Diagnostic IP: You May Swipe Your Card Here to Pay for the Concert Ticket, and Swab over There COVID-19

April 23, 2020
By Noel Courage

There are many precautionary measures that will be required as part of our eventual return to the “new normal” of work and play. In the short term, these include low-tech aspects such as social distancing, promptly quarantining the infected, community masks, and contact tracing. Technology is also front and center of the short-term measures to return to normal, with diagnostics being a key player. 

It has been recognized that having sufficient testing capability is key to reopening the US and Canadian economies. Health officials have sounded the alarm that some U.S. government officials moving to reopen businesses may be getting ahead of the testing capability. Many regions have not only shortages of available tests but also backlogs in processing test results. 

How do we improve testing capability? Innovation and new IP is key. This article will focus on the role of nucleic acid and antibody tests in the new normal that is just around the corner.1 


Detecting Viral Nucleic Acid in a Patient (RT-PCR)

The main diagnostic used to date has been based on detecting viral nucleic acid, called RT-PCR testing. At the start of 2020, test times were often measured in hours. Test times have since dropped rapidly. Abbott launched a test that produces results in as few as 5 minutes. None of the tests are flawless. There are still significant false positive and false negative rates, partly due to issues in the sampling, handling, reagent or testing process. This is why the earliest government test protocols called for two time-separated consecutive negative tests of a patient, in order to increase certainty that the patent was virus-free. Clinical judgment of the physician remains paramount, with the diagnostic test result being a useful tool in their knowledge arsenal. Innovations in product and process improvements, and clear communication, will improve quality of the test results. Abbott has already put out follow-up advice on how to avoid errors in test handling. A second key element of improved testing capability is increased funding and manufacturing of virus test kit materials, such as reagents and swabs, which have often been in short supply.

Other diagnostic innovations include a self-administered home nostril swab test using a Q-tip-style cotton nasal swab (FDA-authorized). Other companies are developing a portable RT-PCT testers that will permit point of care testing, which is critical for rural areas. Point of care testers should also reduce risk of error by not having to transport samples to a central lab for testing. 

There is potential for a saliva-based nucleic acid diagnostic test based on recent encouraging results detecting viruses in saliva. 

These innovations are the product of much R&D effort, time and money. The option to take out IP protection on kits, analyzers and the like helps recoup the investment in research. IP owners are typically quite willing to share IP with other companies under a license that will benefit all. Innovative companies have also recognized the importance of collaboration and getting technology out there by sharing IP.


Antibody Tests (Immunoassays)

A second important type of diagnostic that is now being used are antibody blood tests to identify whether a person has antibodies against the novel coronavirus. RT-PCR tests are still the key diagnostic used by doctors. The antibody test is less relevant for clinical diagnosis because it has a high false negative test rate for early-stage patients because it takes days for a patient’s body to react to the virus and make detectable antibodies. Depending on which type of antibody is detected, there can be a diagnostic value, but the main interest in the antibody test is in assessing immune status – identifying those who have already had, and cleared, the virus. There is a hope that these people have immunity against the virus.2 This test does have its own inaccuracies, and an additional concern is that it is unknown how long the immunity will last – for example, flu vaccines are given annually because immunity fades. These tests are being used extensively in the U.S., but the WHO and Canada have been reluctant to endorse them due to inaccuracy. Canada does intend to conduct antibody testing. Most of the tests in use in the USA have not been reviewed by the FDA, creating quality concerns. 


Diagnostics Helping to Reopen the Economy

It is already becoming apparent how these diagnostic inventions are going to come into play in the new economy. Many writers are speculating on when and how reopening will occur, and what it looks like. A physician recently suggested that rapid diagnostic testing may become a regular and routine activity in daily life before going on mass travel or to big special events, such as concerts or sports games. Low level diagnostics have already been going on for some time, with measuring temperature and screening travelers for symptoms being used as a simple, rough evaluation tool. An early example of the more aggressive diagnostic approach is Ontario giving COVID-19 tests to all long-term care residents being transferred into retirement homes. Ontario will likely end up routinely testing all residents and workers in long-term care. A small number of physicians in Ontario have discussed on social media that some local employers are requiring a negative test result before employees can return to work, and this practice is likely to become more widespread. In Wuhan, workers at some companies are required to have a COVID-19 test before returning to work, regardless of whether they had the disease previously. Emirates Airline claims to have carried out COVID-19 blood tests (antibody tests) on passengers at the airport, with results available in 10 minutes. This appears to be style over substance as far as protecting passengers and flight crew, since the antibody tests have a high rate of false negative. The airline did not state whether any passengers would be refused boarding based on the results of the test, according to CNN. However, many observers took it as a potential glimpse of the future. This is becoming more realistic as test speeds go up and costs go down. It could be driven by many factors beyond public health, such as companies trying to avoid the bad PR and risk of liability of an outbreak associated with them. However, it is not simply not economically feasible or practical to expect testing in many mass-attendance scenarios, such as daily public transit.

The antibody test is also part of the driving force behind the immunity certificate concept, where a former COVID-19 patient is certified as being believed to be virus-free. This is an interesting idea, but not without controversy, since it is not clear how long the immunity will last. 

Looking farther into the future, once portable DNA analyzers are clinically validated and deployed, it is possible that homes may eventually have their own DNA analyzers. That could give rise to BYOTR – bring your own test result.

Again, these diagnostic measures are not perfect. False negative test results will allow people with the novel coronavirus past checkpoints. False positives can exclude others unfairly. People may even test positive after a disease has passed, but not be contagious. Test technology has improved dramatically in a very short time, and there is exciting and reassuring potential for better and faster tests, increasing everyone’s safety. Get ready to see it in action when you head back out.    

So, enjoy your next airplane flight, but be prepared to wear a comfortable mask and potentially do a diagnostic test beforehand. At least physical distancing means you might have a little extra side space.  

1 There are other interesting diagnostics being developed based on technologies such as antigen detection, CRISPR, ultrasound, CT scans and a one minute breath test.

2 A curve ball was seen in South Korea and China in that a small number of patients with antibodies, and believed to have recovered, test positive (detectable viral DNA). It was later determined that this may be due to shedding of dead patient cells (not reinfection or virus reactivation).

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