Clinical Application Research Plan for Fully Automated Chemiluminescent Immunoassay Reagents
For the remaining serum, plasma, urine or other body fluid samples from clinical tests, chemiluminescence immunoassay reagents are used (covering eleven types of markers such as infectious diseases, tumors, hormones, thyroid function, liver fibrosis, inflammatory factors, diabetes, anemia, cardiovascular and cerebrovascular diseases, thrombotic diseases, and reproductive health). The main current platforms in this department are: Antuo (for infectious diseases, liver fibrosis, and reproductive health markers), Abbott (for tumors, diabetes, and anemia markers), Sinergy (for thyroid function, bone metabolism, and gastrointestinal function markers), Beckman (for hormones), and Norman (for infectious markers). Contents such as technology development, technology optimization, and performance evaluation of reagent items are carried out.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Case Selection
- Inclusion Criteria During the study period, based on the clinical application research protocol of the fully automated chemiluminescence immunoassay reagent, the remaining clinical test samples that met the test results or corresponding clinical diagnoses were selected, including but not limited to serum, plasma, urine, etc. Approximately 2,900 samples that met the inclusion criteria for recruitment, test data, and sample traceability information were provided.
- Exclusion Criteria (1) Samples that do not meet the inclusion criteria; (2) Samples with unclear clinical diagnoses; (3) Samples with severe hemolysis, deterioration, chylous blood, obvious microbial contamination, etc., which do not meet the requirements for the test.
- Exclusion Criteria (1) Sample results that do not meet the inclusion criteria or samples that met the exclusion criteria but still underwent testing; (2) Samples that did not complete the required tests for the complete trial or had missing data due to sample or instrument operation; (3) When the test samples underwent retesting due to human error, instrument failure, sample addition failure, etc., the retest results were taken as the standard and the reasons for retesting were recorded.
- Termination Criteria This study uses the remaining serum, plasma, etc. from daily tests, and no additional collection is required. It will not cause any expected harm to the subjects.
By applying the fully automated chemiluminescence immunoassay reagents developed by Xiamen Wantei Kaire Biotechnology Co., Ltd. (covering infectious diseases, tumors, hormones, thyroid function, liver fibrosis, inflammatory factors, diabetes, anemia, cardiovascular and cerebrovascular diseases, thrombotic diseases, and reproductive health and fertility, totaling eleven types of markers), the current department's main platforms are as follows: Antuo (for infectious diseases, liver fibrosis, and reproductive health and fertility markers), Abbott (for tumors, diabetes, and anemia markers), Xin Industry (for thyroid function, bone metabolism, and gastrointestinal function markers), Beckman (for hormones), and Norman (for infectious markers).
- Use the reagents of the above eleven series to test the remaining serum, plasma, urine or other body fluid samples from clinical tests. Compare the test results with the clinical diagnosis or the existing reagent test results in the department to evaluate indicators such as the compliance rate or quantitative correlation of the reagents, and analyze and study the differences of the same-source samples;
- Based on the clinical expected use, applicable population, etc. of the reagents, collect samples that meet the requirements specifically, conduct reference value research for the above eleven series of reagents, to support the clinical application of each project;
- Select the remaining clinical samples that meet the requirements for research and development of the above eleven series of reagents, quality control substances and control samples, etc. At the same time, match the corresponding reagents on various machines for testing, evaluate the stability, sensitivity, specificity, linear range, detection limit, precision and other indicators of the reagents, and verify the applicability of the reagents on different machines.
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
During the study period, in accordance with the clinical application research protocol for the fully automatic chemiluminescent immunoassay reagents, clinical residual samples meeting the testing results or corresponding clinical diagnoses-such as serum, plasma, urine, and others-will be selected. Approximately 2,900 samples that meet the inclusion criteria will be provided, along with their test data and sample traceability information.
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 |
|---|---|
|
sensitivity
Time Frame: 2026.11.01-2028.11.01
|
2026.11.01-2028.11.01
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
linearity range
Time Frame: 2026.11.01-2028.11.01
|
2026.11.01-2028.11.01
|
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
Keywords
Other Study ID Numbers
- NanjingFirst-LAB-01
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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