With the increasing scale of trade in aquaculture products, ISO 17025 accredited laboratories play an essential role in ensuring product quality, consumer safety, and facilitating international trade. ISO 17025 is an international standard that specifies the general requirements for the competence of testing laboratories to ensure reliable results that are crucial for meeting international market demands. Accreditation under ISO 17025 means that the laboratory has been assessed by an external body to guarantee that the testing carried out by the laboratory is compliant with these global standards.
Amongst others, the ISO 17025 standard requires that the laboratory must demonstrate the capability to achieve accurate, repeatable results using a selected method. Consequently, testing methods need to be appropriate, validated and documented. Furthermore, adequate diagnostic test validation and characterisation of the diagnostic performance of diagnostic tests for infectious diseases, as per World Organisation for Animal Health (WOAH) guidelines, are essential to ensure that the application and interpretation of the results are scientifically robust.
Abalone Herpes Virus 1 (AbHV) is listed as a notifiable disease by WOAH. South Africa is currently classified free from infection with Abalone Herpes Virus at country level, underscoring the importance of reliable diagnostic services and regular testing to maintain this status. In this instance appropriately validated, fit for purpose diagnostic testing capability for targeted surveillance in seemingly healthy animals is essential.
Our study utilised a synthetic plasmid as a positive control and validated a duplex real-time PCR assay for detecting AbHV. This method offers high analytical sensitivity and specificity, targeting a 145 bp segment of an open reading frame on the genome. The validation process included rigorous testing for analytical specificity and sensitivity, repeatability, and reproducibility, ensuring that it meets ISO 17025 accreditation requirements, as well as the additional technical requirements of the South African National Accreditation System (SANAS). This is the first assay to be ISO 17025 validated for the abalone aquaculture sector in South Africa and enhances the credibility and marketability of aquaculture products, facilitating global market access. This validated, soon to be accredited, service supports targeted disease surveillance in outwardly healthy populations, early disease detection and control, fostering sustainability and growth in the industry. This compliance with international standards is vital for successful participation in the global market.