SARS-CoV-2 (with the disease referred to as COVID-19), was first reported in Wuhan, China in December 2019. This virus, in addition to SARS and MERS, is among the top three deadly coronaviruses known to man. 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.
The NIDS® COVID-19 Antigen Rapid Test is a rapid, antigen-based test intended for the in vitro qualitative detection of SARS-CoV-2 virus. The test is based on a well-established Lateral Flow Immunoassay (LFI) platform. A patient swab sample is placed in the sample tube containing swab buffer or viral transport media. The sample liquid, upon addition to the test cassette sample well, will migrate laterally along the test strip containing various reagents. If the result is positive, an immune complex will form, resulting in a red colored band visible to the naked eye at the test zone. If the result is negative, no immune complex will be formed, and no color will be shown at the test zone. To make sure the test functions properly, an internal control is also included in the test strip. The end user will need to confirm the presence of the control line on the test strip after completion of testing prior to interpreting any test results.
This test has been validated. FDA independent review of this validation is pending.
The NIDS® COVID-19 Antigen Rapid Test Kit is intended for the in vitro qualitative detection of SARS-CoV-2 virus antigen from SARS-CoV-2 in nasopharyngeal and nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider.
Patient Fact Sheet
Healthcare Fact Sheet
A randomized, double blind clinical trial using patient samples collected from medical facilities is currently under independently clinical evaluation by certified CLIA lab using FDA EUA approved COVID-19 RT-qPCR method for confirmatory testing of the NIDS COVID-19 Antigen Rapid Test.