The U.S. Food and Drug Administration (FDA) has approved two COVID-19 tests made by Ender Diagnostics North America, the U.S. subsidiary of the Swiss-based Ender Diagnostics.
Ender Lab and Ender Mass are IVD test kits based on a rapid molecular isothermal nucleic acid amplification technology that are designed for use by laboratory professionals. Ender Lab provides results within 30 minutes after the extraction of the viral RNA, which makes it significantly faster than polymerase chain reaction (PCR) tests. It has a sensitivity of 97.7% and a specificity of 100%, according to the company.
The Ender Mass test does not require a conventional RNA extraction, and it detects the SARS-CoV-2 virus within 30 minutes after sample preparation.