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.

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.