Provision of custom Milliplex MAP kits for multiplexed biomarker assays

Public Health England (PHE) awarded the contract for the Milliplex MAP kits for multiplexed biomarker assays that are made according to customers specifications to Merk Limited. Research and Technical Services relay in their high containment work on custom-designed luminex panels that are made according to customers specifications. For example, together with the collaborators, a 23-plex panel has been designed (GM-CSF, IFN-a2, IFN-g, IL-1b, IL-2, IL-4, IL-6, IL-8, IL-9. IL-10, IL-12(p70), IL-15, IL-17, IP-10, MIP-1b, TNF-a, G-CSF, IL-1b, IL-5, MIP-1a, MCP-1, VEGF and Eotoxin). The provider must premix the luminex beads, saving valuable laboratory time, ensuring kit consistency and reducing introduction of potential errors within the procedure. The required kits must: - Come with a serum matrix which alters the shape of the calibration curve to give increased consistency with these types of samples - Be standardly supplied with two QC samples to allow interrogation of data accuracy and provide an extra layer of quality assurance; - The calibration range of the standard within kits must be set at 10%; - The kits must come with standards covering all of the analytes to be measured. - Fewer experimental steps are required. This is pertinent as the samples to be tested contain hazard group 4 pathogens so for safety reasons manipulations should be kept to a minimum. In addition, MILLIPLEX™ MAP kits are the only one found to not require prior dilution of samples before addition to the assay, and reagents are mainly supplied at the required dilutions thus reducing manipulations at Containment Level 4.

Following extensive market research, PHE believes that only Milliplex MAP kits for multiplexed biomarker assays meet all the mandatory requirements. Merk Ltd is the only supplier in the market capable of providing those custom Luminex beads.

No queries were received following the publication of VEAT notice (2019/S 055-126910).