Karine Charrière - Academia.edu (original) (raw)

Papers by Karine Charrière

Research paper thumbnail of Medical Devices Development: the Bottom-up or the Top-down Approach

HAL (Le Centre pour la Communication Scientifique Directe), 2017

Biomedical sensors are often developed under a bottom-up approach, i.e. the researcher point of v... more Biomedical sensors are often developed under a bottom-up approach, i.e. the researcher point of view or laboratory approach. This is usually the case for microfluidic based integrated systems. The small number of such devices actually translated for use in clinical situations is mostly due to the need of sample pretreatment by specially trained people and to the fact that industrial transfer had not been taken into account since the very beginning of the development. Conversely, the top-down approach places the end-user at the center of development discussion. In this end-user point of view approach, the participation of industrial, medical and end-users partners more often leads to the design of fully integrated and automated devices which, furthermore, can be manufactured using conventional industrial capabilities. In this opinion communication, we briefly summarize the most common biosensors technologies and we explain how immuno-combined devices may help addressing constraints related to their use in clinical situations in terms of usability by non-trained people, automation and integration.

Research paper thumbnail of Optical detection of red blood cells immunocaptured by biochips in a mobile device called SmarTTransfuser

2014 IEEE 5th International Conference on Photonics (ICP), 2014

In France, before each transfusion, ABO compatibility test is required. The ultimate pre-transfus... more In France, before each transfusion, ABO compatibility test is required. The ultimate pre-transfusion test is manually performed by means of a dedicated card and interpreted by nurses at the patient bedside. Despite this manual test, blood transfusion accidents still exist. Today, no bedside test is completely reliable and the current procedure does not prevent human errors. We propose a new opto-ftuidic device based on the concept of protein biochips and optical detection. Biochips, playing the same role as the reaction zones of the current pre-transfusion cards, are placed into single-use cartridges. ABO compatibility test is automatically performed by means of an external reader/actuator. This project reinforces transfusion safety not only for patients but also for caregivers.

Research paper thumbnail of Clinical evidence requirements according to the IVDR 2017/746: practical tools and references for underpinning clinical evidence of IVD-MDs

Clinical Chemistry and Laboratory Medicine (CCLM)

In May 2022, the European Regulation 2017/746 (IVDR) came into force. It changes the approach of ... more In May 2022, the European Regulation 2017/746 (IVDR) came into force. It changes the approach of in vitro medical devices (IVD-MDs) for industry and institutions. It reinforces the clinical evidence requirements to improve performance, safety and transparency. Despite extended transition periods and existing guides, IVDR remains difficult to interpret and bringing devices into compliance requires efforts. The generation of clinical evidence is essential to demonstrate compliance with IVDR, and encompasses scientific validity, analytical performance and clinical performance. It is required to demonstrate, per intended use in the target population and clinical care pathway, IVD-MDs clinical performance (compared to a predefined clinical performance). Thus, there is a need for IVD-manufacturers and end-users in health care institutions, to obtain guidance on how to generate this clinical evidence. This article aims industrials and clinicians to identify key steps imposed by the IVDR fo...

Research paper thumbnail of Smarttransfuser : A lab-on-chip system for enhancing transfusion security

Before each transfusion of red blood cell concentrate, a final ABO compatibility test is carried ... more Before each transfusion of red blood cell concentrate, a final ABO compatibility test is carried out at the patient's bedside on a piece of card and interpreted visually. Despite this ultimate test, transfusion accidents still occur due to group incompatibility, which can be lethal. In order to improve this test, we have developed a specific device based on microarrays for the validation of a smart and safe transfuser in the context of critical transfusional situations.

Research paper thumbnail of Is Usability Engineering Anticipation Possible during the Initial Research Actions? An Example with the R-Link in Vitro Self-monitoring Device

Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies, 2022

Bipolar disorders are severe and complex psychiatric disorders and lithium remains one of the mos... more Bipolar disorders are severe and complex psychiatric disorders and lithium remains one of the most effective drugs for relapse prevention. Despite its effectiveness, prescription of lithium therapy can be complicated because of its narrow therapeutic range. Furthermore, adherence to treatment is generally low. One means of improving adherence would be to make the patient an actor of his/her treatment. The possibility to control the lithium level with a device that can be used at home would favor this involvement. Although the main part of the work to produce a device is research and development, regulatory analysis, including usability, should not be neglected. Indeed, some design choices should be made taking into account usability constraints. This ensure the fabrication of a device which will be safe, effective and well accepted by the intended users. In this conference, we present actions taken in this direction during the R-Link project. a

Research paper thumbnail of Immunologic blood transfusion accidents: toward a complete compatibility test at the patient’s bedside

International audienceIn most countries in order to ensure the transfusion safety, a direct compa... more International audienceIn most countries in order to ensure the transfusion safety, a direct compatibility test between the red cell concentrate and the receiver’s blood is performed (crossmatch prior any blood transfusion). In some countries (like France), an ultimate ABO compatibility is required, the test is performed at the patient’s bedside and crossmatch is only performed for patients who present irregular antibodies. Up to now, and whatever the country, no complete solution is able to detect an immunological conflict at the patient’s bedside and to prevent 100% of incompatible transfusions

Research paper thumbnail of Optical detection of red blood cells captured on biochips for RH1 compatibility control at the patient’s bedside

International audienceEvery year, several millions of red cell concentrates are transfused. For e... more International audienceEvery year, several millions of red cell concentrates are transfused. For each of them, a pretransfusional compatibility test is performed. In France, an ABO compatibility test at the patient’s bedside is performed, but rhesus compatibility is not yet checked. However, rhesus antigens are very immunogenic and could lead to Rh incompatibility or Rh disease. Rh incompatibility occurs when a woman with Rh-negative blood type is exposed to Rh-positive blood cells

Research paper thumbnail of Medical Devices Development: The Bottom-Up or The Top-Down Approach?

International Journal of Biosensors & Bioelectronics, Dec 7, 2018

Biomedical sensors are often developed under a bottom-up approach, i.e. the researcher point of v... more Biomedical sensors are often developed under a bottom-up approach, i.e. the researcher point of view or laboratory approach. This is usually the case for microfluidic based integrated systems. The small number of such devices actually translated for use in clinical situations is mostly due to the need of sample pretreatment by specially trained people and to the fact that industrial transfer had not been taken into account since the very beginning of the development. Conversely, the top-down approach places the end-user at the center of development discussion. In this end-user point of view approach, the participation of industrial, medical and end-users partners more often leads to the design of fully integrated and automated devices which, furthermore, can be manufactured using conventional industrial capabilities. In this opinion communication, we briefly summarize the most common biosensors technologies and we explain how immuno-combined devices may help addressing constraints related to their use in clinical situations in terms of usability by non-trained people, automation and integration.

Research paper thumbnail of Thérapie cellulaire du système nerveux central : évaluation de la greffe de cellules souches périphériques

Les greffes de cellules souches mesenchymateuses (CSM) dans les modeles animaux de pathologies hu... more Les greffes de cellules souches mesenchymateuses (CSM) dans les modeles animaux de pathologies humaines conduisent a une amelioration fonctionnelle, motrice et /ou cognitive. La proliferation des cellules souches neurales endogenes et l'inhibition de la mort cellulaire des cellules nouvellement generees sont certainement impliquees dans zes effets. Nous avons realise une analyse detaillee des comportements de cellules issues de la moelle osseuse (CMO) apres transplantation in vivo et in vitro. Apres injection de CMO dans la veine laterale de la queue, de nombreuses cellules ont mmigre dans l'encephale et certaine ont acquis un phenotype neuronal ou glial. Nous avons ensuite developpe un modele in vitro de cultures organotypiques d'hippocampe "greffees" par des cellules de moelle osseuse. Nous avons utilise de CMO ou des CSM selectionnees apres un ou cinq passages en culture, greffees directement sur les tranches ou utilisees en co-culture avec celle-ci. Puis no...

Research paper thumbnail of A Biochip Based Medical Device for Point-of-Care ABO Compatibility: Towards a Smart Transfusion Line

Biomedical Engineering Systems and Technologies

ABO mismatch between donor and patient's blood is still the cause of accident which are sometimes... more ABO mismatch between donor and patient's blood is still the cause of accident which are sometimes lethal. The main causes of mis-assignment are human errors and wrong identification of patients or blood product. Only a final compatibility test at the patient's bedside can avoid these errors. In some countries, this test is performed using manual procedures. This does not prevent from human manipulation and interpretation errors. In this paper, we present a prototype able to automatically perform a final ABO compatibility test. It relies on the use of disposable antibodies grafted biochips inserted into a mobile reader/actuator. Red blood cells are selectively captured on biochips grafted with antibodies complementary of antigens present on the cells surface. Detection of capture cells is based on optical absorption techniques. So far, our device achieved blood compatibility test with 99.3 % sensitivity and 97.9 % specificity.

Research paper thumbnail of Type of Article: Opinion Title: Medical Devices Development: the Bottom-up or the Top-down Approach?

Biomedical sensors are often developed under a bottom-up approach, i.e. the researcher point of v... more Biomedical sensors are often developed under a bottom-up approach, i.e. the researcher point of view or laboratory approach. This is usually the case for microfluidic based integrated systems. The small number of such devices actually translated for use in clinical situations is mostly due to the need of sample pretreatment by specially trained people and to the fact that industrial transfer had not been taken into account since the very beginning of the development. Conversely, the top-down approach places the end-user at the center of development discussion. In this end-user point of view approach, the participation of industrial, medical and end-users partners more often leads to the design of fully integrated and automated devices which, furthermore, can be manufactured using conventional industrial capabilities. In this opinion communication, we briefly summarize the most common biosensors technologies and we explain how immuno-combined devices may help addressing constraints r...

Research paper thumbnail of Biochip technology applied to an automated ABO compatibility test at the patient bedside

Sensors and Actuators B-chemical, 2015

In the field of blood transfusion, there is a need to improve the bedside pre-transfusion ABO com... more In the field of blood transfusion, there is a need to improve the bedside pre-transfusion ABO compatibility test. In France, this test is mandatory for each red cell concentrates transfusion. It is performed manually and serious transfusion accidents still occur, principally due to human errors. Therefore, an automated ABO compatibility test is required. Works concerning objective interpretation of ABO compatibility test have been reported but the proposed techniques cannot be easily translated to the patient's bedside. We propose a prototype device which demonstrates the easy use of biochip technology to perform this test: it contains a fluidic system, biochips (two to test the patient and two to test the red cell concentrates) and an optical absorbance detection module. When blood is applied to the biochips, red blood cells are trapped onto the surface if antigens and antibodies are complementary (positive chips). If they are not complementary, very little red blood cells are ...

Research paper thumbnail of Iconographies supplémentaires de l'article : In vitro interactions between bone marrow stromal cells and hippocampal slice cultures

Research paper thumbnail of SmarTTransfuser project: toward an automated point-of-care transfusion safety system

Before each transfusion of red blood cell concentrate, a final ABO compatibility test is carried ... more Before each transfusion of red blood cell concentrate, a final ABO compatibility test is carried out at the patient's bedside on a piece of card and interpreted visually. Despite this ultimate test, transfusion accidents still occur due to group incompatibility, which can be lethal. In order to improve this test, we have developed a specific device based on microarrays for the validation of a smart and safe transfuser in the context of critical transfusional situations. This miniaturized device incorporates a biochip to analyze ABO compatibility in order that the hemagglutination reaction of red blood cells with IgMs in solution be replaced by specific capture and concentration of IgMs on microarrays. Results indicate that a specific immunocapture is obtained with globular concentrates and with different total blood. Smarttransfuser is a smart device developed in collaboration with the French Blood Transfusion Center for the optimization at the patient's bedside of an ultima...

Research paper thumbnail of Blood-to-blood Immunological Compatibility Test: A Possibility with Fluorescent Immuno-Biochips

One of the most feared transfusion accident is the haemolytic reaction. A majority of countries i... more One of the most feared transfusion accident is the haemolytic reaction. A majority of countries imposes a compatibility test before each transfusion, at the patient’s bedside or in laboratory. Regardless of the test performed, it does not prevent human errors and nothing ensures an “error free” procedure. Complete crossmatch is the only test ensuring a complete blood compatibility between donors and patients. It relies on the direct or indirect detection of agglutinations which occur when the patient’s plasma is mixed with the red cells to be transfused. It requires extracting plasma. The work described here will help avoid all the immunologic incompatibilities by the use of a compatibility test without plasma extraction. It relies on an immunobiochip technology in a microfluidic environment with fluorescence detection. This position paper presents preliminary results obtained with artificial samples together with comments on the state of industrial competition and the new device ma...

Research paper thumbnail of Functional Analysis to Drive Research and Identify Regulation Requirements: An Example with a Lithium Monitoring Device

Research paper thumbnail of Test Device for Blood Transfusion Safety - How Acoustics Can Help Preventing Any Red Cells Incompatibility

During red cells concentrates transfusion , red cells incompatibilities still occur despite t he ... more During red cells concentrates transfusion , red cells incompatibilities still occur despite t he laboratory controls based on immuno-hematologic techniques. Red cells incompatibilities appear when patient’s antibodies bind to red cells to be transfused. Up t o now, all pre-transfusion testing are addressed us ing techniques based on immunology. This is time consum ing, expensive and some incompatibility situations cannot be addressed at the patient’s bedside. In th is position paper, we propose a completely novel paradigm. Our hypothesis is that red blood cells se nsitized by the patient’s antibodies see their defo rmability greatly reduced. This induces changes of the rheolo gical properties of the “red cells concentrate /pat ient’s blood” mixture. Studies described in this position paper aim at characterizing these modifications by measuring the characteristics of acoustic waves pro pagating in the mixture and to produce a mobile and automated acousto-micro-fluidic device which wo...

Research paper thumbnail of SmarTTransfuser - A Biochip System for the Final ABO Compatibility Test

Proceedings of the International Conference on Biomedical Electronics and Devices, 2012

Research paper thumbnail of Involvement of Microglia in Neurodegenerative Diseases: Beneficial Effects of Docosahexahenoic Acid (DHA) Supplied by Food or Combined with Nanoparticles

International Journal of Molecular Sciences

Neurodegenerative diseases represent a major public health issue and require better therapeutic m... more Neurodegenerative diseases represent a major public health issue and require better therapeutic management. The treatments developed mainly target neuronal activity. However, an inflammatory component must be considered, and microglia may constitute an important therapeutic target. Given the difficulty in developing molecules that can cross the blood–brain barrier, the use of food-derived molecules may be an interesting therapeutic avenue. Docosahexaenoic acid (DHA), an omega-3 polyunsaturated fatty acid (22:6 omega-3), has an inhibitory action on cell death and oxidative stress induced in the microglia. It also acts on the inflammatory activity of microglia. These data obtained in vitro or on animal models are corroborated by clinical trials showing a protective effect of DHA. Whereas DHA crosses the blood–brain barrier, nutritional intake lacks specificity at both the tissue and cellular level. Nanomedicine offers new tools which favor the delivery of DHA at the cerebral level, es...

Research paper thumbnail of An Automated Medical Device for Ultimate ABO Compatibility Test at the Patient’s Bedside - Towards the Automation of Point-of-care Transfusion Safety

Proceedings of the International Conference on Biomedical Electronics and Devices, 2015

In blood transfusion, accidents still occur because of ABO mismatch between donor and patient's b... more In blood transfusion, accidents still occur because of ABO mismatch between donor and patient's blood. These errors, sometimes lethal, are principally due to wrong identification of patient and/or blood product or to human errors. The best way to avoid these errors is to perform an ultimate ABO compatibility test at the patient's bedside immediately prior to transfusion. Ideally, this test should be performed automatically, without human interpretation and with minimum blood exposure for nurses. This ideal and ultimate method is not yet employed because of the lack of suitable device. In this paper, we propose a system that may fulfil the above mentioned requirements. It is based on selective blood capture on biochip surfaces in a device which automatically drives the different fluids, performs optical detection of captured red cells and finally interprets the optical reading in terms of ABO compatibility. So far, our device achieved blood compatibility test with 99.3 % sensitivity and 97.9 % specificity.

Research paper thumbnail of Medical Devices Development: the Bottom-up or the Top-down Approach

HAL (Le Centre pour la Communication Scientifique Directe), 2017

Biomedical sensors are often developed under a bottom-up approach, i.e. the researcher point of v... more Biomedical sensors are often developed under a bottom-up approach, i.e. the researcher point of view or laboratory approach. This is usually the case for microfluidic based integrated systems. The small number of such devices actually translated for use in clinical situations is mostly due to the need of sample pretreatment by specially trained people and to the fact that industrial transfer had not been taken into account since the very beginning of the development. Conversely, the top-down approach places the end-user at the center of development discussion. In this end-user point of view approach, the participation of industrial, medical and end-users partners more often leads to the design of fully integrated and automated devices which, furthermore, can be manufactured using conventional industrial capabilities. In this opinion communication, we briefly summarize the most common biosensors technologies and we explain how immuno-combined devices may help addressing constraints related to their use in clinical situations in terms of usability by non-trained people, automation and integration.

Research paper thumbnail of Optical detection of red blood cells immunocaptured by biochips in a mobile device called SmarTTransfuser

2014 IEEE 5th International Conference on Photonics (ICP), 2014

In France, before each transfusion, ABO compatibility test is required. The ultimate pre-transfus... more In France, before each transfusion, ABO compatibility test is required. The ultimate pre-transfusion test is manually performed by means of a dedicated card and interpreted by nurses at the patient bedside. Despite this manual test, blood transfusion accidents still exist. Today, no bedside test is completely reliable and the current procedure does not prevent human errors. We propose a new opto-ftuidic device based on the concept of protein biochips and optical detection. Biochips, playing the same role as the reaction zones of the current pre-transfusion cards, are placed into single-use cartridges. ABO compatibility test is automatically performed by means of an external reader/actuator. This project reinforces transfusion safety not only for patients but also for caregivers.

Research paper thumbnail of Clinical evidence requirements according to the IVDR 2017/746: practical tools and references for underpinning clinical evidence of IVD-MDs

Clinical Chemistry and Laboratory Medicine (CCLM)

In May 2022, the European Regulation 2017/746 (IVDR) came into force. It changes the approach of ... more In May 2022, the European Regulation 2017/746 (IVDR) came into force. It changes the approach of in vitro medical devices (IVD-MDs) for industry and institutions. It reinforces the clinical evidence requirements to improve performance, safety and transparency. Despite extended transition periods and existing guides, IVDR remains difficult to interpret and bringing devices into compliance requires efforts. The generation of clinical evidence is essential to demonstrate compliance with IVDR, and encompasses scientific validity, analytical performance and clinical performance. It is required to demonstrate, per intended use in the target population and clinical care pathway, IVD-MDs clinical performance (compared to a predefined clinical performance). Thus, there is a need for IVD-manufacturers and end-users in health care institutions, to obtain guidance on how to generate this clinical evidence. This article aims industrials and clinicians to identify key steps imposed by the IVDR fo...

Research paper thumbnail of Smarttransfuser : A lab-on-chip system for enhancing transfusion security

Before each transfusion of red blood cell concentrate, a final ABO compatibility test is carried ... more Before each transfusion of red blood cell concentrate, a final ABO compatibility test is carried out at the patient's bedside on a piece of card and interpreted visually. Despite this ultimate test, transfusion accidents still occur due to group incompatibility, which can be lethal. In order to improve this test, we have developed a specific device based on microarrays for the validation of a smart and safe transfuser in the context of critical transfusional situations.

Research paper thumbnail of Is Usability Engineering Anticipation Possible during the Initial Research Actions? An Example with the R-Link in Vitro Self-monitoring Device

Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies, 2022

Bipolar disorders are severe and complex psychiatric disorders and lithium remains one of the mos... more Bipolar disorders are severe and complex psychiatric disorders and lithium remains one of the most effective drugs for relapse prevention. Despite its effectiveness, prescription of lithium therapy can be complicated because of its narrow therapeutic range. Furthermore, adherence to treatment is generally low. One means of improving adherence would be to make the patient an actor of his/her treatment. The possibility to control the lithium level with a device that can be used at home would favor this involvement. Although the main part of the work to produce a device is research and development, regulatory analysis, including usability, should not be neglected. Indeed, some design choices should be made taking into account usability constraints. This ensure the fabrication of a device which will be safe, effective and well accepted by the intended users. In this conference, we present actions taken in this direction during the R-Link project. a

Research paper thumbnail of Immunologic blood transfusion accidents: toward a complete compatibility test at the patient’s bedside

International audienceIn most countries in order to ensure the transfusion safety, a direct compa... more International audienceIn most countries in order to ensure the transfusion safety, a direct compatibility test between the red cell concentrate and the receiver’s blood is performed (crossmatch prior any blood transfusion). In some countries (like France), an ultimate ABO compatibility is required, the test is performed at the patient’s bedside and crossmatch is only performed for patients who present irregular antibodies. Up to now, and whatever the country, no complete solution is able to detect an immunological conflict at the patient’s bedside and to prevent 100% of incompatible transfusions

Research paper thumbnail of Optical detection of red blood cells captured on biochips for RH1 compatibility control at the patient’s bedside

International audienceEvery year, several millions of red cell concentrates are transfused. For e... more International audienceEvery year, several millions of red cell concentrates are transfused. For each of them, a pretransfusional compatibility test is performed. In France, an ABO compatibility test at the patient’s bedside is performed, but rhesus compatibility is not yet checked. However, rhesus antigens are very immunogenic and could lead to Rh incompatibility or Rh disease. Rh incompatibility occurs when a woman with Rh-negative blood type is exposed to Rh-positive blood cells

Research paper thumbnail of Medical Devices Development: The Bottom-Up or The Top-Down Approach?

International Journal of Biosensors & Bioelectronics, Dec 7, 2018

Biomedical sensors are often developed under a bottom-up approach, i.e. the researcher point of v... more Biomedical sensors are often developed under a bottom-up approach, i.e. the researcher point of view or laboratory approach. This is usually the case for microfluidic based integrated systems. The small number of such devices actually translated for use in clinical situations is mostly due to the need of sample pretreatment by specially trained people and to the fact that industrial transfer had not been taken into account since the very beginning of the development. Conversely, the top-down approach places the end-user at the center of development discussion. In this end-user point of view approach, the participation of industrial, medical and end-users partners more often leads to the design of fully integrated and automated devices which, furthermore, can be manufactured using conventional industrial capabilities. In this opinion communication, we briefly summarize the most common biosensors technologies and we explain how immuno-combined devices may help addressing constraints related to their use in clinical situations in terms of usability by non-trained people, automation and integration.

Research paper thumbnail of Thérapie cellulaire du système nerveux central : évaluation de la greffe de cellules souches périphériques

Les greffes de cellules souches mesenchymateuses (CSM) dans les modeles animaux de pathologies hu... more Les greffes de cellules souches mesenchymateuses (CSM) dans les modeles animaux de pathologies humaines conduisent a une amelioration fonctionnelle, motrice et /ou cognitive. La proliferation des cellules souches neurales endogenes et l'inhibition de la mort cellulaire des cellules nouvellement generees sont certainement impliquees dans zes effets. Nous avons realise une analyse detaillee des comportements de cellules issues de la moelle osseuse (CMO) apres transplantation in vivo et in vitro. Apres injection de CMO dans la veine laterale de la queue, de nombreuses cellules ont mmigre dans l'encephale et certaine ont acquis un phenotype neuronal ou glial. Nous avons ensuite developpe un modele in vitro de cultures organotypiques d'hippocampe "greffees" par des cellules de moelle osseuse. Nous avons utilise de CMO ou des CSM selectionnees apres un ou cinq passages en culture, greffees directement sur les tranches ou utilisees en co-culture avec celle-ci. Puis no...

Research paper thumbnail of A Biochip Based Medical Device for Point-of-Care ABO Compatibility: Towards a Smart Transfusion Line

Biomedical Engineering Systems and Technologies

ABO mismatch between donor and patient's blood is still the cause of accident which are sometimes... more ABO mismatch between donor and patient's blood is still the cause of accident which are sometimes lethal. The main causes of mis-assignment are human errors and wrong identification of patients or blood product. Only a final compatibility test at the patient's bedside can avoid these errors. In some countries, this test is performed using manual procedures. This does not prevent from human manipulation and interpretation errors. In this paper, we present a prototype able to automatically perform a final ABO compatibility test. It relies on the use of disposable antibodies grafted biochips inserted into a mobile reader/actuator. Red blood cells are selectively captured on biochips grafted with antibodies complementary of antigens present on the cells surface. Detection of capture cells is based on optical absorption techniques. So far, our device achieved blood compatibility test with 99.3 % sensitivity and 97.9 % specificity.

Research paper thumbnail of Type of Article: Opinion Title: Medical Devices Development: the Bottom-up or the Top-down Approach?

Biomedical sensors are often developed under a bottom-up approach, i.e. the researcher point of v... more Biomedical sensors are often developed under a bottom-up approach, i.e. the researcher point of view or laboratory approach. This is usually the case for microfluidic based integrated systems. The small number of such devices actually translated for use in clinical situations is mostly due to the need of sample pretreatment by specially trained people and to the fact that industrial transfer had not been taken into account since the very beginning of the development. Conversely, the top-down approach places the end-user at the center of development discussion. In this end-user point of view approach, the participation of industrial, medical and end-users partners more often leads to the design of fully integrated and automated devices which, furthermore, can be manufactured using conventional industrial capabilities. In this opinion communication, we briefly summarize the most common biosensors technologies and we explain how immuno-combined devices may help addressing constraints r...

Research paper thumbnail of Biochip technology applied to an automated ABO compatibility test at the patient bedside

Sensors and Actuators B-chemical, 2015

In the field of blood transfusion, there is a need to improve the bedside pre-transfusion ABO com... more In the field of blood transfusion, there is a need to improve the bedside pre-transfusion ABO compatibility test. In France, this test is mandatory for each red cell concentrates transfusion. It is performed manually and serious transfusion accidents still occur, principally due to human errors. Therefore, an automated ABO compatibility test is required. Works concerning objective interpretation of ABO compatibility test have been reported but the proposed techniques cannot be easily translated to the patient's bedside. We propose a prototype device which demonstrates the easy use of biochip technology to perform this test: it contains a fluidic system, biochips (two to test the patient and two to test the red cell concentrates) and an optical absorbance detection module. When blood is applied to the biochips, red blood cells are trapped onto the surface if antigens and antibodies are complementary (positive chips). If they are not complementary, very little red blood cells are ...

Research paper thumbnail of Iconographies supplémentaires de l'article : In vitro interactions between bone marrow stromal cells and hippocampal slice cultures

Research paper thumbnail of SmarTTransfuser project: toward an automated point-of-care transfusion safety system

Before each transfusion of red blood cell concentrate, a final ABO compatibility test is carried ... more Before each transfusion of red blood cell concentrate, a final ABO compatibility test is carried out at the patient's bedside on a piece of card and interpreted visually. Despite this ultimate test, transfusion accidents still occur due to group incompatibility, which can be lethal. In order to improve this test, we have developed a specific device based on microarrays for the validation of a smart and safe transfuser in the context of critical transfusional situations. This miniaturized device incorporates a biochip to analyze ABO compatibility in order that the hemagglutination reaction of red blood cells with IgMs in solution be replaced by specific capture and concentration of IgMs on microarrays. Results indicate that a specific immunocapture is obtained with globular concentrates and with different total blood. Smarttransfuser is a smart device developed in collaboration with the French Blood Transfusion Center for the optimization at the patient's bedside of an ultima...

Research paper thumbnail of Blood-to-blood Immunological Compatibility Test: A Possibility with Fluorescent Immuno-Biochips

One of the most feared transfusion accident is the haemolytic reaction. A majority of countries i... more One of the most feared transfusion accident is the haemolytic reaction. A majority of countries imposes a compatibility test before each transfusion, at the patient’s bedside or in laboratory. Regardless of the test performed, it does not prevent human errors and nothing ensures an “error free” procedure. Complete crossmatch is the only test ensuring a complete blood compatibility between donors and patients. It relies on the direct or indirect detection of agglutinations which occur when the patient’s plasma is mixed with the red cells to be transfused. It requires extracting plasma. The work described here will help avoid all the immunologic incompatibilities by the use of a compatibility test without plasma extraction. It relies on an immunobiochip technology in a microfluidic environment with fluorescence detection. This position paper presents preliminary results obtained with artificial samples together with comments on the state of industrial competition and the new device ma...

Research paper thumbnail of Functional Analysis to Drive Research and Identify Regulation Requirements: An Example with a Lithium Monitoring Device

Research paper thumbnail of Test Device for Blood Transfusion Safety - How Acoustics Can Help Preventing Any Red Cells Incompatibility

During red cells concentrates transfusion , red cells incompatibilities still occur despite t he ... more During red cells concentrates transfusion , red cells incompatibilities still occur despite t he laboratory controls based on immuno-hematologic techniques. Red cells incompatibilities appear when patient’s antibodies bind to red cells to be transfused. Up t o now, all pre-transfusion testing are addressed us ing techniques based on immunology. This is time consum ing, expensive and some incompatibility situations cannot be addressed at the patient’s bedside. In th is position paper, we propose a completely novel paradigm. Our hypothesis is that red blood cells se nsitized by the patient’s antibodies see their defo rmability greatly reduced. This induces changes of the rheolo gical properties of the “red cells concentrate /pat ient’s blood” mixture. Studies described in this position paper aim at characterizing these modifications by measuring the characteristics of acoustic waves pro pagating in the mixture and to produce a mobile and automated acousto-micro-fluidic device which wo...

Research paper thumbnail of SmarTTransfuser - A Biochip System for the Final ABO Compatibility Test

Proceedings of the International Conference on Biomedical Electronics and Devices, 2012

Research paper thumbnail of Involvement of Microglia in Neurodegenerative Diseases: Beneficial Effects of Docosahexahenoic Acid (DHA) Supplied by Food or Combined with Nanoparticles

International Journal of Molecular Sciences

Neurodegenerative diseases represent a major public health issue and require better therapeutic m... more Neurodegenerative diseases represent a major public health issue and require better therapeutic management. The treatments developed mainly target neuronal activity. However, an inflammatory component must be considered, and microglia may constitute an important therapeutic target. Given the difficulty in developing molecules that can cross the blood–brain barrier, the use of food-derived molecules may be an interesting therapeutic avenue. Docosahexaenoic acid (DHA), an omega-3 polyunsaturated fatty acid (22:6 omega-3), has an inhibitory action on cell death and oxidative stress induced in the microglia. It also acts on the inflammatory activity of microglia. These data obtained in vitro or on animal models are corroborated by clinical trials showing a protective effect of DHA. Whereas DHA crosses the blood–brain barrier, nutritional intake lacks specificity at both the tissue and cellular level. Nanomedicine offers new tools which favor the delivery of DHA at the cerebral level, es...

Research paper thumbnail of An Automated Medical Device for Ultimate ABO Compatibility Test at the Patient’s Bedside - Towards the Automation of Point-of-care Transfusion Safety

Proceedings of the International Conference on Biomedical Electronics and Devices, 2015

In blood transfusion, accidents still occur because of ABO mismatch between donor and patient's b... more In blood transfusion, accidents still occur because of ABO mismatch between donor and patient's blood. These errors, sometimes lethal, are principally due to wrong identification of patient and/or blood product or to human errors. The best way to avoid these errors is to perform an ultimate ABO compatibility test at the patient's bedside immediately prior to transfusion. Ideally, this test should be performed automatically, without human interpretation and with minimum blood exposure for nurses. This ideal and ultimate method is not yet employed because of the lack of suitable device. In this paper, we propose a system that may fulfil the above mentioned requirements. It is based on selective blood capture on biochip surfaces in a device which automatically drives the different fluids, performs optical detection of captured red cells and finally interprets the optical reading in terms of ABO compatibility. So far, our device achieved blood compatibility test with 99.3 % sensitivity and 97.9 % specificity.