IgA Nephropathy
Conditions
Interventions
Gold Standard:The results of renal biopsy combined with clinical diagnosis as the clinical reference standards.
Index test:Galactose-deficient IgA1 (GD-IgA1) Detection Kit (Chemiluminescence Immunoassay)
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The case group needs to meet the following (1), (2), and (3); the interference group needs to meet the following (1), (2), (3), and (4): (1) Sign the informed consent form; (2) Age and gender are not restricted; (3) Subjects with one of the three conditions: hematuria, proteinuria, and renal function decline in clinical practice, need to undergo renal biopsy and collect samples before the renal biopsy; (4) Subjects with one of the four conditions: triglyceride exceeding the normal range, bilirubin exceeding the normal range, rheumatoid factor exceeding the normal range, and positive antinuclear antibody.
Exclusion criteria
Exclusion criteria: Any of the following conditions shall be excluded: 1. Subjects who have used medicines, including hormones, biological agents or immunological agents within the past three months; 2. Subjects whose samples have not been collected; 3. Subjects whose samples do not meet the testing requirements; 4. Subjects who the researcher deems unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sensitivity;specificity;Total Compliance Rate ;Kappa Coefficient;Positive Concordance Rate;Negative Concordance Rate; | — |
Countries
China
Contacts
Public ContactJingyuan Xie
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed