Dengue IgG/IgM And NS1 Combo Rapid Test

INTENDED USE

The Dengue IgG/IgM And NS1 Combo Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Dengue NS1 antigen and IgG/IgM antibodies to Dengue in human whole blood, serum or plasma specimen.

SUMMARY

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- biting 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 basis. Primary Dengue infection causes IgM antibodies to increase to a detectable level in 3 to 5 days after the onset of fever. IgM antibodies generally persist for 30 to 90 days. Most Dengue patients in endemic regions have secondary infections, resulting in high levels of specific IgG antibodies prior to or simultaneous with IgM response. Therefore, the detection of specific anti-Dengue IgM and IgG antibodies can also help to distinguish between primary and secondary infections. 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 promptly.

The Dengue IgG/IgM And NS1 Combo Rapid Test is a rapid test to qualitatively detect the presence of antibodies (IgG and IgM) to Dengue virus and Dengue NS1 antigens in whole blood, serum, or plasma.

MATERIALS

Materials Provided

1) Test Devices

2) Disposable specimen dropper

3) Package insert

Materials Required But Not Provided

1) Specimen collection container

2) Lancet

3) Centrifuge (for plasma only)

4) Timer

TEST PROCEDURE

Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. 1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
2. 2. Place the test device on a clean and level surface.

Dengue IgG/IgM part

For Serum or Plasma Specimens:

Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5 μL), and transfer the specimen to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 L) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S).

For Whole Blood (Venipuncture/Fingerstick) Specimens:

To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line,  and transfer 1 drop of whole blood (approximately 10 µL) to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 uL) and start the timer. See illustration below.

To use a micropipette: Pipet and dispense 10 µL of whole blood to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 µL) and start the timer. See illustration below.

Dengue NS1 part

To use a dropper: Fill the plastic dropper with the specimen. Holding the dropper vertically, dispense 2 drops (about 60µL) of plasma/ serum specimen or 3 drops(about 90µL)  of whole blood specimen into the sample well making sure that there are no air bubbles.

Note: Add 1 drop of Saline or Phosphate-Saline buffer (common buffers used in clinic not provided in the kit) into the sample well if flow migration is not observed within 30 seconds in the result window, which could occur with a highly viscous specimen.

3. 3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.

INTERPRETATION OF RESULTS

Dengue IgG/IgM part

Dengue NS1 Part

POSITIVE: Both colored C and T bands appear in the test and control region.

NEGATIVE: Only one colored line appears in the control region.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Relative Sensitivity: 97.73%, relative Specificity: 98.06%, overall Agreement:  97.87%