Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) Clinical Trial Protocol

HIGHTOP Biotech

Status: Completed

Conditions: Peritoneal Dialysis-associated Peritonitis

Study type: Observational

Funder types: Industry

Identifiers

NCT05450523

HT1.0

Details and patient eligibility

About

According to the requirements of the "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents", the first registered product (hereinafter referred to as the assessment reagent) - Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) was tested in clinical institutions. ) for clinical validation trials. Prove that the clinical performance of the assessment reagent meets the requirements of the intended use.

Enrollment: 220 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients treated with peritoneal dialysis due to kidney disease, including those with confirmed peritonitis and those without peritonitis. There are no age or gender requirements, and informed consent is required.

Exclusion criteria

1. Patients who have been treated with antibiotics for peritonitis before taking the sample.
2. Incomplete information, including: sample ID number, gender, age, department, clinical diagnosis, sample type, and sampling date.
3. The sample size is insufficient.
4. Repeated cases.
5. The samples whose permeate is red in visual inspection.