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Clinical Evaluation and Self-Testing Application Demonstration of Luminescent Immunoassay Kit

Clinical Evaluation and Self-Testing Application Demonstration of Luminescent Immunoassay Kit: A Multi-Center Diagnostic Test Evaluation Study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123989
Enrollment
Unknown
Registered
2026-05-06
Start date
2025-08-07
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

chronic kidney disease

Interventions

Gold Standard:Urinary microalbumin: ImmunoturbidimetryUrinary a1-microglobulin: ImmunoturbidimetryUrinary ß2-microglobulin: ImmunoassayUrinary RBP: ImmunoassayUrinary NGAL: ImmunoassayUrinary Cys-C: P
Index test:Urinary chronic kidney disease biomarkers were detected using a chemiluminescence immunoassay kit, including microalbumin, a1-microglobulin, ß2-microglobulin, RBP, NGAL, Cys-C, and creatini

Sponsors

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years; 2.Requiring detection of biological markers of chronic kidney disease in urine, including but not limited to: Patients with diabetes, patients with hypertension, individuals with family history of chronic kidney disease, individuals with abnormal routine urinalysis found during physical examination, individuals with other high-risk factors for chronic kidney disease, and follow-up monitoring of patients with chronic kidney disease; 3.Signed informed consent;

Exclusion criteria

Exclusion criteria: 1.Anuria or insufficient urine volume to provide adequate samples; 2.Unable to cooperate with urine collection; 3.Uncontrolled psychiatric disorders or non-compliance with procedures; 4.Deemed unsuitable for inclusion in this study by the investigator;

Design outcomes

Primary

MeasureTime frame
Urinary microalbumin;Urinary a1-microglobulin;Urinary ß2-microglobulin;Urinary cystatin C (Cys-C);Urinary creatinine;Urinary retinol-binding protein(RBP);Urinary neutrophil gelatinase-associated lipocalin (NGAL);

Countries

China

Contacts

Public ContactHaijiao Jin

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

jinhaijiao1108@126.com+86 21 68383121

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026