SARS-CoV-2 Nucleocapsid Total Antibody
| Order Code: | LAB8239 | Order 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. | ||
| Compliance: | 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. |
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Collection Instructions
| Specimen: | Blood |
| 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 |
Interpretive
| 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:
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| 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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