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Labcorp is your trusted source for rheumatoid arthritis diagnostic services
Rheumatoid Arthritis
Harnessing science to improve the health and lives of people with rheumatoid arthritis (RA).
Rheumatoid Arthritis Testing
Rheumatoid arthritis affects an estimated 1.5 million people in the United States.1 For most people with RA, early diagnosis and treatment can control joint pain and swelling and lessen joint damage.
Labcorp is your trusted single-source solution for RA testing, from RA diagnosis to disease activity monitoring and treatment management.
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RA Profiles and Tests
- RheumAssure®
- RAdx6
- SeroNeg RAdx4
- RA Profile with reflex to SeroNeg RAdx4
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Profiles and Tests
- Thiopurine Metabolites
- MTX Polyglutamates
- Hydroxychloroquine, Whole Blood
- Biologic Drug Concentration and Antibody Testing (DoseASSURE™)
RA Profiles and Tests
- RheumAssure®
- RAdx6
- SeroNeg RAdx4
- RA Profile with reflex to SeroNeg RAdx4
Profiles and Tests
- Thiopurine Metabolites
- MTX Polyglutamates
- Hydroxychloroquine, Whole Blood
- Biologic Drug Concentration and Antibody Testing (DoseASSURE™)
RA Diagnosis
Early RA diagnosis and initiation of disease-suppressing therapy may improve clinical outcomes and reduce the accrual of joint damage and disability.2 Labcorp offers several RA-specific markers that, when used in combination, provide industry-leading sensitivity and help support an early diagnosis of RA. Prognosis is dependent on early, accurate diagnosis and establishing an effective treatment plan.3 Diagnosis and classification of RA has relied heavily on anti-cyclic citrullinated peptide (Anti-CCP) and rheumatoid factor (RF) IgM.2 New markers are available to better identify patients with RA, stratify patients for risk of joint destruction and/or radiographic progression, and monitor disease activity and effectiveness of treatment.
RA Diagnosis
RheumAssure®
Labcorp’s RheumAssure panel contains Rheumatoid Factor (RF), Cyclic Citrullinated Peptide (CCP) Antibodies, and 14-3-3 eta protein tests.
- Used together, these three markers are able to diagnose established RA with a sensitivity of 88-96% and early RA with a sensitivity of 78-92%.3,4
- Elevation of one or more RheumAssure markers is consistent with an RA diagnosis, and if all three markers are negative, a diagnosis is less likely
RA Diagnosis
RAdx6 Profile
The RAdx6 combines four novel markers (14-3-3 eta, Anti-Sa, Anti-CEP-1, and Anti-CarP) with two traditional markers (Anti-CCP and RF-IgM) to enhance diagnosis in early or established RA and help predict disease severity.
- Disappearance or decrease of 14-3-3 eta and/or Anti-Sa with treatment is associated with less radiographic progression
- In preclinical RA, Anti-CEP-1 with Anti-CCP antibodies significantly raises the risk of imminently developing clinical RA
- Anti-CarP may predict the development of RA independently of Anti-CCP and may be present years before the onset of symptoms in RA
RA Diagnosis
SeroNeg RAdx4 Profile and RA Profile (RF and Anti-CCP) reflex to SeroNeg RAdx4
These diagnostic and prognostic panels are designed to complement traditional RF and Anti-CCP testing. The profile consists of 14-3-3 eta, Anti-Sa, Anti-CEP-1, and Anti-CarP.
- Enhances RA diagnosis and helps predict disease severity
- Helps identify RA in Anti-CCP-negative and IgM-RF-negative patients and in the diagnosis of early RA
SeroNeg RAdx4 Profile
RA Profile reflex to SeroNeg RAdx4
Disease Activity Monitor and Prognostic Tool
Vectra® by Labcorp
Achieving a state of disease remission in rheumatoid arthritis (RA) is a primary treatment goal. Until the desired treatment target is reached, drug therapy should be adjusted at least every three to six months. The desired treatment target should be maintained throughout the remaining course of the disease. Vectra provides an objective measure of RA inflammation and can be used to complement other disease activity measures.
RA Monitor & Prognosis
Vectra®
Vectra is an advanced blood test that objectively measures inflammation caused by rheumatoid arthritis.
Vectra provides a personalized score by measuring 12 biomarkers and incorporates information on age, gender and adiposity to measure RA inflammation and predict future risk of radiographic progression.5
RA Monitor & Prognosis
Vectra Cardiovascular Risk
Vectra Cardiovascular Risk provides a personalized assessment of inflammation to predict an RA patient’s risk of a cardiovascular event in the next 3-years.6
Vectra is intended to be used at therapy initiation, change in drug therapy, and to monitor a patient once they achieve low disease activity
RA Treatment Monitoring
Although RA treatment is multifaceted, medications play an important role in patient management. Newly developed laboratory assays aid physicians in monitoring use and maximizing effectiveness of both disease-modifying anti-rheumatic drugs (DMARDs) and biologics.
RA Treatment Monitoring
Methotrexate Polyglutamates
Methotrexate (MTX) is subject to wide pharmacokinetic variability. About 30% of patients do not respond to MTX treatment or experience adverse effects.7 Testing for MTX PGs can help assess patient compliance and determine correct dosing to achieve therapeutic levels and clinical response.8
RA Treatment Monitoring
Hydroxychloroquine, Whole Blood
Hydroxychloroquine (HCQ) concentrations may be useful in achieving maximal clinical benefit while minimizing long-term retinal toxicity in lupus and other chronic autoimmune diseases. Monitoring HCQ may also improve adherence.
RA Treatment Monitoring
Thiopurine Drug
Thiopurine-related testing may be used to assess dosing before and during treatment, as well as to identify patients who may be at risk for drug toxicity.9 The FDA-approved label recommends testing consideration for the most common TPMT gene mutations (genotype) or TPMT activity (phenotype) before beginning treatment due to potentially severe bone marrow toxicity.
TPMT Genotyping
TPMT Enzyme Activity
Monitoring Biologics
Labcorp offers serum measurement of drug and anti-drug antibodies for patients on biologic drug therapy. Drug and anti-drug antibody levels provide the pharmacokinetic and immunogenic assessment that discerns the underlying mechanism of an inadequate response to biologic drug. Testing may be ordered at any time during therapy, though sample collection before the next infusion or injection is recommended.
Monitoring Biologics
DoseASSURE™
Labcorp’s DoseASSURE™ suite of tests includes the following drugs and anti-drug antibodies:
Adalimumab and Anti-Adalimumab Antibody ADL
Certolizumab and Anti-Certolizumab Antibody CTZ
Etanercept and Anti-Etanercept Antibody ETN
Golimumab and Anti-Golimumab Antibody GOL
Infliximab and Anti-Infliximab Antibody IFX
Rituximab and Anti-Rituximab Antibody RTX
Ustekinumab and Anti-Ustekinumab Antibody UST
- Patient on Biologic*
- Inadequate Response
- Free drug trough levels are undetectable or low to intermediate and
- Free drug trough level is therapeutic and
- Anti-drug antibody is undetectable to low
- Pharmacodynamic (mechanistic) response failure: Consider switching biologics out-of-class (after confirming active inflammation
- Anti-drug antibody is undetectable to low
- Good Response
- Free drug trough level is sub-therapeutic and
- Anti-drug antibody is undetectable to low
- Dose optimize to maximally beneficial drug trough concentration
- Anti-drug antibody is undetectable to low
- Free drug trough level is persistently at or above target at 12 months and
- Anti-drug antibody is undetectable to low
- Adequate dose: Maintain dose or consider tapering down
- Anti-drug antibody is undetectable to low
- Free drug trough level is sub-therapeutic and
- Inadequate Response
Want to Speak to your Labcorp Representative?
Rheumatology Services Hotline: 800-338-1918
Vectra® Customer Service: 877-743-8639
* Proposed algorithm for RA patients. A consensus has yet to be reached about target ranges and maximally effective concentrations.3 Optimal drug concentration is patient-specific and depends on disease and desired therapeutic endpoint.
References
- Handout on Health: Rheumatoid Arthritis. National Institute of Arthritis and Musculoskeletal and Skin Diseases Website http://www.niams.nih.gov/health_info/Rheumatic_Disease/default.asp#ra_2 . Accessed February 25, 2014.
- Aletha D, Neogi T, Silman AJ. 2010 rheumatoid arthritis classification criteria. Arthritis Rheum. 2010;62(9):2569-2581.
- Maksymowych WP, Naides SJ, Bykerk V, Siminovitch KA, et al. Serum 14-3-3η is a novel marker that complements current serological measurements to enhance detection of patients with rheumatoid arthritis. J Rheumatol. 2014 Nov;41(11):2104-13. doi: 10.3899/jrheum.131446. Epub 2014 Aug 15. PMID: 25128504.
- Maksymowych WP, Boire G, van Schaardenburg D, et al. 14-3-3η Autoantibodies: Diagnostic Use in Early Rheumatoid Arthritis. J Rheumatol. 2015 Sep;42(9):1587-94. doi: 10.3899/jrheum.141385. Epub 2015 Jul 15. PMID: 26178283.
- Curtis, J.R., Weinblatt, M.E., Shadick, N.A. et al. Validation of the adjusted multi-biomarker disease activity score as a prognostic test for radiographic progression in rheumatoid arthritis: a combined analysis of multiple studies. Arthritis Res Ther 23, 1 (2021). https://doi.org/10.1186/s13075-020-02389-4 .
- Curtis, J.R., Xie, F., Crowson, C.S. et al. Derivation and internal validation of a multi-biomarker based cardiovascular disease risk prediction score for rheumatoid arthritis patients. Arthritis Res Ther 22, 282 (2020). https://doi.org/10.1186/s13075-020-02355-0 .
- Goodman S. Measuring methotrexate polyglutamates. Clin Exp Rheumatol. 2010 Sep-Oct; 28 (5 Suppl 61): S24-S26.
- De Rotte MCFJ, den Boer E, de Jong PHP, et al. Methotrexate polyglutamates in erythrocytes are associated with lower disease activity in patients with rheumatoid arthritis. Ann Rheum Dis. 2013;0:1-7.
- Chevaux JB, Peyrin-Biroulet L, Sparrow MP. Optimizing thiopurine therapy in inflammatory bowel disease. Inflamm Bowel Dis. 2011 Jun; 17(6): 1428-1435.