Test Catalog

Test Id : FSARM

Immuno-CRON (+) SARS-CoV-2 (Ancestral & Omicron) Neutralizing Antibody Test

Useful For
Suggests clinical disorders or settings where the test may be helpful

Measurement of specific neutralizing antibodies capable of inhibiting ancestral SARS-CoV-2 and SARS-CoV-2 Omicron variant.

Method Name
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.

No

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

SARS-CoV-2 (Mulitplex) NAb

Aliases
Lists additional common names for a test, as an aid in searching

SARS-CoV-2 (Multiplex) Neutralizing Antibody

SARS-CoV-2 (Multiplex) Virus Neutralizing Antibody Test

Immuno-Cron (+) SARS-CoV-2 Neutralizing Antibody Test

COVID

FSARM

IMMUNO-COV

IMMUNO-CRON

SARS

SARS-CoV-2

SARS-CoV2

Specimen Type
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

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

0.2 mL

Reject Due To
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

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 30 days
Refrigerated 5 days
Ambient 72 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

Measurement of specific neutralizing antibodies capable of inhibiting ancestral SARS-CoV-2 and SARS-CoV-2 Omicron variant.

Clinical Information
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 may be 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. SARS-CoV-2 Omicron variant, is a viral variant of ancestral SARS-CoV-2, which contains numerous mutations in the spike glycoprotein. As a result, neutralizing antibodies generated from prior infection with SARS-CoV-2 (ancestral or other variants) or vaccination with an approved anti-SARS-CoV-2 spike vaccine, are not as effective at neutralizing SARS-CoV-2 Omicron variant. However, cross protection is observed, particularly in individuals receiving three doses of an approved vaccine. The two assays performed as part of the IMMUNO-CRON(+) test are designed to measure neutralizing antibodies against both ancestral SARS-CoV-2 and SARS-CoV-2 Omicron variant.

 

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.

Negative (applies to all ages)

Interpretation
Provides information to assist in interpretation of the test results

Note: a result will be indicated for both ancestral SARS-CoV-2 and SARS-CoV-2 Omicron variant.

Negative: No neutralizing antibodies to ancestral SARS-CoV-2 or SARS-CoV-2 Omicron variant detected. Negative results may occur in samples collected too soon following infection or vaccination, in immunosuppressed patients, in some individuals with prior mild illness, or in individuals with waning immunity.

Borderline: A borderline result means no determination regarding the presence or absence of neutralizing antibodies to ancestral SARS-CoV-2 or SARS-CoV Omicron variant can be made.

 

Positive: Neutralizing antibodies detected against ancestral SARS-CoV-2 or SARS-CoV-2 Omicron variant. Results suggest recent or prior infection with SARS-CoV-2 or vaccination against SARS-CoV-2, resulting in the generation of neutralizing antibodies against ancestral SARS-CoV-2 or SARS-CoV-2 Omicron variant. Correlation with epidemiologic risk factors and other clinical and laboratory findings is recommended.

 

INFORMATION ABOUT TITER VALUES

The titer value represents the level of neutralizing antibodies present in a blood sample. For the IMMUNO-CRON (Omicron variant) assay, titer is determined as the amount of sample required to inhibit 50% of the virus used in the IMMUNO-CRON test. Titer values are expressed as 50% inhibitory concentrations, where the concentration is the reciprocal of the dilution used for testing, such that samples with higher titer have more neutralizing antibodies against SARS-CoV-2 Omicron variant. For the IMMUNO-COV (Ancestral) assay, titers have been calibrated to World Health Organization International Units per milliliter (IU/mL). Please refer to the Imanis website for the most up to date information: www.imanis-immunocov.com.

 

INFORMATION ABOUT THE IMMUNO-COV TEST

This test is a combination of two independent assays, which were performed in the Imanis CLIA laboratory as high complexity laboratory developed tests. Together, the assays quantitatively measure the level (titer) of antibodies in a blood sample capable of blocking live SARS-CoV-2 mimic viruses (Ancestral or Omicron variant) from infecting Vero-ACE2 cells. For the IMMUNO-CRON assay, the limit of detection (LOD) is an IC50 of 40 and the upper limit of quantitation is an IC50 of 5120. For the IMMUNO-COV assay, the limit of detection (LOD) is 22 IU/mL and the upper limit of quantitation is 20,862 IU/mL.

More detailed information about the test is available at the Imanis website: www.imanis-immunocov.com.  

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

Negative results do not rule out SARS-CoV-2 infection or prior vaccination against SARS-CoV-2.

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 vaccination, prior infection with other SARS-CoV-2 variants, or prior 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

The Neutralizing Antibody Assay is a functional assay that detects the presence of specific neutralizing antibodies capable of inhibiting VSV-SARS2-Fluc or VSV-SARS2(Omi)-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 ancestral or Omicron variant spike glycoprotein on its surface and encoding the same spike glycoprotein and a firefly luciferase (Fluc) reporter in its genome.  When either 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 to block infection of Vero-ACE2 cells by VSV-SARS2-Fluc or VSV-SARS2(Omi)-Fluc, and thereby to prevent luciferase expression serves as a proxy readout for antibodies capable of neutralizing ancestral SARS-CoV-2 or SARS-CoV-2 Omicron variant infection.

PDF Report
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.

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.

9-11 days

Performing Laboratory Location
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.

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  • 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.

This test was developed, and its performance characteristics determined by Imanis Life Sciences 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.

86409

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
FSARM SARS-CoV-2 (Mulitplex) NAb Not Provided
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
FSARM SARS-CoV-2 (Mulitplex) NAb 95410-7

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.

Excel | Create a PDF

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

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.

SI Normal Reports | SI Abnormal Reports