Dengue Virus NS1 Antigen Rapid Test Kit (Immunochromatographic Assay)
【Intended Use】
This kit uses immunochromatography technology to qualitatively detect Dengue NS1 Antigen in human Serum, Plasma or Whole Blood samples. Suitable for Early Auxiliary Diagnosis and Screening of Dengue Virus Infection.
【About Dengue Virus】
Dengue virus belongs to a serotype subgroup of the genus Flavivirus in the family Flaviviridae. It is mainly transmitted by vector insects such as Aedes aegypti and Aedes albopictus, causing dengue fever and dengue hemorrhagic fever and dengue hemorrhagic fever with high morbidity and mortality. Leather shock synthesis.
It is widely distributed in tropical and subtropical regions of the world and causes up to 100 million infections every year. Typical dengue infection is characterized by sudden onset of fever, severe headache, myalgia, joint pain, and rash.
Dengue viruses are divided into 1 to 4 serotypes based on the antigenicity of the viral envelope protein E. The antigenicities of various types of viruses overlap, but there is no overlap with other antigenic groups of the Flaviviridae family. The antigenic determinants of viral envelope protein E can not only induce the host to produce protective neutralizing antibodies and hemagglutination-inhibiting antibodies, but may also be involved in the occurrence of dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS).
NS1 is one of the seven dengue virus non-structural proteins and is considered to be related to virus replication. NS1 exists as an immature form as a monomer but is rapidly processed in the endoplasmic reticulum to form a stable dimer. Small amounts of NS1 remain associated with intracellular organelles where cells are thought to be involved in viral replication. The remainder of NS1 was found to be either associated with the plasma membrane or secreted as a soluble hexamer. NS1 is critical for viral viability, but its exact biological function is unknown. Antibodies produced against NS1 during viral infection can cross-react with cell surface antigens on epithelial cells and platelets, which is implicated in the development of dengue fever.
【Detection Principle】
This reagent uses an immunochromatographic method to qualitatively detect dengue virus NS1 antigen in human serum, plasma or whole blood using a double-antibody sandwich method.
The detection area (T) of the nitrate membrane of the dengue NS1 antigen test strip is coated with anti-dengue virus NS1 protein monoclonal antibody, and the quality control area (C) is coated with anti-mouse IgG polyclonal antibody.
When the dengue NS1 antigen is contained in the product and the concentration is higher than the minimum detection limit, the anti-dengue virus NS1 protein monoclonal antibody labeled with colloidal gold combines with the dengue virus NS1 antigen in serum, plasma or whole blood to form a reaction complex.
Under the action of chromatography, the reaction complex moves forward along the woven fabric nitrate membrane, and combines with the pre-coated anti-dengue NS1 antigen monoclonal anti-radiation complex in the detection area (T) of the woven fabric nitrate membrane, and finally forms a complex. A red reaction line visible to the naked eye, the result is positive at this time; on the contrary, when the sample does not contain dengue NS1 antigen or the concentration is lower than the minimum detection limit, no red reaction line appears in the detection area (T), and the result is Negative.
Regardless of whether the sample contains NS1 antigen, a red reaction line will be formed in the quality control area (C).
【Product Features】
1. The membrane width of the kit is not less than 3.0mm, and the liquid migration speed is not less than 10mm/min.
2. Minimum detection limit
The reagent has a good response to all 4 serotypes of dengue fever.
The minimum detection amount of dengue virus type I is 8.3*102 TCID50/mL;
The minimum detection amount of dengue virus type II is 8.3*103 TCID50/mL;
The minimum detection amount of dengue virus type III is 1.5*103 TCID50/mL;
The minimum detection amount of dengue virus type IV is 3.0*103 TCID50/mL;
3. Repeatability
The repeatability reference product is tested 10 times, and the test results are consistent with the known results of the reference product, and the color is uniform.
4. Cross-reaction
This reagent does not cross-react with malaria, hepatitis B, hepatitis C, worm disease, cold, measles, and influenza.
【Package Specification】
Components | Specification | |||
| 1 test/kit | 2 tests/kit | 5 tests/kit | 20 tests/kit | |
| Test card | 1pc | 2pcs | 5pcs | 20pcs |
| Pipette | 1pc | 2pcs | 5pcs | 20pcs |
| Blood collection needle | 1pc | 2pcs | 5pcs | 20pcs |
| Dilution solution | 1pc | 2pcs | 5pcs | 20pcs |
| Waste bag | 1pc | 1pc | 1pc | 1pc |
| User manual | 1pc | 1pc | 1pc | 1pc |
【Testing Process】
【Interpretation of Results】
NS1 Positive: If the Control line(C)andTest line (T) visible simultaneously,the test result is positive.The judgment of positive result is not related tothe strength of the line color.
NS1 Negative: If only the C-line appears,the test result is negative.
Invalid: If the C-line is not visible,the test is invalid.Re-test with new test kit and blood sample.
Note:
*There is no linear relationship between the concentration of NS1 antigen and the strength of the T-line.
*A negative result do not exclude thepossibility of dengue virus infection.More specific diagnostic method should be selected based on clinical manifestations to confirm infection.
【Qualifications】
| CE Certification-AEMPS Registration Letter | CE证书-AEMPS注册信 |
| CE Certification-AEMPS Registration Prove | CE证书-AEMPS网站注册证明 |
| CE Certification-EC Declaration of Conformity | CE证书-EC符合性声明 |
| CE Certification-EAR Certification of Notification | CE证书-EAR证明信 |
| ISO 13485 Certificate | ISO 13485证书 |
| ISO 9001 Certificate | ISO 9001证书 |
| ISO 14001 Certificate | 环境管理体系认证证书 |
| IPMS Certificate | 知识产权管理体系认证证书 |
| ISO 45001 Certificate | 职业健康安全管理体系认证证书 |
Note: This product is not available for the US market.
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