SARS-CoV-2 Nucleocapsid Total Antibody

Order Code:LAB8239Order Name:SARS-CoV-2 Nucleocapsid Total Antibody
Synonyms:COVID-19 Nucleocapsid Aby; COVID Antibody
Methodology:Chemiluminescent immunoassay
CPT Codes: 86769 x1
Turnaround Time:Specimens are sent to the reference laboratory Mon-Fri; results are reported within 1-3 days.

This test has received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration, and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

Collection Instructions

Optimal Volume:1.2 mL
Minimum\Peds Volume:1.2 mL
Container:Red or gold (gel)
Alternate Containers: Red (no gel)
Patient Preparation:For 12 hours before specimen collection, do not take multivitamins or dietary supplements containing biotin (vitamin B7) which is commonly found in hair, skin and nail supplements and multivitamins.
Causes for Rejection:Grossly hemolyzed, lipemic or icteric specimens.

Processing and Shipping

Specimen Processing:Within 2 hours of collection, centrifuge and aliquot 0.6 mL, 0.5 mL minimum. Store in refrigerator.
Shipping Instructions:Ship at refrigerated temperature.
Stability:7 days at room temperature; 14 days refrigerated; 28 days frozen.
Test Performed at or Referral Lab Lab Sendouts  (Mayo Medical Laboratories)
Referral Lab number:COVTA


Reference Range:Negative
Limitations:The sensitivity of Roche Elecsys Anti-SARS-CoV-2 test in early infection is unknown. Negative results do not preclude severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. If an acute infection is suspected, direct testing for SARS-CoV-2 virus is necessary.

This test detects total antibodies against the SARS-CoV-2 nucleocapsid protein. All current SARS-CoV-2 vaccines induce antibodies to the spike glycoprotein only. Therefore this assay will not detect SARS-CoV-2 vaccine induced anti-Spike glycoprotein antibodies and cannot be used to measure vaccine response.

False positive results for Roche Anti-SARS-CoV-2 IgG test may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

Serum biotin concentrations up to 1200 ng/mL do not interfere with this assay.

Performance characteristics have not been established for the following specimen characteristics:
  • Potential endogenous interferences e.g., hemolysis, bilirubin, rheumatoid factors and pharmaceutical compounds other than biotin have not been tested and therefore interference cannot be excluded.
  • Containing particulate matter
  • Cadaveric specimens
Use:Aid in identifying individuals with an adaptive immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), indicating recent or prior infection.

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