Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) Clinical Trial Protocol
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Assessment reagent test results and clinical reference standard statistics [8 months]
The peritoneal dialysis effluent collected from the subjects was tested blindly with the assessment reagents, and the test results were compared with the clinical reference standards. By evaluating the clinical sensitivity and specificity of the assessment reagents, the feasibility of clinical application of the assessment reagents was evaluated.
- Statistical analysis of non-professional self-testing test [8 months]
There is no need to train non-professionals. After reading the instructions and labels, non-professionals can evaluate their ability to understand key information such as instructions and packaging labels through questionnaires; Research, comparison of test results of different forms of reagents, and comparison with professional test results to evaluate their operational capabilities.
Eligibility Criteria
Criteria
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:
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Patients who have been treated with antibiotics for peritonitis before taking the sample.
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Incomplete information, including: sample ID number, gender, age, department, clinical diagnosis, sample type, and sampling date.
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The sample size is insufficient.
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Repeated cases.
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The samples whose permeate is red in visual inspection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The first affiliated hosital of Nangchang university | Nanchang | Jiangxi | China |
Sponsors and Collaborators
- Qingdao HIGHTOP Biotech Co., Ltd.
Investigators
- Study Chair: Qinkai Chen, Chief physician, The first affiliated hosital of Nangchang university
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HT1.0