Aspen Dengue IgG/IgM Ab Rapid 10 Test
The Dengue IgG/IgM Ab Rapid Test Cassette ( Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Dengue virus in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Dengue infections.
PRINCIPLE OF THE TEST
The Dengue IgG/IgM Ab Rapid Test Cassette(Whole Blood/Serum/Plasma) 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 IgG test line region. During testing, the specimen reacts with Dengue antigencoated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region. If the specimen contains IgG antibodies to Dengue, a colored line will appear in IgG test line region. In the IgM component, anti-human IgM is coated in IgM test line region. During testing, the specimen reacts with antihuman IgM. Dengue IgM antibodies, if present in the specimen, reacts with the antihuman IgM and the Dengue antigen-coated particles in the test cassette, and this complex is captured by the anti-human IgM, forming a colored line in IgM test line region. Therefore, if the specimen contains Dengue IgG antibodies, a colored line will appear in t IgG test line region. If the specimen contains Dengue IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain Dengue antibodies, no colored line will appear in either of the test line regions, indicating a negative result
The test cassette contains Dengue antigen conjugated gold colloid particles and antihuman IgM, anti-human IgG coated on the membrane.
For professional in vitro diagnostic use only. Do not use after expiration date. Do not eat, drink or smoke in the area where the specimens or kits are handled. Handle all specimens as if they contain infectious agents. and follow the standard procedures for proper disposal of specimens. Humidity and temperature can adversely affect results.
STORAGE AND STABILITY
The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
SPECIMEN COLLECTION AND PREPARATION
The Dengue IgG/IgM Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) can be performed using whole blood, serum or plasma. For finger stick capillary blood, clean the patient’s hand with an alcohol swab. Allow to dry. Puncture the skin with a sterile lancet. Wipe away the first sign of blood.Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site. Add the Fingerstick Whole Blood specimen to the test cassette by using a dropper or micropipette measuring 10ul. For Serum/Plasma, centrifuge the blood and separate Serum/Plasma as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed specimens. Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long-term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing.
- Sensitivity 98.01%
- Specificity: 99.4%
Remove the Dengue IgG/IgM Ab Rapid test devices from the foil pouch and assure that all test specimens are allowed to reach room temperature
- of or 10µl of whole blood to the sample well of the test device followed by . (when using a sample droper take sample upto the fill line as indicated in the diagram below)
- Wait for the colored line (S) to appear. The test result should be read at 10 minutes . Do not interpret the result after 20 minutes.
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