Kidney Week

Abstract: TH-PO600

Assessing the Utility and Accuracy of Phospholipase A2 Receptor (PLA2R) Antibody in Membranous Nephropathy: A Systematic Review and Meta-Analysis

Session Information

• Membranous Nephropathy, FSGS, and Minimal Change Disease
  October 24, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

• 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

• Ragy, Omar Sherin, Manchester University NHS Foundation Trust, Manchester, United Kingdom

Omar Sherin Ragy, MD, FASN

• Abass, Wessam, University of Leeds Leeds Institute of Health Sciences, Leeds, West Yorkshire, United Kingdom

Wessam Abass, MSc

• Kanigicherla, Durga Anil K, Manchester University NHS Foundation Trust, Manchester, United Kingdom

Durga Anil K Kanigicherla, MD

• Shinkins, Bethany, University of Warwick Medical School, Coventry, United Kingdom

Bethany Shinkins, MSc, PhD

• Bestall, Janine, University of Leeds Leeds Institute of Health Sciences, Leeds, West Yorkshire, United Kingdom

Janine Bestall, PhD

• King, Natalie V., University of Leeds Leeds Institute of Health Sciences, Leeds, West Yorkshire, United Kingdom

Natalie V. King, MSc

• Brenchley, Paul E., Manchester University NHS Foundation Trust, Manchester, United Kingdom

Paul E. Brenchley, PhD

• Smith, Alison F., University of Leeds Leeds Institute of Health Sciences, Leeds, West Yorkshire, United Kingdom

Alison F. Smith, MSc, PhD

• Hamilton, Patrick, Manchester University NHS Foundation Trust, Manchester, United Kingdom

Patrick Hamilton, MBChB, PhD

Background

If used as a first-line triage test to diagnose primary membranous nephropathy, the PLA2R antibody (PLA2R-Ab) test could reduce the proportion of people with nephrotic syndrome needing a kidney biopsy. Evidence to determine an appropriate PLA2R-Ab test threshold, however, is lacking.

Methods

A systematic review of diagnostic accuracy studies was conducted to evaluate serum- or urine-based biomarkers to distinguish primary and secondary membranous nephropathy (MN). We searched for relevant articles in Medline, Embase, Cochrane Library, Scopus, Web of Science, INAHTA, and ClinicalTrials.gov. Cochrane-recommended systematic review and meta-analysis methodology was implemented. QUADAS-2 was used to assess the risk of bias.

Results

Eighty-one studies were eligible for inclusion, and 50 were meta-analyzed stratified by PLA2R-Ab test method using either EUROIMMUN Enzyme-linked immunosorbent assay (ELISA) in 44 studies or EUROIMMUN immunofluorescence test (IF) in 29 studies. The pooled sensitivity and specificity of EUROIMMUN ELISA at a cut-off value of 20 RU/ml were 0.631 (95% CI: 0.546, 0.709) and 0.955 (95% CI: 0.914, 0.977), respectively. The pooled sensitivity and specificity of EUROIMMUN IF at a threshold of 1:10 were 0.705 (95% CI: 0.653 – 0.752) and 0.986 (95% CI: 0.925 – 0.998), respectively. The risk of bias was higher for studies evaluating EUROIMMUN IF compared to the ELISA test. We also explored whether the timing of the index test had an impact on the pooled diagnostic accuracy results; no significant differences were found.

Conclusion

By comprehensively considering the specificity and sensitivity of EUROIMMUN ELISA PLA2R-Ab, we show that 20 RU/mL could be used as an optimal cut-off value to confirm a diagnosis of MN without the need for kidney biopsy.

Funding

• Government Support – Non-U.S.