SARS-CoV-2 Antigen Rapid Test Kit

PLEASE NOTE: We have the single pack for the German market which is approved by the BfArM for home testing and sales in supermarkets.

The Antigen tests are immunoassays that detect the presence of a specific viral antigen, which implies current viral infection. Antigen tests are currently authorized to be performed on nasopharyngeal or nasal swab specimens placed directly into the assay’s extraction buffer or reagent. The antigen tests are not restricted to use on persons of a certain age. THIS PARTICULAR ANTIGEN TEST FROM LEPU IS CURRENTLY USED IN AUSTRIA AS SELF-TEST FOR ALL SCHOOL CHILDREN.

The test returns result in approximately 15 minutes. Proper interpretation of antigen test results is important for accurate clinical management of patients with suspected COVID-19, or for identification of potentially infected persons when used for screening.

DOWNLOAD DATASHEET – CLICK HERE

DOWNLOAD DANISH INLAY CARD – CLICK HERE

DOWNLOAD ENGLISH INLAY CARD – CLICK HERE

DOWNLOAD GERMAN INLAY CARD – CLICK HERE

DOWNLOAD CLINICAL VALIDATION – CLICK HERE

SKU: covid19X25-2-1 Category: Tags: ,

Product Description

The Antigen tests are immunoassays that detect the presence of a specific viral antigen, which implies current viral infection. Antigen tests are currently authorized to be performed on nasopharyngeal or nasal swab specimens placed directly into the assay’s extraction buffer or reagent. The antigen tests are not restricted to use on persons of a certain age. THIS PARTICULAR ANTIGEN TEST FROM LEPU IS CURRENTLY USED IN AUSTRIA AS SELF-TEST FOR ALL SCHOOL CHILDREN.

The test returns result in approximately 15 minutes. Proper interpretation of antigen test results is important for accurate clinical management of patients with suspected COVID-19, or for identification of potentially infected persons when used for screening.

The clinical performance of rapid antigen diagnostic tests largely depends on the circumstances in which they are used. Rapid antigen tests perform best when the person is tested in the early stages of infection with SARS-CoV-2 when viral load is generally highest. They also may be informative in diagnostic testing situations in which the person has a known exposure to a confirmed case of COVID-19. Rapid antigen tests can be used for screening testing in high-risk congregate settings in which repeat testing could quickly identify persons with a SARS-CoV-2 infection to inform infection prevention and control measures, thus preventing transmission. In this case, there may be value in providing immediate results with antigen tests even though they may have lower sensitivity than RT-PCR tests, especially in settings where a rapid turnaround time is required.

Clinicians should understand antigen test performance characteristics in order to recognize potentially false negative or false positive results and to guide patient management. Laboratory and testing professionals who perform rapid antigen tests should also understand the factors that affect the accuracy of antigen testing, as described in this guidance.

HOW TO USE:

 

Download English inlay card as pdf-file here:

UK INLAY

Download German inlay card as pdf-file here:

DE INLAY

 

 

 

 

 

Click belowe to download CE certification and Declaration of Conformity:

CE Certification Selftest

Declaration of Conformity

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