Shanghai Hengyuan shared biochemical reagent performance evaluation method

Founded in 2008, Shanghai Hengyuan Biotechnology Co., Ltd. is a bio-tech enterprise specializing in the research and development and sales of immunology, analytical biology and conventional biochemical reagents. The main products are imported R&D/TSZelisa kit, radio-removal kit, blood clot, antibody, biological research reagents, experimental consumables, etc.

First, the main performance indicators of biochemical reagents

1. Stability: It means that after a period of storage under the specified conditions, the corresponding performance indicators can still be achieved, such as reagent blank absorbance, linear range, sensitivity and so on.

2. Reaction sensitivity: refers to the degree of reaction produced by the reaction of the analyte per unit concentration (or activity). The higher the degree of reactivity, the greater the sensitivity.

3. Precision: the degree of agreement between the results

4. Accuracy: consistency with the results of the reference measurement procedure

5. Linear range: The range of the relationship between the measured concentration or activity value and the set concentration or activity value under specified repeatability and linearity deviation.

6. Matrix effect: A matrix refers to a component other than the analyte in the sample. Substrates often have significant interference with the analytical process of the analyte and affect the accuracy of the analytical results. For example, the ionic strength of a solution has an effect on the activity coefficient of the analyte, which is called a matrix effect.

7. Anti-interference: reagent/sample ratio, reaction time, price, etc.

Second, biochemical reagent performance evaluation method

1. Stability: continuous observation, daily test; thermal acceleration test.

2. Reaction sensitivity: directly calculate the absorbance change or rate of change of the reactant per unit concentration.

3. Precision: According to NCCLSEP5-A.

4. Accuracy: According to NCCLSEP9-A2.

5. Linear range: According to NCCLSEP6-A.

6. Matrix effect: determined by recycling test

7. Anti-interference: according to NCCLSEP7-A

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