CE COVID19 Infectious Disease Test Kit Oral Fluid Test Kit Rapid Qualitative Detection
Brand Name:Citest
Certification:CE
Model Number:INCP-802
Minimum Order Quantity:N/A
Delivery Time:2-4 Weeks
Place of Origin:-
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Product Details
COVID-19 Antigen Rapid Infectious Disease Testing Cassette ,Oral Fluid Specimen
COVID-19 Antigen Rapid Test is a rapid chromatographic immunoassay
for the qualitative detection of SARS-CoV-2 nucleocapsid protein
antigens present in human oral fluid.For professional in vitro
diagnostic use only.
| Product features | Parameters |
| Principle | Chromatographic Immunoassay |
| Format | Cassette |
| Specimen | Oral fluid/Nasopharyngeal Swab/Nasal Swab |
| Certificate | CE |
| Reading Time | 15 minutes |
| Pack | 20 T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
INTENDED USE
The COVID-19 Antigen Rapid Test (Oral Fluid) is a rapid
chromatographic immunoassay for the qualitative detection of
SARS-CoV-2 nucleocapsid protein antigens in oral fluid specimens
from individuals with suspected SARS-CoV-2 infection in conjunction
with clinical presentation and the results of other laboratory
tests. Results are for the detection of SARS-CoV-2 nucleocapsid
protein antigens.
An antigen is generally detectable in upper respiratory specimens
during the acute phase of infection. Positive results indicate the
presence of viral antigens, but clinical correlation with patient
history and other diagnostic information is necessary to determine
infection status. Positive results do not rule out bacterial
infection or co-infection with other viruses. The agent detected
may not be the definite cause of disease. Negative results do not
preclude SARS-CoV-2 infection and should not be used as the sole
basis for treatment or patient management decisions. Negative
results should be treated as presumptive and confirmed with a
molecular assay, if necessary for patient management. Negative
results should be considered in the context of a patient’s recent
exposures, history and the presence of clinical signs and symptoms
consistent with COVID-19.
PRINCIPLE
The COVID-19 Antigen Rapid Test (Oral Fluid) is a qualitative
membrane-based immunoassay for the detection of SARS-CoV-2
nucleocapsid protein antigens in human oral fluid specimen.
SARS-CoV-2 nucleocapsid protein antibody is coated in the test line
region. During testing, the specimen reacts with SARS-CoV-2
nucleocapsid protein antibody-coated particles in the test. The
mixture then migrates upward on the membrane by capillary action
and reacts with the SARS-CoV-2 nucleocapsid protein antibody in
test line region. If the specimen contains SARS-CoV-2 Antigens, a
colored line will appear in test line region as a result of this.
If the specimen does not contain antigens to SARS-CoV-2, no colored
line will appear in the test line region, indicating a negative
result. To serve as a procedural control, a colored line will
always appear in
the control line region, indicating that the proper volume of
specimen has been added and membrane wicking has occurred.
DIRECTIONS FOR USE
Allow the test device, collection device, buffer and/or controls to
equilibrate to room temperature (15-30°C) prior to testing.
Specimen Collection
Important: Before collecting oral fluid, instruct the patients not
to place anything in the mouth including food, drink, gum or
tobacco products for at least 10 minutes prior to collection.
Instruct the patients to deeply cough 3-5 times. It is recommended
to collect oral fluid after deep coughing in the morning.
①Remove the collection device and collect oral fluid specimen. If
there’s not enough oral fluid collected, repeat the above specimen
collection
steps.
Specimen Extraction
②Mix the buffer with the collected oral fluid. Gently shake or
squeeze the tube with mixture for 10 seconds to mix well.
NOTE: The storage of the specimen after extraction is stable for 2
hours at room temperature or 24 hours at 2-8°C.
Test Reaction
Remove the test device from the sealed foil pouch and use it within
one hour. Best results will be obtained if the test is performed
immediately after opening the foil pouch.
③Add Extracted specimen to the Test Device, Wait for the colored
line(s) to appear. Read the result at 15 minutes. Do not interpret
the result after 20 minutes.
INTERPRETATION OF RESULTS
POSITIVE:* Two colored lines appear. One colored line should be in
the control region (C) and another colored line should be in the
Test region (T). Positive result in the Test region indicates
detection of SARS-CoV-2 antigens in the sample.
*NOTE: The intensity of the color in the test line region (T) will
vary based on the amount of SARS-CoV-2 antigen present in the
sample. So any shade of color in the test region (T) should be
considered positive.
NEGATIVE: One colored line appears in the control region (C). No
apparent colored line appears in the test line region (T) indicates
a Negative COVID-19 Antigen test result.
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.
CE COVID19 Infectious Disease Test Kit Oral Fluid Test Kit Rapid Qualitative Detection
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