Senova and ams Mobilize New Rapid Antibody Testing for COVID-19
One of the challenges of the pandemic has been testing delays. A new point-of-care antibody tester aims to change that.
As testing has expanded during the latter stages of the pandemic, medical professionals continue to question the accuracy of existing methods—especially rapid ones. Speed and accuracy have shared a contentious relationship in the diagnostic realm.
However, two companies aim to mitigate those tradeoffs. A new test developed by Senova and ams AG claims to deliver dependable results, minus the need for laboratory analysis.
Senova and ams’ new antibody testing solution—using a combination of sensors, an assay, and a mobile interface. Image used courtesy of ams AG
Assessing the Need for Improved Testing
While testing has become more ubiquitous across the United States and globally, testing quality has come under fire. Furthermore, the practicality of existing methods has been lacking. Traditional tests can take hours—either stranding individuals in high-risk healthcare settings or having family members on the edges of their seats while awaiting answers. This is both stressful and carries added risk since potentially-affected peoples may infect others while results are pending.
Accordingly, a push for rapid testing soon arose. Abbott Labs and others soon debuted test kits which could deliver results in under an hour. But the biggest drawback of rapid testing has been accuracy—particularly the avoidance of false positive or negative tests, the latter being chiefly troublesome. Especially troubling is the fact that 20% to 38% of those tested using the RT-PCR method will receive a false negative result.
Improvements with drive-through testing and bio-sensing field-effect transistor (Bio-FET) technology have shown potential. However, companies like Senova and ams know that more must be done to meet demand.
What's in a Digital Testing Device?
Digital testing devices rely upon three core components: sensors, biological assays, and a readout mechanism giving clear results.
Senova has gained acclaim for its diagnostic medical devices while ams provides “high-performance sensor solutions” to companies worldwide. The two have combined their flagship technologies into a point-of-care solution—useful for doctor’s offices, patient clinics, and non-laboratory medical environments. Whereas alternative methods often require highly-trained personnel to operate devices, the new solution is said to be compact and user-friendly.
Lateral flow technology can gather a number of health metrics. Screenshot used courtesy of ams
The rapid test leverages the following components:
- An ams AS7341L spectral sensor
- A Senova serological IgG/M COVID-19 assay
- A Jabil Healthcare high-volume module, with Bluetooth connectivity
- A compatible smartphone with an installed readout app
App aside, healthcare professionals can upload testing results to cloud-based patient portals.
Jabil Healthcare, a third production partner, has made scaled manufacturing possible. Their included module makes it easy to process samples, and anybody can use it. Furthermore, the readout app gives results that patients can easily understand. Each company’s technology is already available commercially, suggesting that the infrastructure is already in place to begin a distributed rollout by September of this year.
How the COVID-19 Tester Will Work
Senova’s COVID-19 assay (branded Cleartest) is used for late-disease antibody screening. It’s classified as a lateral flow assay, upon which antibodies are applied in a line. Patient samples travel through a nitrocellulose membrane (or thin paper film) after being suspended. They’re further enriched with dyes and pretreatments.
Lateral flow assays are both cheap to produce at scale, and resistant to environmental conditions, making them much less susceptible to tainting. Lateral flow testing is also much easier to produce than other lab-on-a-chip technologies, claims Senova. The sample’s analyte, or chemical makeup, is added atop fixed antibodies.
This is where ams’ spectral sensor comes in. It uses multiple wavelengths to detect a number of analytes within a given sample. The ten-channel component can detect microscopic analyte changes with lateral flow assays, making it a compatible sidekick for Cleartest. Of these channels, eight are optical; the remaining two are devoted to Clear and NIR. The sensor also supports signal processing thanks to six parallel analog-to-digital converters.
ams’ spectral sensor diagrammed in detail. Image courtesy of ams AG
The testing module itself is approximately the size of a credit card. Space-saving is essential in these compact applications, making the spectral sensor’s 3.1 mm x 2 mm x 1 mm dimensions appealing. The small form factor of Senova’s assay—and its ability to detect C-reactive serum proteins (CRP)—is also crucial. This solution illustrates how biological detection and electrical engineering can combine to form an accurate, portable electronic test.
Could Rapid Antibody Testing be the Ultimate Answer?
Both companies claim their method can detect proteins at concentrations a factor of ten less than traditional CRP tests. Although the test is touted as being extremely accurate, we still lack real-world results for evaluation.
Following a rollout to healthcare providers in September, Senova and ams aim to produce at-home test kits. Rapid tests like these that are effective and CE-certified could be the answer to our existing testing woes. That’s an excellent avenue to explore in mitigating the COVID-19 outbreak worldwide.