LTH Medical LTD.

The Dengue Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of dengue IgG/ IgM and virus antigen (Dengue Ag) in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Dengue viruses.  Any reactive specimen with the  Dengue Combo Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

Dengue viruses, a family of four distinct serotypes of viruses (Den 1,2,3,4), are single-strained, enveloped, positive-sense RNA viruses. The viruses are   transmitted by mosquitoes of the daytime-bitting Stegemyia family, principally Aedes aegypti, and Aedes albopictus. Today, more than 2.5 billion people living in the areas of tropical Asia, Africa, Australia, and the Americas are at risk for dengue infection. An estimated 100 million cases of dengue fever and 250,000 cases of life-threatening dengue hemorrhagic fever occur annually on a worldwide basis1-3.

Serological detection of IgM antibody is the most common method for the diagnosis of dengue virus infection. Lately, detection of antigens released during virus replication in the infected patient showed very promising result. It enables diagnosis from the first day after the onset of fever up to day 9, once the clinical phase of the disease is over, thus allows early treatment in placed promptly4-.

The Dengue IgG/IgM Rapid Test Strip 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 serum, or plasma.

The  Dengue Ag Rapid Test Strip is developed to detect circulating dengue antigen in serum or plasma. The test can be performed by untrained or minimally skilled personnel, without laboratory equipment.

REAGENTS AND MATERIALS PROVIDED

1.Each kit contains 20 test devices, each sealed in a foil pouch with three items inside:

a. One cassette device with Dengue IgG/IgM and Ag NS1 test strips.      

b. One plastic dropper.

c. One desiccant.

2.Sample Diluent (1 bottle, 2 mL)

3.One package insert (instruction for use).

ASSAY PROCEDURE

Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.

Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.

Step 3: Be sure to label the device with specimen’s ID number.

Step 4: For whole blood samples:

Fill the dropper with the specimen then add 1 drop (around 10µL) of specimen for the IgG/ IgM test strip and 3 drops  (about 90 µL) of specimen for NS1 test, making sure that there are no air bubbles.

Step5: For Plasma/ Serum samples:

Fill the plastic dropper with the specimen. Holding the dropper vertically, dispense 5 µL of sample and 2 drop of buffer into the sample well of IgG/IgM test strip and dispense 2 drops (about 60 µL) of specimen into the sample well, making sure that there are no air bubbles.

Step 6:  Results can be read in 15 minutes. Positive results can be visible in as short as 1 minute.

Don’t read results after 30 minutes.  To avoid confusion, discard the test device after interpreting the result.

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