This product is a rapid, lateral ﬂow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens from anterior nasal swabs that are self-collected by an individ-ual aged 18 years or older or are collected by an adult from an individual younger than 18 years old. This test is intended for use in individuals with symptoms or other epidemiological reasons to suspect a COVID-19 infection. This product is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection.
The clinical performance study for SARS-CoV-2 Antigen Rapid Test Kit was conducted in Germany. A total of 222 clinical samples were used to perform the test. The positive and negative samples were all conﬁrmed by PCR. The diagnostic sensitivity and diagnostic speciﬁcity of the product was 95.9% (90.8-98.2%) and 100% (96.3-100.0%) respectively.
Results with correlation to Ct value of the positive samples were shown in the table below: