Clinical Trial of Anti-PLA2R-IgG Detection Kit (Time-resolved Fluorescence Immunoassay)

Completed

• Conditions: Nephropathy

• Registration Number: NCT06456801
• Lead Sponsor: Zhejiang University

Brief Summary

Conduct comparative experimental studies on clinical serum samples using assessment reagents and approved products, and evaluate the equivalence between assessment reagents and comparison reagents.

Detailed Description

Conduct comparative experimental studies on clinical serum samples using assessment reagents and approved products, and evaluate the equivalence between assessment reagents and comparison reagents.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

Clear background information and traceable sources of samples from kidney disease patients (number, age, gender, and clinical diagnostic information).

Exclusion Criteria

Exclude serum samples that meet one of the following conditions:

① Samples with insufficient sample size, ② Samples with incomplete sample information.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Calculate the correlation between the test reagents and comparison reagents	1 year.	Calculate the correlation between the test reagents and comparison reagents

Trial Locations

Locations (1)

The First Affiliated hospital Zhejiang University school of medicine; 🇨🇳 Hangzhou, Zhejiang, China