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

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.