The Custom Solutions division of Bioline offers custom assay development services, conducted by our highly‑experienced, London‑based R&D team. This team has been developing assays since Bioline was established in 1992 and has earned a reputation for formulating assays that perform reliably in even the most challenging conditions. Our unparalleled understanding of enzymology, buffer chemistry and how they can be adjusted to influence assay performance have enabled us to design assays that meet a very broad range of performance criteria.
Our development experts are adept at making adjustments to reagent formulations to achieve the highest performance levels in terms of assay sensitivity, reproducibility, accuracy, inhibitor tolerance and specificity. We understand that achieving target performance levels can be about optimizing magnesium concentration, reaction volume, dNTP concentration, pH, dUTP concentration, the inclusion of PCR stabilizers and additives, the choice and concentration of salt, fluorescent dye selection and/or thermal cycling parameters. In the pursuit of reliable assays, we routinely verify thermal stability, assay reproducibility and freeze‑thaw stability.
We place quality at the heart of our actions. Hence, all test development work is performed in accordance with ISO 13485. To ensure the successful, rapid application of the tests we develop, it’s our R&D team that provides any post‑launch technical support.
Bioline is a wholly‑owned subsidiary of Meridian Bioscience, Inc. (NASDAQ:VIVO). Meridian is a life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic test kits, rare reagents, specialty biologicals and components.
The Meridian expertise extends to the development of diagnostic tests that demonstrate the required performance and consistency to meet FDA and CE‑IVD regulatory requirements. Bioline has shaped its own development efforts according to the methodology Meridian applies in the development of diagnostic kits.
Click here if you would like to discuss our assay design capabilities, or any other needs you may have, with one of our experts.