99.6% Specificity COVID 19 Antigen Rapid Test Kit CE1434 OTC Covid 19 Self Test Kit
Brand Name:Citest
Certification:CE1434
Model Number:ICOV-502S
Minimum Order Quantity:N/A
Delivery Time:2-4 Weeks
Place of Origin:-
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Hangzhou Zhejiang
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170-422, Richards Street, Vancouver BC V6B 2Z4, CANADA
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Product Details
COVID-19 Antigen Rapid Test for Self Testing (CE1434 OTC) (Nasal Swab),COVID19 Antigen Rapid Test
| Product: | COVID-19 Antigen Rapid Test For Self Testing (CE1434 OTC) (Nasal Swab),COVID19 Antigen Rapid Test |
| Brand: | Citest |
| Format: | Cassette |
| Reading Time: | 15 Minutes |
| Pack: | IT,2T,5T,7T,10T,20T/25T |
| Sensitivity: | 99.70% |
| Accuracy: | 99.50% |
| Cat No.: | ICOV-502S |
| Specimen: | Nasal Swab |
| Storage Temperature: | 2-30°C |
| Shelf Life: | 24 Months |
| Specificity: | 99.60% |
Application
A rapid test for the qualitative detection of SARS-CoV-2
Nucleocapsid Protein antigens present in nasal swab specimen.For
self-testing in vitro diagnostic use.
INTENDED USE
The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a single-use test
kit intended to detect the SARS-CoV-2 that causes COVID-19 with
self-collected nasal swab specimen. The test is intended for use in
symptomatic individuals meeting the case definition for COVID-19,
and to test asymptomatic individuals limited to contacts of
confirmed COVID-19 cases or probable cases and to at-risk health
workers. 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 are
indicative of the presence of SARS-CoV-2. Individuals who test
positive should self-isolate and seek additional care from their
healthcare provider. Positive results do not rule out bacterial
infection or co-infection with other viruses. Negative results do
not preclude SARS-CoV-2 infection. Individuals who test negative
and continue to experience COVID-like symptoms should seek follow
up care from their healthcare provider.
PRINCIPLE
The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a qualitative
membrane-based immunoassay for the detection of SARS-CoV-2
nucleocapsid protein antigens in human swab specimen.
PRECAUTIONS
Please read all the information in this package insert before
performing the test.
• For self-testing in vitro diagnostic use only. Do not use after
expiration date.
• Do not eat, drink or smoke in the area where the specimens or
kits are handled.
• Do not drink the buffer in the kit. Carefully handle the buffer
and avoid it contacting skin or eyes, rinse with plenty of running
water immediately if contacting.
• Store in a dry place at 2-30 °C (36-86 °F), avoiding areas of
excess moisture. If the foil packaging is damaged or has been
opened, please do not use.
• This test kit is intended to be used as a preliminary test only
and repeatedly abnormal results should be discussed with doctor or
medical professional.
• Follow the indicated time strictly.
• Use the test only once. Do not dismantle and touch the test
window of the test cassette.
• The kit must not be frozen or used after the expiration date
printed on the package.
• Test for children should be under the guidance of an adult.
• Wash hands thoroughly before and after handling.
• 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.
PROCEDURE
Wash your hands with soap and water for at least 20 seconds before
and after test. If soap and water are not available, use hand
sanitizer with at least 60% alcohol. Remove the cover of the tube
with Extraction buffer and place the tube in the tube holder in the
box.
Nasal swab specimen Collection
1. Remove the sterile swab from the pouch.
2. Insert the swab into your nostril until you feel slight
resistance (Approx. 2cm up your nose). Slowly twist the swab,
rubbing it along the insides of your nostril for 5-10 times against
the nasal wall.
3. Gently remove the swab.
4. Using the same swab, repeat step 2 in your other nostril.
5. Withdraw the swab
Specimen Preparation
1. Place the swab into the Extraction tube, ensure it is touching
the bottom and stir the swab to mix well. Press the swab head
against to the tube and rotate the swab for 10-15 seconds.
2. Remove the swab while squeezing the swab head against the inside
of the Extraction tube.
3. Place the swab in the biosafety bag.
4. Close the cap or fit the tube tip onto the tube.
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. Place the test
cassette on a plat and level surface.
2. Invert the specimen extraction tube and add 3 drops of extracted
specimen to the sample well(S) of the test cassette and start the
timer. Do not move the test cassette during test developing.
3. Read the result at 15 minutes. Do not read the result after 20
minutes.
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).
*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. A positive results means it is very likely you
have COVID-19, but the positive
samples should be confirmed to reflect this. Immediately go into
self-isolation in accordance with the local guidelines and
immediately contact your general practitioner/doctor or the local
health department in accordance with the instructions of your local
authorities. Your test result will be checked by a PCR confirmation
test and you will be explained the next steps.
NEGATIVE: One colored line appears in the control region (C). No
apparent colored line appears in the test line region (T).
You are unlikely to have COVID-19. However, it is possible for this
test to give a negative result that is incorrect (a false negative)
in some people with COVID-19. This means you could possibly still
have COVID-19 even though the test is negative. In addition, you
can repeat the test with a
new test kit. In case of suspicion, repeat the test after 1-2 days,
as the coronavirus cannot be precisely detected in all phases of an
infection.
Even with a negative test result, distance and hygiene rules must
be observed, migration/traveling, attending events and etc. should
follow your local COVID guidelines/requirements.
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 or contact with a COVID-19 test center.
SUMMARY
The novel coronaviruses belong to the β genus. COVID-19 is an acute
respiratory infectious disease. People are generally susceptible.
Currently, the patients infected by the novel coronavirus are the
main source of infection; asymptomatic infected people can also be
an infectious source. Based on the current epidemiological
investigation, the incubation period is 1 to 14 days, mostly 3 to 7
days.
The main manifestations include fever, fatigue and dry cough. Nasal
congestion, runny nose, sore throat, myalgia and diarrhea are found
in a few cases .
99.6% Specificity COVID 19 Antigen Rapid Test Kit CE1434 OTC Covid 19 Self Test Kit
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