A reliable rapid functional lab test to help in diagnosing heparin-induced thrombocytopenia (HIT) in daily practice

Recently brought under the spotlights because of the Astra-Zeneca anti-COVID 19 vaccine-associated thrombosis, HIT is a potentially life-threatening complication of treatment with anticoagulant heparin whose diagnostic work-up is still an issue.

An article recently published in Biomedicines reported the performance of a rapid flow cytometry-based assay (FCA) as being like the performance of the Gold Standard (Serotonin Release Assay: SRA) and whose optimization led to the development of HIT Confirm® which may possibly help in diagnosing HIT on the frontline.

FCA results were standardized according to the Heparin Platelet Activation (HEPLA) index which interestingly reflects the heparin-dependent immune-mediated mechanism of HIT. Based on the final HIT diagnosis established by expert opinion adjudication, the sensitivity and specificity of the FCA were 88 and 95%, respectively, values very similar to those of the SRA (88 and 97%, respectively).

Full article here: Biomedicines | Free Full-Text | Functional Flow Cytometric Assay for Reliable and Convenient Heparin-Induced Thrombocytopenia Diagnosis in Daily Practice (mdpi.com)

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 (mdpi.com)

Right now, discover the new Emosis YouTube channel

On this channel, may watch a recent interview of Frédéric Allemand and Jean Amiral, guests from Ecosystem, B Smart TV channel’s program dedicated to entrepreneurship. Frederic and Jean will answer questions from Thomas Hugues (a renowned French TV anchor) about blood tests developed by Emosis to address pressing medical needs of patients suffering from cardioneurovascular diseases The interview also investigates the motivation of a renowned scientist-entrepreneur to support Emosis venture, and provide company’s update, especially about how Emosis innovation is relevant for managing some complications of COVID-19.

The two previous interviews of Frédéric Allemand broadcasted by B-Smart are also on display in Emosis YouTube channel, with a focus on the founding of the company and on the development of Emosis innovative in vitro diagnostic solutions.

More to come! Including explainer videos and tutorials. We are pleased to invite you to subscribe!

Emosis Diagnostics - YouTube

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

May patients be subject to hit because of SARS-CoV-2? A prospective study answers the question.

Conducted in France and Switzerland by the Hospital of Lariboisière Paris and the University Hospital of Geneva, the study on hospitalized SARS-CoV-2-infected patients has just been published in Thrombosis & Haemostasis journal (December issue)..

In hospitalized SARS-CoV-2-infected patients, elevated prevalence of thromboembolic events (TE) has been reported with subsequent recommendations to reinforce prophylactic anticoagulation using low-molecularweight (LMWH) or unfractionated-heparin (UFH).

For each patient referred by the attending physician for HIT suspicion, Lariboisière and Geneva Hospitals performed tests among which the HIT ConfirmTM test developed by Emosis.

Finally, the study suggests that COVID-19 patients receiving LMWH do not appear to be especially susceptible to HIT. Prevalence of HIT-associated antibodies is comparable to other critical illness settings and those antibodies do not seem to be associated with increased risk of TE and death.

To read more, please click on following link Thieme E-Books & E-Journals - Thrombosis and Haemostasis / Issue (thieme-connect.com)