Options for the use of rapid antigen tests for COVID-19 in the EU/EEA and the UK
On 28 October 2020, a European Commission Recommendation on COVID-19 testing strategies, including the use of rapid antigen tests was published. That recommendation calls for European Union/European Economic Area (EU/EEA) Member States and the United Kingdom (UK) to agree on criteria to be used for the selection of rapid antigen tests, and to share and discuss information regarding the results of validation studies. This ECDC document is intended to facilitate further discussions between Member States with the aim of reaching agreement on the criteria to be used for the selection of rapid antigen tests, as well as scenarios and settings during which it is appropriate to use rapid antigen tests. This document is also intended to support clinical validations of rapid antigen tests.
- Rapid antigen tests can contribute to overall COVID-19 testing capacity, offering advantages in terms of shorter turnaround times and reduced costs, especially in situations in which RT-PCR testing capacity is limited.
- Test sensitivity for rapid antigen tests is generally lower than for RT-PCR.
- Rapid antigen tests perform best in cases with high viral load, in pre-symptomatic and early symptomatic cases up to five days from symptom onset.
- ECDC agrees with the minimum performance requirements set by WHO at ≥80% sensitivity and ≥97% specificity.
- ECDC recommends that EU Member States perform independent and setting-specific validations of rapid antigen tests before their implementation.
- The use of rapid antigen tests is appropriate in high prevalence settings when a positive result is likely to indicate true infection, as well as in low prevalence settings to rapidly identify highly infectious cases.
- Rapid antigen tests can help reduce further transmission through early detection of highly infectious cases, enabling a rapid start of contact tracing.
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