In vitro diagnostic reagents refer to in vitro diagnostic reagents managed by medical devices, including reagents, kits, calibrators, quality control products, etc. used for in vitro detection of human samples in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation, and health status evaluation. It can be used alone or in combination with instruments, tools, equipment, or systems.
The use of serum in in vitro dispute resolution reagents is mainly in blocking solutions, enzyme dilutions, and quality control/calibration basic serum.
In the in vitro diagnostic reagent industry, commonly used solid-phase sealants are buffers composed of non target proteins in a certain proportion, including animal serum such as bovine serum, horse serum, sheep serum, non serum proteins such as casein, and commonly used unrelated proteins such as bovine serum albumin.
High purity bovine serum can also be used to prepare enzyme dilutions, utilizing the buffering properties of its own serum protein system to protect the spatial structure and activity of enzyme substances. It is required that serum products contain as low impurities as possible, such as oxidases, hormones, and impurities.
The serum has undergone special stability treatment, which has the properties of clarity, transparency, absence of impurities, no precipitation, and does not affect the detection results. At the same time, it can also protect the standard. It can be directly used as a basic dilution serum for IVD standards/quality control products. Adding antigens/antibodies directly to the serum can reduce production costs.
The application of serum in in in vitro diagnostic reagents should pay attention to the collection, processing, storage of serum samples, and the use of anticoagulants. During the production process, attention should be paid to the batch consistency of serum, whether the serum has been thermally inactivated, whether there will be cross reactions, and the interference of endogenous substances. For example, serum contains multiple proteins and antibodies, which may cross react with reagents and affect detection specificity.
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