Test Catalog

Test Id : LFRI

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Progentec aiSLE DX Lupus Flare Risk Index, Plasma

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Overview

Test Catalog

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

Aiding in the assessment of risk of flare in lupus patients when used in conjunction with standard clinical assessment

Highlights

This advanced biomarker-based blood test can help assess the risk of a systemic lupus erythematosus-related flare within the next 12 weeks.

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

Immunoassay

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

Lupus Flare Risk Index, P

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

Monocyte chemoattractant protein-1 (MCP1)/CCL2

Interleukin-5 (IL-5)

Interleukin-17A (IL-17A)

Interleukin-7 (IL-7)

Interleukin-4 (IL-4)

Tumor necrosis factor-alpha (TNF-a)

Monocyte chemoattractant protein-3 (MCP3)/CCL7

B Lymphocyte Stimulator (BAFF)/BLys

Osteopontin (OPN)

Tumor necrosis factor receptor 1 (TNFR1)/TNFRSF1A

Tumor necrosis factor receptor 2 (TNFR2)/TNFRSF1B

Progentec

Progentec Diagnostics

Specimen Type
Describes the specimen type validated for testing

Plasma

Ordering Guidance

This test is intended to be ordered for adult patients. If the test is ordered for a patient younger than 18 years testing will be canceled.

Shipping Instructions

Specimen must be shipped frozen. Testing will be canceled if received ambient or refrigerated.

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

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Yellow top (ACD solution A)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Centrifuge at 1500 x g for 20 minutes.

2. Aliquot plasma into plastic vial.

3. Freeze specimen within 2 hours of collection.

Note: Critical frozen. Separate specimens must be submitted when multiple tests are ordered.

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.

0.5 mL

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

Gross hemolysis Reject
Gross lipemia Reject
Heat-treated specimen Reject

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
Plasma Frozen 74 days

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

Aiding in the assessment of risk of flare in lupus patients when used in conjunction with standard clinical assessment

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

This test measures the concentrations of a set of immune modulatory soluble mediators, including cytokines, chemokines, and soluble receptors shown to be altered in plasma prior to clinical disease flare in patients with systemic lupus erythematosus. (1) A proprietary weighted algorithm is used to calculate the patient’s flare risk index (FRI) score ranging from -30 to +30. The magnitude of the score indicates the patient’s risk of developing a flare in the next 12 weeks. Decision curve analysis was used to define cutoff values for low (<-6.4), medium (-6.4 to 9.0), and high (>9.0) risk scores. Applying these cutoff values a maximum sensitivity of 97% and maximum specificity of 98% was observed for the FRI. Additional complementary analyses demonstrated that a patient with a positive score is over 5 times more likely to flare in the next 12 weeks than a patient with a negative score (odds ratio =5.2, p=0.0001). A patient with a positive score >9.0 is highly likely to flare (odds ratio of 9.3, p=0.0233) while a patient with a negative score less than 6.4 is not likely to flare (odds ratio of 18.0, p=0.0003).

 

The following 11 biomarkers are analyzed and used to calculate the FRI test score: B-lymphocyte stimulator (BLyS/BAFF), interleukin-4 (IL-4), IL-5, IL-7, IL-17A, monocyte chemoattractant protein-1 (MCP1), monocyte chemoattractant protein-3 (MCP3), osteopontin (OPN), tumor necrosis factor-alpha (TNF-a), TNF receptor 1 (TNFR1), and TNFR2. These proteins represent several major immune pathways including chemokine/adhesion (MCP-1, MCP-3), homeostasis (IL-7), Th1-type (OPN), Th-2-type (IL-4, IL-5), Th-17-type (IL-17A), and the TNFR superfamily (BlyS/BAFF, TNF-a, TNFR1, TNFR2).

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.

Monocyte chemoattractant protein-1 (MCP1)/CCL2: 54-368 pg/mL

Interleukin-5 (IL-5): 0.260-2.000 pg/mL

Interleukin-17A (IL-17A): 2.100-11.000 pg/mL

Interleukin-7 (IL-7): 1.10-12.00 pg/mL

Interleukin-4 (IL-4): 1.000-3.200 pg/mL

Tumor necrosis factor-a (TNF-a): 1.80-12.00pg/mL

Monocyte chemoattractant protein-3 (MCP3)/CCL7: 0.82-16.00pg/mL

B Lymphocyte Stimulator (BAFF)/BLys: 370-995 pg/mL

Osteopontin (OPN): 14,958-95,972 pg/mL

Tumor necrosis factor receptor 1 (TNFR1)/TNFRSF1A: 617-1595 pg/mL

Tumor necrosis factor receptor 2 (TNFR2)/TNFRSF1B: 1079-3589 pg/mL

Interpretation
Provides information to assist in interpretation of the test results

This test measures the concentrations of 11 blood plasma proteins. An algorithm is applied to these concentrations to calculate a flare risk index score that ranges from -30 to +30 with the magnitude indicating the likelihood of the patient experiencing a lupus flare in the next 12 weeks.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Clinical interpretation of individual biomarker levels has not been established but may be indicative of the pathophysiology of immune, infectious, or inflammatory pathologies.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Munroe ME, Blankenship D, DeFreese D, et al. A flare risk index informed by select immune mediators in systemic lupus erythematosus. Arthritis Rheumatol. 2023;75(5):723-735. doi:10.1002/art.42389

2. Thanou A, Jupe E, Purushothaman M, Niewold TB, Munroe ME. Clinical disease activity and flare in SLE: Current concepts and novel biomarkers. J Autoimmun. 2021;119:102615. doi:10.1016/j.jaut.2021.102615

3. Munroe ME, Vista ES, Merrill JT, Guthridge JM, Roberts VC, James JA. Pathways of impending disease flare in African-American systemic lupus erythematosus patients. J Autoimmun. 2017;78:70-78. doi:10.1016/j.jaut.2016.12.005

4. Munroe ME, Vista ES, Guthridge JM, Thompson LF, Merrill JT, James JA. Proinflammatory adaptive cytokine and shed tumor necrosis factor receptor levels are elevated preceding systemic lupus erythematosus disease flare. Arthritis Rheumatol. 2014;66(7):1888-1899. doi:10.1002/art.38573

Method Description
Describes how the test is performed and provides a method-specific reference

Analyte specific antibodies are pre-coated onto a microfluidic Simple Plex cartridge. Samples are diluted and added to the cartridge. The sample runs through a microfluidic channel that binds the protein of interest. The Ella platform washes off any unbound analyte and adds a detection reagent. Each channel utilized for analyte capture encompasses three glass nano reactors coated with a capture antibody, providing analyte values in triplicate. A calculated analyte value is then generated from the factory-calibrated standard curve that is built into every cartridge.

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.

Wednesday

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.

1 to 7 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

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

Progentec Diagnostics, Inc

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.

Progentec Diagnostics developed and characterized this test. It is intended for clinical use and the reported results should be interpreted in relation to each patient’s clinical condition and medical history. This test is a laboratory developed test (LDT) and is not cleared by the US Food and Drug Administration (FDA). Progentec Diagnostics Clinical Laboratory is certified under the Clinical Laboratory Improvement Amendment (CLIA) of 1988 and accredited by the College of American Pathologists to perform high complexity clinical testing.

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.

0447U

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
LFRI Lupus Flare Risk Index, P 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.
FR1 Mono chemoattrac prot-1 (MCP1) CCL2 Not Provided
FR2 Interleukin 5 (IL-5) Not Provided
FR3 Interleukin 17A (IL-17A) Not Provided
FR4 Interleukin 7 (IL-7) Not Provided
FR5 Interleukin 4 (IL-4) Not Provided
FR6 Tumor necrosis factor alpha Not Provided
FR7 Mono chemoattrac prot-3 (MCP3) CCL7 Not Provided
FR8 B Lymphocyte Stimulator (BAFF) BLyS Not Provided
FR9 Osteopontin (OPN) Not Provided
FR10 Tumor necrosis factor receptor 1 Not Provided
FR11 Tumor necrosis factor receptor 2 Not Provided
FR12 aiSLE DX FRI Score Not Provided
FR13 Comments 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

Test Update Resources

Change Type Effective Date
New Test 2024-04-25