Antigen Test Kit Colloidal Gold,Disposable Dengue IgG IgM Rapid Test Efficient Detection Reagent

Rapid And Efficient Eetection Reagent For Dengue Fever IgG/IgM

      The Dengue IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti–dengue virus and IgM anti-dengue virus in human whole blood, serum or plasma. It is intended to be used by the professionals as a screening test and as an aid in the diagnosis of infection with dengue viruses. Any reactive specimen with the Dengue IgG/IgM Rapid Test must be confirmed with alternative testing method(s).

Detection Principle

      The Dengue IgG/IgM Rapid Test Device (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 Test region, anti-human IgM and IgG is coated. 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 IgM or IgG in test line region. If the specimen contains IgM or IgG antibodies to Dengue, a colored line will appear in test line region. Therefore, if the specimen contains Dengue IgM antibodies, a colored line will appear in test line region1. If the specimen contains Dengue IgG antibodies, a colored line will appear in test line region2. 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 appeared in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

SPECIMEN COLLECTION AND STORAGE

     All reagents are ready to use as supplied. Store unused test devices unopened at 2°C-30°C. The positive and negative controls should be kept at 2°C-8°C. If stored at 2°C-8°C, ensure that the test device is brought to room temperature before opening. The test device is stable through the expiration date printed on the sealed pouch. Do not freeze the kit or expose the kit over 30°C.

PROCEDURE

Bring the specimen and test components to room temperature Mix the specimen well prior to assay once thawed.Place the test device on a clean, flat surface.

• For whole blood sample:

Fill the dropper with the specimen then add 1 dropper of specimen into the sample well. The volume is around 10µL. Making sure that there are no air bubbles.Then add 2 drops (about 80µL) of Sample Diluentimmediately into the sample well.

• For Plasma/ Serum sample:

Fill the dropper with the specimen not to exceed the specimen line. The volume of the specimen is around 5µL. Dispense the entire specimen into the center ofthe sample well making sure that there are no air bubbles.Then add 2 drops (about 80µL) of Sample Diluentimmediatelyinto the sample well.

Note: Practice a few times prior to testing if you are not familiar with the mini dropper. For better precision, transfer specimen by a pipette capable to deliver 5µL of volume. Set up a timer.Read the result at 15 minutes. Don’t read result after 30minutes. To avoid confusion, discard the test device after interpreting the result

INTERPRETATION OF RESULTS

LIMITATIONS OF THE TEST

1. . The Assay Procedure and the Test Result Interpretation must be followed closely when testing the presence of antibodies to dengue virus in serum or plasma from individual subjects. Failure to follow the procedure may give inaccurate results. 
2. The Dengue IgG/IgM Rapid Test is limited to the qualitative detection of antibodies to dengue virus in human whole blood, serum or plasma. The intensity of the test band does not have linear correlation with the antibody titer in the specimen. 
3. The Dengue IgG/IgM Rapid Test can not be used to differentiate if the infection is primary or secondary. No information of dengue serotypes can be provided with this test. 
4. Serological cross reactivity with other flaviviruses is common (e.g., Japanese encephalitis, West Nile, yellow fever, etc.), therefore, it is possible that patients infected with these viruses may show some level of the reactivity with this test. 
5. A negative or non-reactive result for an individual subject indicates absence of detectable dengue virus antibodies. However, a negative or non-reactive test result does not preclude the possibility of exposure to or infection with dengue virus. 
6. A negative or non-reactive result can occur if the quantity of the dengue virus antibodies present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected. 
7. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results. 
8. If the symptom persists, while the result from Dengue IgG/IgM Rapid Test is negative or nonreactive result, it is recommended to re-sample the patient few days late or test with an alternative test device. 
9. The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.

KIT COMPONENTS

• Individually packed test devices       Each device contains a strip with colored conjugates and reactive reagents pre-spreaded at the corresponding regions
• Disposable pipettes       For adding specimens use
• Buffer       Phosphate buffered saline and preservative
• Package insert       For operation instruction

MATERIALS REQUIRED BUT NOT PROVIDED

Materials Provided 

• Test devices •
• Droppers •
• Buffer •
• Package insert

Materials Required But Not Provided 

• Specimen collection containers 
• Timer 
• Centrifuge