Description
ã€PRINCIPLE】
The COVID**9 Antigen Rapid Test is based on colloidal gold
immunochromatography assay. This kit detects COVID**9 antigens
through visual interpretation of color development on the strip.
COVID**9 antibodies are immobilized on the test region of the
membrane respectively. During testing, the extracted specimen
reacts with anti- COVID**9 antibodies conjugated to colored
particles and precoated onto the sample pad of the test. The
mixture then migrates through the membrane by capillary action and
interacts with reagents on the membrane. If there is sufficient
COVID**9 antigens in the specimen, colored band will form at the
according test region of the membrane. The presence of a colored
band in the test region indicates a positive result for the
particular viral antigens, while its absence indicates a negative
result. The appearance of a colored band at the control region
serves as a procedural control, indicating that the proper volume
of specimen has been added and membrane wicking has occurred.
ã€TEST PROCEDURE】
Reagents and devices must be at room temperature (***0 ℃) prior
to testing. 1.Place the extraction tube with opening facing up.
Press the extraction solution bottle to Add 6 full drops (**0 **0
µL) of extraction buffer into the extraction tube without touching
the edge of the tube. 2.The extraction of specimen: Put the swab
that had collected specimen into the extraction tube, and rotate
the swab at least *0 times against the inside of the Extraction
Tube
Note: Please read the instruction for use carefully before use. - 3
- Leave the swab in the extraction buffer for 1 minute. Press the
swab against the bottom and side of the Extraction Tube as you
remove it. Try to release as much liquid as possible. Dispose of
the used swab in accordance with your biohazard waste disposal
protocol. 3.Put on the tube tip. 4.Loading: Remove the test device
from its sealed pouch, and place it on a clean, level surface. then
slowly add 2 drops （approximately *0μL） of extracted sample
into the sample well. 5.Read the results at ****0 minutes.
ã€INTERPRETATION OF TEST RESULTS】 NOTE：Do not
interpret the result after *0 minutes.
1.POSITIVE
RESULT: Two lines appear. One line should always appear in
the control line region(C), and another one apparent colored line
should appear in the test line region.
2.NEGATIVE RESULT:One colored band appears in the
control band region (C). No band appears in the test band region
(T) . If the test result is negative and clinical symptoms persist,
additional testing using other clinical methods is recommended.
3.INVALID RESULT: 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 device. If the
problem persists, discontinue using the test kit immediately and
contact your local distributor
