In vitro diagnostic reagents refer to in vitro diagnostic reagents managed by medical device management, including reagents, reagent kits, calibration products, quality control products, etc. used for in vitro testing of human samples in the processes of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation and health status evaluation. They can be used alone or in combination with life sciences instruments, equipment or systems.
Classification of in vitro diagnostics
According to the degree of product risk from low to high, in vitro diagnostic assay reagents are divided into three types of products: Class I, Class II, and Class III products.
The first class of in vitro diagnostic reagent products mainly include:
Microbial culture medium (not used for microbial identification and drug sensitivity test);
Products for sample processing, such as hemolysin, diluent, staining solution, etc.
The second class of in vitro diagnostic reagent products mainly include:
Reagents for protein detection;
Reagents for sugar detection;
Reagents for hormone detection;
Reagents for enzyme detection;
Reagents for ester detection;
Reagents for vitamin detection;
Reagents for inorganic ion detection;
Reagents for drug and metabolite detection;
Reagents for self-antibody detection;
Reagents for microbial identification or drug sensitivity test;
Reagents for other physiological, biochemical, or immune function indicator detection.
The third class of in vitro diagnostic reagent products mainly include:
Reagents related to the detection of pathogenic pathogen antigens, antibodies, and nucleic acids;
Reagents related to blood type and tissue matching;
Reagents related to human gene detection;
Reagents related to genetic diseases;
Reagents related to the detection of anesthetic drugs, psychotropic drugs, and toxic drugs used for medical treatment;
Reagents related to the detection of the action targets of therapeutic drugs;
Reagents related to the detection of tumor markers;
Reagents related to the detection of allergy (allergen).
What information does in vitro diagnostic reagent products contain?
The information of in vitro diagnostic reagent products includes the following information points: reagent project code, reagent name, specification, model, unit of measurement, supplier, manufacturer, product registration certificate, reference purchase price, manufacturer's quotation, import status, batch number, and other relevant basic information.
Supplier and manufacturer information includes the following information points: supplier name, supplier code, registered address, legal representative, authorized business representative, contact number, file number, business license and validity period, production license number and other relevant basic information.
What are the performance evaluations of in vitro diagnostic reagents?
The performance of in vitro diagnostic reagents is mainly reflected in three aspects:
Analytical performance: mainly includes precision, accuracy, sensitivity, specificity, linear range and other performances.
Diagnostic performance: the sensitivity and specificity of the substance being tested.
Stability: the validity period, transportation stability, bottle opening stability, and acceleration stability of the product.
The raw materials and processes used for reagents should have clear quality requirements, and the final product performance should meet clinical use requirements. The main factors that affect the performance of in vitro diagnostic reagent products are raw materials, process and reaction system establishment, performance evaluation method, establishment of internal reference products of the enterprise, and clinical evaluation.
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