The response to the COVID-19 pandemic proves just how creative, resilient, and effective the worldwide healthcare community can be.
By Jim Poggi
The current COVID-19 pandemic has shaped current events, the global economy, the medical-surgical supply chain, social practices, and lab testing in ways we could scarcely imagine before it occurred. It has been over 100 years since the tragic flu pandemic of 1918, and COVID-19 is the most dramatic and far-reaching public health crisis in recent history. While it has challenged us individually and as a society in many ways, it has also created remarkable opportunities for learning. In this article I plan to explore things we are learning for the first time, and learnings being reinforced by COVID-19. It is a formidable list!
Our vocabulary is expanding along with our testing and treatment options
Emergency Use Authorization, social distancing, contact tracing, antibody testing, and pandemic are all words we have had some familiarity with over the years. But, this is the first time that I can remember using them all on a daily basis.
What’s the scoop on EUA approvals as of mid September?
Emergency Use Authorization (EUA) has been the gateway for a flood of COVID-19 test products in particular. It is used instead of the more rigorous 510(k) clearance process more typical in the lab business to speed availability of testing products. As of mid-September, over 200 test kit products have received EUA approval. This includes 163 molecular diagnostic assays, 46 antibody test methods, 4 antigen detection assays and one kit specific for patient management, an assay for IL-6, which is elevated in patients who will likely suffer serious complications from COVID-19 and experience the “cytokine storm” most often associated with sepsis. Just knowing that the cytokine storm is a serious complication of a COVID-19 infection is an important learning from the pandemic. Ultimately, it will help lead to more effective diagnosis and treatment modalities for COVID-19 and sepsis.
In addition to the number of EUA approvals, it is interesting to note the remarkable range of assay formats and sample types represented for diagnosis. RT-PCR, ELISA and lateral flow assay formats all have a place in the portfolio. Sample types include venous and capillary blood, saliva and more recently stool samples. We are learning that each sample type has different uses and characteristics. It is becoming clear that stool samples show SARS CoV-2 antigen longer than blood or saliva, which could indicate that clearance of the virus from the gastrointestinal system is the final hurdle to systemic clearance of the virus.
Debate on whether RT-PCR is too sensitive for detection of SARS CoV-2 is ongoing
One of the fundamental benefits of RT-PCR has always been the fact that it can take a very low titer of the nucleic acid of interest and amplify it to make it detectible. But, there is a school of thought that it is too sensitive when used as a proxy for whether a patient is still infectious to others. Some scientists suggest reporting the number of thermocycles required to detect the virus as a means to understand the viral load. Others suggest that the variability of methods and lack of specific standardization of RT-PCR methods makes this impractical. My personal view is that there is a clear need for sensitivity for differential diagnosis of SARS CoV-2 from other infectious agents, especially as we approach the height of the typical respiratory infection season. It remains to be seen whether there will be a uniform way to use RT-PCR cycle counts as a proxy for infectivity. I don’t believe it is practical this season.
Proficiency Testing for COVID-19 assays is here
PT and QC have been two of the most important tools to understand relative method performance and individual lab and technologist performance. No where could this be more important than for assays for critical disease pandemics, especially when EUA has lessened the burden of performance data needed to enter the market. My research indicates a wealth of PT methods are available from the usual commercial sources and the College of American Pathologists. RT-PCR methods are well represented and antibody methods are becoming available quickly as well. It is also worth noting that Health and Human Services requires labs conducting COVID-19 tests to report results, irrespective of their CLIA license. HHS released specific guidance to laboratories specifying the needed data and reporting requirement in June, 2020.
We can break the speed limit to respond to a pandemic
The supplier community and distributors have proven time and time again that they have the agility, creativity, and supply chain connections to do the amazing on short notice. COVID-19 has shone a light on just how remarkable these efforts can be and also has demonstrated some needs for improvement in manufacturing diversity, raw material, and logistical planning.
The ability for the supply chain to deal with the extraordinary demand for PPE products, in particular, has been outstanding. While some items like gloves remain in short supply, masks, face shields and gowns have all recovered nicely from the initial shock of demand. Legacy suppliers have stepped up, new sources of supply have emerged and some companies have shifted focus from their core product portfolio to begin manufacturing and distributing needed PPE supplies.
As noted earlier, there is a wealth of test kits available. This is not only due to the use of EUA, but also due to powerful R&D organizations galvanizing their resources to provide needed assays rapidly. In the process, we have also seen new types of assays and new indications for use emerge.
Progress has been impressive and dramatic. On the therapeutic side of things, I must admit I was skeptical of whether Operation Warp Speed was a buzz phrase or whether it could truly produce vaccines and antibody treatments at record speed, due to the need to demonstrate safety and efficacy. There are currently more than 150 COVID-19 vaccines in development, and a large number of other therapeutic agents including antibody therapeutics. It may to too early to predict precisely when the first vaccines will be available, but it is clear that the speed of vaccine development and deployment against COVID-19 will be a record pace.
It is true that adversity leads to opportunity and the worldwide response to the COVID-19 pandemic proves just how creative, resilient, and effective the worldwide healthcare community can be when challenged. What we learn from COVID-19 will benefit us in countless ways from supply chain improvements, new assay development, and advances in how to treat infectious diseases and prevent complications. We live in remarkable times.