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.

How are in vitro diagnostic reagents classified?

In vitro diagnostic reagents are classified into Class I, Class II, and Class III products according to their risk level, from low to high.

Intended use of in-vitro diagnostic reagents

The intended use of in-vitro diagnostic reagents refers to the intended use of in-vitro diagnostic reagents, which is generally approved by the food and drug administration and has scientific and legal basis, such as "auxiliary diagnosis", "diagnosis", "early diagnosis", "screening", "treatment monitoring", "individualized medication" (companion diagnosis), etc. The instruction manual should also indicate whether it is a quantitative or qualitative test, and what sample type requirements are needed.