COVID-19 tests

Singclean® COVID-19 test kit
(colloidal gold method) from the mouth

Singclean® COVID-19 Test Kit(Colloidal Gold Method) is a solid phase immunochromatographic test for the rapid and high quality detection of COVID-19 antigen in human saliva samples. The test result is within 15 minutes.


DETAILED PRODUCT DESCRIPTION:

TEST IS:

  • Non-invasive
  • Painless
  • Easy to apply
  • Accurate result within 15 minutes

TEST PRINCIPLE:

The COVID-19 (Colloidal Gold Method) test kit is an immunochromatographic test for colloidal gold. The test uses COVID-19 (SARS-CoV-2) antibody (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 (SARS-CoV-2) antibody conjugated to colloidal gold and mouse IgG-gold conjugates. When treated sample buffer containing sample is added to the sample well, COVID-19 (SARS-CoV-2) combines 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 the T test line, the complex is captured and forms a burgundy-coloured band that confirms the reactive test result. The absence of a coloured band in the test area indicates a non-reactive test result. The test contains an internal control (C-band) which should show a burgundy coloured conjugate band regardless of the colour development on any of the test bands. Otherwise, the test result is invalid and the sample must be retested with a new kit.

INSTRUCTIONS FOR USE

  • 3Do not eat, drink, smoke or brush your teeth 30 minutes before saliva collection.
  • Bring the test kit to room temperature before testing.
  • Remove the wrapper from the cotton swab.
  • Hold the tip of the cotton swab on your tongue until the tip is soaked with saliva (at least 2 minutes).
  • Remove the test cartridge from the sealed foil bag and use it as soon as possible. The best results will be obtained if the analysis is performed within one hour.
  • Place the test device on a clean and level surface.
  • Place the antigen extraction tube on the workbench. Place the vial of antigen extraction buffer vertically downwards, squeeze the vial so that the buffer drips freely into the extraction tube without touching the edge of the tube, and add 6 drops (about 200 ul) to the extraction tube.
  • Insert a cotton swab into the extraction tube containing the antigen extraction buffer and rotate the cotton swab about 10 times by pressing the head of the swab against the wall of the tube to release the antigen in the swab, then let it stand for about 1 minute.
  • Remove the cotton swab from the extraction tube and simultaneously squeeze the tip of the swab so that as much liquid as possible flows out of the swab. Dispose of used swabs in accordance with bio-waste disposal methods
  • Install the drip tray on the extraction tube, close it tightly, and let it stand for about 1 minute.
  • Open the aluminium foil bag and remove the test card, add 3 drops (approximately 100 ul) to the sample hole in the test card (or add 100 ul using a pipette) and start the stopwatch.
  • Wait until a coloured stripe appears. The result should be read in 15 minutes. Do not evaluate the test after 20 minutes, such a test may already be invalidated.

INTERPRETATION OF RESULTS

  • NEGATIVE: If only a C band is present, the absence of any burgundy colour in the T band indicates that the COVID-19 antigen (SARS-CoV-2) is not detected in the sample. The result is negative.
  • COVID-19 POSITIVE: In addition to the presence of a C band, if a T band is also displayed, the test indicates the presence of COVID-19 (SARS-CoV-2) antigen in the sample. The result is positive for COVID-19.
  • FAILURE: The control strip is not displayed. Insufficient sample volume or incorrect test procedures are most likely. 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.

SUPPLIED MATERIAL / PACKAGE CONTENTS

  • Sealed bags, each containing a test cartridge, desiccant
  • Stick with cotton swab
  • Antigen extraction buffer
  • Antigen extraction tube
  • Working pad (the packaging box can be used as a tube holder)
  • Instructions for use

WARNING

  • Do not use after the expiry date.
  • Read this package insert carefully before performing the test. Failure to follow the instructions will result in an inaccurate test result.
  • Do not use the test if the tube/pouch is damaged or broken.
  • The test is intended for single use only. Do not use it again under any circumstances.
  • Treat all samples as if they contain infectious material. Observe established precautions against microbiological hazards during testing and follow standard procedures for proper sample disposal.
  • Wear protective clothing such as lab coats, disposable gloves and eye protection during testing.
  • Moisture and temperature can adversely affect results.
  • Do not perform testing in a room with strong airflow, i.e., electric fan or strong air conditioning.

RESTRICTIONS

  • Whenever possible, use fresh samples.
  • Optimal test performance requires strict adherence to the test procedure described in this package insert. Deviations may lead to abnormal results.
  • A negative result for an individual subject indicates the absence of detectable COVID-19 (SARS-CoV-2) antigen. However, a negative test result does not exclude the possibility of exposure to or infection with COVID-19.
  • A negative result may occur if the amount of COVID-19 (SARS-CoV-2) antigen present in the sample is below the detection limits of the test or if the COVID-19 (SARS-COV-2) antigen could not be collected
  • 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 the physician after all clinical and laboratory findings have been evaluated.


Related documents:

Certifikát
(515 kB)

Návod na použití
(880 kB)

Wholesale

At Online Medical we have hundreds of thousands of products in stock. We only supply wholesale to our B2B partners, which include hospitals, pharmacies, offices, schools and large corporations. We pride ourselves on the speed of delivery of contracted goods due to our large inventory and wide range of products in the field of medical supplies and protective equipment.

We always price individually, so don't hesitate to contact us now. Your stock of medical supplies and protective equipment will be ready for the onslaught of Covid-19. You will always have enough mandatory tests for your employees, and you will not run out of quality FFP2 respirators or respirators. You can protect your workers with peace of mind with protective suits and quality disinfection.

Ask for a larger quantity

Address:
Na Pankráci 1062/58
140 00 Prague 4, Czech Republic

Phone:
+420 253 253 753

E-mail:
info@onlinemedical.cz