ANTIGEN TEST

Our Coronavirus Antigen Rapid Test Cassette (w/Swab) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) swab specimens for in-site testing of lab testing of individuals who are suspected of a COVID-19. It is intended to aid in the rapid screening of SARS-CoV-2 infections and detects the presence of a specific viral antigen, which implies a current viral infection.

 

Our Covid-19 Antigen Rapid Test represents a major advancement in the rapid and on-site detection of Covid-19, delivering highly accurate test results in as little as 10-15 minutes. It is an easy to use diagnostic that incorporates direct nasopharyngeal (NP) swab specimens taken onsite, directly from individuals who may have been exposed to or who are suspected of being COVID-1 positive. It is a high quality rapid diagnostic designed to assist in the identification of SARS-CoV-2 delivering documented and repeated performance in our Clinical Evaluation.

 

Its’ primary purpose is to identify a current infection in individuals who are either symptomatic or asymptomatic, consistent with COVID-19 or who have recently been exposed to individuals diagnosed with COVID-19 and has detected the presence of COVID-19 in individuals in some cases from as early as day 1 of the infection to the next 10 days following presence of symptoms.

Our Coronavirus -19 Antigen Rapid Test is designed to incorporate nasopharyngeal or nasal swab specimens which are then inserted directly into the assay’s extraction buffer tube and then, after 1 minute,  into our Covid-19 Rapid Test cassette providing visual results in less than 15 minutes at the point of care. Almost immediately, the flow of test specimen flows up the test strip, illuminating the Control Line It is a discrete system not dependent upon other equipment or readers. The complete system is provided with no need to purchase or coordinate the provision of testing with other supply chains with the test maintained at room temperature. All materials to provide an individual test is incorporated into the purchased product.

Pending issuance of the Emergency Use Authorization we are required to include this in our website:

 

WARNING

This test has not been reviewed by the FDA.

 

Negative results do not rule out SARS-CoV-2 infection, particularly those who have been

in contact with the virus. Follow up testing with a molecular diagnostic test should be

considered to rule out infection in these individuals.

 

Use of this test is limited to laboratories certified to perform high complexity testing,

including testing at point-of-care when the site is covered by the laboratory's CLIA

certificate of high-complexity testing.

This test is not for home-use or at-home specimen collection.

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This product is intended for professional use and not for home use.

Our Covid-19 Antigen Rapid Test Cassette is available in two presentations:

Our Pre-EUA (PEUA)version as per US FDA guidelines and our European Union CE version.

COVID-19 ANTIGEN RAPID TEST CASSETTE - Pre-EUA version

Our Covid-19 Antigen Rapid Test has received the PEUA from the US FDA allowing the diagnostic to be sold within the USA to CLIA High Complexity Labs. It includes the US FDA version of the Instructions For Use.

 

Following Clinical Analysis of our PEUA diagnostic, our Pre-EUA (PEUA) End-Point Test Performance is as follows:

            Sensitivity (PPA)    95.74%        (45/47)

            Specificity (NPA)    99.60%        (250/251)

            Accuracy  (OPA)    98.99%        (295/298)

 

 

COVID-19 ANTIGEN RAPID TEST CASSETTE - European Union CE version 

Our Covid-19 Antigen Rapid Test-CE version has been issued the European Union CE Mark for entry and distribution throughout the European Union as well as to those countries that accept the CE international registration. The kit comes complete with the CE version of the Instructions for Use

 

Following Clinical Analysis of our CE version diagnostic, our CE Marked End-Point Test Performance is as follows:

            Sensitivity (PPA)    98.32%        (117/119)

            Specificity (NPA)    99.60%        (743/746)

            Accuracy  (OPA)    99.42%        (862/865)