Dengue Day 1 Test

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INTENDED USE

Dengue Day 1 Test is a rapid solid phase immuno-chromatographic test for the qualitative detection of Dengue NS1 Antigen and 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 the earlier diagnosis of Dengue infection & presumptive diagnosis between primary and secondary Dengue infection.

SALIENT FEATURES

  • First line testing kit for detecting dengue infection from day 1 using NS1 Antigen & differential detection of IgM & IgG Antibodies.
  • Diagnosis of both Primary & Secondary Infection.
  • Detects all 4 serotypes of Dengue virus
  • Detection of all the 4 Dengue serotypes (DEN-1, DEN-2, DEN-3 and DEN-4).
  • Highly Sensitive & Highly Specific
  • Long shelf life: 24 months at 2-30°C.
  • Convenient pack sizes: 10 Tests, 30 Tests & 50 Tests.
Dengue Day 1 test kit consists of two devices: one device for detection of Dengue NS1 antigen and second device for the differential detection of Dengue IgM/IgG antibodies in Human serum/plasma. Dengue NS1 Antigen device contains two lines; 'C' (Control line) & "T" (Dengue NS1 Antigen test line). Test line is coated with anti-dengue NS1 Ag. When a sample is added to the device, Dengue NS1 antigen if present in the sample will bind to the anti-dengue NS1 gold colloidal conjugate making antigen antibodies complex. This complex migrates along the membrane to the test region and forms the visible pink line at “T” as antibody-antigen-antibody gold colloid forms. 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 anti-human IgM or IgG antibodies coated on the membrane respectively. Colloidal gold complexes containing dengue 1-4 antigens is captured by the bound anti-dengue IgM or IgG on respective test bands located in the test 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 respective device will vary depending upon the amount of antigen /antibody present in the sample. The appearance 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.
Dengue Day 1 Test 10 Tests IR028010
Dengue Day 1 Test 30 Tests IR028030
Dengue Day 1 Test 50 Tests IR028050

PERFORMANCE CHARACTERISTICS (INTERNAL EVALUATION) OF Dengue Day 1 Test
Sample Type No. Of Samples tested Result of Licenced test Dengue NS1 Ag Dengue IgM/IgG
Negative for Ag & Ab 4030 4030 3950 3910
Dengue Antigen Positive 175 175 168 -
Dengue IgM Positive 120 120 - 114
Dengue IgG Positive 79 79 - 75

Dengue NS1 Ag-
Sensitivity-96% and Specificity- 98%.
 
For Dengue IgM/IgG Antibody test-
Sensitivity-95% and Specificity- 97%.

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