Description
This laboratory test quantitatively measures the SARS-CoV-2 nucleocapsid (N) protein associated with circulating exosomes isolated from plasma/serum.
Exosomes are small extracellular vesicles released by cells into the bloodstream. Following viral infection, viral proteins may be present within or associated with these vesicles.
The assay detects nucleocapsid protein associated with purified extracellular vesicles (including exosomes). Protein that is fully degraded, not vesicle-associated, co-purified outside vesicles, or present below the analytical detection limit may not be measurable.
Because currently authorised spike-based COVID-19 vaccines do not contain the nucleocapsid protein, detection is generally associated with the presence of viral material rather than vaccination alone.
While the test identifies the presence of nucleocapsid protein, it cannot determine the exact timing of infection or the specific viral variant.
Test results should always be interpreted together with clinical symptoms, medical history, and other laboratory findings.