CompletedNot Applicable

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

China220 participantsStarted 2021-12-28

Plain-language summary

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.

Who can participate

SexALL

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Exclusion criteria

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

What they're measuring

Assessment reagent test results and clinical reference standard statistics

Timeframe: 8 months

Statistical analysis of non-professional self-testing test

Timeframe: 8 months

Trial details

NCT IDNCT05450523

SponsorQingdao HIGHTOP Biotech Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-09-07

View on ClinicalTrials.gov More Peritoneal Dialysis-associated Peritonitis trials