NEW YORK – After 22 years as a remote monitoring solutions and telehealth provider, Laipac Technology has moved into the diagnostic testing space with its rapid SARS-CoV-2 antigen test that draws on artificial intelligence to improve the accuracy of result interpretation.
In addition to its wearable technology, Internet of Things solutions, and GPS products, the company began developing a product in 2019 to detect paralytic shellfish toxins using lateral flow antigen testing and artificial intelligence, but when the COVID-19 pandemic hit, it decided to apply that technology to SARS-CoV-2 antigen testing, Cofounder and CEO Diego Lai said.
The Toronto-based company has used its expertise in artificial intelligence to create the LooK Spot COVID-19 Rapid Antigen Test, which uses AI to go beyond a human operator's interpretation of colorimetric results to mitigate the chances that they will be misread or misinterpreted.
An algorithm was developed then trained with thousands of different images of color response information from samples with different viral concentrations, and thus can determine the differences in color that can't be detected by the naked eye.
The firm's $90 reader attaches to any smartphone and detects the image of the test result. It then sends the image through the artificial intelligence-based algorithm, which analyzes the result and returns a positive or negative finding in five to eight minutes, Lai said. The reader can test thousands of samples and lasts for at least five years, he added.
"Most of the antigen rapid tests in the market today use visual interpretations by each operator," Lai said. This can cause problems "in low positive cases where the colors [are] very difficult to identify by the operator," Lai said. Visual interpretation can also be impacted by lighting in the testing area and variations in an interpreter's eyesight, he added. By using an algorithm to interpret results, that potential for error is significantly reduced.
The reader is important because different phones have different manufacturers and different cameras, so the images taken may not be standardized across all devices. Because the reader controls the lighting and automates the testing process, that discrepancy can be avoided, Lai said. It also has an internal UV light to sterilize itself after each test.
Part of the issue with visual interpretation, Lai said, is that the human eye is limited in its ability to perceive colors. "Our eyes are most sensitive to yellowish-green color at the normal light level," rather than the faint red in a low-positive result test, he wrote in an email. "At a low light level, human eyes lose the ability to discriminate color. The sensitivity to blue, violet, and ultraviolet is increased, but sensitivity to yellow and red is reduced."
That difficulty reading results can lead to a 20 to 30 percent discrepancy in results for visual interpreting antigen tests in the field, Lai said.
Mara Aspinall, a professor of practice in biomedical diagnostics at Arizona State University's College of Health Solutions, said there is "no question that there is a lot of variability in calling positives when the reaction strip is only faintly colored." Because of this, "for individuals doing this only once, or infrequently, it is good to have the interpretation automated."
Although the LooK Spot test mostly functions as a traditional lateral flow immunoassay, there is increased automation in determining test results. In traditional antigen tests, the nasal swab is collected, put in a buffer solution, and placed on a cassette, where an operator then reads and interprets the test result.
The LooK Spot test follows this basic method, although the reader connects to the smartphone to self-calibrate, and each cassette has a unique QR code that can be scanned into the LooK Pass app to link it to the specific patient. Patients can download the app and register online before getting tested to receive their results directly to their phone.
Capturing this data is also useful for manufacturers and researchers to track the utility of the test, Aspinall said. "After all, we are carrying around a powerful computer with extraordinarily sophisticated cameras – why not use it?"
Once the sample is placed on the cassette and the cassette is plugged into the reader, the algorithm identifies the result and sends it back to the operator. It doesn't need to be performed by a skilled operator, and to ensure the test is done correctly, Laipac is providing training videos and guides on its website, Lai said.
However, Aspinall noted that using an algorithm to evaluate the cassette image is not "what we really think of as AI – this is usually used to mean that the device is continuously learning and improving," she said. "While that might be true, I do not see that as of much consequence."
Although the firm investigated using saliva as the sample type, Lai said it liked nasal samples better since there are more viral antigens in a nasal sample than in saliva. Saliva sample collection is also less uniform and has many restrictions, including requiring someone to not eat or drink beforehand.
Lai emphasized that the test, which qualitatively detects the SARS-CoV-2 antigen of the nucleocapsid protein, is intended to be used for screening at the point of care and is intended to help the economy recover by helping businesses reopen and events take place and provide screening.
He said that many at-home tests are more for peace of mind than reopening the economy, since anyone who has a negative home test will still need to be retested when going back to work, trying to enter a restaurant, or appearing at an event. "In all those places, they have to screen them again," he said. "You cannot just claim 'Oh I did a home test in my home just now.'"
If an individual receives an initial positive test for SARS-CoV-2 with the LooK test, a second test should be performed, Lai said. If that also comes back positive, a confirmatory PCR test should be done, he added.
Another key pro of the test is its high sensitivity and specificity, Lai said. In a clinical trial at St. Joseph's Hospital in Hamilton, Ontario, the test demonstrated sensitivity of 97 percent and specificity of 98 percent within the first eight days of symptom onset, although the trial was only conducted on 95 samples.
As variants of the SARS-CoV-2 virus have appeared globally and caused concern for diagnostic test developers about whether their tests still work with the variants, Laipac performed a variant analysis for the LooK Spot test and found it can detect the UK, South African, and Brazilian variants, although it cannot differentiate between the three.
Laipac has filed for Emergency Use Authorization from the US Food and Drug Administration for the $8 test and the reader, and Lai said the FDA told the company it is in the "final stage" of EUA consideration. The test received CE-IVD marking in January. It has also nabbed approval from the United Arab Emirates' Ministry of Health and Prevention and regulatory approval in Japan. The company has filed for Health Canada approval, and is applying for approval in the United Kingdom, Australia, Czech Republic, Saudi Arabia, Qatar, Bahrain, Panama, Ecuador, and Chile, among other countries.
Lai noted that uptake in the Middle East has been particularly strong, and last month the company announced it had partnered with UAE companies YAS Pharmaceuticals and Pure Health to provide full integration with multiple information technology applications for real time reporting.
Although Lai declined to provide specific sales numbers, he said Laipac is outsourcing the manufacturing of the test and is currently producing 1 million tests per month, with the goal to ramp up to 10 million. Upon FDA authorization, Lai said the company is "eyeing" a potential capacity of 20 million or more tests per month. It is also in discussions with some countries for large volume deployment of the tests, he added.
The firm is also developing the LooK Spot 2, which is expected to be available in May or June. The machine will have five slots to run five of the antigen tests at once, allowing up to 600 people to be tested per hour, Lai said.
Even as vaccines continue to roll out, Lai said there will still be a need for rapid SARS-CoV-2 testing. People with vaccines can't just "run free," he continued. "You still have to test them ... the usage for this kind of test will be booming," he said.