Test Details
Methodology
Enzyme-linked immunosorbent assay (ELISA)
Result Turnaround Time
7 - 10 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Test Includes
Anti-Ro (SS-A); Anti-La (SS-B); Anti-Fodrin Abs, IgG and IgA
Use
Anti-Ro (SS-A) antibodies occur in 40-50% of SLE, 60-75% of primary Sjogren's syndrome (PSS) and in a high proportion of secondary SS whether the associated disease is in SLE, RA, PSS, polydermato-myositis, or primary biliary cirrhosis, but is >90% of subacute cutaneous lupus and in vasculitis-associated SS.
Autoantibodies to SS-B/La antigen are detected by EIA in 70-90% of primary and about 50% of secondary Sjogren syndrome (SS) and as well as in 30% of SLE and 80% of subacute cutaneous lupus and a majority of infants with complete heart block.
Antibodies directed against alpha-fordin can be useful in diagnosing early stage Sjorgen's syndrome.
Limitations
This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration.
Specimen Requirements
Specimen
Serum
Volume
3 mL
Minimum Volume
2 mL (Note: This volume does not allow for repeat testing.)
Container
Red-top tube or gel-barrier tube
Collection Instructions
Separate serum from cells within one hour of collection. Transfer to a plastic transport tube before shipping
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 7 days |
Refrigerated | 14 days |
Frozen | 60 days |
Freeze/thaw cycles | Stable x1 |
Reference Range
• Negative: <20
• Weak Positive: 20–39
• Moderate Positive: 40–80
• Positive: >80
Storage Instructions
Refrigerate.
Causes for Rejection
Grossly hemolyzed; bacterial contamination; lipemic specimen; icteric specimen; non-serum specimen types
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 520196 | Sjogren's Profile Plus (RDL) | 97564-9 | 520218 | Anti-Ro (SS-A) Ab (RDL) | Units | 33569-5 |
| 520196 | Sjogren's Profile Plus (RDL) | 97564-9 | 520225 | Anti-La (SS-B) Ab (RDL) | Units | 45142-7 |
| 520196 | Sjogren's Profile Plus (RDL) | 97564-9 | 520135 | Anti-Fodrin Ab, IgG (RDL) | Units | 96928-7 |
| 520196 | Sjogren's Profile Plus (RDL) | 97564-9 | 520136 | Anti-Fodrin Ab, IgA (RDL) | Units | 96918-8 |
| Order Code | 520196 | |||||
| Order Code Name | Sjogren's Profile Plus (RDL) | |||||
| Order Loinc | 97564-9 | |||||
| Result Code | 520218 | |||||
| Result Code Name | Anti-Ro (SS-A) Ab (RDL) | |||||
| UofM | Units | |||||
| Result LOINC | 33569-5 | |||||
| Order Code | 520196 | |||||
| Order Code Name | Sjogren's Profile Plus (RDL) | |||||
| Order Loinc | 97564-9 | |||||
| Result Code | 520225 | |||||
| Result Code Name | Anti-La (SS-B) Ab (RDL) | |||||
| UofM | Units | |||||
| Result LOINC | 45142-7 | |||||
| Order Code | 520196 | |||||
| Order Code Name | Sjogren's Profile Plus (RDL) | |||||
| Order Loinc | 97564-9 | |||||
| Result Code | 520135 | |||||
| Result Code Name | Anti-Fodrin Ab, IgG (RDL) | |||||
| UofM | Units | |||||
| Result LOINC | 96928-7 | |||||
| Order Code | 520196 | |||||
| Order Code Name | Sjogren's Profile Plus (RDL) | |||||
| Order Loinc | 97564-9 | |||||
| Result Code | 520136 | |||||
| Result Code Name | Anti-Fodrin Ab, IgA (RDL) | |||||
| UofM | Units | |||||
| Result LOINC | 96918-8 |