COVID-19 Antigen Test Kit
COVID-19 Test Kit For Self-Testing Use CE1434

For Nasal Swab

Intended Use

COVID-19 Test Kit (Colloidal Gold Method) is a solid phase immunochromatographic assay for the rapid, qualitative detection of antigen to 2019 Novel Coronavirus in human nasal cavity. This test provides only a preliminary result for self-testing. Therefore, any reactive specimen with the COVID-19 Test Kit (Colloidal Gold Method) must be confirmed with alternative testing method(s) and clinical findings.

Pack Formats

1 test/box

20 tests/box

Singclean nasal self testing 1 test.jpgSingclean nasal self testing 20 tests.jpg













Introduction

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; asymptomatically 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.

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 4-30.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-19 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 (15-25) 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 2-4cm), rotate gently 5 times, and gently rotate to remove the swab.

nasal swab antigen test kit for self testing.png

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 200μL) 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 10 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 100μL) into the sample hole of the test card (or use a pipette to add 100μL), and start the timer.

7. Wait for the colored line to appear. The result should be read in 15 minutes. Do not interpret the result after 20minutes.

covid 19 self testing.jpg

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-19(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 1-2 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-19(SARS-CoV-2) antigen in the specimen. The result is COVID-19 positive.

There is currently a suspicion of a COVID-19 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-19-Test Center.

Performance Characteristics

Clinical Sensitivity, Specificity and Accuracy

The results of the COViD-19 Test Kit (Colloidal Gold Method) were compared to results of RT-PCR assays for SARS-CoV-2 in nasal swab specimens. A total of 499 nasal cavity specimens were tested in this study. The COVID-19 clinical specimens contain specimens from individuals with symptoms within 7 days. The results of test reagent and control reagent both were 350 negative specimens and 149 positive specimens. The sensitivity and specificity calculated were valid in this study.

Singclean nasal clinical data (1).png

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-19 (SARS-CoV-2) antigen. However, a negative test result does not preclude the possibility of exposure to or infection with COVID-19.

4.A negative result can occur if the quantity of the COVID-19(SARS-CoV-2) antigen present in the specimen is below the detection limits of the assay, or failed to collect the COVID-19(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 18-60. Elderly or minors please use it with their guardian.


Specifications
1 test/box 20 tests/box
Applicable scope

COVID-19 Test Kit (Colloidal Gold Method) is a solid phase immunochromatographic assay for the rapid, qualitative detection of antigen to 2019 Novel Coronavirus in human nasal cavity. This test provides only a preliminary result for self-testing. Therefore, any reactive specimen with the COVID-19 Test Kit (Colloidal Gold Method) must be confirmed with alternative testing method(s) and clinical findings.


COVID-19 Test Kit (Colloidal Gold Method) is a solid phase immunochromatographic assay for the rapid, qualitative detection of antigen to 2019 Novel Coronavirus in human nasal cavity. This test provides only a preliminary result for self-testing. Therefore, any reactive specimen with the COVID-19 Test Kit (Colloidal Gold Method) must be confirmed with alternative testing method(s) and clinical findings.