Covid update: 18 February 2021

18 Feb 2021

A round up of this week's coronavirus-related news and countermeasures from the photonics industry.

Diagnostics company Luminostics has announced the receipt of emergency use authorization from the US Food and Drug Administration and production scale-up activities for its Clip Covid Rapid Antigen Test to meet demand in the fight against Covid-19.

The test is a lateral flow immunoluminescent assay that uses glow-in-the-dark nanochemistry along with a smart phone’s optics, an inexpensive adapter, and artificial intelligence to detect SARS-CoV-2 viral antigens from nasal swabs in around 30 minutes.

The EUA and production ramp come on the heels of Luminostics’ award of a $26.1 million contract by NIH (and BARDA) in October 2020 under the Rapid Acceleration of Diagnostics (RADx) initiative.

Luminostics says the Clip Covid test is among the most accurate FDA-authorized rapid antigen tests available on the market with 100% specificity and 96.9% sensitivity compared to FDA-authorized, laboratory-based high-sensitivity RT-PCR in an independently run multi-site prospective clinical study.

Test results are objectively displayed on the smart phone’s screen, “eliminating the sorts of errors that plague result interpretation of visual lateral flow tests,” says Luminostics. This approach enables high-throughput processing of over 30 tests per operator per hour from sample collection to result.

“We are grateful to the FDA for their rapid review of our EUA application and to NIH and BARDA for their support. Our team is excited about ramping up production and helping meet the massive demand for rapid and accurate Covid-19 testing,” said Luminostics co-founder and CEO, Dr. Bala Raja.

Luminostics, which is based in Northern California and manufactures its test kits and analyzers in the USA, continues to increase its production capacity and expects to be manufacturing over 2,000,000 tests per month by April, 2021, and more than 4,000,000 tests per month by summer.

“Demand for the Clip Covid is currently far outpacing supply, but we will continue to ramp up production until this virus abates and the market tells us to stop. Our immediate goals, besides ramping up production, are to expand our emergency use authorization’s labeling for non-prescription, non-laboratory use of Clip Covid,” added Dr. Raja.

Scientists at École Polytechnique Fédérale de Lausanne (EPFL), Switzerland, have developed a method for boosting the sensitivity of rapid-detection tests – such as those used for the new coronavirus. The results of their feasibility study have just been published in Nano Letters.

Pregnancy tests and rapid-detection tests for the new coronavirus work in the same way. They contain a surface – usually made of metal – on which chemical nanosensors detect specific compounds in a sample of urine, saliva or blood that indicate the presence of a given protein or part of a virus.

“The tests show up as positive if their sensors come into contact with the target compound,” said Olivier Martin, head of EPFL’s Nanophotonics and Metrology Laboratory.

This biological mechanism is invisible to the naked eye, but the way the metal is structured makes it able to interact with light, creating disturbances in the light’s movement. “These disturbances are what tell us that a sensor on the metal surface has come into contact with the target compound,” said Martin.

“The process creates an optical wave, which propagates and appears as a red line on a pregnancy test, for example.” His team worked with scientists at EPFL’s Bionanophotonic Systems Laboratory, headed by Hatice Altug, to make the technology more sensitive and more effective.

Silicon as soundbox

To conduct their experiments, the scientists used aluminum for the metal surface on which the nanosensors are placed. Just below the aluminum they added a layer of silicon, which doesn’t conduct electricity. “The silicon acts like a soundbox,” said Martin.

“Picture a kettledrum – its surface vibrates when a drummer hits it, and it’s the soundbox underneath that lets us hear the vibrations. In our system, the silicon layer serves as a resonator and amplifies the metal’s reaction, making the system more sensitive. That means we can detect smaller proteins or smaller concentrations of viruses.”

Their sandwich-type system works on a nanometric scale. But why did they decide to develop such miniature technology? “We have to operate on the same scale as the objects we want to detect – in this case, proteins and viruses. Also, the optic response is different depending on the scale we’re using. A bar of silver can look grey to us, but on a nanometric scale, the silver particles actually appear blue,” said Martin.

“Developing our sandwich technology was a real challenge. Next we plan to experiment with other metals, which will give rise to new challenges. We also need to optimize the structure of our device so that the optical resonance is as strong as possible.”

Epson Robots, which manufactures Selective Compliance Assembly Robot Arm (SCARA) robots, has announced that NuTec Tooling Systems, a developer of custom automation solutions, has built a syringe coating machine, including four Epson Cleanroom SCARA robots for a pharmaceutical OEM.

The robots are employed at various stations within the machine to provide precise, efficient, and cost-effective automation to the customer's syringe manufacturing process. The concept phase of the project started in 2018, and the machine was ready for operation in November 2020, enabling the OEM to work with government agencies at a critical time to develop a cost-effective process for manufacturing mass quantities of syringes to use in the fight against Covid-19.

The OEM customer asked NuTec to develop a new machine to automate syringe manufacturing using a proprietary coating process, which gives plastic syringes properties similar to glass. Historically, the OEM's competitors produced syringes from glass, which is more costly than plastic. The process, especially when automated, helps reduce costs and makes mass production feasible.

“Epson's high-speed G6-Series SCARA robots with Epson RC+® software enable precision processes with exceptional repeatability assembly pick and place capabilities," said Brent Martz, director of Sales and Marketing, NuTec Tooling Systems.

“The ease of use and application versatility within the Epson RC+ development environment plus an ISO-3 rating and compliance with clean room standards makes them ideal for this project and the medical sector in general where speed and precision are vital to the manufacturing process.”