In the in vitro diagnostics (IVD) industry, calibration and quality control products are two indispensable and important products. Although their names may seem similar, in actual use, their functions and roles are completely different. Many people are both familiar and unfamiliar with them, and even easily confused in practical operation. In this article, we will delve into the differences between calibration standards and quality control standards.

In Vitro Diagnostic Reagents

The 'ruler' in the detection system: calibration standard

In the detection system of in vitro diagnostic products, calibration standards play the role of "rulers". The detection system usually consists of sample processing products, detection reagents, calibration products, quality control products, and applicable instruments. The key role of calibration standards is to use known concentrations of substances to construct calibration curves for detection systems, thereby ensuring the accuracy and consistency of detection results.

The usage scenarios of calibration products usually include the following situations: installation of new equipment, replacement of reagent batch numbers, instrument maintenance, or regular calibration as specified in the product manual (such as once a month). During the calibration process, it is necessary to strictly follow the instructions and keep detailed records to ensure that the detection system operates within the calibration validity period.

The concentration and stability of the calibration substance are crucial during the calibration process. Any deviation may lead to errors in the test results, thereby affecting the accuracy of clinical diagnosis. Therefore, the selection and use of calibration standards should be particularly rigorous to ensure that they can provide reliable measurement standards for the detection system.

Monitor in the detection system: quality control product

Unlike calibration standards, the core function of quality control products is to monitor the precision and stability of the detection system. It is the "monitor" of the detection system, used to verify whether the system is in a normal state. The frequency of using quality control products is relatively high, and quality control testing is usually required before starting testing every day. Only when the quality control results meet the requirements of the instruction manual, can the daily testing continue.

The core value of quality control products lies in their ability to promptly detect abnormal situations in the detection system. For example, if the quality control results exceed the expected range, it may indicate a problem with the reagents, instruments, or operating procedures. Through daily monitoring of quality control products, it is possible to effectively avoid erroneous detection results caused by system deviations, thereby ensuring the reliability of clinical diagnosis.

It should be noted that quality control products cannot replace calibration products. If quality control products are used for calibration, it may mask the true deviation of the system, leading to inaccurate test results. Therefore, calibration and quality control products play their respective roles in the detection system and are indispensable.

Desheng New Materials: IVD raw material manufacturer

In the in vitro diagnostic industry, the quality of calibration and quality control products is directly related to the accuracy and stability of the detection system. As an important partner in the IVD industry, Desheng New Materials has extremely strict requirements for the use of calibration and quality control products. With advanced technology and strict quality management system, it provides enterprises with high-purity and high stability IVD raw material products, such as chemiluminescence reagents, color reagents, biological buffering agents, enzyme preparations, etc. Desheng New Materials is willing to work together with IVD enterprises to drive innovation and empower technology, and jointly promote the development of the in vitro diagnostic industry.