SARS CoV-2 Nucleocapsid, Total Antibody, Serum

Label Mnemonic: COVIDT
Epic code: LAB9602
Order form: Laboratory Requisition
Supply order: Supply Order Form
Billing: Billing Policies
CPT code: 86769
Specimen(s):
Plasma
Collection Medium:
BD Gold SST 5 mL Vacutainer
Minimum:

1.5 mL serum

Testing Schedule:

Monday, Wednesday, Friday

Turn Around Time:

1–4 days upon receipt at performing laboratory

Reference Range:

Negative

Interpretive Data:

Negative:


No antibodies to SARS-CoV-2 detected. Negative results may occur in serum collected too soon following infection, in patients who are immunosuppressed, or in patients with mild or asymptomatic infection. This test does not rule out active or recent COVID-19 infection and will not detect SARS-CoV-2 vaccine-induced antibodies. Follow-up testing with a molecular test is recommended in symptomatic patients.


Positive:


Severe acute respiratory syndrome coronavirus 2 antibodies to the nucleocapsid protein detected. Results suggest recent or prior infection with SARS-CoV-2. Serologic results should not be used to diagnose recent SARS-CoV-2 infection.

Test Limitations:

Negative results do not preclude SARS-CoV-2 infections. If an acute infection is suspected, direct testing for SARS-CoV-2 virus is necessary. See Ordering Guidance.


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. Extremely high concentrations of biotin in patient serum due to heavy administration or supplementation of biotin may falsely depress anti-SARS-CoV-2 antibody detection.


Performance characteristics have not been established for the following specimen characteristics:

  • Potential endogenous interferences, eg, 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
Methodology:

Electrochemiluminescence immunoassay

Sample Processing:
Centrifuge at a speed and time necessary to get barrier separation of plasma/serum and cells within 1 hour of collection. Send specimen in original tube. Do Not transfer to another tube.
Each sample must be labeled with at least TWO full patient identifiers (First/Last Name & DOB are sufficient for non-UIHC affiliated clients) to avoid sample rejection/delays.
Sample Storage:
Refrigerate.
All sample storage requirements are intended for delivery to UIHC within 24 hours of collection for testing. If samples won't arrive in this time period, please call the UIHC Core Lab for alternative storage/shipping instructions (319-356-3527).
Transport Instructions:
Place labeled specimen into zip-lock type biohazard bag; seal bag.
Place completed requisition into outside pocket of bag.
Transport in cooler with refrigerated coolant packs.