Clinical Application Research Plan for Fully Automated Chemiluminescent Immunoassay Reagents

Case Selection

1. 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.
2. 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.
3. 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.
4. 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).

1. 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;
2. 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;
3. 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.