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COVID-19 Antigen Self-Test

Ref. 200063-1

Rapid self-test for the qualitative detection of SARS-CoV-2 antigens in human nasal swab specimens

COVID-19 Antigen Self-Test

SARS-CoV-2 VIRUS

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has been recognized as the virus responsible for the COVID-19 pandemic.

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As with other respiratory diseases, SARS-CoV-2 can cause an asymptomatic infection, causing mild symptoms such as cold, sore throat, cough and fever, loss of taste and/or sense of smell, or more severe symptoms such as pneumonia and respiratory distress with a fatal outcome. The incubation period of SARS-CoV-2 varies from 1 to 14 days, with an average of 5 to 6 days.

WHO IS THIS TEST FOR?

COVID-19 ANTIGEN SELF-TEST is dedicated for anyone who wants to verify a possible SARS-CoV-2 ongoing infection.

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Antigenic tests for COVID-19 allow to carry out a qualitative detection of SARS-CoV-2 in nasal samples and are intended as rapid diagnostic devices to be carried out for home use. It is recommended to use COVID-19 ANTIGEN SELF-TEST during the time frame relating to possible exposure to the virus.

TECH SPECS

COVID-19 ANTIGEN SELF-TEST is an immunochromatographic assay for the qualitative detection of Nucleocapsid antigens in nasal specimens.

Specificity 99.3%
Sensitivity 93.5%
Accuracy 97.6%

CONTENT

  • 1 test cassette
  • 1 vial with dropper containing the extraction buffer
  • 1 nasal swab
  • instructions for use

USE PROCEDURE

  1. Place the vial in the hole on the back of the package and open it, unscrewing the blue cap;
  2. Collect the nasal sample by inserting the swab inside the first nostril up about 1.5 cm. Rotate the swab, extract it and repeat the procedure in the second nostril;
  3. Insert the swab inside the extraction liquid, rotate it and remove it by squeezing the sides of the tube, in order to extract as much liquid as possible;
  4. Add 3 drops of the extracted sample and wait 15 minutes before reading the result.

RESULTS INTERPRETATION

Negative SARS-CoV-2 antigens levels are not present in the sample or they are present in very low concentrations, which are not detectable by the device.
Positive SARS-CoV-2 antigens have been detected by the diagnostic system. It is suggested to contact a specialist or the local health department for further information.

BIBLIOGRAPHY

1. European Centre for Disease Prevention and Control, Disease background of COVID-19 (https://www.ecdc.europa.eu/en/2019-ncov- background-disease)
2. WHO Director-General’s opening remarks at the media briefing on COVID-19 - 11 March 2020 (https://www.who.int/dg/speeches/detail/who-directorgeneral-s-opening-remarks-at-the-media-briefing-on-covid-19 11-march-2020)
3. Centers for Disease Control and Prevention, Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical- specimens.html)
4. European Centre for Disease Prevention and Control. Diagnostic testing and screening for SARS-CoV-2. 2020. https://www.ecdc.europa.eu/en/covid-19/latest-evidence/diagnostic- testing. Accessed January 2022.
5. WHO, Advice on the use of point-of-care immunodiagnostic tests for COVID-19
https://www.who.int/news-room/commentaries/detail/advice-on-the-use-of-point-of-care-immunodiagnostic-tests-for-covid-19
6. Council of the European Union, Council Recommendation on a common framework for the use and validation of rapid antigen tests and the mutual recognition of COVID-19 test results in the E, 20 January 2021.

F.A.Q.

The test has been carried out correctly when the instructions for use are followed. It includes the reading time and the interpretation of the results shown at the "RESULTS INTERPRETATION" section of the instructions for use.

It is advisable to perform the test in the presence of symptoms attributable to COVID-19, or if it is suspected that you have come into contact with positive subjects in the last 5 days.

The color intensity of the control and test bands may vary depending on the concentration of antigens present in the sample. Therefore, any color hue in the test region (T) should be considered as positive.