Test #

231

Test CPT Codes

86769 x3

COVID-19 Immune Index™ - IgG, IgM, IgA Antibody Testing by CLIA Correlated with Virus Neutralization

Test Type

Diagnostic Immunology

Test Disease

COVID-19 Infection

Test Technology

Chemiluminescent Immunoassay (CLIA)

Clinical Utility

Follow-up

Test Specimen

Dried Blood Spot (DBS):

  • Dried blood spots collected and dried on an appropriate DBS card

  • Fill circles completely and evenly to the outer edge

  • Reverse side should look similar to the front

  • Dry the DBS card for at least 1 hour prior to packaging for shipping


Serum/Plasma:

  • Serum Separator Tube preferred

  • Absolute minimum volume: 1mL


About This Test

Positive results to antibodies against SARS-CoV-2 are generally indicative of an individual’s current or prior infection with the COVID-19 virus, however, the duration of these antibodies remaining in circulation has not yet been established. These test results should always be considered in the context of a patient’s clinical history, physical examination, epidemiologic exposures and vaccination history before making the final diagnosis.

  • IgM isotype antibodies develop within 5 to 7 days and indicates recent infection.

  • IgG isotype antibodies develop after 10 days and remain in circulation longer. It may indicate past infection or vaccine mediated immune response.

  • IgA isotype antibody development is variable in its response and may indicate It may indicate past infection or vaccine mediated immune response.

Test Storage

Dried Blood Spot (DBS):

  • After appropriate drying time, card may be stored at room temperature for up to three days


Serum/Plasma:

  • If possible, separate serum from cells after 30 minutes but within 2 hours

  • If unable to separate serum, send to lab within 48 hours of draw

  • After separation from cells, store serum:

  • Ambient: 48 hours

  • Refrigerated: 2 weeks

  • Frozen: 1 year (avoid repeatedfreeze/thaw cycles)


Transport Conditions (DBS and Serum/Plasma):

  • Ambient: within 48 hours of collection

  • Refrigerated: within 2 weeks of collection

  • Frozen: within 1 year of collection, if serum is separated from blood cells (avoid repeatedfreeze/thaw cycles)


Rejection Criteria (DBS and Serum/ Plasma):

  • Contaminated, heat-inactivated, hemolyzed, or severely lipemic specimens

  • Frozen whole blood in sample

Turnaround Time (TAT)

≤ 2 days

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