Harvard University’s Wyss Institute for Biologically Inspired Engineering licensed its Erapid electrochemical sensing platform to IQ Group Global to integrate with the Australian consortium’s transistor technology in a SARS-CoV-2 test. The combined solution could greatly simplify serological testing for the virus and help monitor immunity in individuals and populations over time.

The Erapid technology provides a low-cost platform that can multiplex simultaneous detection and quantification of multiple biomarkers, including proteins, antibodies, RNA, and small molecules in blood, saliva, or other biological fluids. Using the platform, the Wyss team developed an effective SARS-CoV-2 point-of-care detection system that indicates active infection or an active immune response indicating prior infection or vaccination.

The diagnostic is designed for use at home or in pharmacies or doctor’s offices and returns results in 10 to 15 minutes. The Harvard Office of Technology Development licensed the technology as part of the University’s commitment to the COVID-19 Technology Access Framework.

“Broad, fast, and accurate COVID-19 diagnosis outside the hospital setting remains one of the main challenges in this relentless pandemic, especially now that we are clearly facing yet another wave of infections,” said Donald Ingber, founding director of the Wyss Institute and co-developer of the Erapid technology. “Our Erapid technology offers the possibility of developing inexpensive diagnostic tests that have the potential to accurately determine the presence of infection, the stage of the infection, and the patient’s response to the virus all simultaneously.”

The Harvard platform uses a novel antifouling coating that employs bovine serum albumin interlaced with conductive nanomaterials including gold nanowires to create a nanocomposite matrix that enables the multiplexed detection of a range of biomolecules. The coating keeps down the technology’s cost and increases its sensitivity and specificity. Meanwhile, the multiplex structure permits an integrated device control so each user can verify the test’s validity.

“Our nanocomposite-coated electrodes retain almost 90% of their ability to detect signal even after being stored for one month in whole serum or plasma. In contrast, when we tested the best published anti-fouling coatings (e.g., self-assembled monolayers containing polyethylene glycol or betaine) in the same system, they lost all signal sensitivity when incubated with biological fluids for one day,” Pawan Jolly, a senior staff scientist at Wyss and co-leader of the Erapid project, explained to BioWorld.

SARS-CoV-2-specific antibodies are attached to the coating to detect viral proteins or RNA, or antibodies. If they are detected, the platform sends an electrical signal. The strength of the signal indicates the levels of target molecules present in the sample.

“Erapid’s features and capabilities would make it an effective tool for easily tracing active immunity in infected individuals and those that recovered from COVID-19 to help determine their basis for resistance,” said Jolly. “Such a versatile platform that helps us better understand how the disease develops, persists, and can be controlled could be an invaluable asset in the fight against the pandemic.”

IQ’s biosensor keeps it simple

A recently completed pilot study found that the Harvard technology worked effectively with IQ’s biosensor platform to identify IgG and IgM antibodies. The technology has the potential to screen for viral RNA and protein antigens that indicate active infection, though that has not yet been tested.

IQ is adapting technology it developed for its fingerprick-free Saliva Glucose Biosensor for the COVID-19 test. Its platform features a printable organic thin-film transistor strip, which the company is testing for use in more than 130 indications ranging from tumor markers to allergens, hormones and other infectious diseases.

“Given the analytical characteristics of the biosensor and its stage of development, the combined technologies position us excellently to develop a more accurate, sensitive, and real-time SARS-CoV-2 test for diagnostic, point-of-care testing and pre-vaccination screening to meet this urgent global need,” said IQ CEO George Syrmalis.

The company envisions a printable strip that’s the size of stick of chewing gum.

“We have the capacity to print 400 biosensors per square meter of film. It’s not a difficult test, there are no assay times, no complex manufacturing process that goes into those,” said Syrmalis told BioWorld. “Logically thinking, it’s considerably easier to produce. We can locate a printer in the States and in a few weeks’ time be printing hundreds of thousands of tests per week.”