Test Code 1433E 14-3-3 eta, Serum
Specimen Required
Supplies: Sarstedt Aliquot Tube 5 mL (T914)
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL Serum
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
Useful For
A potentially improved approach for the early identification of patients at-risk for or with early and established rheumatoid arthritis (RA) in combination with specific autoantibody tests
This test is intended to be used as an aid in the early diagnosis of RA and management of the disease.
Method Name
Enzyme-Linked Immunosorbent Assay (ELISA)
Reporting Name
14-3-3 eta, SSpecimen Type
Serum SSTSpecimen Minimum Volume
Serum: 0.4 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum SST | Refrigerated (preferred) | 14 days |
| Frozen | 100 days | |
| Ambient | 48 hours |
Reference Values
< 0.19 ng/mL
Interpretation
Serum 14-3-3 eta was tested in a clinically characterized rheumatoid arthritis (RA) and early RA patient Mayo Clinic patient cohort, where 275 of 446 patients (82.6%) were seropositive (defined as having 3rd generation anti-CCP IgG antibody [CCP3] >20 U and/or rheumatoid factor [RF] >14 IU/mL). A 14-3-3 eta cutoff of ≥0.19 ng/mL for both early and established RA patients was used to calculate the sensitivity and specificity of 14-3-3 eta for RA (n=113) and early RA (n=95).
Serum 14-3-3 eta slightly increased sensitivity for RA (87.0%) and early RA (75.8%) when used in concert with anti-CCP3 IgG and RF, versus the use of a combination of anti-CCP3 IgG and RF alone (RA sensitivity 82.6%, and early RA sensitivity 74.7%).
The addition of 14-3-3 eta offers an increase in specificity for RA (99.1%), and early RA (99.1%), relative to observed positivity with RF and anti-CCP3 IgG antibodies without the use of 14-3-3 eta (RA specificity 94.7%, and early RA specificity 94.7%).
|
Serum 14-3-3 eta concentration (ng/mL) |
Qualitative Interpretation |
|
<0.19 |
Negative |
|
≥0.19-0.39 |
Mild positive |
|
≥0.40-0.79 |
Moderate positive |
|
≥0.80 |
Strong positive |
Clinical Reference
1. Kilani RT, Maksymowych WP, Aitken A, et al. Detection of high levels of 2 specific isoforms of 14-3-3 proteins in synovial fluid from patients with joint inflammation. J Rheumatol. 2007;34(8):1650-1657
2. Maksymowych WP, Naides SJ, Bykerk V, et al. Serum 14-3-3 eta is a novel marker that complements current serological measurements to enhance detection of patients with rheumatoid arthritis. J Rheumatol. 2014;41(11):2104-2113
3. Guan SZ, Yang YQ, Bai X, et al. Serum 14-3-3 eta Could Improve the Diagnostic Rate of Rheumatoid Arthritis and Correlates to Disease Activity. Ann Clin Lab Sci. 2019;49(1):57-62
4. Subedi R, Misbah A, Najada AA, Ocon AJ. Evaluation of 14-3-3eta protein as a diagnostic biomarker in the initial assessment of inflammatory arthritis. J Rheum Dis. 2025;32(2):130-135
5. Shovman O, Gilburd B, Watad A, et al. The diagnostic value of 14-3-3 eta protein levels in patients with rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2018;32(4):610-617
6. Maksymowych WP, Boire G, van Schaardenburg D, et al. 14-3-3? Autoantibodies: Diagnostic Use in Early Rheumatoid Arthritis. J Rheumatol. 2015;42(9):1587-1594
7. Carrier N, Marotta A, de Brum-Fernandes AJ, et al. Serum levels of 14-3-3 eta protein supplement C-reactive protein and rheumatoid arthritis-associated antibodies to predict clinical and radiographic outcomes in a prospective cohort of patients with recent-onset inflammatory polyarthritis. Arthritis Res Ther. 2016;18:37
8. Hammam N, Salah S, Kholef EF, Moussa EM, Marotta A. 14-3-3 eta Protein in serum and synovial fluid correlates with radiographic damage and progression in a longitudinal evaluation of patients with established rheumatoid arthritis. Mod Rheumatol. 2020;30(4):664-670
9. Nelson HA, Martins TB, Saadalla A, Nandakumar V. Evaluation of the clinical performance of anti-mutated citrullinated vimentin antibody and 14-3-3 eta testing in rheumatoid arthritis. Clin Chem Lab Med. 2024;63:790-796
Day(s) Performed
Wednesday
Report Available
3 to 9 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
83520
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| 1433E | 14-3-3 eta, S | 75880-5 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 624066 | 14-3-3 eta, S | 75880-5 |