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
{"title":"Validation of a PCR method for the detection Campylobacter spp. in milk powder","authors":"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","doi":"10.47866/2615-9252/vjfc.3953","DOIUrl":null,"url":null,"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.","PeriodicalId":12896,"journal":{"name":"Heavy metals and arsenic concentrations in water, agricultural soil, and rice in Ngan Son district, Bac Kan province, Vietnam","volume":"81 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2022-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Heavy metals and arsenic concentrations in water, agricultural soil, and rice in Ngan Son district, Bac Kan province, Vietnam","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.47866/2615-9252/vjfc.3953","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
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.
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。