REALY TECH Novel Antigen Saliva Rapid Test (pack of 5)
REALY TECH Novel Antigen Saliva Rapid Test (pack of 5)
299.00  incl. VAT Add to cart

REALY TECH Novel Antigen Saliva Rapid Test (pack of 5)

299.00  incl. VAT

The test is approved for self-testing on the basis of an exception from the Ministry of Health

59.8 CZK / test

  • The test can be used for self-testing according to the exception for Antigenic tests issued by MZČR according to § 4 ODST. 8 GOVERNMENT REGULATION No. 56/2015 SB.
  • Testing time 10 minutes.
  • Sensitivity: 93,94 %.
  • Specificity: > 99 %.
  • Easy samplingthat you performed by the test person.
  • This reduces the risk of virus transmission when performing the test.
  • Quick and easy saliva sampling shortens the time required to perform the test.
  • The test can also be used in children, for which neck or nasopharyngeal sampling is always problematic.
  • Non-invasive

In stock 10 and more pieces - available today

✔️ Easy return with PPL carrier within 14 days.
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The test is approved for self-testing on the basis of an exception from the Ministry of Health

List of exceptions HERE.

PAYMENTS OF THE INSURANCE COMPANY - Manufacturer of antigen tests for which the Ministry has issued an exemption pursuant to Section 4, Paragraph 8 of Government Decree No. 56/2015 Coll.
According to the Ministry of Industry and Trade, you do not have to buy tests only from registered companies, but you only need to use the approved tests (make, type, manufacturer) of the MZCR. Detailed instructions

can be found here…https://www.mpo.cz/cz/rozcestnik/informace-o-koronavirus/pruvodce-testovanim-ve-firmach–259808/

IN STOCK!

REALY TECH Novel Antigen Rapid test for coronavirus package 5 pcs

Quick test for a new coronavirus antigen (SARS-CoV-2) for self-testing. Saliva test is an in vitro diagnostic test for the qualitative detection of coronavirus antigens SARS-CoV-2 present in human saliva, for use of rapid immunochromatographic method. Identification is based on the detection of monoclonal antibodies specific for the new coronavirus antigen. The product image is for illustrative purposes only.

If you are interested in purchasing tests for companies (100 pcs and more), please contact the infoline on tel: 702819650

Product benefits

  • The test can be used for self-testing according to the exception for Antigenic tests issued by MZČR according to § 4 ODST. 8 GOVERNMENT REGULATION No. 56/2015 SB.
  • Testing time 10 minutes.
  • Sensitivity: 93,94 %.
  • Specificity: > 99 %.
  • The great advantage of the test is simple and easy samplingperformed by the test person.
  • This reduces the risk of virus transmission when performing the test. Saliva sampling is not associated with discomfort, such as neck or nasopharyngeal sampling.
  • Quick and easy saliva sampling shortens the time required to perform the test.
  • The test can also be used in children, for which neck or nasopharyngeal sampling is always problematic.

Certificates:

Declaration of conformity

Clinical validation

 

 

Package leaflet (English)

Package leaflet (German)

 

COVID-19 is an acute respiratory infectious disease. People are generally prone. Currently, the main source of infection is patients infected with the new coronavirus; asymptomatic infected people can also be a source of infection. Based on the current epidemiological examination is incubation period 1 to 14 days, usually 3 to 7 days. The main symptoms include fever, fatigue and dry cough. In some cases, nasal congestion, runny nose, sore throat, myalgia and diarrhea may occur.

 

Limitations:

  • The antigenic rapid test device (via saliva) for the new coronavirus (SARS-CoV-2) is an acute phase screening test for qualitative detection.
  • The sample taken may contain an antigen concentration below the sensitivity threshold of the reagent, so that a negative test result does not rule out infection with the new coronavirus.
  • The antigenic rapid salinity test device (via saliva) for the new coronavirus (SARS-CoV-2) detects viable and non-viable antigen against the new coronavirus. The performance of the assay depends on the amount of antigen in the sample and may not correlate with cell culture performed on the same sample. A positive test does not rule out the possibility that other pathogens may be present, therefore it is necessary to compare the results with all other available clinical and laboratory information for an accurate diagnosis.
  • A negative test result may occur if the level of extracted antigen in the sample is lower than the sensitivity of the test or if the sample is of poor quality. • Efficacy of the test has not been established in monitoring antiviral therapy for new coronavirus.
  • Positive test results do not rule out co-infection with other pathogens.
  • Negative test results are not intended to detect coronavirus infection other than SARS-CoV-2.
  • Children tend to spread the virus longer than adults, which can lead to differences in sensitivity between adults and children. • The concentration of the virus in saliva is greatly affected by factors such as food, diet, smoking, breath fresheners, etc. Therefore, follow these instructions carefully before sampling.
  • A negative result may occur if the antigen concentration in the sample is below the detection limit of the test or if the sample was collected or transported incorrectly, therefore a negative test result does not rule out SARS-CoV-2 infection and should be confirmed by viral culture or PCR.

 

Instructions for use: 

Allow the assay device, sample, and extraction buffer to equilibrate to room temperature (15-30 ° C) before testing. Do not put anything in your mouth for 10 minutes before taking an oral fluid sample, including food, drink, chewing gum, tobacco, water, and mouthwash products.

  1. Fill enough saliva into the saliva cup / bag.
  2. Use a dropper to remove saliva from the cup, transfer 4 drops of saliva to the extraction tube.
  3. Remove the extraction tube and extraction buffer bottle, remove the buffer bottle cap, and add all of the extraction buffer to the extraction tube.
  4. Remove the nozzle and attach it to the extraction tube, gently shaking it vertically for about 5 seconds to mix the saliva well with the extraction buffer.
  5. Fold the used cup / bag in half and dispose of it in a plastic bag as medical waste in accordance with local regulations.
  6. Remove the test device from the sealed foil bag and use it as soon as possible. For best results, perform the test immediately after opening the foil pouch. Place the test equipment on a clean and level surface.
  7. Transfer the vertical 3 drops of sample to the well of the test device and start the timer.
  8. The result will be in 10 to 20 minutes. Do not interpret the result for more than 20 minutes.

Result

Positive: Two red lines appear. One red line appears in the control area (C) and one red line in the test area (T). The color shade may vary, but the test should be considered positive whenever only a faint line is present.

Negative : Only one red line appears in the control area (C) and none in the test area (T). A negative result indicates that there are no new coronavirus particles in the sample or that the number of viral particles is below a detectable range.

Not valid : No red line appears in the control area (C). The test is invalid even if there is a line in the test area (T). Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control area failure. Check the test procedure and repeat the test with a new test device. If the problem persists, stop using the test kit immediately and contact your local distributor

Packing: 5 pcs

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