COVID-19 Spike RBD Antibody & Titer with Reflex to ARDL, Legacy Fairview
| Sunquest Code: | CV19AB | ||
| Epic Code: | LAB8200 | Epic Name: | COVID-19 Spike RBD Aby and Titer Reflex |
| Synonyms: | SARS-COV-2 antibody; Novel Coronavirus Antibody | ||
| Methodology: | Elisa | ||
| CPT Code: | ----------CPTCODES HERE---------- | ||
| Turnaround Time: | Specimens are sent to reference laboratory Mon-Sat; results are reported in 1-2 days. | ||
| Compliance: | 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. |
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Collection Instructions
| Specimen: | Blood |
| 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)) |
Interpretive
| Reference Range: | Negative |
| Limitations: | Patients with recent COVID-19 vaccination or recent symptoms onset from COVID-19 infection 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 by endpoint titer. COVID-19 antibodies may be elevated due to vaccination, or a past or current COVID-19 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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systemlabguide@fairview.org for TestID: 6827"