Dengue IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) Diagnostic Cassette CE Approved

Dengue IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) Diagnostic Cassette CE Approved
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Product Details

Dengue IgG/IgM Rapid Test Device

1.Product Description

(1)The Dengue IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid test that utilizes a combination of Dengue antigen coated colored particles for the detection of IgG and IgM Dengue antibodies in human whole blood, serum, or plasma. 

2.Clinical Sensitivity, Specificity and Accuracy

(1)For the primary and secondary infection, the overall sensitivity is 95.8%, the overall specificity is >99.0% and the overall accuracy is 99.3%.

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3.Materials Provided

(1)Test devices    

(2)Droppers  

(3)Buffer 

(4)Package insert

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4.Dengue Rapid Test Device vs. ELISA


      Dengue Infection              Result         IgM                        IgG



      Primary Infection

              Positive         14                         0
              Negative          3                        17
                Total         17                        17
     Relative Sensitivity        82.4%                         0%



   Secondary Infection

               Positive         39                        55
               Negative         16                         0
                 Total         55                        55
     Relative Sensitivity        70.9%                       >99.0%



Non-Dengue Infection

               Positive          0                         0
               Negative        378                       378
                  Total        378                       378
     Relative Sensitivity      >99.0%                       >99.0%

For the primary and secondary infection, the overall sensitivity is 95.8%, the overall specificity is >99.0% and the overall accuracy is 99.3%

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