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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06456801

Enrollment

219

Registered

2024-06-13

Start date

2021-03-01

Completion date

2021-10-01

Last updated

2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephropathy

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Calculate the correlation between the test reagents and comparison reagents	1 year.	Calculate the correlation between the test reagents and comparison reagents

Countries

China

Outcome results