Tests for antibodies

Singclean® rapid antibody test

These tests are CE certified and comply with 56/2015 Coll. on Technical Requirements for Diagnostic Medical Devices and European Directive 98/79/EEC.

Certified in the Netherlands. Guaranteed result accuracy of 95% (when following the instructions in the manual!). These are not government imported tests!!

Purpose of use

The Singclean COVID-19 IgM/IgG (Blood/Serum/Plasma) Rapid Test Kit is used to detect IgM/IgG antibody to COVID-19 in human blood, serum and plasma using colloidal gold. It will quickly and accurately determine if patients are infected with COVID-19. Dr. Nanshan Zhong, China's leading expert on COVID-19, strongly recommends the antibody testing kit to quickly identify large numbers of infected patients and asymptomatic carriers. It is widely used by the Chinese Centers for Disease Control and Prevention. Right now, the demand for COVID-19 IgM/IgG Rapid Test Kit, is increasing drastically in the world.

Singclean tests are reliable. These are not tests imported by either the Czech or Spanish government. Singclean is a company based in Sweden. Singclean produces a variety of other tests (pregnancy, HIV, etc..).

Advantages of the IgM / IgG test

  • Easy to use: no special equipment required
  • Speed: results can be read with the naked eye in 10 to 15 minutes
  • Accuracy: its sensitivity is much higher than nucleic acid PCR
  • Can be used to distinguish COVID-19 infection or other diseases

Who are SingClean COVID-19 rapid coronavirus tests for?

For people who demonstrate an immune reaction - temperature, cough, etc. Basically, we can say that for a person with symptoms of illness, the rapid test serves as a check if the symptoms are a manifestation of the coronavirus or if it is a classic illness like flu, cold, etc.

The rapid test is also intended for people who have had COVID-19 or are recovering from it. A person who is still actively ill has both IgM and IgG antibodies in their blood, which our test identifies. A person who is recovering from COVID-19 disease has only IgG antibodies in the blood, which our test identifies.

The SingClean rapid tests are not intended for blanket testing of, for example, colleagues of an infected person if they are asymptomatic and less than a week has passed since the last contact with the patient. In the case of asymptomatic disease, the levels of antibodies tested will not reach sufficient levels for rapid testing until 5-7 days after infection. A reliable test can therefore be performed up to one week after the last contact. However, it should be remembered that in an asymptomatic person the result only reliably indicates infection a week ago, but if you have had an encounter with another source of infection in the meantime and have become infected, the rapid test will no longer alert you to this, unlike the laboratory test.

Testing steps:

  1. The test must be at room temperature for at least 30 minutes before opening.
  2. The entire test must be performed at the same temperature for 30 minutes. Also avoid drafts from open windows, air conditioning, etc.
  3. Massage the collection site - the belly of the finger or the edge of the belly of the finger.
  4. Disinfect the collection site with the alcohol pad provided.
  5. Remove the cap of the lancet (round part) and prick the tip into the collection site.
  6. Wipe off the first drop of blood with sterile gauze (you can use a sterile patch pad).
  7. Use a disposable micropipette to suction the blood. The blood level must reach above the narrowest part of the pipette.
  8. Drop 2 drops of blood (or 1 drop of serum or plasma) into the smaller hole at the bottom of the test.
  9. Add 2 drops of reaction buffer to the same hole.
  10. Results can be read with the naked eye after 10-15 minutes 

(Note: Test results after more than 20 minutes are invalid!)

Display of results

  • Only line for C = result is negative, test subject does not show COVID-19 infection
  • Lines for IgM and C / lines for IgG and C / lines for IgM, IgG and C = antibodies indicative of COVID-19 disease are indicated. Rapid tests are not a substitute for laboratory testing and are not taken as official recognition of the diagnosis. Contact your physician to discuss the possibility of undergoing laboratory testing. Observe quarantine precautions.
  • C line did not appear = there was an error in testing or the test is inconclusive. Wait 24 hours and use a new test.

When can a test report a false positive?

If you have already had a COVID-19 coronavirus infection in the past, the antibodies checked by the rapid test are estimated to remain in your system for years. Therefore, the rapid tests will be reported as positive regardless of whether you are sick now. This does not mean that you cannot become infected again. Cellular immunity is assumed to take years to build up over time.

In which cases does the rapid test report a false negative?

In addition to the aforementioned testing of asymptomatic persons too soon after sufficient antibody levels have been generated, false negative results in infected persons may occur on rare occasions. Our assays check the levels of two antibodies (lgM and lgG) which together have a 95% confidence level, i.e. only a 5% error rate. If you have symptoms and are convinced that you are infected with COVID-19 despite a negative rapid test result, wait 24 hours (antibody levels will increase, especially with fever) and repeat the test with a new test.

Storage and stability:

The kit can be stored at room temperature or refrigerated (2-30 °C). DO NOT FREEZE. Test kits are stable and therefore usable until the expiration date printed on the sealed bag. 

Do not use after the expiration date.Tests must remain in the sealed bag until use. After opening the sealed test bag, use within 30 minutes. Prolonged exposure to moisture in the air may cause erroneous test results. The test, pipette and other components should be treated as potentially hazardous waste.

Package contents

  • 1x Singclean COVID-19 IgM-IgG Combination Rapid Test (Colloidal Gold Method) sealed with moisture-proof bags
  • 1x alcohol pad with disinfectant
  • 1x disposable lancet with special tip for capillary blood collection
  • 1x disposable micropipette for blood suction
  • 1x syringe with tip 0.10ml of reaction buffer solution (buffer)
  • For hygiene reasons, the goods cannot be returned within the 14-day period.

Related documents:

Prohlášení o shodě
(395 kB)

Návod na použití
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