Clinical trial process of osteocalcin detection reagent
First, the purpose of the test.
The purpose of this clinical trial is to evaluate the accuracy and reliability of osteocalcin detection reagents, and to provide a scientific basis for the marketing of osteocalcin detection reagents.
2. Test object.
1.Healthy adults: 20-45 years old, no chronic diseases, no abnormal bone metabolism.
2.Patients with abnormal bone metabolism: including patients with osteoporosis, poor fracture healing, bone tumors and other abnormal bone metabolism diseases.
3. Test methods.
1.Sample collection: Collect serum or plasma samples from subjects, and the sample size is required to be 5ml.
2.Test operation: The reagents in the osteocalcin detection kit are added to the sample according to the requirements of the instructions, and the steps of incubation, washing, and color development are carried out.
3.Results: According to the standard curve in the kit instructions, the absorbance of the sample was converted to osteocalcin concentration.
4. Data analysis and result reporting.
1.Data collation: Organize the basic information of the subjects, test data, etc., to ensure that the data is accurate.
2.Data analysis: Statistical analysis of the test data, including mean, standard deviation, confidence interval and other indicators, to evaluate the performance of osteocalcin detection reagent.
3.Result report: Write a clinical trial report, including the purpose, method, results, conclusions, etc., and submit it to the relevant departments for approval.
5. Ethical requirements.
1.Ensure the rights and safety of subjects: During the trial, the rights and dignity of subjects must be respected, their informed consent must be ensured, and adverse reactions must be dealt with in a timely manner.
2.Principle of confidentiality: The personal information of the subjects and the test data are kept strictly confidential to ensure the security and confidentiality of the data.
3.The principle of scientificity and impartiality: operate in strict accordance with the clinical trial protocol to ensure the scientificity and fairness of the data.