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HelpTest Code EURO Phospholipase A2 Receptor, Enzyme Linked Immunosorbent Assay, Serum
Reporting Name
Phospholipase A2 Receptor, ELISA, SUseful For
Distinguishing primary from secondary membranous nephropathy
Method Name
Only orderable as part of a profile. For more information see PMND1 / Primary Membranous Nephropathy Diagnostic Cascade, Serum
Enzyme-Linked Immunosorbent Assay (ELISA)
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
SerumSpecimen Required
Only orderable as part of a profile. For more information see PMND1 / Primary Membranous Nephropathy Diagnostic Cascade, Serum.
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Collection Instructions: Centrifuge and aliquot serum into plastic vial within 2 hours of collection
Specimen Minimum Volume
0.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 14 days | |
| Frozen | 14 days | ||
| Ambient | 8 hours |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | OK |
| Gross icterus | OK |
Reference Values
Only orderable as part of a profile. For more information see PMND1 / Primary Membranous Nephropathy Diagnostic Cascade, Serum.
<14 RU/mL: Negative
14 to 19 RU/mL: Borderline
≥20 RU/mL: Positive
Day(s) Performed
Monday, Wednesday, Friday
CPT Code Information
83520
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| EURO | Phospholipase A2 Receptor, ELISA, S | 73737-9 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| EURO | Phospholipase A2 Receptor, ELISA, S | 73737-9 |
Test Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.Secondary ID
606475Clinical Information
Membranous nephropathy (MN) is a rare disease in which immune complexes deposit at the glomerular basement membrane, causing damage to the filtration barrier, resulting in proteinuria. Recent studies have shown that in approximately 70% of patients with primary MN (pMN), the immune complexes consist of autoantibodies against the podocyte protein M-type phospholipase A2 receptor (PLA2R).(1) There is also evidence that levels of anti-PLA2R autoantibodies correlate well with disease activity and progression.(2) The presence of anti-PLA2R antibodies could also potentially be used to differentiate pMN from other causes of nephrotic syndrome if a biopsy is not possible. Among patients with chronic kidney disease awaiting kidney transplantation, higher levels of anti-PLA2R could predict those more likely to recur after transplantation.(2)
Interpretation
Therapy outcome can be monitored by measuring the anti-phospholipase A2 receptor antibody titer. A titer increase, decrease, or disappearance generally precedes a change in clinical status. Thus, the determination of the antibody titer has a high predictive value with respect to clinical remission, relapse, or risk assessment after kidney transplantation.
Cautions
This test should not be used as a stand-alone test but an adjunct to other clinical information. A diagnosis of primary or secondary membranous nephropathy (MN) should not be made on a single test result. The clinical symptoms, results on physical examination, and laboratory tests (eg, serological tests), when appropriate, should always be taken into account when considering the diagnosis of primary versus secondary MN.
Absence of circulating anti-phospholipase A2 receptor autoantibodies does not rule out a diagnosis of primary MN.
Clinical Reference
1. Beck LH Jr, Bonegio RGB, Lambeau G, et al: M-type phospholipase A2 receptor as target antigen in idiopathic membranous nephropathy. N Engl J Med. 2009 Jul 2;361(1):11-21
2. Schlumberger W, Hornig N, Lange S, et al: Differential diagnosis of membranous nephropathy with autoantibodies to phospholipase A2 receptor 1. Autoimmun Rev. 2014 Feb;13(2)108-113
Method Description
The test kit provides microtiter strips, each with 8 break-off reagent wells. In the case of positive samples, specific IgG antibodies (also IgA and IgM) will bind to the antigens. To detect the bound antibodies, a second incubation is carried out using an enzyme-labelled antihuman IgG (enzyme conjugate) catalyzing a color reaction.(Package insert: Anti-PLA2R ELISA [IgG] Kit, EUROIMMUN US; V 07/08/2020)