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SARS-CoV-2 IgG Antibody (COVID-19)

Coronavirus, Corona, corona, Covid, covid, Covid-19

Test Codes

SOFT: CVIG2,  EPIC: LAB7955,  SunQuest: CVIGG2,  EPIC: LAB03876     

Specimen Collection Criteria

Collect (preferred specimen): One Gold-top SST tube. (Minimum Whole Blood: 4.0 mL)

Physician Office/Draw Specimen Preparation

Let SST specimens clot 30-60 minutes then immediately centrifuge to separate serum from cells. Refrigerate (2-8°C or 36-46°F) the centrifuged SST tube within two hours of collection. (Minimum: 2.0 mL)

Preparation for Courier Transport

Transport: Centrifuged SST tube or serum aliquot, refrigerated (2-8°C or 36-46°F). (Minimum: 2.0 mL serum)

Rejection Criteria

• Hemolyzed specimens.
• Severely lipemic specimens.
• Specimens with obvious microbiological contamination

In-Lab Processing

Let SST specimens clot 30-60 minutes. Centrifuge SST or Microtainers^® to separate serum from cells. Deliver immediately to the appropriate testing station.

Storage

Specimen Stability for Testing:

Centrifuged SST Tubes and Microtainers^® with Separator Gel
Room Temperature (20-26°C or 68-78.8°F): 2-4 hours
Refrigerated (2-8°C or 36-46°F): 7 days
Frozen (-20°C/-4°F or below): Unacceptable

Serum Specimens (Pour-Overs)
Room Temperature (20-26°C or 68-78.8°F): 2-4 hours
Refrigerated (2-8°C or 36-46°F): 7 days
Frozen (-20°C/-4°F or below): 7 days

Specimen Storage in Department Prior to Disposal:

Refrigerated (2-8°C or 36-46°F): 7 days

Laboratory

Royal Oak, Chemistry Laboratory

(Dearborn, Chemistry Laboratory)

Performed

Sunday – Saturday
Results available within 3 – 5 days of receipt by the Laboratory.

Reference Range

Negative.

Test Methodology

Chemiluminescence Immunoassay.

Interpretation

This serological test result should always be interpreted together with clinical history and other results such as direct viral detection of SARS-CoV-2 (COVID-19).  The performance characteristics of this test were determined by Beaumont Laboratory.  The test has been cleared by the US Food and Drug Administration under an Emergency Use Authorization.

Clinical Utility

• IgG antibodies to SARS-CoV-2 are detected in the majority of individuals approximately two weeks after the onset of COVID-19 symptoms. If a specimen is collected too early (i.e. prior to seroconversion), the test will yield a negative result.
  
  
• Presence of IgG antibodies indicates a previous exposure to SARS-CoV-2 and is a measure of immunological responsiveness. However, it is not known at this time if the presence of antibodies confers protective immunity against the virus.   
  
  
• The SARS-CoV-2 IgG assay is not a diagnostic test. Direct viral detection assays that employ molecular methods such as nucleic acid amplification, are the only laboratory tests that are diagnostic for COVID-19. 

• IgG results should not be used to make decisions on infection status 

Epidemiology

The 2019 novel Coronavirus SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in December, 2019 near Wuhan City, Hubei Province, China. As this is an emerging pathogen, the incidence and distribution of the virus in the US and world-wide is constantly evolving. Currently, SARS-CoV-2 cases in the US include those that are associated with travel, cases among close contacts of known cases and community-acquired cases where the source of the infection is unknown.

Incubation Period

According to estimates from the World Health Organization (WHO), the incubation period for SARS-CoV-2 ranges from 2 – 14 days with a median incubation period of 5 days.

CPT Codes

86769
LOINC 94507-1

Contacts

Last Updated

5/11/2020