ISO/TS 23758:2021 ミルクおよび乳製品中の動物用医薬品の残留物を検出するための定性的スクリーニング方法の検証のためのガイドライン | ページ 5

3.1

biological method

method that is used to detect cellular responses to analytes

3.2

qualitative method

method that gives a yes/no response, with no indication of the concentration of the putative analyte

3.3

matrix

non-analyte portion of the sample

Note 1 to entry: Matrices are included in the scope.

3.4

detection capability

CCβ

smallest content of the analyte that can be detected, identified and/or quantified in a sample with an error probability of β

Note 1 to entry: The β error is the probability that the tested sample is truly non-conformant even though a conformant measurement has been obtained.

3.5

cut-off level

response or signal from a screening test which indicates that a sample contains an analyte at or above the screening target concentration

3.6

blank matrix sample

negative control sample

sample from animals with known history of treatment which have not been exposed to the substance in question

Note 1 to entry: If samples from such animals are not available, samples which have been previously confirmed as conformant and not containing residues of the substance of interest by suitably sensitive physicochemical tests can also be acceptable.

Note 2 to entry: See Table 1.

3.7

positive control sample

control sample that is spiked with the test analyte at the screening target concentration

Note 1 to entry: This can, however also be an incurred-positive sample (i.e. sample taken from animals which have been treated with the substance in question) or Certified Reference Material.

3.8

screening target concentration

concentration at which a screening test categorizes the sample as “screen positive” (potentially non-conformant)

Note 1 to entry: This should always be lower than the regulatory limit.

3.9

validation

confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application, such as a test or measurement method, have been fulfilled

Note 1 to entry: Validation often determines the fitness for purpose of a method.

3.10

verification

procedure applied to a method which has been previously validated in the case of a transfer validation

Note 1 to entry: The verification procedure is applied by a receptor laboratory for the same matrix as initially validated, to demonstrate that the method will work reliably in that laboratory with locally sourced milk and is fit for purpose.

3.11

originator laboratory

laboratory that has performed the complete validation of the method

Note 1 to entry: This is by preference an ISO/IEC 17025 accredited independent laboratory and preferably not the laboratory that developed the method. The laboratory should have experience in residue testing and in validation of screening tests for the detection of residues of veterinary drugs in milk.

3.12

receptor laboratory

laboratory that will perform the verification of the method

Note 1 to entry: This could be any laboratory interested in using the method.

3.13

spectrum

range of substances that a test can detect

Note 1 to entry: Some tests detect several classes of antibiotics and a large number of substances, whereas others are more specific.

3.14

regulatory limit

level defined by food legislation for residues in food

Note 1 to entry: Regulatory limits can be MRL (see 3.15), MRPL (see 3.16), RPA (see 3.17).

3.15

maximum residue limit for veterinary drugs

MRL

maximum concentration of residue resulting from the use of veterinary drugs that is recommended by the Codex Alimentarius Commission to be legally permitted or recognized as acceptable in food

Note 1 to entry: Antibiotics are used to treat and prevent diseases in animal husbandry and as a result, low residues of antibiotics can be present in food. MRLs are set for pharmacologically active substances used or intended to be used in veterinary medicinal products placed on the market. In the EU the MRLs are set by EMA (European Medicines Agency).

3.16

minimum required performance limit

MRPL

minimum content of an analyte in a sample, which at least has to be detected and confirmed

Note 1 to entry: MRPL is intended to harmonize the analytical performance of methods for substances for which no permitted limit has been established.

3.17

reference point for action

RPA

level of a residue of a pharmacologically active substance established for control reasons in the case of certain substances for which a maximum residue limit has not been laid down following certain EU regulations

Note 1 to entry: EU Regulation 470/2009 is applicable for maximum residue limits.

Note 2 to entry: RPAs are currently based on analytical considerations (i.e. the lowest concentration that can be quantified using a validated analytical method). The aim is “to define an analytical concentration for a non-allowed pharmacologically active substance that can be determined by official control laboratories and that is low enough to adequately protect the consumers of food commodities which contain that substance”^[19].

3.18

positive/ negative result

result of the test after interpretation of the reading of the test taking into account the (pre-set) cut-off level

Note 1 to entry: Positive result: presence of antimicrobial residues (microbial inhibitor test) or presence of residues of veterinary drugs.

Note 2 to entry: Negative result: absence of antimicrobial residues (microbial inhibitor test) or absence of residues of veterinary drugs. Since only screening tests are involved, no judgement about ‘conformant’ or ‘non-conformant’ can be made.

3.19

repeatability limit

value less than or equal to which the absolute difference between two measurement results obtained under repeatability conditions is expected with a probability of 95 %

3.20

probability of detection

POD

proportion of positive analytical outcomes for a qualitative method for a given matrix at a given analyte level or concentration

Note 1 to entry: POD is concentration dependent (AOAC, 2014^[7]).