Rapid SARS-CoV-2 Antigen Test Card is a lateral flow immunoassay intended for the comparative detection of nucleocapsid protein from SARS-CoV-2 in nasal swab specimens.
Features:
High Accuracy: Straight-forward nasal swab collection with clinically proven high-accuracy results.
Affordability: Anyone can easily use our three-step, cost-effective portable testing kit
Easy to Use: TTesting can be easily administered in almost any environment without additional special equipment. Easy to transport with no special storage requirements, a test kit is all you need. A nasal swab sample can be self-collected by an individual aged 14 years and older. Children aged 2 to 13 years should be tested by an adult.
Rapid Results: Compared to standard RT-PCR tests which could take multiple days for patients to receive their results, Boson Antigen testers will show results within 15–20 minutes.
Product Information:
Quantity: 5 tests/kit
Sample type: Nasal swab
Storage temperature: 2–30°C
Test time: 15–20 minutes (do not read results after 30 minutes)
Kit Contents: Everything needed to run a test.
- 5 Rapid SARS-CoV-2 Antigen Test Cards (Individually packaged)
- 5 Individual Sample Buffers
- 5 Sterilized swabs (Individually packaged)
- 5 Extraction tubes (Individually packaged)
- 1 Instruction for use
Intended Use
The Rapid SARS-CoV-2 Antigen Test Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or without symptoms or other epidemiological reasons to suspect COVID-19.
This test is also authorized for home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals aged 2 years and older with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
The Rapid SARS-CoV-2 Antigen Test Card does not differentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the Rapid COVID-19 Antigen Test Card should self-isolate and seek follow up care with their physician or healthcare provider as additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of COVID-19, such as in individuals without known exposures to COVID-19 or residing in communities with low prevalence of infection.
All negative results should be treated as presumptive and confirmation with a molecular assay may be necessary if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.
Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.
Individuals who test negative and continue to experience COVID-like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care from their healthcare provider.
The Rapid SARS-CoV-2 Antigen Test Card is authorized for self-use and/or as applicable an adult lay user testing another person 2 years or older in a non-laboratory setting.
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