100% Sensitivity IgG IgM Combo Dengue Rapid Test Kit

Dengue IgG/IgM Antibody Rapid Test

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

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

Main Features

♦ High Sensitivity: 100%

♦ Specificity: 100%

♦ 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 line

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

♦ 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.

Principle

Serum, plasma, or Whole blood samples may be used with this test. A sample is dispensed on to the membrane The sample then migrates by capillary action towards the test site where anti-Human IgG and anti-Human IgM are immobilized as two distinct lines. The IgG & IgM antibodies present in the sample will bind to the immobilized anti-Human IgG and Anti-Human IgM lines on the membrane. Next the sample buffer is applied which in turn reconstitutes the dried Dengue gold conjugate.

The Dengue conjugate then migrates towards the test zone and binds to Dengue Anti-Human IgG and Dengue Anti-Human IgM complex on the membrane as two separate purple/blue lines if Dengue antibodies are present in the sample. The intensity of the test lines will vary depending upon the amount of antibody present in the sample. The appearance of purple/blue line in a specific test region (IgG or IgM) should be considered as positive for that particular antibody type (IgG or IgM). There will be a third control line on the membrane which will be invisible until the test is run. It will show up as a Red control line to indicate that the test is functioning properly.

Storage

Store the test kits at temperature 4-30°C,in the sealed pouch for the duration of the shelf life (24 months).

Assay Procedure

All test cassettes, buffers and specimens must be at room temperature (4- 300C) before running the assay procedure. Whole blood samples should be used immediately.

1. Pipette 5μl sample (serum/plasma/whole blood) into the sample well. Wipe the outside of the pipette tip carefully to remove excess of sample.

2. Next dispense 4 drops (120μl) of sample diluent buffer into the buffer well.

3. Record the results after 15-20 minutes. Discard the test cassette after 20 minutes.

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.

Performance Characteristics

1.A panel of samples containing confirmed positive and negative samples were used. The reference test kit used was from Pan Bio (Australia). The results are tabulated below.

2. CROSS REACTIVITY: No cross reactivity was observed with Hemoglobin (20 mg/100 ml) , and Triglycerides (500 mg/100 ml).