IVD Australia



Background: Autoantibodies against phospholipase A2 receptors (PLA2R) are a new, specific marker for the kidney disease primary membranous glomerulonephritis (pMGN). pMGN is a chronic inflammatory autoimmune disease of the glomeruli, which is accompanied by a progressive reduction in kidney function. It is one of leading causes of nephrotic syndrome in adults, which is characterized by protein leaking into the urine and swelling of tissues. Anti-PLA2R antibodies were discovered in 2009 as the cause of pMGN. Their level in the body is linked to the severity and clinical activity of the disease.

About the Tests: With the Anti-PLA2R ELISA and the Anti-PLA2R IIFT tests, clinicians can measure the amount of anti-PLA2R antibodies in a patient’s blood sample. Both tests are based on established technologies. In the enzyme-linked immunosorbent assay (ELISA) the antibody detection is performed in microplates coated with purified antigen, and results are evaluated using a photometer (measurement of colour intensity). In the indirect immunofluorescence test (IIFT) the antibody detection is performed using microscope slides containing specially prepared cells, and results are evaluated under the microscope (measurement of fluorescence intensity). Both the ELISA and the IIFT procedures can be automated to make the analyses quicker and more reliable.

Health Benefits: Anti-PLA2R antibody detection allows doctors to establish a definite diagnosis of pMGN. As anti-PLA2R antibodies are only found in pMGN, a positive results means that doctors can be certain that the patient has pMGN and not another kidney disease. It is especially important to distinguish pMGN from secondary membranous glomerulonephritis, which manifests with similar symptoms, but has a different cause and requires different treatment. Accurate diagnosis means that patients can start suitable treatment as soon as possible and potentially reduce the severe long-term effects of the disease, which in the worst cases require kidney transplantation.

Anti-PLA2R measurements also allow doctors to monitor the activity of disease, for example how a patient responds to a course of immunotherapy. If a patient experiences remission, the level of anti-PLA2R antibodies decreases, even before other commonly used indicators of kidney function (proteinuria). An increase in the level of anti-PLA2R antibodies indicates a relapse. Regular checks of anti-PLA2R antibodies allow doctors to adjust the amount of medication given to match the current activity of the disease.

Financial Benefits: The Anti-PLA2R ELISA and the Anti-PLA2R IIFT serological assays offer a non-invasive alternative to biopsy, which is traditionally used to diagnose pMGN. As standardized, easy-to-perform routine laboratory tests, they represent a cost-effective method for the diagnosis of pMGN.




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