231

Test CPT Codes

86769 x3

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