Test Catalog

Test Id : FSERO

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SeroNeg RAdx3 Profile

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Overview

Test Catalog

Method Name
A short description of the method used to perform the test

ELISA

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

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

SeroNeg RAdx3 Profile

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

FSERO

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Collection Container/Tube: 10 mL Red

Submission Container/Tube: Plastic vial

Specimen Volume: 3 mL

Acceptable: SST

Collection Instructions: Draw blood in a plain red-top tube(s), serum gel tube is acceptable. Spin down and send 3 mL of serum refrigerated in a plastic vial.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

3 mL (volume does NOT allow for repeat testing)

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis: Reject
Thawing: Warm OK; Cold OK
Gross lipemia: Reject
Gross icterus Reject
Other: Anything other than serum; bacterial contamination

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 Refrigerated (preferred) 14 days
Frozen 60 days
Ambient 7 days

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

SeroNeg RAdx3 is a diagnostic and prognostic panel for Rheumatoid Arthritis designed to complement traditional RF and Anti-CCP testing. This profile, consisting of 14-3-3 eta protein, Anti -CEP-1 Ab and Anti-Sa Ab, enhances the diagnosis of established or early RA (in individuals seronegative for RF and Anti-CCP Ab) and also helps predict disease severity. Decrease in 14-3-3eta and/or Anti-Sa Ab with treatment is associated with less radiographic progression. The presence of Anti-CEP1 and Anti-CCP Antibodies suggests the imminent progression of pre-clinical RA into clinical RA

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.

Interpretation for:

14.3.3 ETA, Rheum. Arthritis:

Reference Range: <0.20 ng/mL

Negative:                <0.20 ng/mL

Weak Positive:       0.20-0.39 ng/mL

Moderate Positive: 0.40-0.79 ng/mL

Strong Positive:     >0.79 ng/mL

 

Interpretation for:

Anti-CEP-1 Ab, IgG and Anti-Sa Ab, IgG:

Reference Range: <20

Negative: <20 units

Weak Positive: 20-39 units

Moderate Positive: 40-80 units

Strong Positive: >80 units

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

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 to 14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Esoterix Endocrinology

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.

  • 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 account representative. 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 LabCorp. It has not been cleared or approved by the 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.

83520

83516 x2

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
FSERO SeroNeg RAdx3 Profile 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.
Z5779 14.3.3 ETA, Rheum. Arthritis 75880-5
Z5780 Anti-CEP-1 Ab, IgG 96561-6
Z5781 Anti-Sa Ab, IgG 54022-9

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 | 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