Test Details
Methodology
Semi-Quantitative Indirect Immunofluorescence (IIF)/Semi- Quantitative Enzyme-Linked Immunosorbent Assay (ELISA)
Use
This test is used to support the diagnosis of epithelial antibody-associated immunobullous diseases in individuals who present with blisters, bullae, vesicles or erosive lesions involving the skin and/or mucous membranes. Clinical presentations may also include pruritus, secondary lesions or mimicking conditions such as eczema or urticaria, even when blistering is not evident. This testing is also appropriate for ongoing evaluation and monitoring of disease activity following a confirmed diagnosis of an immunobullous disorder. This assay is intended for comprehensive initial evaluation to support the diagnosis and differentiation of blistering, eczematous, erosive, pruritic or urticarial conditions affecting the skin and mucous membranes. It assists in identifying epithelial antibody-mediated immunobullous disorders, including pemphigoid, pemphigus and their variants, which may demonstrate nonspecific or overlapping clinical features. It is also recommended for monitoring the emergence of epithelial antibodies associated with immune checkpoint inhibitor treatments anti-PD-1 and anti-PD-L1.
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, transfer tube
Collection Instructions
Serum samples may be stored for up to eight hours at room temperature before freezing at -20°C. Samples should not be repeatedly frozen and thawed.
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
Bacterial contamination, hemolysis, lipemia