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Several Basic Indicators of Excellent Diagnostic Reagents

1. Blank diagnostic reagent


The reagent blank can be understood as the value detected when the content of the substance to be tested is theoretically zero. The general practice is to measure with water as a sample, and theoretically this value should be zero.


But the actual situation is not the case. Even if the sample added is water, it will show a certain degree of reactivity. The constant blank response degree does not affect the performance of the reagent, but if the blank response degree fluctuates greatly, the clinical results may be inaccurate. Mainly due to the instability of the reaction system of the diagnostic reagents, such as the instability of the antiseptic system, buffer system, enzymatic reaction system, etc., will lead to the change of the blank reaction degree.


2. Analysis sensitivity of diagnostic reagents


Analysis sensitivity refers to the slope of the calibration curve (or analysis curve), which can reflect the sensitivity of the diagnostic reagent to changes in the content of the substance to be tested. If the sensitivity is higher, corresponding to the change in the content of the substance to be tested, the greater the change in the detected experimental value. In this way, even if the content of the tiny substance to be tested changes, it will be found very easily.


3. The linear range of diagnostic reagent indicators


If within a numerical interval, the content of the substance to be tested and the analytically detected value form a good one-to-one correspondence, then we can call this numerical interval the linear range of the diagnostic reagent. The wider the numerical range covered by the linear range, the wider the coverage of clinical samples.


4. Precision and accuracy of diagnostic reagents


Simply put, precision is the repeatability of test results.


Accuracy reflects the degree of consistency between the detected value of the substance to be tested and the actual value.


5. Analysis specificity of diagnostic reagent indicators


Analytical specificity refers to the ability of the test result of the analyte to not be interfered by other components. In other words, the test results of diagnostic reagents will be affected by the presence of some substances, leading to deviations from the actual situation. Common interfering factors include hemolysis, blood lipids, bilirubin and VC. And there is infection test kit.


If the test result is not affected at all, unless the human body does not have these substances. They are interferences for diagnostic tests, but they are components that maintain human body functions and are indispensable.


In this case, only the diagnostic reagent itself can overcome the difficulties. How to overcome it? Improve your own anti-interference ability. If in an environment where a large number of interfering substances exist, the diagnostic reagent can also control the deviation of the detection result from the actual value within an acceptable range, and the anti-interference ability of the reagent is also qualified.


6. Index stability of diagnostic reagents


Stability can be understood as the shelf life of diagnostic reagents to ensure that the test results of the reagents are stable and reliable within a certain period of time. Stability can be divided into long-term stability and opened bottle stability.

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