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
Relative Sensitivity: 96.15% (86.80%-99.53%)* Relative Specificity: >99.9% (94.04%-100.0%)* Overall Agreement: 98.21% (93.70%-99.78%)* *95% Confidence Interval | | CMV Rapid Test | |
| + | - | Total |
| EIA Test | + | 50 | 2 | 52 |
| - | 0 | 60 | 60 |
| 50 | 62 | 112 |
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
