West Nile virus Antigen Rapid Test
PRINCIPLE
West Nile Virus Antigen Rapid Test is a sandwich solid phase immunochromatographic assay. To perform the test, an aliquot of diluted sample is added to the sample well of the test cassette. The sample flows through a pad containing antibodies against West Nile Virus coupled to red-colored colloidal gold. If the sample contains West Nile Virus antigens, the antigen will bind to the antibody coated on the colloidal gold particles to form antigen-antibody-gold complexes. These complexes move on the nitrocellulose membrane by capillary action toward the test line region on which West Nile Virus antibodies are immobilized separately. As the complexes reach the test line, they will bind to the antibody corresponding to the bacteria on the membrane to form of a line. A red control line will always appear in the result window to indicate that the test has been correctly performed and the test device functions properly. If bacteria is not present or lower than the detection limit of the test, only the control line will be visible. If the control line dose not developed, the test is invalid.
MATERIALS
Materials Provided
|
· Individually packed test devices |
· Dropper |
|
· Buffer |
· Workstation |
|
· Package insert |
|
|
· Throat swab |
|
|
Materials Required but Not provided |
|
|
· Timer |
|
TEST PROCEDURE
Allow the test, reagents, swab specimen, and/or controls to reach room temperature (15-30°C) prior to testing.
- Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
- Extract the West Nile Virus antigen according to the specimen type.
INTERPRETATION OF RESULTS
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
NOTE:
- The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
- Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.
LIMITATIONS OF THE TEST
- The West Nile Virus Antigen Rapid Test is for professional in vitro diagnostic use, and should only be used for the qualitative detection of human West Nile Virus infection.
- The test result should be used only to evaluate with patient with signs and symptoms of the disease. A definitive clinical diagnosis should only be made by the physician after all clinical and laboratory finding have been evaluated.
- As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (HAMA) in the specimen. Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain HAMA. Such specimens may cause false positive or false negative results.
- As all diagnostic tests, a confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
Accuracy: 96.27% (95%CI: 93.03%～98.28%)
