Updated Guide for Using COVID-19 Self Tests in the EU/EEA

The ECDC published a document on March 17, 2021, that outlines the public health considerations for the use of self-tests to detect SARS-CoV-2 by public health authorities in the European Union/European Economic Area (EU/EEA).

Self-testing could therefore enhance disease control with prompt identification and isolation of cases. However, shifting the responsibility of reporting test results from health professionals and laboratories to individuals could lead to underreporting, and make response measures such as contact tracing and quarantine of contacts even more challenging, says the ECDC.

Only rapid antigen detection tests (RADTs) for self-testing for direct detection of SARS-CoV-2 virus particles in infectious individuals are considered within this document.

RADTs that can be used as self-tests to detect SARS-CoV-2 are becoming available in the EU/EEA. These tests require individuals to collect a specimen, conduct a test and interpret the results by themselves.

When writing this document, there were only a few RADTs available for self-testing for COVID-19, and there was no CE-marked RADT for self-testing placed on the EU market in compliance with Directive 98/79/EC. An additional challenge is that samples from self-testing would not be available for sequencing and monitoring variants of concern.

From a public health perspective, self-tests can offer advantages when complementing professionally administered RADTs or RT-PCR tests.

They can improve the accessibility to testing and enable individuals to obtain the result very quickly, supporting the early detection of infectious cases and reducing further community transmission.