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Diagnos Dengue Card

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INTENDED USE

Diagnos Dengue card is a rapid solid phase Immuno-chromatographic test for the qualitative differential detection of IgM and IgG antibodies to dengue virus in Human serum /Plasma. This test is for in vitro diagnostic use only and is intended as an aid in for presumptive diagnosis between primary and secondary dengue infection.

SALIENT FEATURES

  • Rapid, visual and qualitative Immunoassay.
  • Differential detection of IgM & IgG Antibodies.
  • Detection of all the 4 Dengue serotypes (DEN-1, DEN-2, DEN-3 and DEN-4).
  • See through device for easy interpretation of results.
  • Unique sample processing method ensures highest accuracy in results.
  • Results with in 20 minutes.
  • Longer shelf life : 24 months at 2-30°C.
  • Convenient pack size : 10 tests
  • Evaluated by Haffkine’s Institute Mumbai-
    Sensitivity-91% and Specificity- 98%.
Diagnos Dengue card test is based on immunochromatographic test principle for the differential detection of Dengue IgM/IgG antibodies.
Dengue IgM/IgG test device contains three lines; “C” (Control line), “M”(IgM test line) & “G”(IgG test line).IgM test line is coated with anti-human IgM and IgG test line is coated with anti-human IgG.When a sample is added to the device,IgG and IgM antibodies in the sample react with red particles coated with Dengue proteins. As this sample/particle mixture migrates along the length of the test, the anti-dengue IgG or IgM antibody particle complex is captured by the relevant IgG and /or IgM test bands located in the test device window causing a pale to dark red band to form at the IgG or IgM Region of the test device window. The intensity of the test bands in the device will vary depending upon the amount of antigen /antibody present in the sample. The appreance of any pink/ red colour in a specific test region should be considered as positive for that particular antigen and/or antibody type (IgG or IgM). A red procedural control line should always develop in the test device window to indicate that the test has been performed properly.
ORDERING INFORMATION
PRODUCT NAME PACK SIZE CATALOG NO.
Diagnos DENGUE CARD 10 Test IR011010

PERFORMANCE CHARACTERISTICS (INTERNAL EVALUATION) OF Diagnos Dengue card
Sample TypeNo. Of Samples testedResult of Licenced testDiagnos Dengue card Results
Negative for Ab to Dengue 4030 4030 3910
Dengue IgM Positive120120114
Dengue IgG Positive797975

Sensitivity-95% and Specificity- 97%.


PRECISION:

Within-run(Intra assay) and between-run (Interassay) precisions have been determined by testing 10 replicates of five specimens: one negative. Two dengue IgM positive and Two Dengue IgG positive. The C.V (%) of all the five samples were within 10 % of the time.

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