Test to verify the analytical sensitivity of COVID-19 Rapid Antigen Test Kits

This document sets out the testing requirements to verify that COVID-19 Rapid Antigen Test (RAT) kits included in the Australian Register of Therapeutic Goods (ARTG) meet the analytical sensitivity requirements outlined in the World Health Organisation (WHO) Technical Specifications of an acceptable analytical sensitivity range of 100 – 1000 TCID₅₀/mL.

Results from this testing verifies the ability of a test kit to report a reactive result on a dilution of viral stock with determined TCID50/mL concentrations.