Evaluation of the Performance of Rapid Diagnostics for SARS-CoV-2 Self-testing in the Hands of Untrained

The aim of this study is to independently evaluate the usability and performance of rapid assays detecting SARS-CoV-2 antigen(s) and intended for self-testing. For this, the results of the test performed and interpreted by an untrained lay user will be compared to the results obtained by a trained healthcare professional using the same test kit, and, separately, to the current gold standard for testing, RT-PCR detecting SARS-CoV-2 RNA

Phase 1 Inclusion Criteria:18 years of ageAble to speak and read local language depending on site of recruitmentProvided voluntary written consent to participate in this studPhase 11 inclusion Criteria:18 years of ageAble to speak and read local language depending on site of recruitmentSuspected to have COVID-19 (as per WHO or national guidelines).SYMPTOMATIC group)Contacts of confirmed cases of COVID-19Individuals residing or working in an area with high risk of transmission of virusIndividuals residing or travelling to an area with community transmissionIndividuals working in any health care setting, including within health facilities or within the communityWritten consentProvided the required number of specimens suitable for testing. Exclusion criteriaParticipated in Phase I or Phase II of the studyPrior medical or clinical laboratory trainingPrior experience with self-testing for SARS-CoV-2Hemodynamic instability as determined by the treating physicianunable to cooperate with respiratory sample collection or on oxygen therapyRecent history of excessive nose bleedsAny condition which, in the opinion of the investigator feels unable to participate in the study