Clinical Application Research Plan for Fully Automated Sample Processing System
By utilizing the fully automated sample processing system from Xiamen U-Medical Instruments Co., Ltd. (compatible with the Wan200+/Wan600+ fully automatic chemiluminescent immunoassay systems and the Wan BC2800 fully automatic biochemical analyzer), serum, plasma, urine, or other bodily fluid samples are processed automatically throughout the entire workflow, covering pre-analytical, analytical, and post-analytical stages.
A systematic evaluation is conducted on the system's functional performance, user satisfaction, ease of operation, and stability during use.
Key performance indicators such as turnaround time (TAT) and sample throughput are assessed through node monitoring and recording across the entire sample processing workflow.
Statistical analysis is performed on the system's failure rate, maintenance requirements, and emergency response capabilities under continuous operation conditions.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
No restrictions on audience
Description
Inclusion Criteria:
- During the research period, according to the clinical application research plan of the fully automated sample processing system, the remaining clinical test samples that match the test results or corresponding clinical diagnoses were selected, including but not limited to serum, plasma, urine, etc.
Exclusion Criteria:
-
Exclusion Criteria
- Samples that do not meet the inclusion criteria;
- Samples with unclear clinical diagnosis;
- Test samples that are severely hemolyzed, deteriorated, contain chylous blood, or are significantly contaminated by microorganisms, etc., and do not meet the requirements.
Removal Criteria
- Sample results that do not meet the inclusion criteria or for which exclusion criteria were met but testing was still conducted;
- Samples that did not complete the required tests for the complete trial or had missing data due to sample or instrument operation;
- When test samples require re-testing due to human error, instrument failure, sample addition failure, etc., the re-tested results shall be taken as the standard, and the reasons for re-testing shall be recorded.
Study Plan
How is the study designed?
Design Details
- Observational Models: CASE_ONLY
- Time Perspectives: PROSPECTIVE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluate the sample turnaround time
Time Frame: 202611.01-2030.12.31
|
202611.01-2030.12.31
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NanjingFirst-LAB-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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