Dengue Antibody Cassette Test IgG / IgM One Step Diagnosis

Dengue Rapid Test Diagnostic Kit Antibody IgG/IgM One Step Diagnosis

INTENDED USE

The Dengue IgG and IgM Antibody Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of dengue virus in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Dengue infections.

INTRODUCTION

Dengue is a flavivirus, transmitted by Aedes aegypti and Aedes albopictus mosquitoes.1 It is widely distributed throughout the tropical and subtropical areas of the world,1 and causes up to 100 million infections annually.2 Classic Dengue infection is characterized by a sudden onset of fever, intense headache, myalgia, arthralgia and rash. 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.3 Most Dengue patients in endemic regions have secondary infections,4 resulting in high levels of specific IgG antibodies prior to or simultaneous with IgM response.5 Therefore, the detection of specific anti-Dengue IgM and IgG antibodies can also help to distinguish between primary and secondary infections.

The Dengue Rapid Test Device (Whole Blood/Serum/Plasma) 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 whole blood, serum, or plasma.

PRINCIPLE

The Dengue IgG/IgM Rapid Test is a qualitative membrane-based immunoassay for the detection of Dengue antibodies in whole blood, serum, or plasma. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in test line region 1 of the test. During testing, the specimen reacts with Dengue antigen-coated particles in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in test line region 1. If the specimen contains IgG antibodies to Dengue, a colored line will appear in test line region 1. In the IgM component, anti-ligand is coated in test line region 2 of the test. During testing, the specimen reacts with ligand anti-human IgM. Dengue IgM antibodies, if present in the specimen, reacts with the ligand anti-human IgM and the Dengue antigen-coated particles in the test strip, and this complex is captured by the anti-ligand, forming a colored line in test line region 2.

Therefore, if the specimen contains Dengue IgG antibodies, a colored line will appear in test line region 1. If the specimen contains Dengue IgM antibodies, a colored line will appear in test line region 2. If the specimen does not contain Dengue antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always change from blue to red in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

MAIN CONTENTS

Rapid Test Cassette in Pouch

Buffer

Disposable dropper

Package insert

STORAGE

Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C).

The test is stable through the expiration date printed on the sealed pouch.

The test must remain in the sealed pouch until use.

DO NOT FREEZE.

Do not use beyond the expiration date.

OPERATION PROCEDURE

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

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. Place the test device on a clean and level surface.

For Serum or Plasma Specimens:

Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5 uL), and transfer the specimen to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 mL) 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: Pipette 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.

INTERPRETATION

For details, please contact Dewei staff for Instruction Manual!