| Web: | mayocliniclabs.com |
|---|---|
| Email: | mcl@mayo.edu |
| Telephone: | 800-533-1710 |
| International: | +1 855-379-3115 |
| Values are valid only on day of printing | |
Test Id : FSAR2
SARS-CoV-2 Neutralizing Antibody
Useful For
Suggests clinical disorders or settings where the test may be helpful
Suggests clinical disorders or settings where the test may be helpful
Detection of specific neutralizing antibodies capable of inhibiting SARS-CoV-2-virus.
Method Name
A short description of the method used to perform the test
A short description of the method used to perform the test
Virus Neutralizing Antibody Test
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Indicates the status of NY State approval and if the test is orderable for NY State clients.
No
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Lists a shorter or abbreviated version of the Published Name for a test
SARS-CoV-2 Neutralizing Antibody
Aliases
Lists additional common names for a test, as an aid in searching
Lists additional common names for a test, as an aid in searching
COVID
SARS
SARS-CoV2
SARS-CoV-2
IMMUNO-COV
FSAR2
Specimen Type
Describes the specimen type validated for testing
Describes the specimen type validated for testing
Serum
Ordering Guidance
Molecular testing is recommended for diagnosis of coronavirus disease 2019 (COVID-19) in symptomatic patients.
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Collection Instructions: Draw blood in a serum gel tube(s), plain red-top tube(s) is acceptable. Centrifuge and aliquot serum; send one aliquot. DO NOT heat-inactivate. Ship 1 mL serum in a plastic vial, frozen.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory
0.2 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross Hemolysis | Reject |
| Gross Lipemia | Reject |
| Gross Icterus | Reject |
| Other | NA |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Frozen (preferred) | 30 days | |
| Refrigerated | 72 hours | ||
| Ambient | 24 hours |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Suggests clinical disorders or settings where the test may be helpful
Detection of specific neutralizing antibodies capable of inhibiting SARS-CoV-2-virus.
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a positive-sense, single-stranded RNA virus that causes coronavirus disease 2019 (COVID-19). Like other coronaviruses that infect humans, SARS-CoV-2 can cause both upper and lower respiratory tract infection. Symptoms can range from mild (ie, the common cold) to severe (ie, pneumonia) in both healthy and immunocompromised patients. SARS-CoV-2 transmission occurs primarily via respiratory droplets. During the early stages of COVID-19, symptoms maybe nonspecific and resemble other common respiratory tract infections, such as influenza. The incubation period for COVID-19 ranges from 3 to 14 days. Typically, immunocompetent individuals with COVID-19 develop detectable antibodies against SARS-CoV-2 approximately 8 to 11 days following onset of symptoms or vaccination. Patients tested prior to this time may be negative for SARS-CoV-2 antibodies.
Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
22-1669 IU/mL
Interpretation
Provides information to assist in interpretation of the test results
Provides information to assist in interpretation of the test results
POSITIVE: Neutralizing antibodies recognizing SARS-CoV-2 were detected in the blood at a level higher than the test threshold of 22 IU/mL. Results suggest prior infection with SARS-CoV-2 or vaccination against SARS-CoV-2.
NEGATIVE: Neutralizing antibody titer is below the test threshold of 22 IU/mL. Negative results may occur in samples collected too soon following infection or immunization, in immunosuppressed patients, or in individuals with waning immunity.
BORDERLINE: No determination regarding the titer of neutralizing antibodies can be made. Borderline samples have either very low antibody titers or are negative for antibodies that neutralize SARS-CoV-2.
INFORMATION ABOUT TITER VALUES: Titer values represent the level of neutralizing antibodies present in a blood sample. IMMUNO-COV titers have been calibrated to World Health Organization International Units per milliliter (IU/mL). Current scientific literature describes the degree of protection from COVID-19 conferred by different neutralizing antibody titers. Please refer to the Imanis website for the most up to date information: www.imanis-immunocov.com.
Note: Before October 2021, titers were reported in IMMUNO-COV VNT units. VNT and WHO IU/mL units are comparable. Multiply VNT result by 0.6954 to get equivalent WHO IU/mL value. Multiply WHO IU/mL result by 1.4380 to get equivalent VNT value.
INFORMATION ABOUT THE IMMUNO-COV TEST: This test was performed in the Imanis CLIA laboratory as a high complexity laboratory developed test. The test quantitatively measures the level (titer) of antibodies in a blood sample capable of blocking a live SARS-CoV-2 mimic virus from infecting Vero-ACE2 cells. The test limit of detection (LOD) is 22 IU/mL. The test upper limit of quantitation is 1669.
More detailed information about the test is available at the Imanis website: www.imanis-immunocov.com or in the following reference: Vandergaast et al. (2021) mSphere 6: e0017021. doi: 10.1128/mSphere.00170-21.
| Convert from | Convert to | Multiply by |
| IU/mL | VNT | 1.4380 |
| VNT | IU/mL | 0.6954 |
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these 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.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC63 or 229E.
Method Description
Describes how the test is performed and provides a method-specific reference
Describes how the test is performed and provides a method-specific reference
The Neutralizing Antibody Assay is a functional assay that detects the presence of specific neutralizing antibodies capable of inhibiting VSV-SARS2-Fluc infection. Vero cells (African green monkey-derived kidney epithelial cells) that have been stably transduced to overexpress angiotensin converting enzyme 2 (ACE2) are infected with a virus displaying the SARS-CoV-2 spike glycoprotein on its surface and encoding the same SARS-CoV-2 spike glycoprotein and a firefly luciferase (Fluc) reporter in its genome. When this virus infects the Vero cells, the cells begin to produce firefly luciferase. A luciferase substrate is then added to assay plates to allow for a luminescence readout, wherein total luminescence (relative light units, RLU) corresponds to the extent of virus infection. The ability of antibodies in human serum or plasma to block infection of Vero-ACE2 cells by VSV-SARS2-Fluc, and thereby to prevent luciferase expression serves as a proxy readout for antibodies capable of neutralizing SARS-CoV-2 infection.
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Indicates whether the report includes an additional document with charts, images or other enriched information
Referral
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Friday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
9 to 11 days
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Indicates the location of the laboratory that performs the test
Imanis Life Sciences
Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
This test was developed, and its performance characteristics determined by Imanis Life Sciences, LLC in a manner consistent with CLIA requirements. This test has not been reviewed, cleared, or approved by the U.S. Food and Drug Administration.
CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
86409
Test Setup Resources
Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.
Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.
Normal and Abnormal sample reports are provided as references for report appearance.
SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.