Dengue IgG/IgM 3.0 Rapid Test-Cassette(Serum/Plasma)

Principle of the Assay

The Dengue IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy

colored conjugate pad containing dengue

recombinant envelope antigens conjugated with colloid gold (dengue conjugates) and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing two test bands

(G and M bands) and a control band (C band).

The G band is pre-coated with the antibody for the detection of IgG anti-dengue virus, M band is coated with antibody for the detection

of IgM anti-dengue virus, and the C band is pre-coated with goat anti rabbit IgG.

When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgG anti-dengue virus if present in the specimen will bind to the dengue conjugates. The immunocomplex is then captured by the reagent coated on the G band, forming a burgundy colored G band, indicating a dengue virus IgG positive test result and suggesting a recent or repeat infection.

IgM anti-dengue virus, if present in the specimen, will bind to the dengue conjugates. The immunocomplex is then captured by the reagent pre-coated on the M band, forming a burgundy colored M band, indicating a dengue virus IgM positive test result and suggesting a fresh infection.

Absence of any test bands (G and M) suggests a negative result.

The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test bands(G and M). Otherwise, the test result is invalid and the specimen must be retested with another device.

Components

1.Each kit contains 40 test devices, each sealed in a foil pouch with two items inside:
a. One cassette device.
b. One desiccant.
2.25 or 30 x 5 µL mini droppers.
3.Sample Diluent (2 bottles, 5 mL).
4.One package insert (instruction for use).
 

Specimen Collection

Consider any materials of human origin as infectious and handle them using standard biosafety procedures.

Plasma

1. Collect blood specimen into a lavender, blue or green top collection tube (containing EDTA, citrate or heparin, respectively in Vacutainer® ) by veinpuncture.

2. Separate the plasma by centrifugation.

3. Carefully withdraw the plasma into new pre-labeled tube.

Serum

• Collect blood specimen into a red top collection tube (containing no anticoagulants in Vacutainer®) by veinpuncture.
• Allow the blood to clot.
• Separate the serum by centrifugation.
• Carefully withdraw the serum into a new pre-labeled tube.

Test specimens as soon as possible after collecting. Store specimens at 2°C-8°C if not tested immediately.

Store specimens at 2°C-8°C up to 5 days. The specimens should be frozen at -20°C for longer storage.

Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing. Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.