Test Details
Methodology
ELISA
Use
The intended use of the assay is semiquantitative determination of human IgG antibodies against envoplakin in serum and supports the delimitation of a paraneoplastic pemphigus from bullous pemphigoid, pemphigus vulgaris or pemphigus foliaceus. Paraneoplastic pemphigus (PNP), also referred to as paraneoplastic autoimmune multiorgan syndrome (PAMS), is a rare condition associated with lymphoproliferative disorders and other malignancies. It can occur at any age and typically presents with severe pemphigus like clinical features and a high mortality rate. Patients with PNP/PAMS produce serum antibodies against multiple epithelial types (simple, columnar, transitional), targeting several antigens, with envoplakin being a major one. Measurement of IgG envoplakin antibody levels by ELISA, whether elevated or normal, cannot independently confirm or exclude PNP/PAMS; rather, it serves as a supportive marker when interpreted alongside other diagnostic indicators. Elevated IgG envoplakin levels may correlate with disease severity and activity, making them useful for monitoring disease progression.
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
1.0 mL
Minimum Volume
0.5 mL (Note: This volume does not allow for repeat testing.)
Container
Gel-barrier tube, red-top tube, serum transfer tube
Collection Instructions
If a tube other than a gel-barrier tube is used, transfer the separated serum to a plastic transport tube. Do not freeze the gel-barrier tube (pour off the serum first).
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 14 days |
| Refrigerated | 14 days |
| Frozen | 14 days |
| Freeze/thaw cycles | Stable x3 |
Storage Instructions
Room temperature
Causes for Rejection
Gross hemolysis; grossly lipemic; gross icterus
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 160085 | Envoplakin Antibody ELISA | 160078 | Envoplakin Antibody ELISA | Ratio | Pending | |
| Order Code | 160085 | |||||
| Order Code Name | Envoplakin Antibody ELISA | |||||
| Order Loinc | ||||||
| Result Code | 160078 | |||||
| Result Code Name | Envoplakin Antibody ELISA | |||||
| UofM | Ratio | |||||
| Result LOINC | Pending |