Clungene ANTIGEN LAIENTEST, 5 Stück/Pack
Der Clungene COVID-19 Rapid Test ist ein In-vitro-Diagnostikum für die Eigenanwendung zum Nachweis.
Wichtige Merkmale die für den Antigentest sprechen, sind vor allem die hohe Qualität dieses deutschen Produktes. Besondere Merkmale sind
- Einfach zu nutzen durch eine einfache Probeentnahme im vorderen Nasenbereich
- Schnell und komfortabel mit leicht abzulesenden Ergebnissen nach nur 15 Minuten
- Ausgezeichnete Leistungsmerkmale:
- Spezifität 99,4%
- Sensitivität 97,1%
- Aktenzeichen der Sonderzulassung des BfArM: 5640-S-168/21
- BfArM-AT-Nummer: AT373/21
Das Bundesamt für Arzneimittel und Medizinprodukte (BfArM) listet den Lungene Covid19 Antigen Schnelltest (Nasal) als Laien Antigen Test von Hangzhou Clongene Biotech., Ltd. in seiner Liste der Antigen-Tests zum direkten Erregernachweis des Coronavirus SARS-CoV-2, was wiederum bedeutet, dass eine Erstattungsfähigkeit gemäß der „Verordnung zum Anspruch auf Testung in Bezug auf einen direkten Erregernachweis des Coronavirus SARS-CoV-2“ vorliegt.
- Weitere Informationen zu Laienzulassung finden Sie hier: Tests zur Eigenanwendung durch Laien
- Informationen zur BfArM Zulassung: https://www.bfarm.de/DE/Medizinprodukte/Antigentests/Antigen-Tests_zur_Eigenanwendung.html
- 5 x SARS-CoV-2 Antigen Testkassette (versiegelter Folienbeutel)
- 5 x Steriler Abstrichtupfer
- 5 x Extraktionsröhrchen
- 1 x Gebrauchsanweisung
How do I deal with the test result?
If a rapid antigen test is positive, you are obliged to report this information to the health office responsible for you. The result is then usually verified by a PCR test. For your own protection and also for the protection of those around you, you should quarantine yourself as soon as possible, inform your household members and contacts, and pay increased attention to hygiene and protective measures.
A negative rapid antigen test indicates that it is unlikely that you have Covid-19 at this time. However, it is possible for this test to give a false negative result. This means that you may have Covid-19 even though the test is negative. If you develop symptoms or have doubts about your test result, you should contact your doctor immediately and have an additional PCR test performed in consultation with your doctor.
How reliable is this Covid-19 rapid test?
This Covid-19 rapid test has achieved high sensitivity and specificity rates in clinical testing (see Technical Data). It is listed by the German Federal Office for Drugs and Medical Devices (BfArM) for use by lay persons. It is therefore a scientifically tested medical device with high reliability, approved by the competent German authority.
However, please note that test results can be false positive and false negative and a negative self-test does not guarantee that you do not have Covid-19 or that you are not infectious.
What do sensitivity, specificity, and accuracy mean?
For Covid-19 testing, the terms sensitivity, specificity, and accuracy indicate how high the percentage of correct results was in the clinical test.
Sensitivity indicates the percentage of corona infections actually present that were correctly detected by the test. Example: A sensitivity of 97% means that 97 persons out of 100 corona infected persons were correctly detected, in 3 persons a false negative result was issued.
Specificity describes the value of correct results on uninfected individuals. Example: A specificity of 98% means that a negative result was correctly displayed in 98 out of 100 uninfected persons, but a false positive result was displayed in 2 persons.
The accuracy value, also called the overall coincidence rate, is the average of sensitivity and specificity, i.e. it indicates in how many cases out of one hundred a correct result is displayed.
What is the difference between antigen tests, PCR tests and antibody tests for Covid-19?
There are different types of tests for Covid-19. Molecular tests (also known as PCR tests) detect genetic material of the virus. Antigen tests detect proteins of the virus.
While antigen tests are very specific for the virus, they are not as sensitive as molecular tests. This means that a positive result is very accurate, but a negative result does not rule out infection. If your test result is negative even though you have symptoms or have had contact with a person who has the disease, you should discuss with your doctor whether an additional PCR test would be useful.
Another type of test is an antibody test. A Covid 19 antibody test detects antibodies that your immune system has made in response to a previous Covid 19 infection. Antibody tests are not useful for diagnosing acute Covid 19 infection.