Validation of a Five Plate Test, the STAR protocol, for the screening of antibiotic residues in muscle from different animal species according to European Decision 2002/657/EC
Validation of a Five Plate Test, the STAR protocol, for the screening of antibiotic residues in muscle from different animal species according to European Decision 2002/657/EC
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DOI：
10.1080/19440041003677483
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发表时间：
2010-01-01
影响因子：
2.9
通讯作者：
Verdon, E.
中科院分区：
文献类型：
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作者：
Gaudin, V.;Hedou, C.;Verdon, E.
STAR 方案是社区参考实验室 (CRL) 几年前开发的五板试验 (FPT)，用于筛查牛奶和肌肉中的抗菌剂残留。本文根据欧洲决定 2002/657/EC 和内部验证指南介绍了该方法的验证。我们的实验室在几个月内针对 STAR 方案实施了基于“模拟组织”和待验证的 16 种代表性抗菌剂清单的验证方案。确定了该方法的性能特征（特异性、检测能力 CC、适用性、耐用性）。总之，STAR方案适用于不同动物物种（猪、牛、羊、家禽）肌肉中抗生素残留的广谱检测。该方法具有良好的特异性（假阳性率=4%）。确定了来自不同家族的 16 种抗生素与其各自最大残留限量 (MRL) 的关系：β-内酰胺类（青霉素和头孢菌素 MRL）、四环素类（MRL 和 2.5 MRL）、大环内酯类（2 MRL）、喹诺酮类（2 MRL）、某些磺胺类药物（3 MRL）和甲氧苄啶（2 MRL）。然而，STAR 方案对氨基糖苷类 (8 MRL) 和氟苯尼考 (10 MRL) 的敏感性并不令人满意 (MRL)。本研究的两个目标得到满足：首先，根据欧洲决定 2002/657/EC 验证 STAR 协议，然后证明为实施该决定而制定的验证指南适用于微生物平板测试，甚至适用于肌肉。模拟组织的使用似乎是带有抗生素溶液的尖刺圆盘和所产生的组织之间的良好折衷。此外，选择一系列具有代表性的抗生素可以缩小验证范围，而这本来就耗费大量的时间和精力。
The STAR protocol is a Five Plate Test (FPT) developed several years ago at the Community Reference Laboratory (CRL) for the screening of antimicrobial residues in milk and muscle. This paper presents the validation of this method according to European Decision 2002/657/EC and to an internal guideline for validation. A validation protocol based on 'simulated tissues' and on a list of 16 representative antimicrobials to be validated was implemented in our laboratory during several months for the STAR protocol. The performance characteristics of the method were determined (specificity, detection capabilities CC, applicability, ruggedness). In conclusion, the STAR protocol is applicable to the broad-spectrum detection of antibiotic residues in muscles of different animal species (pig, cattle, sheep, poultry). The method has good specificity (false-positive rate = 4%). The detection capabilities were determined for 16 antibiotics from different families in relation to their respective maximum residue limit (MRL): beta-lactams (penicillins and cephalosporins MRL), tetracyclines (MRL and 2.5 MRL), macrolides (2 MRL), quinolones (2 MRL), some sulphonamides (3 MRL), and trimethoprim (2 MRL). However, the sensitivity of the STAR protocol towards aminoglycosides (8 MRL) and florfenicol (10 MRL) was unsatisfactory (MRL). The two objectives of this study were met: firstly, to validate the STAR protocol according to European Decision 2002/657/EC, then to demonstrate that the validation guideline developed to implement this decision is applicable to microbiological plate tests even for muscle. The use of simulated tissue appeared a good compromise between spiked discs with antibiotic solutions and incurred tissues. In addition, the choice of a list of representative antibiotics allowed the reduction of the scope of the validation, which was already costly in time and effort.