Medical Diagnostic Adenovirus Test Kit Rapid Chromatographic Immunoassay

Product Specification

One Step Adenovirus Rapid Diagnostic Cassette, feces specimen,gold colloidal method, easily and quick

Product Name:

One Step Adenovirus Rapid Diagnostic test

Intended Use:

The Adenovirus Rapid Test Cassette (Feces) is a rapid chromatographic immunoassay for the qualitative detection of Adenovirus in human feces specimens to aid in the diagnosis of adenovirus infection.

Test Principle:

The Adenovirus Rapid Test Cassette (Feces) is a qualitative, lateral flow immunoassay for the detection of adenovirus in human feces specimens. In this test, the membrane is pre-coated with anti-adenovirus antibody on the test line region of the test. During testing, the specimen reacts with the particle coated with anti-adenovirus antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-adenovirus antibody on the membrane and generate a colored line in the test line region. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

Specimen collection and pre-treatment:

Use the specimen collection container for specimen collection. Best results will be obtained if the assay is performed within 6 hours after collection.

For solid specimens: Unscrew and remove the dilution tube applicator. Be careful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 3 different sites of the feces to collect approximately 50 mg of feces (equivalent to 1/4 of a pea).

For liquid specimens: Hold the pipette vertically, aspirate fecal specimens, and then transfer 2 drops (approximately 50 µL) into the specimen collection tube containing the extraction buffer.

Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Specimens prepared in the specimen collection tube may be stored for 6 months at -20°C if not tested within 1 hour after preparation.

Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.

As the test begins to work, you will see color move across the membrane.

Wait for the colored band to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

Note: If the specimen does not migrate (presence of particles), centrifuge the extracted specimens contained in the extraction buffer vial. Collect 80 µL of supernatant, dispense into the specimen well (S) of a new test device and start afresh following the instructions mentioned above.

INTERPRETATION OF RESULTS

POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

PERFORMANCE CHARACTERS:

Table: Adenovirus Rapid Test vs. Latex Agglutination

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.