Validation of diagnostic assays
Validation of diagnostic assays is a strict requirement before the assays can be applied. Assay validation is a process that determines whether an assay is fit for the purpose for which it has been developed.
It requires establishing the analytical and diagnostic performance, as well as key parameters like robustness, repeatability, sensitivity and specificity. Wageningen Bioveterinary Research (WBVR) offers validation of veterinary assays as a commercial service.
Biobank with material
Thanks to decades of experience in veterinary research, we have built up a huge biobank with sample material. This includes a comprehensive collection of viral and bacterial isolates that can be used for validation purposes. In addition, biological samples from animals are available, such as positive and negative reference sera for specific pathogens. These biologicals are available in our webshop.
Facilitating PCR design
Nowadays, molecular detection of pathogens using PCR is common practice in diagnostics. The first step in PCR development is selection of primers and probes that are specific for the target pathogen. This is essential, because the oligonucleotides should not cross-react with related pathogens. To facilitate PCR design, we have developed a tool that can validate PCR designs in silico using the latest versions of public nucleotide databases. This tool is very useful in designing new PCRs, and can also be applied to regularly re-evaluate existing PCRs to verify if designs are still up to date.
Contact our expert
Please feel free to contact the expert of our contract research organization (CRO) if you have a question concerning assay validation.