The COVID-19 At-Home Test provides results for individuals with symptoms suggestive of COVID-19. The Self Test can be performed by the general public. Testing whenever and wherever needed can be the basis for safer decision making.
An aid in identifying individuals infected by SARS-CoV-21
The COVID-19 At-Home Test is an immunochromatography test for the qualitative detection of SARS-CoV-2 antigen in human nasal samples.
This test is used to detect antigens of the SARS-CoV-2 virus in individuals with symptoms suggestive of COVID-19 and is designed as a self test for the general public. It is an in vitro diagnostic medical device.
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is an enveloped, single-stranded RNA virus of the family Coronaviridae. Coronaviruses share structural similarities and are composed of 16 nonstructural proteins and 4 structural proteins: spike (S), envelope (E), membrane (M), and nucleocapsid (N). Coronaviruses cause diseases with symptoms ranging from those of a mild common cold to more severe ones such as Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2.2,3
SARS-CoV-2 is transmitted from person-to-person primarily via respiratory droplets, while indirect transmission through contaminated surfaces is also possible.4-7 The virus accesses host cells via the angiotensin-converting enzyme 2 (ACE2) receptor, which is most abundant in the lungs.8,9
The incubation period for COVID-19 ranges from 2 - 14 days following exposure, with most cases showing symptoms approximately 4 - 5 days after exposure.4,10,11 The spectrum of symptomatic infection ranges from mild (fever, cough, fatigue, loss of smell and taste, shortness of breath) to critical.12,13 While most symptomatic cases are not severe, severe illness occurs predominantly in adults with advanced age or underlying medical comorbidities and requires intensive care. Acute respiratory distress syndrome (ARDS) is a major complication in patients with severe disease. Critical cases are characterized by e.g., respiratory failure, shock and/or multiple organ dysfunction, or failure.12,14,15
The SARS-CoV-2 virus causes respiratory tract infection. It is transmitted mainly via respiratory droplets after close contact, and primary viral replication is presumed to occur in mucosal epithelium of the upper respiratory tract (nasal cavity and pharynx).2 At these locations viral load peaks within the first week after symptom onset, and then declines.3
A COVID-19 At-Home Test detects the presence of the SARS-CoV-2 virus from part of the upper respiratory tract swab specimens by identifying specific antigens that are carried by the virus. The test identifies current infection during the acute phase of COVID-19, while the virus is still present in large quantities in the respiratory tract.
At Roche Diagnostics we believe wide accessibility to such simple, convenient, fast and instrument-free tests can contribute significantly to better managing the ongoing pandemic crisis.
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