CAJ | 학술논문

为探索沙门氏菌可替代方法实验室内验证的具体程序，依据ISO 16140：2003/Amd 1：2011《食品和动物饲料微生物学-可替代方法的验证方案》，以赛默科技SureTect沙门氏菌实时PCR检测方法为例，对照参照方法进行了实验室内验证。所涉及的性能指标包括：①相对准确性、相对特异性和相对灵敏度；②相对检测限；③包含性和排他性。统计检验表明，该方法与参照方法在相对准确性、相对特异性和相对灵敏度方面无显著性差异，两种方法的相对检测限也无显著性差异。两种方法包含性和排他性检测结果基本一致。上述验证程序表明，检测方法的实验室内验证需遵循特定的程序，该验证程序可科学评价沙门氏菌可替代方法的性能。此次实验室内验证也可为类似的微生物检测方法验证提供参考。
위탐색사문씨균가체대방법실험실내험증적구체정서，의거ISO 16140：2003/Amd 1：2011《식품화동물사료미생물학-가체대방법적험증방안》，이새묵과기SureTect사문씨균실시PCR검측방법위례，대조삼조방법진행료실험실내험증。소섭급적성능지표포괄：①상대준학성、상대특이성화상대령민도；②상대검측한；③포함성화배타성。통계검험표명，해방법여삼조방법재상대준학성、상대특이성화상대령민도방면무현저성차이，량충방법적상대검측한야무현저성차이。량충방법포함성화배타성검측결과기본일치。상술험증정서표명，검측방법적실험실내험증수준순특정적정서，해험증정서가과학평개사문씨균가체대방법적성능。차차실험실내험증야가위유사적미생물검측방법험증제공삼고。
In order to show the detailed procedure of in-house validation of the alternative methods for Salmonella spp., this study was conducted with SureTect real-time PCR Test for Salmonella spp. as an example and the reference method according to ISO 16140:2003/Amd:2011 Microbiology of food and animal feeding stuffs-Protocol for the validation of alternative method. The following performance indices were obtained:①The Relative Accuracy, Relative Specificity and Relative Sensitivity;②Relative Detection Level;③Inclusivity and Exclusivity. Statistical testings proved that there were no significant differences between the two methods for Relative Accuracy, Relative Specificity, Relative Sensitivity and Relative Detection Level respectively. As to the inclusivity and exclusivity, the results of the strains were almost congruent. The validation procedure mentioned above revealed that specific procedure should be implemented when in-house validation was launched and the procedure in this study could assess the performance of the alternative methods for Salmonella spp. reasonably. Moreover, this in-house validation can be used as a paradigm for similar work of microbial tests.