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Test Code COV2AB SARS CoV 2 Antibody - Covid 19 Antibodies

Important Note

Indications for testing:    This 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.  At this time it is unknown how long antibodies persist following infection and whether the presence of antibodies confers protective immunity.

This serum antibody test should not be used for primary diagnosis of acute SARS-CoV-2 infection.  The preferred test for that is the direct viral testing (PCR) from a nasal pharyngeal swab. 

Additional information may be found in the May 2020 LabWire announcement.

Additional Codes

Epic Test ID

LAB3778

Specimen Requirements & Patient Preparation

Specimen Type: Serum.   Heparin is also acceptable. See comments below.

Container/Tube: Gold or Red

Specimen Volume: 5 mL

Specimen Minimum Volume: 1 mL serum

 

Heparin plasma is also acceptable.  See specimen stabiltiy section for additional details.

Methodology

Roche Elecsys immunoassay for the qualitative detection of antibodies (including IgG) to SARS-Cov-2. For additional details on this methodology please see this link

 

Specimen Transport Temperature

Refrigerate

Specimen Stability

Serum samples are stable:

                                            3 days at 15‑25 °C  

                                            7 days at 2‑8 °C

                                            28 days at ‑20 °C (± 5 °C).

Note: Plasma samples have the same stability, however due to the breakdown of fibrinogen, for an add-on test, they need to be poured off and re-spun before testing.

Day(s) Test Set Up

Daily, 24/7.

 

Performing Laboratory

Bronson Laboratory Services-Chemistry

Reference Values

Negative

A negative test result does not rule out the possibility of an infection with SARS‑CoV‑2.  Samples from the early phase of illness can yield negative findings. Therefore, this test cannot be used to diagnose an acute infection. Testing with a molecular diagnostic should be performed to evaluate for active infection in symptomatic individuals.   

Note:  over time, serological titers may decline and eventually become negative.

 

Please note:  Positive results indicate  SARS-CoV-2 antibodies were detected.  Such results suggest recent or prior infection with SARS-Cov-2.  Correlation with epidemiologic risk factors and other clinical and laboratory findings is recommended. It is not known at this time if the presence of antibodies to SARS‑CoV‑2 confers immunity to reinfection.

 

 

Test Classification and CPT Coding

86769