One Step anti-DENGUE-IGM/IGG Test

One step anti-Dengue IgG.IgM: A colloidal gold enhanced immunoassay for the determination of IgM/IgG anti-DENGUE virus antigen

One Step anti-DENGUE-IGM/IGG Test :

Intended Use:

The EZ-Trust Dengue(IGM&IGG) Tri-line rapid screen test is a colloidal gold enhanced , rapid immunochromatographic assay for the qualitative detection of antibodies(IGM&IGG) to dengue virus(DV) in human whole blood, serum or plasma. This test is a screening test, and all positives must be confirmed using an alternate test such as western blot. The test is intended for healthcare professional use only.

 

 Features:

 

Format	Cassette/Strip
Specimen	Whole blood/Serum/Plasma
Shelf life	2 years
Storage for Cassette	2-30°C
Sensitivity	90%
Specificity	90%

 

Sample Collection and Storage:

Whole blood:

Collect whole blood specimens following regular clinical laboratory procedures.Heparinized capillary tubes with anticoagulant must be used for collecting blood samples.Whole blood specimens should be used immediately after collection.

Serum or Plasma:

Collect serum or plasma specimens following regular clinical laboratory procedures.Storage: Specimen should be refrigerated if not used the same day of collection. Specimens should be frozen if not used within 3 days of collecting. 0.1% of sodium azide can be added to specimen as preservative without affecting the results of the assay.

Performance Characteristics:

1. Specificity

In an in-house laboratory study, 63 confirmed negative samples were evaluated with Advanced Quality One Step Anti-Dengue (IgM & IgG) Tri-line Test using EIA as reference tests. The study gave 95% specificity for the test.

2. Sensitivity

In the above-mentioned study, Advanced Quality One Step Anti-Dengue (IgM & IgG) Tri-Line Test was evaluated with 32 confirmed positive samples. The sensitivity of Advanced Quality One Step Anti-Dengue (IgM & IgG) Tri-line Test was found to be 97% relative to consensus with EIA results.

One Step anti-DENGUE-IGM/IGG Test