Primary Membranous Nephropathy Diagnostic Cascade


Abbrev Code:MMMISC   
Order Code:LAB4909Order Name:Laboratory Miscellaneous Order
Methodology:Enzyme-linked immunosorbent assay (ELISA) with reflex to indirect immunofluorescence (IFA) [PLA2R] with reflex to indirect immunofluorescence (IFA) [THSD7A]
CPT Codes: 83520 x1, 86255 x1, 86255 x1
Turnaround Time:Specimens sent to reference laboratory Monday-Friday; results are reported within 8 days.
Compliance:

This test was developed and its performance characteristics determined by Laboratory Medicine and Pathology, Mayo Clinic. This test has not been cleared by the U.S. Food and Drug Administration.



Collection Instructions

Specimen:Blood
Optimal Volume:5 mL
Minimum\Peds Volume:2.2 mL
Container:Red (gel)
Alternate Containers: Red (no gel)
Collection Instructions:Deliver to lab as soon as possible to allow for required processing within 2 hours of collection.
Causes for Rejection:Gross hemolysis


Processing and Shipping

Specimen Processing:Centrifuge and aliquot a minimum of 1 mL serum within 2 hours of collection. Store at refrigerated temperature.
Shipping Instructions:Ship at refrigerated temperature.
Stability:8 hours at room temperature; 14 days at refrigerated or frozen.
Test Performed at or Referral Lab Lab Sendouts  (Mayo)
Referral Lab number:PMND1


Interpretive

Reference Range:ANTI-PHOSPHOLIPASE A2 RECEPTOR (PLA2R) ENZYME-LINKED IMMUNOSORBENT ASSAY:
<14 RU/mL: Negative
14 to 19 RU/mL: Borderline
> or =20 RU/mL: Positive

PLA2R IMMUNOFLUORESCENCE:
Negative

THROMBOSPONDIN TYPE-1 DOMAIN-CONTAINING 7A ANTIBODIES:
Negative
Limitations:Absence of circulating anti-phospholipase A2 receptor autoantibodies does not rule out a diagnosis of primary MN.
Use:Distinguishing primary from secondary membranous nephropathy using an algorithmic approach.
Monitoring patients with membranous nephropathy at very low antibody titers.
Screening for anti-phospholipase A2 receptor antibodies.


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