is an immunoassay intended for qualitative detection of antibodies to SARS‑CoV‑2 (COVID-19) in human serum and plasma (K2‑EDTA, K3‑EDTA, Li‑heparin).
The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection.
This serological assay can contribute to the identification of individuals exposed to the virus and assess the extent of exposure of a population, and might thereby help to decide on application, enforcement or relaxation of containment measures.1
Serum sample (SST preferred). Specimens should be collected with appropriate infection control precautions following CDC Interim Infection Prevention and Control Recommendations for Patients with Confirmed Coronavirus Disease 2019 (COVID-19) or Persons Under Investigation for COVID-19 in Healthcare Settings.
Sensitivity: A total of 5,272 samples (from diagnostic routine, blood donors, a common cold panel, and a coronavirus panel*) obtained before December 2019 were tested with the Elecsys® Anti-SARS-CoV-2 assay. Specificity: A total of 204 samples from 69 symptomatic patients with a PCR confirmed SARS-CoV-2 infection were tested with the Elecsys® Anti-SARS-CoV-2 assay. One or more consecutive specimens from these patients were collected after PCR confirmation at various time points. Sensitivity (95 % CI).