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IVD Instrument Analytical Sensitivity and Analytical Specificity
  • June 7,2022.

Two important parameters are often used in modern medicine to evaluate whether a certain technology or a certain index is reliable to determine the disease - "sensitivity" and "specificity". Then, for IVD companies, when we combine the above two parameters and other factors, select a certain index to determine a certain disease, and produce corresponding IVD products, we will face another problem. : How to evaluate the performance of this IVD product?


01 Analytical Sensitivity


The "analytical sensitivity" defined by IUPAC is the change in the analytical signal caused when the concentration or content of the measured component changes by 1 unit, and refers to the slope of the calibration curve (the abscissa is the concentration, and the ordinate is the measurement signal). The steeper the calibration curve, the higher its analytical sensitivity.


But in IVD products, analytical sensitivity and detection limit are defined as the same concept, namely: the lowest detectable analyte concentration. The lower the corresponding concentration, the better the product performance of IVD. Determining the lower reportable limit of a detection system is an important analytical performance.


02 Analysis specificity


Analytical specificity refers to the ability of an analytical method to detect a component or only a specified analytical reactant and not other substances in the sample.

Generally, the analysis specificity is divided into two parts, one part is the verification of cross-reaction, antigens that are prone to cross-reaction, antibodies and heterophilic antibodies. The other part is interfering substances, the influence of common interfering substances in samples on the test results, such as high fat, jaundice, rheumatoid factor, anticoagulant and other interfering factors.


Hecho Technology provides Customized Optical Fiber, including Fiber Optic Bundles for PCR, POCT devices, With excellent product performance, combined with strong R&D and production capabilities, helps the IVD industry to improve the sensitivity of the instrument.

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