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Test Code EURO Phospholipase A2 Receptor, Enzyme Linked Immunosorbent Assay, Serum

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)

Reporting Name

Phospholipase A2 Receptor, ELISA, S

Specimen Type

Serum


Specimen 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

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

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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.

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

Secondary ID

606475

Useful For

Distinguishing primary from secondary membranous nephropathy

Reject Due To

Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

Clinical 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)

Day(s) Performed

Monday, Wednesday, Friday

Report Available

3 to 7 days

Specimen Retention Time

7 days