Producción de un material de referencia piloto de la proteína Spike del virus SARS-CoV-2.

Abstract

The most widely used diagnostic method for the detection of the coronavirus causing Acute Respiratory Syndrome (SARS-CoV-2) is the reverse transcription-polymerase chain reaction (RT-PCR), however, other alternative procedures have emerged to complement it such as those based on antigen or antibody analysis, and other less common ones such as those based on biosensors and volatile organic compounds (VOCs). In spite of their frequent use in diagnosis for antigen-based analysis, there are no tools available to ensure the validity of the results. Therefore, at the National Metrology Institute, during the development of this business internship within the framework of the STATE YOUNG program, the short-term stability and homogeneity of the SARS-CoV-2 Spike protein (Invitrogen RP-87671) was evaluated at temperatures of 4, - 20 and -80°C. These two variables were determined by means of a series of tests that were carried out in order to determine the validity of the results of the analysis. These two variables were determined by quantifying the fluorescence emitted by the secondary antibody in the indirect ELISA test. The results show that the candidate Reference Material was stable and homogeneous in the short term at the temperatures studied. Mass production of this RM will depend on long-term studies.