FDA No Instrument 3min IgG/IgM Antibody Dengue Rapid Test Kit

Product Specification

Dengue IgG/IgM Ab Rapid Test

For the qualitative detection of Dengue ( IgG & IgM ) in serum/plasma and whole blood

Dengue Rapid Test Kit Dengue Fever IgG/IgM Combo Home Use Mosquito-Borne Infectious Disease

Main Features

☀ High Sensitivity: 100%

☀ Specificity: 100%

☀ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes

☀ Reliable: Accuracy higher than 97.5%, early detection of the presence of Dengue Antibody

☀ Simple: No Instrument Required

☀ Convenient: Room Temperature Storage, Built-In Control

☀ Certified by Authoritative Certification System and Standards

☀ Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"

Intended Use

The Dengue IgG and IgM Combo Rapid Test is a qualitative test for the detection of IgG and IgM Antibodies to dengue virus in human serum plasma ,or whole blood.

The test provides a differential detection of anti-dengue IgG and anti-dengue-IgM antibodies and can be used for the presumptive distinction between a primary and secondary dengue infection.

This test is for In-Vitro Diagnostic use only.

Interpretation of Results

Negative:The control line is the only line visible in the test zone. No IgG or IgM antibodies were detected. The result does not exclude dengue infection. A new sample should be drawn from the patient in 3-5 days and then should be retested.

IgG Positive: The control line and G line are visible in the test zone. The test is positive for IgG antibodies. This is indicative of a past dengue infection.
 

IgM Positive: The control line and M line are visible in the test zone. The test is positive for IgM antibodies. This is indicative of a primary dengue infection.
 

IgM and IgG Positive: The control line, M and G lines are visible in the test zone. The test is positive for IgM and IgG antibodies. This is indicative of a secondary dengue infection (see limitation).

Invalid: The test results are INVALID, if no control line is visible, regardless of the presence or absence of lines in the IgG or IgM test zone of the strip. Repeat the test using a new cassette.

Storage

Store the kit between 4°C and 30°C. Do not store the kit in direct sunlight. Only remove and open the number of cassettes to be immediately used. The test kit should be used until the expiration date of the kit. Please refer to the package label for the expiration date.

Reagents and Materials Provided

☀ 40 pouched cassettes with desiccant.

☀ Dropper bottle of sample diluent buffer.

☀ One operating instruction.

Materials Required But Not Provided

☀ Stop watch.

☀ Adjustable 0.5 - 10μl pipette (adjustable)

Expected Value

Primary dengue is characterized by the presence of detectable IgM antibodies 5 days after the onset of infection. Secondary dengue is characterized by the elevation of specific IgM antibodies and the evaluation of specific IgG antibodies.