ams (SIX: AMS), a leading worldwide supplier of high performance sensor solutions, and Senova, a manufacturer of in vitro diagnostic medical devices based in Germany, announced today they have successfully concluded tests using a combination of Senova technology and ams spectral sensor technology to improve performance and usability of a lateral flow-based test to detect antibodies related to the COVID-19 (SARS-CoV-2) virus. A specifically developed sensor module based on the ams AS7341L spectral sensor solution allows spectrally resolved read out of lateral flow immune assays.
The ams spectral sensor technology was successfully tested in combination with Senova´s commercially available serological IgG/M COVID-19 assay (Cleartest ®) which is used for confirmatory diagnostics in a later stage of the disease and in large-scale antibody screening programs.
Based on this, ams and Senova are entering into a partnership to combine the read-out technology of ams with the lateral flow-test capabilities of Senova. The two companies have agreed on realizing a disposable electronic lateral flow test towards testing for immunity against the COVID-19 (SARS-CoV-2) virus based on antibody detection.
The device, using lateral flow technology coupled with a spectral sensor, enables a read-out that is accurate, cost effective, quantitative, and provides an objective result which requires no user interpretation. In contrast to the established PCR method, the test kit can be applied in doctor’s offices and other point-of-care situations at low cost.
Recent experiments further proved feasibility of quantitative detection of serum proteins (such as C-reactive protein (CRP) down to concentrations as low as tens of pg/ml (picograms/ml). This is more than a factor of 10 more sensitive than the detection achieved with most of the standard rapid test read-out devices. In combination with COVID-19 (SARS-CoV-2) antigen assays, this provides the platform for COVID-19 (SARS-CoV-2) virus detection in saliva and nasal swab samples in the early stage of COVID-19 (SARS-CoV-2), to be developed in a second step.
To reach manufacturing scale in an accelerated timeframe, ams will partner with Jabil Healthcare, a leading healthcare manufacturing solutions provider, to integrate its sensor technology into a high-volume turnkey module, featuring a Bluetooth connection.
By providing the market with a device that is highly accurate, disposable and low-cost, the companies aim to more quickly enable authorities, health providers and other care facilities to realize much needed antibody testing at the point-of-care, eliminating the time-consuming need to send antibody test strips to a remote laboratory. With a low price-point and easy connectivity to a smartphone app or cloud upload, the device allows raw spectral data to be sent to a local Bluetooth connected device (e.g. smartphone) for read out. This data can be further transferred to a cloud for evaluation. The result is then communicated back to the local Bluetooth device and, if desired by the user, broad-based test result information can become part of a national or international monitoring system. Protection of sensitive user data will be ensured by adequate measures, such as data encryption and privacy policies.
ams, Senova and Jabil are expected to ramp production of a CE medical-certified, disposable test kit for professional use by September 2020, and ams will aim to provision a device certified for home use in a following step.
Jennifer Zhao, EVP Advanced Optical Sensors Division at ams, commented, “ams’ innovation through miniaturized and cost-effective spectral sensor technology is more valuable than ever for healthcare applications. Enabling rapid test devices to detect colorimetric and fluorescence information through a tiny, yet powerful, optical sensor supports wide-spread testing for viruses and antibodies at disposable cost levels. With this technology we hope to contribute to the fight against the pandemic the world is facing right now.”
“This collaborative project is a great opportunity to provide a new generation of point-of-care tests which combines fundamental improvements in accuracy and superior handling at the same time. A digital COVID-19 antibody test kit will be the next important element to support healthcare providers worldwide in the current situation,” added Hans Hermann Söffing, CEO at Senova.
“Jabil Healthcare is thrilled to support ams and Senova in the development and large-scale manufacturing of their digitalized and disposable lateral flow-based test solution. Our design and development team in Europe is providing innovation at the highest level within a limited timeframe. With our global footprint, regulatory rigor, and large experience in manufacturing electronic components and sub-assemblies for the diagnostics industry, we are supporting the supply of worldwide demand for ams, Senova, and their partners who will access this platform,” said David Panneton, VP of Diagnostics, Jabil Healthcare.