Test Catalog

Test Id : PA2RE

Phospholipase A2 Receptor Enzyme-Linked Immunosorbent Assay, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Distinguishing primary from secondary membranous nephropathy

 

Monitoring patients with membranous nephropathy, over time, for trends in anti-PLA2R antibody levels

Highlights

Anti-phospholipase A2 Receptor (PLA2R) antibodies are highly specific for the diagnosis of primary membranous nephropathy.

 

As many as 70% to 75% of patients with primary membranous nephropathy are positive for anti-PLA2R.

 

A titer increase, decrease, or disappearance generally precedes a change in clinical status.

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
PA2RI Phospholipase A2 Receptor IFA, S Yes No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

ELISA (PA2RE) testing is always performed initially. IFA testing (PA2RI) is performed based on the ELISA results. If ELISA results are greater than or equal 2 or less than or equal to 20 the IFA testing will reflex on. 

Method Name
A short description of the method used to perform the test

Enzyme-Linked Immunosorbent Assay (ELISA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Phospholipase A2 Receptor ELISA, S

Aliases
Lists additional common names for a test, as an aid in searching

Anti-PLA2R

PLA2R

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

ELISA (PA2RE) testing is always performed initially. IFA testing (PA2RI) is performed based on the ELISA results. If ELISA results are greater than or equal 2 or less than or equal to 20 the IFA testing will reflex on. 

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 1 mL 

Collection Instructions:

1. Serum gel tubes should be centrifuged within 2 hours of collection.

2. Red-top tubes should be centrifuged and aliquoted within 2 hours of collection.

Forms

If not ordering electronically, complete, print, and send a Renal Diagnostics Test Request (T830) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
Frozen 14 days
Ambient 8 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

Distinguishing primary from secondary membranous nephropathy

 

Monitoring patients with membranous nephropathy, over time, for trends in anti-PLA2R antibody levels

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

ELISA (PA2RE) testing is always performed initially. IFA testing (PA2RI) is performed based on the ELISA results. If ELISA results are greater than or equal 2 or less than or equal to 20 the IFA testing will reflex on. 

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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 (CKD) awaiting kidney transplantation, higher levels of anti-PLA2R could predict those more likely to recur after transplantation.(2)  Mayo Clinic Renal Lab data suggest that there is a high-concordance between the enzyme-linked immunosorbent assay (ELISA) and indirect immunofluorescence assay PLA2R results; however, the ELISA assay alone may be preferred for monitoring patients with membranous nephropathy over time for trends in anti-PLA2R antibody levels.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative: <14 RU/mL

Borderline: > or =14-19 RU/mL

Positive: > 19 RU/mL

Interpretation
Provides information to assist in interpretation of the test results

Therapy outcome can be monitored by measuring the anti-phospholipase A2 receptor (PLA2R) 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
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Beck L, Bonegio R, Lambeau G, et al: M-type phospholipase A2 receptor as target antigen in idiopathic membranous nephropathy. N Engl J Med 2009;361:11-21

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
Describes how the test is performed and provides a method-specific reference

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: EUROIMMUN Anti-PLA2R ELISA [IgG] Kit, EUROIMMUN US, Morris Plains, NJ, V 9/23/2014)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

3 to 7 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

83520

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports