Our Mission is to develop, manufacture and deliver on-time
high-quality, easy-to-use and reliable IVD assays
for the clinical diagnosis.
Sentinel Diagnostics is an Italian company specialized in the development and the production of In Vitro Diagnostics.
Established in 1983 by two Italian independent entrepreneurs, Sentinel Diagnostics has a long and proud history as an independent IVD developer and manufacturer.
Sentinel Diagnostics is the first IVD manufacturer in Italy and it is among the biggest in Europe in its areas of activity. The aim of our daily work is to provide high quality and reliable IVD products for the clinical diagnosis.
Sentinel Diagnostics distributes its products through the major players in the diagnostic field, as well as with a network of committed, established, independent distributors.
- We develop, manufacture and deliver on-time worldwide high-quality diagnostic reagents and solutions in Clinical Chemistry and Immunochemistry, Fecal Immunochemical Testing and Molecular Diagnostics;
- We continuously invest to develop and maintain a state of the art manufacturing site in Milan, Italy, where we produce our diagnostics supported by a Quality Management System compliant with ISO 9001:2015, ISO 13485:2016 & EN ISO 13485 : 2016, ISO 13485:2016 MDSAP (Australia, Brazil, Canada, USA and Japan);
- We have a growing, internationally diverse, committed and entrepreneurial team of 150 employees;
- We are a private company and the passion of the founders remains as strong as it was when the company was founded.
The Clinical Chemistry and Immunochemistry division is the largest and the first born in Sentinel Diagnostics.
Our specialties and latex based reagents are world renowned and appreciated, since we provide high quality assays, designed or adapted for the most widespread Clinical Chemistry analyzers.
We offer a complete product portfolio, which comprises Sentinel branded products, private labels and OEM.
Our full customization capabilities, together with the high manufacturing capacity, made us a trustful and strong partner in developing and supplying Clinical Chemistry and Immunochemistry assays.
Our Fecal Immunochemical Testing division was created around Sentinel Diagnostics’ patented universal tube for the collection of fecal samples, which has been specifically designed to be used on any Clinical Chemistry analyzer.
Its benefits include:
- easy collection: the fecal sample can be easily collected by the patient;
- sample stabilization: the sample is stabilized over time thanks to the specific extraction buffer inside the tube;
- single step analysis: the tube can be directly inserted in the rack of any Clinical Chemistry analyzer. No pre-analytical step needed.
The Molecular Diagnostics line was born in 2008 and has experienced an extensive growth over the years.
Our molecular portfolio is built on the proprietary technology STAT-NAT (Stabilized Amplification Technology – Nucleic Acid Testing), which is based on a new protective compound, able to stabilize the activity of enzymes for a very long time and to allow storage and shipment at room-temperature.
The Molecular Diagnostics line has recently expanded with new tests. Now, it includes the virology panel that contains a test for the detection of SARS-CoV-2 infection (COVID-19).
Sentinel Diagnostics’ production plant covers each stage of manufacturing: from the treatment of water, which is the basic component of all our products, up to reagent preparation, bottling, labeling and packaging.
We guarantee lot to lot consistency using standardized preparation procedures, process control and through the verification of the performance of each reagent on the most widespread analyzers, available in our validation laboratories.
We are very flexible in the realization of products according to client specification, in order to accomplish every need.