25T COVID 19 Antigen Rapid Test Kit SARS-CoV-2 Nucleocapsid Protein Antigen Test
Brand Name:Citest
Certification:CE
Model Number:INCP-502
Minimum Order Quantity:N/A
Delivery Time:2-4 Weeks
Place of Origin:-
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170-422, Richards Street, Vancouver BC V6B 2Z4, CANADA
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COVID-19 Antigen Rapid Test (Swab), Detection of SARS-CoV-2 Nucleocapsid Protein antigens
Application
COVID-19 Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein antigens in swab specimen. For professional in vitro diagnostic use only.
Sensitivity, Specificity and Accuracy
The SARS-CoV-2 Antigen Rapid Test (Swab) has been evaluated with
swab specimens obtained from the patients. RT-PCR (Nasopharyngeal
Swab) is used as the reference method for the SARS-CoV-2 Antigen
Rapid Test (Swab). Specimens were considered positive if RT-PCR
(Nasopharyngeal Swab) indicated a positive result. Specimens were
considered negative if RT-PCR (Nasopharyngeal Swab) indicated a
negative result.
HOW TO USE ?
The COVID-19 Antigen Rapid Test (Swab) is a rapid chromatographic
immunoassay for the qualitative detection of SARS-CoV-2
Nucleocapsid Protein antigens in swab 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 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.
| 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 |
PRINCIPLE
The COVID-19 Antigen Rapid Test (Swab) is a qualitative
membrane-based immunoassay for the detection of SARS-CoV-2 Antigens
in human swab specimen. SARS-CoV-2 antibody is coated in the test
line region. During testing, the specimen reacts with SARS-CoV-2
antibody-coated particles in the test. The mixture then migrates
upward on the membrane by capillary action and reacts with the
SARS-CoV-2 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.
PRECAUTIONS
1. This package insert must be read completely before performing
the test. Failure to follow directions in package insert may yield
inaccurate test results.
2. For professional in vitro diagnostic use only. Do not use after
expiration date.
3. Do not eat, drink or smoke in the area where the specimens or
kits are handled.
4. Do not use test if pouch is damaged.
5. Handle all specimens as if they contain infectious agents.
Observe established precautions against microbiological hazards
throughout in the collection, handling, storage, and disposal of
patient samples and used kit contents.
6. Wear protective clothing such as laboratory coats, disposable
gloves and eye protection when specimens are assayed.
7. Wash hands thoroughly after handling.
8. Please ensure that an appropriate amount of samples are used for
testing. Too much or too little sample size may lead to deviation
of results.
9. Sterile Swabs for the collection of Nasopharyngeal specimen and
Nasal specimen are different, Do not mix the using of the two types
of sampling swabs.
10.Viral Transport Media (VTM) may affect the test result;
extracted specimens for PCR tests cannot be used for the test.
11.The used test should be discarded according to local
regulations.
12.Humidity and temperature can adversely affect results.
SPECIMEN COLLECTION, TRANSPORT AND STORAGE
Nasopharyngeal Swab Specimen Collection
1. Insert a sterile swab into the nostril of the patient, reaching
the surface of the posterior nasopharynx.
2. Swab over the surface of the posterior nasopharynx.
3. Withdraw the sterile swab from the nasal cavity.
Nasal Swab Specimen Collection
1. Insert a sterile swab less than one inch (about 2 cm) into a
nostril (until resistance is met at the turbinates).
2. Rotate the swab 5-10 times against the nasal wall. Using the
same swab repeat the collection procedure with the second nostril.
3. Withdraw the sterile swab, avoid excess volume and high-viscous
nasal discharge.
Caution:
If the swab stick breaks during specimen collection, repeat
specimen collection with a new swab.
Specimen transport and storage
Specimens should be tested as soon as possible after collection. If
swabs are not been processed immediately, it is highly recommended
the swab sample is placed into a dry, sterile, and tightly sealed
plastic tube for storage. The swab specimen in dry and sterile
condition is stable for up to 24 hours at 2-8°C.
DIRECTIONS FOR USE
Allow the test, extracted specimen and/or controls to equilibrate
to room temperature (15-30°C) prior to testing.
1. Remove the test cassette 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.
2. Invert the specimen extraction tube and add 3 drops of extracted
specimen (approx.75-100μl) to the specimen well(S) and then start
the timer.
3. Wait for the colored line(s) to appear. Read the result at 15
minutes. Do not interpret the result after 20 minutes.
POSITIVE:* Two distinct 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).
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.
SUMMARY
The SARS-CoV-2 Antigen Rapid Test (Swab) is a rapid chromatographic
immunoassay for the qualitative detection of SARS-CoV-2
Nucleocapsid protein antigens in swab specimen 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.
25T COVID 19 Antigen Rapid Test Kit SARS-CoV-2 Nucleocapsid Protein Antigen Test
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