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FDA Updates Serology Templates for Covid-19 Test Developers

Posted by Laurie Bonner | Nov 24, 2020 | Compliance, Covid 19 |

The two new templates offer recommendations on what to include in emergency use authorization requests for serology tests.

Test from Johns Hopkins could prove useful for large-scale screening and epidemiological surveys.

Clarion infectious disease diagnostics software-as-a-service (SaaS) gives labs data and insights to help fight antimicrobial resistance.

This proprietary test is a multi-analyte protein biomarker assay which is designed to be run from a simple blood draw.

Hologic’s Aptima HIV-1 Quant Dx assay is now the first dual-claim assay for both diagnosis and viral load monitoring in the United States.