ams and Senova develop rapid point-of-care antibody test for Covid-19

ams AG (SIX: AMS), a leading supplier of high-performance sensor solutions, and Senova, a German manufacturer of in vitro diagnostic medical devices, today announced that they have collaborated to successfully complete a trial combining Senova technology with ams spectral sensor technology to improve the performance and usability of lateral flow tests for the detection of antibodies associated with the Covid-19 (SARS-CoV-2) virus. ams has developed a sensor module specifically based on the AS7341L spectral sensor to read lateral immunoassay data using spectral resolution.

The successful trial combined ams spectral sensor technology with Senova’s commercially available serum IgG/M Covid-19 test (Cleartest ®) for use as a confirmatory diagnosis in later stages of the disease and in large-scale antibody screening programmes.

Based on this successful trial, ams and Senova have entered into a partnership to combine ams’ readout technology with Senova’s lateral flow testing capabilities. The two companies have decided to jointly develop a disposable electronic lateral flow test device based on antibody detection to enable immunity testing against the Covid-19 (SARS-CoV-2) virus.

The device uses lateral flow detection technology and spectral sensors to accurately and cost-effectively read quantitative test data, providing objective results that do not require user interpretation. Compared with existing PCR testing methods, the test kit is low-cost and suitable for use in doctors' offices and other point-of-care settings.

Recent trials have further demonstrated the feasibility of quantitative detection of serum proteins such as C-reactive protein (CRP) at concentrations as low as tens of pg/ml (picograms/ml). This is more than 10 times more sensitive than most standard rapid test readout devices. If combined with Covid-19 (SARS-CoV-2) antigen detection, it can also provide a platform for Covid-19 (SARS-CoV-2) virus detection through saliva and nasal swab samples in the early stages of Covid-19 (SARS-CoV-2), which will be the next development target.

To reach production scale more quickly, ams will work with Jabil Healthcare, a leading healthcare manufacturing solutions provider , to integrate its sensor technology into high-volume, turnkey modules with Bluetooth connectivity.

The aim is to bring to market a highly accurate, disposable, low-cost device that will help authorities, healthcare providers and other care facilities achieve much-needed instant antibody testing more quickly, eliminating the need to waste time sending antibody test strips to remote laboratories. The device is low-priced and can be easily connected to a smartphone app or uploaded to the cloud, so that raw spectral data can be sent to a local Bluetooth-enabled device (such as a smartphone) for reading. This data can also be further transmitted to the cloud for evaluation. The results are then transmitted back to the local Bluetooth device, and if the user so desires, this extensive test result information can also be incorporated into national or international monitoring systems. For sensitive user data, appropriate measures will be taken to protect it, such as data encryption and privacy policies.

ams, Senova and Jabil expect to ramp up production of the single-use professional test kits with CE certification for medical products by September 2020, with ams aiming to offer certified devices for home use next.

“For healthcare applications, the innovations enabled by ams through miniaturized and cost-effective spectral sensor technology are more valuable than ever before,” said Jennifer Zhao, Executive Vice President of the Advanced Optical Sensors Division at ams. “Rapid testing devices that detect both colorimetric and fluorescence information through small and powerful optical sensors will enable widespread testing for viruses and antibodies at low cost. We hope that this technology can contribute to the fight against the current global pandemic.”

 “This collaborative project is a great opportunity to deliver a new generation of point-of-care testing with radically improved accuracy while also achieving exceptional processing efficiency. The digital Covid-19 antibody test kit will be the next big product to support healthcare providers around the world today,” added Hans Hermann Söffing, CEO of Senova.

 “Jabil Healthcare is pleased to support ams and Senova in the development and mass production of a digital, single-use lateral flow test solution. Our European design and development team will deliver the highest level of innovation in a tight time frame. With our global footprint, strict regulatory requirements and extensive experience in the production of electronic components and subassemblies for the diagnostics industry, we will support the global needs of ams, Senova and the partners who access the platform,” said David Panneton, Vice President of Diagnostic Products at Jabil Healthcare.