SARS-CoV-2 Antigen Rapid Test Kit
An aid to identifying people infected by SARS-CoV-2
The Rapid SARS-CoV-2 Antigen Test is a rapid and reliable chromatographic immunoassay for the qualitative detection of specific SARS-CoV-2 antigens present in the human nasopharynx. This test is an aid in detecting the SARS-CoV-2 virus antigen in individuals suspected of COVID-19. This product is strictly designed for professional use in laboratory and point-of-care environments.
SARS-CoV-2: an overview of the structure, transmission and detection of the virus
Severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) is an enveloped single-stranded RNA virus of the Coronaviridae family. Coronaviruses share structural similarities and are composed of 16 non-structural proteins and 4 structural proteins: peak (S), envelope (E), membrane (M), and nucleocapsid (N). Coronaviruses cause illnesses with symptoms ranging from mild to the severe common cold, such as coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.
SARS-CoV-2 is transmitted from person to person mainly through respiratory droplets, while indirect transmission through contaminated surfaces is also possible. The virus accesses host cells through the receptor for angiotensin-converting enzyme 2 (ACE2), which is more abundant in the lungs. The incubation period for COVID-19 varies from 2 to 14 days after exposure, and most cases show symptoms approximately 4 to 5 days after exposure. The spectrum of symptomatic infection ranges from mild (fever, cough, fatigue, loss of smell and taste, shortness of breath) to critical.
Although most symptomatic cases are not severe, severe disease occurs predominantly in older adults or with 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, for example, respiratory failure, shock, and/or multiple organ dysfunction or failure
The benefit of having a SARS-CoV-2 antigen test available
The SARS-CoV-2 virus causes a respiratory tract infection. It is transmitted primarily through respiratory droplets after close contact, and primary viral replication is presumed to occur in the mucosal epithelium of the upper respiratory tract (nasal cavity and pharynx). In these locations, the viral load reaches its peak. peak within the first week after onset of symptoms then declines.
A SARS-CoV-2 antigen test detects the presence of the SARS-CoV-2 virus from part of the upper respiratory tract swab samples by identifying a nucleoprotein carried by the virus. The test identifies the current infection during the acute phase of COVID-19, while the virus is still present in large quantities in the respiratory tract.
Features and Benefits of the Rapid SARS-CoV-2 Antigen Test
In addition to laboratory PCR tests, antigen assays can also be offered as rapid tests in close-patient settings. The Rapid SARS-CoV-2 Antigen Test is a rapid chromatographic immunoassay intended for the qualitative detection of specific SARS-CoV-2 antigens present in combined nasopharyngeal or nasopharyngeal/oropharyngeal specimens. This test is intended to detect SARS-CoV-2 virus antigen in people suspected of COVID-19. This product is strictly designed for professional use in laboratory and point-of-care settings. Like laboratory instruments, it detects a SARS-CoV-2 antigen, the nucleoprotein.
Therefore, it can be used to assess whether a person is infected with SARS-CoV-2 by providing a qualitative result showing coloured bands indicating the presence of SARS-CoV-2 antigens. The rapid SARS-CoV-2 antigen test enables rapid decision-making, e.g. Eg if it is necessary to quarantine patients, which reduces the risk of further spread. In addition to that, it allows the detection of people after a confirmed exposure to a person infected with SARS-CoV-2 or people at risk of exposure, such as healthcare workers.
The rapid SARS-CoV-2 antigen test enables decentralized testing at the point of care and helps expand the range and number of direct virus testing in otherwise inaccessible locations. Rapid tests at the point of care can sometimes be the only viable option if laboratory tests are not sufficiently available. On top of that, the SARS-CoV-2 Rapid Antigen Test is an instruments test, allowing testing in rural or low infrastructure areas.
The benefits of the rapid SARS-CoV-2 antigen test at a glance:
- Get a quick result in 15-30 minutes, no need for a follow-up appointment to discuss the result
- Easy handling that does not require specific training
- No instrument required
- Allow decentralized testing or access to testing in areas where lab testing is not available
Test kit information
The kit is ready to use and contains all the necessary equipment to perform a test. The following components are required for a test and are included in the kit:
- Test device (individually in a foil bag with desiccant)
- Extraction buffer tube
- Nozzle cap
- Sterile swab
- Film (can be attached to the test device when testing outdoors)
- Instructions for use
- Quick reference guide