Test Catalog

Test Id : FSCPR

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Scleroderma Comprehensive Profile

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Overview

Test Catalog

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
FANTP ANA Titer and Pattern No No
FCA70 Repeat Anti Scl-70 No No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If Anti-Scl-70 Ab is >=20, Repeat Anti Scl-70 Is performed at an additional charge. If Anti-Nuclear Ab by IFA is positive, reflex test ANA Titer and Pattern is added at no additional charge.

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

RIPA Gel Radiography

Immunofluorescence Antibody

Enzyme-linked immunosorbent assay (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

Scleroderma Comp Profile

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

FSCPR

SCL Panel

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If Anti-Scl-70 Ab is >=20, Repeat Anti Scl-70 Is performed at an additional charge. If Anti-Nuclear Ab by IFA is positive, reflex test ANA Titer and Pattern is added at no additional charge.

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.

1 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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

If Anti-Scl-70 Ab is >=20, Repeat Anti Scl-70 Is performed at an additional charge. If Anti-Nuclear Ab by IFA is positive, reflex test ANA Titer and Pattern is added at no additional charge.

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

Anti-U1 RNP Abs can be found in 2-14% of limited SSC and 5% of diffuse SSc. They are associated with isolated pulmonary arterial hypertension, arthritis and esophageal dysfunction. Anti-Th/To Abs are present in 2-6% of patients with limited SSc and are rarely found in diffuse SSc. They have specificity and are associated with isolated pulmonary arterial HTN, pulmonary fibrosis and renal crisis.

Anti-U3 RNP (Fibrillarin) Abs are highly specific for diffuse SSc with a sensitivity of 4-10%. They are associated with isolated arterial hypertension, myositis, renal and cardiac manifestations of SSc.

Anti-PM/SCL Abs are found in 25% of Scleroderma/myositis overlap, 10% of idiopathic inflammatory myopathy and 2% of Scleroderma cutaneous changes and ILD.

Anti-RNA Polymerase III Abs are useful in the diagnosis of SSc and for the identification of patients at risk for developing renal crisis, progressive skin thickening and cancer. The prevalence of IgG RNAP III antibodies is 20-35% in diffuse SSC and 9% in limited SSc.

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.

Anti-Nuclear Ab by IFA, Anti-U3 RNP(Fibrillarin), Anti-Th/To Ab:

Reference Range: Negative

 

Anti-Centromere Ab:

Reference Range: <1:40

 

Anti-SCL-70 Ab:

Reference Range: <20

 

Anti-RNA Polymerase III, Anti-U1RNP Ab, and Anti-PM/Scl-100 Ab:

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.

14 to 25 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.

86038

83516

86235 x 5

86256

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
FSCPR Scleroderma Comp 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.
Z5784 Anti-Nuclear Ab by IFA Not Provided
Z5785 Anti-Centromere Ab Not Provided
Z5786 Anti-RNA Polymerase III Not Provided
Z5787 Anti-Scl-70 Ab Not Provided
Z5788 Anti-U1 RNP Ab Not Provided
Z5789 Anti-U3 RNP (Fibrillarin) Not Provided
Z5790 Anti-Th/To Ab Not Provided
Z5791 Anti-PM/Scl-100 Ab Not Provided

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