Simoa® SARS-CoV-2 N Protein Antigen Test

Immunoassay for the qualitative detection of the nucleocapsid protein (N protein) antigen from SARS-CoV-2 . For use under the Emergency Use Authorization (EUA) only.

The Simoa SARS-CoV-2 N Protein Antigen Test is an automated paramagnetic microbead-based immunoassay intended for the qualitative detection of the nucleocapsid protein (N protein) antigen from SARS-CoV2 in nasopharyngeal swab and anterior nasal swab specimens collected and frozen in Huachenyang iClean Viral Transport Medium (VTM), CDC’s formulation of VTM, normal saline, or phosphate buffered saline (PBS) from individuals who are suspected of COVID-19 by their healthcare provider within 14 days for nasopharyngeal swabs and within 5 days of symptom onset for anterior nasal swab specimens. For anterior nasal swab specimens collected and frozen in transport media only, this test is also authorized for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested twice over two (or three) days with at least 24 hours (and no more than 36 hours) between tests. This test is also intended for qualitative detection of the nucleocapsid protein (N protein) antigen from SARS-CoV-2 in saliva specimens that have been collected and frozen from individuals who are suspected of COVID-19 by their healthcare provider within 7 days of symptom onset. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity tests.

Please see the Simoa SARS-CoV-2 N Protein Antigen Test Instructions for Use for the full instructions for use, including Limitations, Warnings, and Precautions