Periodic Reporting for period 6 - SCAUT (Ser-Col; from finger to laboratory; personalized and automated serum collection for laboratory diagnostics)
Periodo di rendicontazione: 2021-07-01 al 2022-03-31
The Ser-Col® is a patent-pending serum separation device that simplifies and combines both blood collection and serum separation. With a few drops of blood from a finger stick, serum can be collected which is stable for several months prior to analysis of clinically relevant serum parameters, and thereby reducing biohazardous waste production by 50%. Ser-Col simplifies and reduces the cost of serum sampling by replacing the blood tube, trained personnel, cold storage, and centrifuge with a reliable and easy to use device that links target population to centralized diagnostics laboratories, ultimately leading to the long-term reduction of the burden of infectious diseases.
The Ser-Col has the potential to support a new standard in infectious disease diagnosis. Successful implementation of the SCAUT project in healthcare practices will be a crucial link between the novel advancements in infectious disease diagnosis and treatment and access to affected population in both the developed and developing world.
The overall objective of the SCAUT project is to accelerate the market launch of Ser-Col®, a sustainable finger-prick based device facilitating at-home collection of blood, for the analysis of clinically relevant serum parameters.
The Ser-Col has the potential to support a new standard in infectious disease diagnosis. Successful implementation of the SCAUT project in healthcare practices will be a crucial link between the novel advancements in infectious disease diagnosis and treatment and access to affected population in both the developed and developing world.
The overall objective of the SCAUT project is to accelerate the market launch of Ser-Col®, a sustainable finger-prick based device facilitating at-home collection of blood, for the analysis of clinically relevant serum parameters.
Month 1-6: The first 6 months of the SCAUT project were in the light of the design of a patient friendly, easy to use and fully automated processable and circular Ser-Col device.
Month 7-12: the most important goal for this period was the development and production of the Ser-Col mold for the production of Ser-Col that can be fully automated assembled and processed and has a strong focus on circularity.
Month 13-18: in this period the so-called First Out of Tools (FOTs) of Ser-Col were produced and tested on both user friendliness and automated processing in the SCAUT. Some minor changes had to be made to the FOT’s. The Second Out of Tools (SOT’s) were found suitable for the next steps: analytical and clinical validation of both SCAUT and Ser-Col. In Month 18 the first SCAUT machine was placed at Labonovum for clinical validation. This marked a key milestone in the project.
Month 19-24: Medical and Analytical validation studies of the SCAUT machine are all positive so far. In this period the first Ser-Cols were delivered to clinical partners CHUM and YSMU where first clinical samples have been collected. Due to COVID-19, no SCAUT could be placed at CHUM, hence Ser-Cols will be processed at Labonovum. Extensive documentation is required for international shipping, hence the first processing of clinical samples facing some delay. The production prototype of the Ser-Col assembly machine is undergoing its final rounds of checks and optimization. Labonovum has been working on the Commercialisation and Marketing strategy.
Month 25-30: The Ser-Col assembly machine was finalized. Ser-Cols were used for patient sample collection at partners CHUM and YSMU. Samples have been processed using the SCAUT machine at Labonovum. In the next reporting period, samples will be analyzed so that the Ser-Col and SCAUT machine can ultimately be validated. Dissemination activities included an item on national TV in Armenia.
Month 31-39: The Ser-Cols were analyzed at partners CHUM and YSMU, first results were discussed between medical staff of Labonovum, CHUM and YSMU. First results of the Ser-Col validation will be explained by CHUM and YSMU further on in the report. Furthermore the SCAUT machine has been tested with dummy devices and small numbers of samples from YSMU. Few technical issues in the SCAUT machine were detected and BSS solved the technical issues. Commercialization and Marketing strategy has been further extended and ISO 13485 certification of Labonovum is in a final stage. More research has been performed with Ser-Cols on Hycor Noveos for allergy diagnosis and a validation study with Streeklaboratorium Haarlem on HIV with Ser-Col.
Month 7-12: the most important goal for this period was the development and production of the Ser-Col mold for the production of Ser-Col that can be fully automated assembled and processed and has a strong focus on circularity.
Month 13-18: in this period the so-called First Out of Tools (FOTs) of Ser-Col were produced and tested on both user friendliness and automated processing in the SCAUT. Some minor changes had to be made to the FOT’s. The Second Out of Tools (SOT’s) were found suitable for the next steps: analytical and clinical validation of both SCAUT and Ser-Col. In Month 18 the first SCAUT machine was placed at Labonovum for clinical validation. This marked a key milestone in the project.
Month 19-24: Medical and Analytical validation studies of the SCAUT machine are all positive so far. In this period the first Ser-Cols were delivered to clinical partners CHUM and YSMU where first clinical samples have been collected. Due to COVID-19, no SCAUT could be placed at CHUM, hence Ser-Cols will be processed at Labonovum. Extensive documentation is required for international shipping, hence the first processing of clinical samples facing some delay. The production prototype of the Ser-Col assembly machine is undergoing its final rounds of checks and optimization. Labonovum has been working on the Commercialisation and Marketing strategy.
Month 25-30: The Ser-Col assembly machine was finalized. Ser-Cols were used for patient sample collection at partners CHUM and YSMU. Samples have been processed using the SCAUT machine at Labonovum. In the next reporting period, samples will be analyzed so that the Ser-Col and SCAUT machine can ultimately be validated. Dissemination activities included an item on national TV in Armenia.
Month 31-39: The Ser-Cols were analyzed at partners CHUM and YSMU, first results were discussed between medical staff of Labonovum, CHUM and YSMU. First results of the Ser-Col validation will be explained by CHUM and YSMU further on in the report. Furthermore the SCAUT machine has been tested with dummy devices and small numbers of samples from YSMU. Few technical issues in the SCAUT machine were detected and BSS solved the technical issues. Commercialization and Marketing strategy has been further extended and ISO 13485 certification of Labonovum is in a final stage. More research has been performed with Ser-Cols on Hycor Noveos for allergy diagnosis and a validation study with Streeklaboratorium Haarlem on HIV with Ser-Col.
The current state of-the-art method of serum collection method comes with the following challenges:
o Collection Blood collection in vacutainer tube by venipuncture.
o Preparation Serum separation by centrifugation.
o Storing Serum storage at -20°C or colder.
With the Ser-Col, this project delivered a unique product that addresses all three challenges of the current state of the art into in one device. The Ser-Col enables to directly withdraw serum from patient’s finger without the need to separate blood cells by centrifugation and refrigeration. This can simply be accomplished by applying blood from a single finger stick on to the device containing the special filter paper, which by lateral flow of blood cells separated the serum. The collected serum is allowed to dry within the protective case, where the serum specimen is stable at ambient temperature without sample freezing. The Ser-Col has significant advantages over existing serum separator tubes by reducing turnaround time, removing labour-intensive and sample wasting steps in the current blood diagnostic process.
The SCAUT project has:
• Demonstrated analytical and clinical validity of the Ser-Col,
• Delivered an automated platform for automated serum retrieval in diagnostic laboratory use, and
• Ser-Col devices are ready for CE-marking.
The target users of the Ser-Col® are entities performing serum collection and analysis and include patients, hospital nurses, general practitioners, clinical chemistry labs/departments, and diagnostic centres. These users have some specific, and some overlapping needs indicated in bold:
• Easy to use, serum collection tool (patients, hospital nurses, general practitioners)
Serum collection by the Ser-Col can be performed by anyone, anywhere and anytime without intimidating needles. This facilitates easy use and fast adoption in routine patient blood collection and diagnosis, improving patient recruitment and compliances.
• Automated serum analysis workflow (clinical chemistry labs/departments)
Serum value are always measured by clinical chemistry labs/departments that must achieve a high-throughput given the high workload and the pressure on cost-reduction that also these laboratories face. SCAUT will automate this process.
• Cost-efficient logistics for serum samples (patients, general practitioners, health insurance)
SCAUT works on a logistics system that does not involve patients travelling from home to collect serum, a high workload at the general practitioner’s/clinical office to collect the blood, and expenditure on specialized transport.
o Collection Blood collection in vacutainer tube by venipuncture.
o Preparation Serum separation by centrifugation.
o Storing Serum storage at -20°C or colder.
With the Ser-Col, this project delivered a unique product that addresses all three challenges of the current state of the art into in one device. The Ser-Col enables to directly withdraw serum from patient’s finger without the need to separate blood cells by centrifugation and refrigeration. This can simply be accomplished by applying blood from a single finger stick on to the device containing the special filter paper, which by lateral flow of blood cells separated the serum. The collected serum is allowed to dry within the protective case, where the serum specimen is stable at ambient temperature without sample freezing. The Ser-Col has significant advantages over existing serum separator tubes by reducing turnaround time, removing labour-intensive and sample wasting steps in the current blood diagnostic process.
The SCAUT project has:
• Demonstrated analytical and clinical validity of the Ser-Col,
• Delivered an automated platform for automated serum retrieval in diagnostic laboratory use, and
• Ser-Col devices are ready for CE-marking.
The target users of the Ser-Col® are entities performing serum collection and analysis and include patients, hospital nurses, general practitioners, clinical chemistry labs/departments, and diagnostic centres. These users have some specific, and some overlapping needs indicated in bold:
• Easy to use, serum collection tool (patients, hospital nurses, general practitioners)
Serum collection by the Ser-Col can be performed by anyone, anywhere and anytime without intimidating needles. This facilitates easy use and fast adoption in routine patient blood collection and diagnosis, improving patient recruitment and compliances.
• Automated serum analysis workflow (clinical chemistry labs/departments)
Serum value are always measured by clinical chemistry labs/departments that must achieve a high-throughput given the high workload and the pressure on cost-reduction that also these laboratories face. SCAUT will automate this process.
• Cost-efficient logistics for serum samples (patients, general practitioners, health insurance)
SCAUT works on a logistics system that does not involve patients travelling from home to collect serum, a high workload at the general practitioner’s/clinical office to collect the blood, and expenditure on specialized transport.