Antigenic COVID-19 certified nasal swab test for coronavirus

Ref. SC5186

COVID-19 Test Kit (Colloidal Gold Method)

The Singclean COVID-19 Test Kit (colloidal gold method) is a solid phase immunochromatographic test for rapid and high-quality detection of antigen from COVID-19 in a human nasal swab sample. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 test kit (colloidal gold method) must be confirmed by alternative test methods and clinical findings.

This rapid antigen test kit is the second test kit developed by Singclean Medical to test COVID-19 based on the colloidal gold method after the worldwide release of the Singclean COVID-19 IgG / IgM Test Kit.

This kit is an in vitro diagnostic medical device intended for self-testing.

INTENDED USE

The COVID-19 Test Kit (Colloidal Gold Method) is a solid phase immunochromatographic assay for the rapid and qualitative detection of the new coronavirus 2019 antigen in the human nasal cavity. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 test kit (colloidal gold method) must be confirmed by alternative test methods and clinical findings.

PACKAGING

1 test set

INTRODUCTION

The new coronaviruses belonging to the genus β. COVID-19 is an acute respiratory infectious disease. Humans are generally prone to infection. Currently, the main source of infection is patients infected with the new coronavirus; asymptomatically infected people can also be a source of infection. Based on the current epidemiological inquiry, the incubation period is 1 to 14 days, usually 3 to 7 days. The main symptoms include fever, fatigue and dry cough. In several cases, there is a stuffy nose, runny nose, sore throat, myalgia and diarrhoea.

PRINCIPLE OF THE TEST

COVID-19 Test Kit (Colloidal Gold Method) is an immunochromatographic test using colloidal gold. The assay uses COVID-19 antibody (SARS-CoV-2) (test line T) and IgG antibody (control line C) immobilized on a nitrocellulose strip. The burgundy-coloured conjugate pad contains colloidal gold conjugated to another COVID-19 antibody (SARS-CoV-2) conjugated to colloidal gold and mouse IgG-gold conjugates. When treated sample-containing buffer is added to the sample well, COVID-19 (SARS-CoV-2) is combined with the COVID-19 antibody conjugate to form an antigen complex. This complex migrates through the nitrocellulose membrane by capillary action. When the complex encounters the COVID-19 antibody line of test line T, the complex is captured and forms a coloured band that confirms the result of the reactive assay. The absence of a coloured bar in the test area indicates a non-reactive test result. The assay includes an internal control (line C), which should show a burgundy band of IgG antibody conjugate regardless of colour development on any of the other test lines. Otherwise, the test result is invalid, and the sample must be retested with a new kit.

CONTENT

MATERIAL PROVIDED
Sealed bag containing test cassette
Cotton swab stick (for nasal collection only）
Antigen extraction buffer
Antigen extraction tube
Leaflet

NECESSARY MATERIAL NOT PROVIDED
Timer

STORAGE AND STABILITY

The kit can be stored at room temperature or refrigerated (4-30 °C). The test device is stable until the expiration date printed on the sealed case. The test equipment must remain in the closed packaging until use. Protect from frost.

Do not use after the expiry date.

WARNINGS AND PRECAUTIONS

1. IVDst: Intended for self-testing. Do not use after the expiry date.
2. Read the package leaflet before the test. Failure to follow the instructions may result in inaccurate test results.
3. Do not use it if the tube (bag) is damaged or broken.
4. The test is for single use only. Do not reuse it under any circumstances.
5. Treat all specimens as if they contain infectious agents. During testing, follow established precautions against microbiological risks and follow standard procedures for proper sample disposal.
6. Wear protective clothing such as lab coats, disposable gloves, and eye protection when testing specimens.
7. Humidity and temperature may adversely affect results.
8. Do not perform the test in a room with strong airflow, i.e. electric fan or strong air conditioning.

SAMPLING

1. Testing with the COVID-19 kit (Colloidal gold method) can be performed by nasal swab sampling).
2. Testing should be performed immediately after sampling.
3. Bring samples to room temperature before testing.
4. If samples are to be sent, they should be packed in accordance with local regulations for the transport of etiological substances.

PERFORMING THE TEST

Allow the test cassette, sample, and antigen extraction buffer to equilibrate to room temperature (15-30 °C) before testing.

1. Remove the test cartridge from the sealed foil pouch and use it as soon as possible. The best results will be obtained if the test is performed within one hour.
2. Place the test device on a clean and flat surface.

Test procedure:

1. Ask the patient to remove the secretions on the surface of the anterior nasal cavity, keep the head slightly tilted, and gently and slowly insert the nasal swab rod into the nasopharynx. When you encounter resistance, you have reached the posterior nasopharynx, stay for a few seconds to absorb the secretions, and gently twist to pull out the tampon.
2. Place the antigen extraction tube on the workbench. Place the antigen extraction buffer vial vertically down, squeeze the vial to allow the buffer to drip freely into the extraction tube without touching the edge of the tube, and add 6 drops (about 200 μl) to the extraction tube.
3. Place the swab sample in an extraction tube pre-added with antigen extraction buffer and rotate the swab rod approximately 10 times. Press the head of the swab against the wall of the tube to release the antigen in the swab, then let it stand for about a minute.
4. Pull out the stick while squeezing the tip of the tampon to drain as much fluid as possible from the tampon. Dispose of used swabs in accordance with bio-waste disposal methods.
5. Install the drip tray on the extraction tube and close it tightly and let it stand for about 1 minute.
6. Open the aluminium foil bag and remove the test card, add 3 drops (approximately 100 μl) to the sample hole on the test card (or add 100 μl using a pipette) and start the timer.
7. Wait until the coloured line (T) appears. The result should be read in 15 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

NEGATIVE: If only line C is visible, the absence of any burgundy colour in the T band indicates that no COVID-19 antigen (SARS-CoV-2) was detected in the sample. The result is negative.

POSITIVE: If, in addition to the presence of line C, a T line is developed, the test indicates the presence of COVID-19 antigen (SARS-CoV-2) in the sample. The result is a positive COVID-19.

INVALID: The control line does not appear. The most likely reason for a control line failure is insufficient sample volume or incorrect procedures. Check the procedure and repeat the test with a new test cartridge. If the problem persists, stop using the test kit immediately and contact your local distributor.

TEST LIMITATIONS

1. If possible, use fresh samples.
2. Optimal test performance requires strict adherence to the test procedure described in this package insert. Deviations can lead to incorrect results.
3. A negative result in an individual subject indicates the absence of detectable COVID-19 antigen (SARS-CoV-2). However, a negative test result does not rule out the possibility of exposure or infection to COVID-19.
4. A negative result may occur if the amount of COVID-19 (SARS-CoV-2) antigen in the sample is below the detection limits of the test or if COVID-19 (SARS-COV-2) antigen has not been collected in the patient's nasal cavity.
5. As with all diagnostic tests, the final clinical diagnosis should not be based on the result of a single test but should be made by a physician only after all clinical and laboratory findings have been evaluated.

REFERENCE
1. Weiss SR, Leibowitz JL. Coronavirus pathogenesis. Adv Virus Res 2011; 81: 85-164.
2. Masters PS, Perlman S. Coronaviridae. In: Knipe DM, Howley PM, eds. Fields virology. 6th ed. Lippincott Williams & Wilkins, 2013: 825-58.
3. Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol 2016; 24: 490-502.
4. Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol 2019; 17: 181-192.

Manufacturer
Hangzhou Singclean Medical Products Co., Ltd.
No. 125(E), 10th street, Hangzhou Economic and Technological Development Zone, Zhejiang, China.P.C.: 310018

Representative in Europe
SUNGO Europe B.V.
Add: Olympisch Stadion 24, 1076DE Amsterdam, Netherlands

Instructions for use:

Instructions for use (English)

Instructions for use (Español)

Instructions for use (Português)

Instructions for use (Français)

Attachments to download:

Brochure 

Instructions for use

CE Certificate self-testing

Declaration of Conformity

Authorization Czech Ministry of Health

Statement on product detection mutations BA4 BA5 - 07/07/2022

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