COVID-19 Virus Antibody & Titer Reflex to ARDL, Legacy Fairview

Sunquest Code:CV19AB  
Epic Code:LAB8200Epic Name:COVID-19 Antibody and Titer Reflex
Synonyms:SARS-COV-2 antibody; Novel Coronavirus Antibody
Turnaround Time:Specimens are sent to reference laboratory Mon-Sat; results are reported in 1-2 days.

This test was developed and its performance characteristics determined by the University of Minnesota Advanced Research and Diagnostic Laboratory (ARDL), which is regulated under CLIA as qualified to perform high-complexity testing.  The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Collection Instructions

Optimal Volume:2 mL
Minimum\Peds Volume:0.7 mL
Container:Red (no gel), Red or gold (gel)
Causes for Rejection:Gross hemolysis

Processing and Shipping

Specimen Processing:Within 2 hours of collection centrifuge and aliquot 1 mL; 0.25 mL minimum.  Serum is the preferred sample; however, Lithium heparin or EDTA plasma will be accepted.  Store in refrigerator.
Shipping Instructions:Ship at refrigerated temperature.
Stability:Room temperature: 8 hours; Refrigerated: 7 days; Frozen: 1 year.
Test Performed at or Referral Lab Lab Sendouts  (Advanced Research and Diagnostic Laboratory (ARDL))


Reference Range:Negative
Limitations:Patients within 10 days of symptom onset for COVID-19 may not produce sufficient levels of detectable antibodies.  Immunocompromised COVID-19 patients may take longer to develop antibodies.  If results are equivocal, repeat testing with additional blood samples is recommended if clinically indicated.
Use:Qualitative screen for total antibodies to COVID-19 (SARS-CoV2) with semi-quantitative measurement of IgG COVID-19 antibodies by endpoint titer, COVID-19 antibodies may be elevated due to a past or current infection.  This test has not been reviewed by the FDA.  Negative results do not rule out COVID-19 infection.  Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV2 infection or to inform infection status.  COVID-19 PCR test should be ordered if current infection is suspected.  False positive results may occur in rare cases due to cross-reacting antibodies.

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