GB/T 23182-2025Guideline for method development, validation & verification and internal quality control in feed quality and safety detection (English PDF)

3.1 Qualitative method

Analytical methods for identifying substances based on their chemical, biological, or physical properties.

[Source. GB/T 27417-2017, 3.5]

3.2 Quantitative method

Analytical methods for determining the mass or mass fraction of an analyte.

Note. Express numerical values using appropriate units.

[Source. GB/T 27417-2017, 3.6, with modifications]

3.3 Confirmatory method

It can provide all or part of the information about the target substance, based on which the nature of the substance can be clearly defined, and, if necessary, further analysis can be performed at the concentration level of interest. Methods of measurement.

[Source. GB/T 27417-2017, 3.7]

3.4 Screening method

It has the ability to efficiently process large numbers of samples, and is used to detect the presence of a substance or a group of substances at a concentration level of interest. method.

Note. These methods are used to screen a large number of samples for potential positive results and to avoid false negatives. The test results obtained by these methods are typically qualitative.

Results or semi-quantitative results.

[Source. GB/T 27417-2017, 3.8]

3.5 sensitivity

The degree of change in the response quantity of an analytical method to a change in the unit concentration or unit amount of analyte.

3.6 Trueness

The degree of agreement between the average of an infinite number of repeated measurements and a reference value.

[Source. ISO /IEC Guide 99 2007, 2.14]

3.7 accuracy

The degree of consistency between the measured value (result) of the analyte in the sample and the true value or agreed true value of the measured substance.

3.8 matrix effects

The influence of one or more components in the sample matrix on the detection results of the target analyte.

Note. Compared to the detection results of the target analyte in the reagent, the matrix effect may cause the target analyte response signal to be enhanced or weakened.

[Source. GB/T 32467-2015, 9.29]

3.9 linear range

The concentration range of the analyte exhibits a linear relationship with the instrument response value and meets quantitative requirements (precision and accuracy).

3.10 Limit of detection (LOD)

The analytical method can detect the lowest amount (or lowest concentration) of the analyte from the sample background signal within a given confidence level, but accuracy is not guaranteed. Quantitative.

3.11 concentration)

The analytical method, while meeting quantitative requirements (precision and accuracy), can quantitatively determine the lowest amount (or lowest value) of the analyte in the sample.

3.12 Recovery rate

The percentage of the measured value of the analyte in a known exact sample or the test substance added to a blank sample relative to its true value.

3.13 Precision

The degree of consistency between the measured values obtained by repeatedly measuring the same sample using analytical methods.

3.14

The percentage of the standard deviation (SD) of multiple measurements to the arithmetic mean.

3.15 repeatability

Under repeatability conditions, the degree of consistency between independent test results.

3.16 The conditions under which objects obtain mutually independent results

In the same laboratory, by the same operator using the same equipment and reagents, according to the same test method, and within a short period of time, from the same test subject...

3.17 reproducibility

Under reproducibility conditions, the degree of consistency between test results.

3.18 The conditions for obtaining test results

In different laboratories, by different operators using different equipment and reagents, following the same testing method, samples were taken from the same test subject.

3.19 minimum limit

The limits for substances that specify and require a certain quantitative characteristic.

[Source. GB/T 27417-2017, 3.9, with modifications]

3.20 Method selectivity

The method can distinguish the target analyte from other components in the sample (such as other analytes, matrix components, and other possible interfering substances). degree.

[Source. GB/T 32467-2015, 9.14]

3.21 Method robustness

Method durability The sensitivity of analytical methods to minute variations in conditions that are not typically controlled or kept perfectly consistent in the laboratory.

[Source. GB/T 32467-2015, 9.15]

3.22 Method validation

Through experiments, the laboratory provides objective and valid evidence to prove that a specific testing method meets its intended purpose.

3.23 [Source. GB/T 27417-2017, 3.3]

In a laboratory setting, at reasonable time intervals, the same or different samples are analyzed using a method under predetermined conditions.

Analytical experiments are conducted to demonstrate that a specific detection method meets its intended purpose.

3.24 [Source. GB/T 27417-2017, 3.4]

To demonstrate the effectiveness of a specific detection method by performing the same method on the same sample in two or more laboratories under predetermined conditions. It meets its intended use.

3.25 Method verification

The laboratory, through verification, provided objective and valid evidence to prove that it met the requirements stipulated in the testing method.

[Source. GB/T 27417-2017, 3.2]