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HelpTest Code LFRI Progentec aiSLE DX Lupus Flare Risk Index, 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
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.
Secondary ID
621644Useful For
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
Immunoassay
Reporting Name
Lupus Flare Risk Index, PSpecimen Type
PlasmaSpecimen Minimum Volume
0.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Plasma | Frozen | 74 days |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Heat-treated specimen | Reject |
Clinical Information
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
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
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
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
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
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.
Day(s) Performed
Wednesday
Report Available
1 to 7 daysSpecimen Retention Time
7 daysPerforming Laboratory
Progentec Diagnostics, IncTest Classification
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
0447U
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| LFRI | Lupus Flare Risk Index, P | Not Provided |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 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 |