COVAG Study - Covid-19 Antigen Study

1. Background:

Coronavirus disease 2019 (COVID-19) has quickly spread worldwide from Wuhan (China) since December 2019. Reliable diagnostic technologies are pivotal to the fight against COVID-19. While real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) based testing of respiratory specimens remains the gold standard for COVID- 19 diagnostics, several commercial assays for antibodies against (SARS-CoV-2) have emerged during the previous months (Stocking et al., 2020).

Measuring the presence or absence of viral proteins (antigens), antigen tests may provide results diagnosing an active SARS-CoV-2 infection much faster than RT-PCR or equivalent tests. It has been argued that antigen tests may have a lower sensitivity than RT-PCR or equivalent RNA-based tests, and as a result they are much more likely to give false-negative results in individuals with lower amounts of virus. This may possibly make them unreliable in individuals with an asymptomatic course of the disease, in individuals in the first days of infection, and later than 5-7 days after onset of symptoms (SYNLAB press release, 22.09.2020). 2. Objective:

The objective of this non-interventional study is to demonstrate that rapid antigen tests for SARS-CoV-2 (Abbott and Roche) provide fast results and perform equally well than RT-PCR, at least in symptomatic patients with high viral loads. 3. Study Design:

The study will be performed in at the Corona Test Center Stuttgart Cannstatter Wasen operated by Dr. med. Hans-Jörg Wertenauer, Stuttgart, in close collaboration with the SYNLAB MVZ Leinfelden-Echterdingen GmbH. Approximately 2000 patients will be enrolled at after having signed the Informed Consent Form (ICF). Upon a scheduled study duration of eight weeks, the investigators will be able to collect the required 2000 samples (50 patients per day).