Medical device science popularization and education is a long-term and important task

With the growing public demand for health and disease prevention services, there is a rising awareness of the quality and safety of diagnostic reagents used in healthcare.

What are in-vitro diagnostic reagents?

According to China's "Registration and Administration Measures for In Vitro Diagnostic Reagents" issued in 2014, in vitro diagnostic reagents (IVDs) managed as medical devices are reagents, reagent kits, calibrators, quality control products, etc., used for in vitro testing of human samples in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis investigation, and health status assessment.

What are some common in-vitro diagnostic reagents used in medical laboratories?

Medical laboratories are an important diagnostic tool, diagnosing a patient's physical condition by analyzing biological molecules in the body, such as proteins, lipids, and nucleic acids.

Do you know the role of in-vitro diagnostic reagents in medical testing?

In vitro diagnostic reagents are important tools in medical testing, used to detect molecules, cells, and tissue pathological characteristics in the human body. They are widely used in clinical and research fields, providing rapid, accurate, and reproducible results to assist physicians in formulating diagnostic and treatment plans, thereby improving the effectiveness of disease diagnosis and treatment.

Medical device science popularization and education is a long-term and important task

With the growing public demand for health and disease prevention services, there is a rising awareness of the quality and safety of diagnostic reagents used in healthcare. There are increasing demands for transparency and quality control regarding the comparability of test results for the same item across different hospitals and at different times within the same hospital.

How to judge the technical functions of in vitro diagnostic reagents

1. Analytical functions: mainly include precision, accuracy, sensitivity, specificity, linearity or determination scale, etc. Some technical indicators in the product instructions may not be completely consistent.