Singclean® COVID**9 Test Kit (Colloidal
Gold Method) For Self-Testing Use Intended Use
COVID**9 Test Kit (Colloidal Gold Method) is a solid phase
immunochromatographic assay for the rapid, qualitative detection of
antigen to ***9 Novel Coronavirus in human nasal cavity. This test
provides only a preliminary result for self-testing. Therefore, any
reactive specimen with the COVID**9 Test Kit (Colloidal Gold
Method) must be confirmed with alternative testing method(s) and
clinical findings.
Pack Formats
1 test/box
*0 tests/box
Introduction
The novel coronaviruses belong to the β genus. COVID**9 is an acute
respiratory infectious disease. People are generally susceptible.
Currently, the patients infected by the novel coronavirus are the
main source of infection; asymptomatically infected people can also
be an infectious source. Based on the current epidemiological
investigation, the incubation period is 1 to *4 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.
Materials Supplied
Sealed pouches each containing a test cassette, a desiccant
Sampling cotton swabs (for nasal cavity sampling only)
Antigen extract buffer
Antigen extraction tube
Paper workbench (The small one-test-box can be used as a
workbench)
lnstructions for use
Materials Required But Not Provided
Timer
Storage and Stability
The kit can be stored at ***0℃.The test device is stable through the
expiration date printed on the sealed pouch.
The test device must remain in the sealed pouch until use.
Do not freeze.
Do not use beyond the expiration date.
Warnings and Precautions
1.For non-professional self-testing use.Do not use after expiration
date.
2.This package insert must be read completely before performing the
test. Failure to follow the insert givesinaccurate test
results.
3. Do not use it if the tube/pouch is damaged or broken.
4.Test is for single use only.Do not re-use under any
circumstances.5.Humidity and temperature can adversely affect
results.
Specimen Collection
1. COVID**9 Test kit (Colloidal Gold Method) can be performed using
nasal cavity sampling.
2. Testing should be performed immediately after specimen
collection.
3. Bring specimens to room temperature prior to testing.
Test Procedure
Allow test cassette, specimen, and antigen extract buffer control
to equilibrate to room temperature (****5℃) prior to testing. Please wash and
disinfect your hands before the test.
1. Remove the test cassette from the sealed foil pouch and use it
as soon as possible. Best results will be obtained if the assay is
performed within one hour.
2. Place the test device on a clean and level surface.
Operation process:
1.Remove the secretions on the surface of the anterior nasal
cavity, keep the head slightly tilted, and gently and slowly insert
the swab through the nasal cavity (about **4cm), rotate gently 5
times, and gently rotate to remove the swab.
2. Place the antigen extraction tube on the workbench. Place the
antigen extraction buffer bottle vertically downward, squeeze the
bottle to make the buffer drip freely into the extraction tube
without touching the edge of the tube, and add 6 drops (about
**0ml) to the extraction
tube.
3.Put the swab specimen into the extraction tube pre-added with the
antigen extraction buffer, and rotate the swab about *0 times while
pressing the swab head against the tube wall to release the antigen
in the swab, then let it stand for about 1 minute.
4.Remove the swab while squeezing the tip of the swab so that as
much liquid in the swab can be discharged as possible.
5.Install the dripper on the extraction tube and cap it tightly,
and let it stand for about 1 minute.
6.Open the aluminum foil bag and take out the test card, add 3
drops (about **0ml) into
the sample hole of the test card (or use a pipette to add
**0ml), and start the
timer.
7. Wait for the colored line to appear. The result should be read
in *5 minutes. Do not interpret the result after *0minutes.
Interpretation of Results Negative:
If only the C band is present, the absence of any burgundy color in
the T band indicates that no COVID**9(SARS-Cov*2) antigen is
detected in the specimen. The result is negative.
If the test result is negative:
Continue to follow all applicable rules regarding contact with
others and protective measures. Even if the test is negative, an
infection may be present.
ln case of suspicion, repeat the test after **2 days, because the
Coronavirus cannot be accurately detected at all stages of
infection. Positive:
lf the C and T band is present, the test indicates for the presence
of COVID**9(SARS-CoV*2) antigen in the specimen. The result is
COVID**9 positive.
There is currently a suspicion of a COVID**9 infection.
Contact physician/family physician or local health department
immediately.
Follow local guidelines for self-isolation.
Have a PCR confirmatory test performed. 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 cassette. If the problem persists, discontinue using the
test kit immediately and contact your local distributor.
ln case of an invalid test result:
Possibly advance warning due to incorrect test performance.
Repeat the test.
lf test results are still invalid, contact a physician or a
COVID***-Test Center. Limitations
1.Use fresh samples whenever possible.
2.Optimal assay performance requires strict adherence to the assay
procedure described in this insert sheet. Deviations may lead to
aberrant results.
3.A negative result for an individual subject indicates absence of
detectable COVID**9 (SARS-CoV*2) antigen. However, a negative test
result does not preclude the possibility of exposure to or
infection with COVID**9.
4.A negative result can occur if the quantity of the
COVID**9(SARS-CoV*2) antigen present in the specimen is below the
detection limits of the assay, or failed to collect the
COVID**9(SARS-COv*2) antigen in the nasal cavity of the
patient.
5.The test kit provides a self-assessment. A conformed diagnosis
should only be made by a physician after all clinical and
laboratory findings have been evaluated.
6.Only use for in vitro diagnostic, and cannot reused.
7.The antigen extract buffer is used to extract specimens, and
shall not be used internal or external by humans or animals.
Swallowing will cause a serious accident. lf happens, please seek
medical attention immediately. The antigen extract is irritating to
eyes and skin, if splashed into eyes accidentally, please rinse
with water soon. If necessary, consult a doctor and maintain
ventilation during the procedure.
8.This product is only used for self-testing by people aged ****0.
Elderly or minors please use it with their guardian.
