||Main Cell Type
||Dendritic cells modulate T cell, B cell, monocyte/macrophage function to link innate and adaptive immunity.
||B cells function within the adaptive immune response and are responsible for the development and secretion of antibodies. CD20 is a pan-B cell marker.
||Macrophages modulate the immune response.
||Professional antigen-presenting cells
||MHC Class II is responsible for the presentation of pathogenic epitopes to the immune system.
- The antibody panel content of Ultivue’s kits is defined from voice-of-customer inputs, from collaborators, prospective customers and key opinion leaders.
Ultivue's product development process begins with the screening and careful selection of antibody clones for each target. Clones are selected for their target specificity, reliability, and widespread acceptance in clinical labs.
- Once selected antibodies have been conjugated to unique DNA barcodes, they are tested to verify that the antibody conjugates retain the same performance as the unconjugated material. This is carried out by comparing the staining quality with gold standard methods and certifying the staining by a qualified reviewer.
- To establish multiplexed panels, a titration series for each antibody conjugate is carried out in FFPE tissue control samples to select optimal antibody staining concentrations. Assay protocol steps are optimized as needed.
- When applicable, the analytical sensitivity of the assay for a given target is tested using standards with a known concentration gradient, such as cell pellet controls.
- To confirm reproducibility specifications, functional testing of the entire kit is accomplished via inter-instrument, inter-day, inter-analyst, and intra-run testing for all protocols. Samples are imaged on a wide range of microscopes and slide scanners from leading suppliers.
- Images from reference samples are formally reviewed by consulting pathologists. Alpha and/or Beta pre-production kits are evaluated by prospective customer labs to ensure the assay meets performance expectations and that the kit documents and instructions are clear and complete.
- Multiple stability tests are run for every component of the kit including real-time, accelerated, in-use, on-board, shipping, and freeze-thaw cycle stability.
- The kits for immuno-profiling are designed to offer seamless integration into standard immunohistochemistry research workflows. The optimized manual and automated protocols enable a rapid path from sample to answer in a single day.
- The kit is configured to offer an easy-to-use, fast, and fully automated tissue staining solution using the Leica BOND RX® system. The reagents enable the detection of up to four markers and a nuclear counterstain on whole slides using research fluorescence tissue scanners such as the Leica Aperio VERSA® amongst other validated imaging solutions. The resulting multiplexed images are compatible with most digital pathology image analysis solutions, such as the IndicaLabs Halo® platform, enabling the automated quantification of spatial and cellular expression data over whole tissue sections.
- As an example, our kits enable the automated staining of four targets and nuclear counterstain on up to 30 slides at one time on the Leica BOND RX®, in 5 hours. Using current imaging systems, a 2 cm2 FFPE section can be imaged in five fluorescent channels in less than 15 minutes, enabling a true sample to answer workflow within a work day.