IgA Nephropathy ImmunoActivity Test Kit (ELISA)

Registration No.: Gan Xie Zhu Zhun 20262400131

Product Introduction

The NephroPlex™ kit, developed by Shenzhen Luwei Biotechnology Limited, uses exclusively patented molecular probe technology to detect circulating poly-IgA immune complexes in peripheral blood. Deposition of these complexes in the kidneys plays a major role in the onset of IgA nephropathy. Experiments have shown that this marker can be used to assess immune activity in patients with IgA nephropathy.

With this first-in-class peripheral blood biomarker specific to IgA nephropathy, the IgA Nephropathy ImmunoActivity Test Kit (ELISA) is expected to advance immune activity monitoring, adjunctive diagnosis, rapid assessment of treatment response and long-term management for patients with diagnosed IgA nephropathy. It is also expected to advance early diagnosis and risk assessment in patients with abnormal findings such as proteinuria and hematuria.

Validation experiments

Patients with IgA nephropathy had a higher IgA immune activity index than healthy controls and patients with other forms of glomerulonephritis.
Experiment 1
Patients with IgA nephropathy had a higher IgA immune activity index than healthy controls and patients with other forms of glomerulonephritis.
The CD89-captured poly-IgA complex assay showed greater specificity and sensitivity and the highest AUC when compared with total IgA1 and Gd-IgA1.
Experiment 2
The CD89-captured poly-IgA complex assay showed greater specificity and sensitivity and the highest AUC when compared with total IgA1 and Gd-IgA1.
Kaplan–Meier survival curves for diagnosed patients with high and low IgA immune activity indices.
Experiment 3
Kaplan–Meier survival curves for diagnosed patients with high and low IgA immune activity indices.

Assay advantages

The assay is rapid and requires only a small blood sample.

Verified assay stability, repeatability and accuracy.

Clinical applications

1. Early diagnosis

In patients with proteinuria or hematuria who have not undergone a kidney biopsy, a high immune activity index indicates a high risk of IgA nephropathy.

ROC curve comparing biopsy-confirmed IgA nephropathy cases and healthy controls.
  • Comparison of biopsy-confirmed IgA nephropathy cases and healthy controls
  • 108 patients with IgA nephropathy and 63 healthy controls
  • AUC = 0.89
  • Specificity: 75%
  • Sensitivity: 89%
2. Efficacy assessment

Monitoring immune activity in IgA nephropathy may show improvement earlier than conventional clinical measures such as eGFR, giving physicians and patients more timely feedback.

Effective treatment significantly reduces IgA complex levels

Effective treatment significantly reduces IgA complex levels

Product manual