The Rapid Response™ COVID-19 Antigen Detection Test is a lateral flow immunochromatographic assay intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swabs specimens from individuals with signs and symptoms of upper respiratory infection within the first six (6) days of symptom onset. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the Rapid Response™ COVID-19 Antigen Detection Test and followed with a molecular test.
The test does not differentiate between SARS-CoV and SARS-CoV-2.
- 20 Test cassettes
- 20 Sterile swabs
- 20 Pre-filled buffer tubes with flip-top
- 2 Tube holders
- Instructions for Use
- Quick Reference Guide
The Rapid Response™ COVID-19 Antigen Detection Test is a lateral flow immunochromatographic assay intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swabs specimens from individuals with signs and symptoms of upper respiratory infection within the first six (6) days of symptom onset. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the Rapid Response™ COVID-19 Antigen Detection Test and followed with a molecular test.
The test does not differentiate between SARS-CoV and SARS-CoV-2.
Detects SARS-CoV-2 (COVID-19)
For prescription use only. CLIA Waived coming soon
Read results in 15 minutes
Non-invasive anterior nasal swab
Coronaviruses belong to the β genus. Coronavirus disease 19 (COVID-19) is an acute respiratory infectious disease in patients infected by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The virus incubation period typically ranges from 1 to 14 days, and symptoms may appear within 2 to 14 days following exposure. Possible symptoms include fever or chills, fatigue, new loss of taste or smell, shortness of breath or difficulty breathing, cough, nasal congestion or runny nose, sore throat, myalgia, nausea or vomiting, headache, and diarrhea.
The Rapid Response™ COVID-19 Antigen Detection Test is for the detection of SARS-CoV02 infection. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection.
The test uses antibodies to detect nucleocapsid protein from SARS-CoV-2 in direct nasal (anterior nares) swabs. If SARS-CoV-2 nucleocapsid antigen is present in the sample, a line will form at the test line “T”, which means the test is positive. A control will always appear at “C” on a test that is functioning properly.
Positive Percent Agreement (PPA) = (140/164) = 85.4% (95% CI: 79.1% - 90%)±
Negative Percent Agreement (NPA) = (640/642) = 99.7% (95% CI: 98.9% - 99.9%)±
The Limit of Detection for the Rapid Response™ COVID-19 Antigen Detection Test was determined to be 250 IU/mL (12.5 IU/swab).±
±Clinical study value from product insert.
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Please refer to the product insert for more details.
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