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SARS-CoV-2 Antibody Profile, Nucleocapsid and Spike

CPT: To be determined. Updates will be made when available.
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Synonyms

  • SARS-CoV-2

Expected Turnaround Time

1 - 3 days


Related Documents


Specimen Requirements


Specimen

Serum or plasma


Volume

2.3 mL


Minimum Volume

1.4 mL (Note: This volume does not allow for repeat testing.)


Container

Gel-barrier tube, red-top tube, or serum transfer tube; or plasma from lithium heparin tube, EDTA, or sodium citrate tube


Collection

Standard aseptic technique


Storage Instructions

Room temperature


Stability Requirements

Temperature

Period

Room temperature

14 days

Refrigerated

14 days

Frozen

28 days (stability provided by manufacturer or literature reference)

Freeze/thaw cycles

Stable x3


Causes for Rejection

Gross hemolysis; visible microbial contamination


Test Details


Use

To evaluate for evidence of previous SARS-CoV-2 infection in individuals with a history of COVID-19 vaccination to aide in the diagnosis of Multisystem Inflammatory Syndrome in children (MIS-C) or adults (MIS-A). The presence of antibodies specific to the SARS-CoV-2 viral nucleocapsid protein is consistent with natural infection as currently available COVID-19 vaccines induce antibodies against the viral spike protein receptor binding domain (RBD) only.


Limitations

These tests should not be used to diagnosis or exclude acute SARS-CoV-2 infection. The results should always be assessed in conjunction with patient's medical history, clinical presentation, and other findings. Negative test results do not rule out the possibility of an infection with SARS-CoV-2. Serum or plasma samples from the very early (pre-seroconversion) phase can yield negative findings. Therefore, these tests cannot be used to diagnosis an acute infection. It has also been reported that certain patients with confirmed infection do not develop SARS-CoV-2 antibodies. Furthermore, waning of antibody titers has been reported in some individuals within a range of months after infection, a feature which has also been reported for other coronaviruses.

These tests have not been FDA cleared or approved. These tests have been authorized by FDA under an Emergency Use Authorization (EUA). These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-2(b) (1), unless the authorization is terminated or revoked sooner. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens.


Methodology

Electrochemiluminescence Immunoassay (ECLIA)


LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
160236 SARS-CoV-2 Antibody Profile 164069 SARS-CoV-2 Ab, Nucleocapsid 94762-2
160236 SARS-CoV-2 Antibody Profile 164091 SARS-CoV-2 Semi-Quant Total Ab U/mL 94769-7
160236 SARS-CoV-2 Antibody Profile 164092 SARS-CoV-2 Spike Ab Interp 94661-6

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf