Validation of a PCR method for the detection Campylobacter spp. in milk powder

Phuc Nguyen Do, Ngan Nguyen Ly Hoang, Hien Le Thi, Phong Ngo Thanh, Tram Tran Bao, Hien Nguyen Ngoc Thanh, Thanh Truc Nguyen Thi, Phuong Hoang Hoai
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Abstract

An alternative PCR method for rapid detection of Campylobacter spp. in milk powder was validated according to TCVN 12365-2:2018 (ISO 16140-2:2016). In this study, performed with paired study, validation examines the following parameters: (1) sensitivity (sensitivity for the alternative method: SEalt, sensitivity for the reference method: SEref, relative trueness: RT, false positive ratio for the alternative method: FPR), (2) relative level of detection (RLOD) and (3) inclusivity and exclusivity. The result showed that: sensitivity for the alternative method: 85.7%, sensitivity for the reference method 92.8%, relative trueness: 85%, false positive ratio for the alternative method: 16.7%, relative level of detection: 0,859 CFU/25g. For inclusitivity testing, two reference strains were detected. For exclusitivity testing, all of 20 strains were not detected. All the parameters tested were met according to TCVN 12365-2:2018 (ISO 16140-2: 2016) requirements.
奶粉中弯曲杆菌PCR检测方法的验证
根据TCVN 12365-2:2018 (ISO 16140-2:2016)的要求,建立了一种快速检测奶粉中弯曲杆菌的PCR方法。在本研究中,采用配对研究,验证检验了以下参数:(1)灵敏度(替代方法的灵敏度:seal,参考方法的灵敏度:SEref,相对真实度:RT,替代方法的假阳性率:FPR),(2)相对检测水平(RLOD)和(3)包容性和排他性。结果表明:替代方法的灵敏度为85.7%,参考方法的灵敏度为92.8%,相对正确率为85%,替代方法的假阳性率为16.7%,相对检出水平为0.859 CFU/25g。在包容性测试中,检测到两个参考菌株。20株菌株均未检出。所有测试参数均符合TCVN 12365-2:2018 (ISO 16140- 2:20 16)要求。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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