Purpose

This assay is for the semi-quantitative detection of IgG antibodies against the spike glycoprotien of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19.  It allows detection of IgG antibodies in both patients with previous COVID infection and those who have been vaccinated with  any of the SARS-CoV-2 vaccines available in the US. The test cannot distinguish if a patient has antibodies as 
a result of vaccination or from a previous infection.
 

Collect

SST/Serum Gold Top Vacutainer Tube
Minimum Volume:  0.5 - 1.0 mL
 

Specimen Preparation

Allow serum tube to clot completely at room temperature for a minimum of 20 mins. Separate serum from cells within 2 hours of collection.

Storage/Transport Temperature

Refrigerated

Stability (from collection to initiation)

After separation from cells:
  • Room temperature  (15-30°C) –   2 days
  • Refrigerated at 2‑8°C -   7 days
  • Frozen (≤ -20°C) –   Longer stability

Cerner Orderable(s)

COVID IgG Antibody, Spike, Semi-Quantitative Assay

Performed

Samples are processed centrally at St Joseph’s Hospital 

This test has not been FDA cleared or approved but has been authorized for emergency use by the FDA under an EUA for use by laboratories certified under CLIA.

Reported

Within 24 hrs

Synonyms

  • COVID IgG antibody

Reference Interval

Negative

Interpretive Data

A positive result indicates prior infection and/or vaccination.  While the numerical value (index) corresponds to the relative amount of IgG antibodies detected, neither a positive result nor the index should be interpreted as an indicator of the degree of immunity or protection from infection.  A negative result indicates SARS-CoV-2 IgG antibodies were not detected but does not exclude a recent or prior infection.

The cutoff is 50.0 AU/mL.

As with all analyte determinations, the result should be used in conjugation with information available from clinical evaluation and other diagnostic procedures.
 
Collection

Purpose

This assay is for the semi-quantitative detection of IgG antibodies against the spike glycoprotien of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19.  It allows detection of IgG antibodies in both patients with previous COVID infection and those who have been vaccinated with  any of the SARS-CoV-2 vaccines available in the US. The test cannot distinguish if a patient has antibodies as 
a result of vaccination or from a previous infection.
 

Collect

SST/Serum Gold Top Vacutainer Tube
Minimum Volume:  0.5 - 1.0 mL
 

Specimen Preparation

Allow serum tube to clot completely at room temperature for a minimum of 20 mins. Separate serum from cells within 2 hours of collection.

Storage/Transport Temperature

Refrigerated

Stability (from collection to initiation)

After separation from cells:
  • Room temperature  (15-30°C) –   2 days
  • Refrigerated at 2‑8°C -   7 days
  • Frozen (≤ -20°C) –   Longer stability
Ordering

Cerner Orderable(s)

COVID IgG Antibody, Spike, Semi-Quantitative Assay

Performed

Samples are processed centrally at St Joseph’s Hospital 

This test has not been FDA cleared or approved but has been authorized for emergency use by the FDA under an EUA for use by laboratories certified under CLIA.

Reported

Within 24 hrs

Synonyms

  • COVID IgG antibody
Result Interpretation

Reference Interval

Negative

Interpretive Data

A positive result indicates prior infection and/or vaccination.  While the numerical value (index) corresponds to the relative amount of IgG antibodies detected, neither a positive result nor the index should be interpreted as an indicator of the degree of immunity or protection from infection.  A negative result indicates SARS-CoV-2 IgG antibodies were not detected but does not exclude a recent or prior infection.

The cutoff is 50.0 AU/mL.

As with all analyte determinations, the result should be used in conjugation with information available from clinical evaluation and other diagnostic procedures.
 
Administrative