An Optimized and Standardized Rapid Flow Cytometry Functional Method for HIT

Flow cytometry-based assays appear to be an emerging widely available class of functional tests for Heparin-induced thrombocytopenia (HIT), possibly for frontline diagnostic work-up, according to an article published by Biomedicines, the open access journal from MDPI.

Abstract. The diagnosis of HIT combines a clinical scoring of pretest probability and laboratory testing. First-line routine tests are antigen binding assays detecting specific anti-bodies. The most sensitive of these tests have a high HIT-negative predictive value enabling to rule-out HIT diagnosis when negative. However, HIT-positive predictive value is low, and a functional assay evaluating the pathogenicity of the antibodies should be performed to exclude false-positive results. In contrast to screening assays, functional assays are highly specific but technically challenging, and thus performed in referral laboratories, where platelet activation is detected using radioactive serotonin (SRA; serotonin release assay) or visually (HIPA; heparin-induced platelet activation). Flow cytometry is a possible alternative. It is however currently not widely used, mostly because of the lack of standardization of the published assays. The article describes the analytical assessment and validation underlying the standardization of a flow cytometry assay (HIT-FCA) which subsequently led to the development of a CE mark assay (HIT Confirm®, Emosis, Illkirch, France).

To access the entire article, please click on Biomedicines | Free Full-Text | An Optimized and Standardized Rapid Flow Cytometry Functional Method for Heparin-Induced Thrombocytopenia (

ISO 9001:2015 and ISO 13485:2016, a new re-certification!

Emosis is proud to announce that company’s certification under the norms ISO 13485:2016 and ISO 9001:2015 is maintained for the fourth year!

This achievement underscores that Emosis demonstrates the sustained focus and vision required to maintain and continually improve company’s ISO-based quality management system (QMS).

It is a critical step to successfully prepare forthcoming audit and (re-)certification of Emosis products by a Notified Body according to the new EU legislation applicable to in vitro diagnostic (IVD) medical devices, Diagnostic Regulation (IVDR) (EU) 2017/746.

This regulation that considerably strengthen the emphasis on certain essential aspects of the CE marking regulatory process, such as risk-based classification, conformity assessment and product certification including performance assessment by third-party independent Notified Bodies designed by the Competent Authorities of each EU member state, and post-market performance surveillance and reactovigilance.

We are thankful to our teams that are already committed to develop Emosis products consistently with the requirements of this new regulation which will ultimately improve the quality of care for the patients.

Download ISO 9001 certificate - Download ISO 13485 certificate

How does Emosis deal with Covid-19? An interview of Frédéric Allemand on B Smart TV

Frédéric Allemand, co-founder and CEO of Emosis, answered famous journalist Jean-Marc Sylvestre questions on the brand-new business TV channel B Smart.

Discover the interview (in French - duration: 5 minutes) :