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
This test is a component of MyoMarker 3 Plus Profile.
Use
Anti-SAE 1 IgG autoantibody can be used to assist in the diagnoses and characterization of a subset of dermatomyositis (DM). It is highly specific for DM (>95%) and is present in 5-8% of the European DM population. Initial disease onset may consist of mild myopathic features with severe skin involvement; however, extensive myalgia and muscle disease with weakness can appear as the disease progresses. It is associated with dysphagia and systemic symptoms (i.e. fevers, weight loss, increased inflammatory markers). In one cohort, an association with ILD and cancer had been found.
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
1 mL
Minimum Volume
0.5 mL (Note: This volume does not allow for repeat testing.)
Container
Gel tube or red-top tube
Collection Instructions
Separate serum from cells within one hour of collection. Transfer to a plastic transport tube before shipping. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 7 days |
Refrigerated | 14 days |
Frozen | 60 days |
Freeze/thaw cycles | Stable x1 |
Storage Instructions
Refrigerate or freeze.
Causes for Rejection
Grossly hemolyzed, bacterial contamination, lipemic, icteric, non-serum specimen types
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 520011 | Anti-SAE1 Ab, IgG (RDL) | 101220-2 | 520044 | Anti-SAE1 Ab, IgG (RDL) | Units | 101220-2 |
| Order Code | 520011 | |||||
| Order Code Name | Anti-SAE1 Ab, IgG (RDL) | |||||
| Order Loinc | 101220-2 | |||||
| Result Code | 520044 | |||||
| Result Code Name | Anti-SAE1 Ab, IgG (RDL) | |||||
| UofM | Units | |||||
| Result LOINC | 101220-2 |