NIDS® COVID-19 Antigen Rapid Test At-Home Use
For Over-the-Counter (OTC) at-Home Use
FDA Emergency Use Authorization (EUA): https://www.fda.gov/media/163318/download
Contact us for more information: Tel.: 302 283 1730 Email: email@example.com
SARS-CoV-2 (with the disease referred to as COVID-19), was first reported in December 2019. This virus, which causes COVID-19, in addition to SARS and MERS, is among the top three deadly coronaviruses known to man. SARS-CoV-2 is an enveloped, single-stranded RNA virus of the β genus. The virus can trigger mild to severe respiratory illness and has spread rapidly worldwide. The median incubation time of this virus is about 5 days with symptoms manifestation within 14 days of infection. Some of the symptoms of COVID-19 may include fever, cough, shortness of breath, and loss of taste or smell, among others.
To perform the test, a nasal swab patient specimen is extracted in NIDS Antigen swab buffer. The sample mixture is dispensed into the sample well of the device, and test results are interpreted visually at 15 minutes based on the presence or absence of pink/purple-colored lines. Please see the Result Interpretation Illustration below:
The NIDS COVID-19 Antigen Home Test is a rapid lateral flow immunoassay (LFI) intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. The test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years and older with symptoms of COVID-19 within the first 7 days of symptom onset. Please see the Instructions For Use here:
The NIDS COVID-19 Antigen Rapid Test Kit does not differentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein. Antigen is generally detectable in MT nasal swabs during the acute phase of infection. Positive results indicate the presence of viral antigen, 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. Additional confirmatory testing with a molecular test for positive results may be necessary for results with and without serial testing, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection. 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 should be treated as presumptive and may be confirmed with a molecular assay, if necessary, for patient management. 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 with COVID-19. For serial testing programs, additional confirmatory testing with a molecular test for negative results 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.