Intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. The product can be used in any laboratory environment and in an environment other than a laboratory that meets the requirements specified in the instructions for use and local regulations.
The test provides preliminary results. Negative results will not exclude SARS-CoV-2 infection, and cannot be used as the sole basis for treatment or other management decisions. The test is not intended to be used as a donor screening test for SARS-CoV-2.
- Antibody tests are important to confirm that an infection has occurred.
- Rapidly expand capacity to test for the COVID-19 coronavirus.
- Make evidence more widely available.
- Decentralized testing can help alleviate saturation in hospitals.
- Time to result: 10 – 20 minutes.
- A simple digital blood sample.