COVID-19 Total Antibodies Serology (Anti-Spike)
| Label Mnemonic: | COV-SPIKE |
| Epic code: | LAB9101 |
| Downtime form: | A-1a Doctor/Provider Orders - Pathology Core and Specialty Care Nursery |
Chemistry
6240 RCP
356-3527
6240 RCP
356-3527
Specimen(s):
Plasma
Collection Medium:
 |
| Plasma Separator Tube 4.5 mL |
Minimum:
3 mL whole blood from light green top tube or TWO Microtainer® devices
Delivery Instructions:
Deliver to laboratory within 1 hour of collection
Testing Schedule:
24 hrs/day, 7 days a week, including holidays.
Turn Around
Time:
4 hours (upon receipt in laboratory)
Reference Range:
Negative
Interpretive Data:
This Roche assay targets total antibodies to the SARS-CoV-2 spike (S) protein which is also the antigenic target of the vaccines currently available in the United States. Positive results in this assay are possible from either natural infection or vaccination. In natural infection, antibodies are present in a high percentage of patients by 3 weeks after RT-PCR positivity or initial symptoms. While studies have indicated that anti-spike antibodies typically are detectable by several weeks after vaccination, antibody response may be suppressed in those with immune deficiencies or in rare cases with immunocompetent individuals.
Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. A positive result suggests exposure to SARS-CoV-2 but does not necessarily indicate protective immunity. The results of this test should not guide PPE use or adherence to physical distancing practices. False-positive results may occur due to cross-reactivity from pre-existing antibodies (e.g., other coronaviruses) or other causes.
The clinical applicability of semi-quantitative results provided by this assay is currently unknown. The semi-quantitative results should not be interpreted as an indication or degree of immunity, nor should they be compared to other SARS-CoV-2 antibody assays.
This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). It has been authorized by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate or high complexity testing. This test has been performed according to the manufacturer's instructions under the EUA. This test should not be used for screening of donated blood.
Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. A positive result suggests exposure to SARS-CoV-2 but does not necessarily indicate protective immunity. The results of this test should not guide PPE use or adherence to physical distancing practices. False-positive results may occur due to cross-reactivity from pre-existing antibodies (e.g., other coronaviruses) or other causes.
The clinical applicability of semi-quantitative results provided by this assay is currently unknown. The semi-quantitative results should not be interpreted as an indication or degree of immunity, nor should they be compared to other SARS-CoV-2 antibody assays.
This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). It has been authorized by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate or high complexity testing. This test has been performed according to the manufacturer's instructions under the EUA. This test should not be used for screening of donated blood.
Comments:
Additional information for healthcare providers:
(Roche Diagnostics assay)
Additional information for patients:
(Roche Diagnostics assay)
(Roche Diagnostics assay)
Additional information for patients:
(Roche Diagnostics assay)
Test
Limitations:
Hemolysis: No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 1 g/dL).
Lipemia: No significant interference up to an L index of 2000 (approximate triglycerides concentration: 400 mg/dL). Note there is poor correlation between turbidity and triglyceride concentration.
Icterus: No significant interference up to an I index of 66 (approximate conjugated and unconjugated bilirubin concentration: 66 mg/dL).
Biotin: No significant interference up to 1200 ng/mL biotin.
Lipemia: No significant interference up to an L index of 2000 (approximate triglycerides concentration: 400 mg/dL). Note there is poor correlation between turbidity and triglyceride concentration.
Icterus: No significant interference up to an I index of 66 (approximate conjugated and unconjugated bilirubin concentration: 66 mg/dL).
Biotin: No significant interference up to 1200 ng/mL biotin.
Methodology:
Electrochemiluminescence immunoassay
CPT Code:
86769