Covid-19 Antigen Rapid Test AG-ANRT002
Covid-19 Antigen Rapid Test AG-ANRT002
Specification
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 individual 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.
Product Feature
Non-invasive，Simple to use
No prescription needed
Rapid, get the result in 15 minutes
Stable, with high accuracy
Inexpensive,cost-efficiency
Clinical performance
The clinical performance study for the 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 confirmed by PCR. The diagnostic sensitivity and diagnostic specificity of the product was 95.9%（90.8-98.2%)and100%(96.3-100.0%)respectively.
Results with correlation to Ct value of the positive samples were shown in the table below
| Ct Value | Diagnostic sensitivity | 95%CI |
| ≤30 | 96.2% | 88.3-98.7% |
| ≤32 | 96.0% | 90.0-98.4% |
| ≤34 | 95.5% | 90.0-98.1% |
| ≤36 | 95.9% | 90.8-98.2% |
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