Leptospira antibody detection reagent clinical trial process
First, the purpose of the test.
To determine the accuracy, specificity and stability of the leptospira antibody detection reagent in clinical applications, and to provide a scientific basis for the marketing of the reagent.
Second, the experimental design.
1.Test subjects: Patients and healthy people from different regions, different age groups, and different genders were selected as research subjects.
2.Test samples: Fresh blood samples were collected from the subjects for leptospira antibody testing.
3.Test method: The double-blind method was used for the test, the control group was detected with standard reagents, and the test group was tested with the reagents to be detected.
4.Data analysis: Statistical analysis of the detection results was performed to compare the accuracy, specificity and stability of the two groups of reagents.
Third, the test process.
1.Investigator training: Conduct training for researchers participating in the trial to ensure that the investigators are familiar with the test protocol, master the sample collection and processing methods, and understand the use of reagents and precautions.
2.Sample collection: Collect fresh blood samples from study subjects and record sample information such as name, age, gender, region, etc.
3.Sample Processing: The collected blood sample is centrifuged, the serum is isolated, and the serum is stored in a -20 freezer for later use.
4.Reagent preparation: Prepare the reagents to be tested and the standard reagents separately.
5.Detection test: The double-blind method is used to detect the test, and the investigator uses the reagent to be tested and the standard reagent are used to test the serum sample and record the test results.
6.Data statistics: Statistical analysis of the detection results was carried out to compare the accuracy, specificity and stability of the two groups of reagents.
7.Summary of results: Conclusions were drawn based on the test data, and clinical trial reports were written to provide a scientific basis for the marketing of the reagent.