Introduction
The SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) is intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein in human nasopharyngeal or nasal swab sampled from individuals suspected of COVID-19. Positive results should not be used alone for determining SARS-CoV-2 infection status, but should be combined with clinical observations, patient history, epidemiological information, and other laboratory evidence. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.
Parameters
Testing time: 10-15 minutes
Sensitivity: 98.4%
Specificity: 98.1%
*no device required
Certificates
CE-IVD
Schneller SARS-CoV-2-Antigen-Test (kolloidale Goldmethode).pdf
Klinischer Bewertungsbericht für SARS-CoV-2-Antigen-Schnelltest (mit Gold-Kolloid).pdf