FDA OKs two COVID-19 tests from Ender

2019 09 16 18 27 8672 Quality Check Mark 400

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.

Page 1 of 22
Next Page