection for: Antibodies (IgG and IgM) to Dengue virus in whole blood, serum, or plasma.
Specimen volume: Serum or Plasma Specimen:5μL
Venipuncture or Fingerstick Whole Blood Specimen:10pl
Reading time: 10 minutes
Relative sensitivity: 95.7%(95%CI*:88.0%~99.1%);
Relative specificity: 99.9%(95% CI *:99.1%~100.0%);
Accuracy: 99.3%(95% CI *:97.9%~99.8%)
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 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 in whole blood. serum or plasma specimens only Neither the quantitative value nor the rate of increase in Dengue antibody concentration can be determined by this qualitative test.
2.Denque IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) will only indicate the presence of Dengue antibodies in the specimen and should not be used as the sole criteria for the diagnosis of Dengue
3.In the early onset of fever. anti-Dengue lgM concentrations may be below detectable levels. For primary infection, an lgM antibody-capture enzyme linked immunosorbent assay(MAC-ELISA)showed that 80% of the Dengue patients tested exhibited detectable levels of lgM antibody by the fifth day after infection, and 99% of the patients tested lgM 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 lgM and a high molar fraction of lag that is broadly reactive to flaviviruses characterize the antibodies. 5 The lgM signal may be faint and the cross reaction in the region of lgG line may appear.
4.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
5.The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy
6. Results from immunosuppressed patients should be interpreted with caution
7.As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician
8.lf the test result is negative and clinical symptoms persist. additional testing using other clinical methods is recommended. A negative result does no at any time preclude the possibility of Dengue infection.1. who are we?We are based in Zhejiang, China, start from 2015,sell to South Asia(40.00%),South America(10.00%),Africa(10.00%),MidEast(10.00%),Eastern Asia(10.00%),Western Europe(10.00%),Southern Europe(10.00%). There are total about 201-300 people in ouroffice.2. how can we guarantee quality?Always a pre-production sample before mass production;Always final Inspection before shipment;3.what can you buy from us?infectiouse disease test,drug of abuse test,tumor marker test,tumor markers test,cardiac marker test4. why should you buy from us not from other suppliers?high-tech enterprise , specialized in the research, development productio and sales of raw materials, more than 2000 square meters, including 400 square meters of GMP100 000-level purification workshop , follow with ISO5. what services can we provide?Accepted Delivery Terms: FOB,CFR,CIF,EXW,FCA,DDP,DDU;Accepted Payment Currency:USD,EUR,CNY;Accepted Payment Type: T/T,Credit Card,PayPal,Western Union,Cash;Language Spoken:English,Chinese,Japanes
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