Overview of metrological traceability of total PSA diagnostic kits inbrazilian clinical laboratories

Abstract

Introduction: Specific Prostate Antigen (PSA) is crucial for monitoring prostate cancer, which is one of the leading causes of male mortality in Brazil and the USA. The reliability of PSA results provides an efficient diagnosis to direct to therapy, treatment response evaluation, and epidemiology. However, known discrepancies exist in the results obtained from different laboratories. Metrological traceability emerges as a key factor for the comparability and precision of these results and is a subject of little knowledge in the laboratory community. Objective: This study aimed to identify the metrological traceability of Total PSA kits registered in Brazil. Method: A search was conducted on the ANVISA product registration page, where the origin and instructions for use of the kits provided by in vitro diagnostic (IVD) manufacturers were analyzed. Results: The ANVISA data showed that 75.0% of IVD producers use the WHO 96/670 product, and 25.0% do not mention metrological traceability. Foreign products prevail (87.5%), with only two national kits registered, which do not provide information on traceability. Conclusions: the Brazilian market for Total PSA diagnostic kits (excluding rapid tests and free PSA) is predominantly dominated by foreign products that use the WHO 96/670 reference material. The lack of information on traceability in a significant number of IVD products highlights the need for regulatory and educational actions to promote awareness and compliance with metrological traceability principles of, thereby improving the quality and reliability of laboratory tests for public health protection.