SARS-CoV-2 IgG Serology Assay

SARS-CoV-2 IgG

Serology testing for SARS-CoV-2 is at increased demand in order to better quantify the number of cases of COVID-19, including those individuals who may be asymptomatic or have recovered. Antibody testing may be a vital tool for determining who has already been infected and might have immunity to the coronavirus.

The U.S. Food and Drug Administration (FDA) has said there are three use cases for serological tests:

  • They could one day help support decision making as to whether people can return to work
  • They could determine the people who may qualify for a vaccination once it is available
  • They could identify individuals who have recovered to see if they can donate plasma that may be used as a treatment for people with severe forms of the disease caused by the novel coronavirus

It's important to target the right antibodies

The Access SARS-CoV-2 IgG assay is designed to target antibodies against the coronavirus spike protein that may be more likely to confer immunity, and detects antibodies to the RBD (Receptor Binding Domain) of the spike protein, which may be important for immunity, based on laboratory studies.

99.8% specificity
100% sensitivity* and 99.8% specificity validated against 1,395 negative broad population-based samples
* 18 days between positive PCR & sample collection; for sensitivity analysis, a total of 247 samples were collected from 192 individual patients - Beckman Coulter source

This Genova Diagnostics Test is Administered under the FDA Emergency Use Authorization (EUA).

Sample Type: Serum

Cash Price per Test*: $100

Insurance Price per Test: No Initial Insurance Payment Needed

*Medicare:
This test is only covered by Medicare if the patient was diagnosed with a known current or known prior COVID-19 infection or suspected current or suspected past COVID-19 infection. In these cases, the patient's laboratory order form should be marked accordingly, and no up-front payment is needed. If the test is being used solely for screening purposes, the Medicare patient will need to complete an ABN form (found here) and supply $100 with their collection pack for the test to be performed.

Analyte List
SARS-CoV-2 IgG Antibodies
Specimen Requirements
Minimum 3 ml serum