Immunoassay for the qualitative 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-CoV-2 in nasopharyngeal swab specimens collected 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 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
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