CMV Rapid Diagnostic test Cassette to detect Cytomegalovirus in human blood ,gold colloidal method, easily and quick

Intended Use:

The Cytomegalovirus Rapid Test is a rapid qualitative lateral flow test designed for the quantitive detection of Cytomegalovirus (CMV) in human serum/plasma samples.

Test Principle:

The Cytomegalovirus Rapid Test Device (Serum/Plasma) has been designed to detect CMV through visual interpretation of color development in the internal strip. The membrane was immobilized with antigens of CMV on the test region. During the test, the specimen is allowed to react with colored recombinant mouse anti-human IgM latex conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough CMV antibodies in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready

to begin testing.

2. Remove the device from the sealed pouch and lay it on a flat and dry surface.

3. Using the provided pipette, add one drop of fresh specimen to the sample well.

4. Hold the buffer bottle vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoidcross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.

5. Read the result between 15-20minutes. Do not read results after 20 minutes.

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: CMV Rapid Test vs. EIA Test