Research Scientist III Eurofins Viracor Biopharma Services Lenexa, Kansas
Viral PCR results have long been key endpoints relevant to many therapeutic and vaccine trials. Yet when a testing laboratory develops or transfers in a viral PCR, a process is not available for ensuring this method is harmonized with other assays for that same pathogen. In particular, approaches to harmonization with regards to inter- laboratory / inter-assay accuracy & precision across a dynamic range is lacking and needed. The purpose of standardization is to enable inter-laboratory and inter-assay comparisons globally. One tool is the World Health Organization International Standards (WHO ISs) which are the gold standards for global-wide nucleic acid amplification testing (NAAT) standardization. However, there is a lack of standardized acceptance criteria from the WHO. The work performed in the study established an acceptance criteria for anchoring and calibrating the secondary standards to WHO ISs with accuracy and precision across an appropriate dynamic range, which is a step forward in reducing the of inter- laboratory / inter-assay variability.
Learning Objectives:
Upon completion, participant will be able to understand the importance of inter-laboratory and inter-assays global harmonization.
Upon completion, participant will be able to demonstrate the difference in calibrators utilized in conversion.
Upon completion, participant will be able to define the acceptance criteria for accurate conversion.
