What is this rapid COVID test kit?
This rapid COVID test for sale is available for over the counter use for individuals and business owners looking to secure a supply of rapid COVID tests for onsite testing at home or in the office. This rapid test kit will give an easy to read result in about 15 minutes for an active COVID infection. This rapid test kit was also recently approved for a shallow nasal collection, making sample collection much more efficient and comfortable.
This test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Intended Use of Rapid COVID-19 Antigen Nasal Test Kit
- This COVID-19 Antigen test is a lateral flow immunochromatographic assay
intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in
nasopharyngeal swab specimens directly collected, or collected in BD universal transport media,
from individuals suspected of COVID-19 by their healthcare provider within five days of symptom
- This test is authorized for Over The Counter Use (OTC)
- Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. The antigen
is generally detectable in anterior nasal swab specimens during the acute phase of infection.
- Positive results indicate the presence of viral antigens, but the clinical correlation with patient
history and other diagnostic information is necessary to determine infection status. Positive
results do not rule out a bacterial infection or co-infection with other viruses. The agent detected
may not be the definite cause of disease. Laboratories within the United States and its territories
are required to report all results to the appropriate public health authorities.
- Negative results are presumptive and confirmation with a molecular assay, if necessary, for
patient management may be performed. 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 a
patient’s recent exposures, history and the presence of clinical signs and symptoms consistent