We are excited to announce the successful completion of our latest GMP production for the 13-Plex Pneumococcal IgG Serological Luminex Assay. This latest milestone represents a significant achievement in our commitment to delivering high-quality solutions for the manufacturing of Luminex assays under strict quality and regulatory criteria.
This quantitative Luminex assay, designed for the precise measurement of IgG antibodies, targets 13 serotypes of S. pneumoniae, aligning with the strains covered by the PCV13 (Prevenar 13) vaccine. With the capability to detect antibodies against specific serotypes including Pn 1, Pn 3, Pn 4, Pn 5, Pn 6A, Pn 6B, Pn 7F, Pn 9V, Pn 14, Pn 18C, Pn 19A, Pn 19F, and Pn 23F, this assay provides critical insights into an individual’s immunological status. Developed under stringent GMP conditions, the Luminex assay ensures accuracy, reliability and reproducibility in detecting antibodies against key serotypes.
Utilizing the advanced Luminex® xMAP™ technology, the assay provides researchers and clinical labs with a powerful tool for sero-surveillance studies and S. pneumoniae-related research. Furthermore, its potential application in vaccine development underscores its significance in advancing public health initiatives.
With production now completed under GMP standards, this Luminex Assay is equipped with all necessary components and accompanying documentation to serve as a critical reagent in diagnostic laboratories. These laboratories will utilize it to develop and validate the 13-Plex Pneumococcal IgG Serological Luminex Assay as a Laboratory Developed Test (LDT) under CLIA regulations. This accomplishment reflects our ongoing dedication to driving innovation in healthcare and in-vitro diagnostics.