Whether or not the nation would be ready for a theoretical bird flu pandemic, it’s worthwhile to look at how the testing industry might perform. I should be clear that as I write this, there a just a few human cases in the United States. I’m not even sure a next pandemic comes from another respiratory threat (compared to mosquitoes, say). But let’s assess the possibility. The in vitro diagnostics, or clinical test, industry was the front line in responding to the COVID-19 pandemic. They would be the front line for any pandemic where treatments or vaccines are not employed yet.
In the case of bird flu, I’d argue that the manufacturers of in vitro diagnostics equipment would be well positioned, if not “ready” for such a testing challenge, at least in an early pandemic phase.
This confidence comes from three factors:
- Influenza, unlike COVID-19, is not a new disease, and threats of avian flu are not new, the threat has been present for decades, and IVD manufacturers have been alerting healthcare and governments to the threat and developing products. Tests would have to be adjusted, not made from scratch.
- The second reason is respiratory panels – tests for a battery of diseases affecting the respiratory system where the provider does not know which one to suspect the patient has. Unlike single tests, which live or die market-wise on the particular infection’s commonality, panels have the side benefit of keeping tests for various less common infections market-viable to some extent, so they could be available when needed. Some panel tests can detect seasonal flu subtypes that can be ruled out.
- Thirdly, there are scores of standard influenza tests in great quantity. Already out there. While not able to immediately detect the type of flu, they’d at least get started with detecting the disease culprit from other diseases, perhaps initiating patient isolation or Tamiflu, and assumptions can be made until a more specific test is available. This is an improved situation from March 2020, when no tests existed except at CDC. (Flu tests were used in 2020, but as a rule-out).
If I had to add a fourth, I’d guess that increases by the major companies in manufacturing and stepping up contract manufacturing relationships have put the industry in a better position than it was in 2020. That’s not to say there aren’t challenges and surprises that could hit. I’ll discuss some of those at the end.
Anyone who has read the news lately knows that Highly Pathogenic Avian Influenza (HPAI) is a highly contagious and often deadly disease in poultry, caused by avian influenza A (H5) and A (H7) viruses. The name scares: maybe more than it should right now. The term “highly pathogenic” refers to the severe impact on birds, not necessarily humans. It is also known as a bird or avian flu. HPAI viruses can be transmitted from wild birds to domestic poultry and other bird and animal species. While bird flu viruses do not typically infect humans, there have been occasional cases of human infection.
What we don’t have yet, is human-to-human transmission, though the threat is there.
According to the U.S. Centers for Disease Control and Prevention (CDC), “avian influenza A rarely infects people. The CDC continues to monitor emergency department data and flu testing data for any unusual trends in flu-like illness, flu, or conjunctivitis.”
Tests Providing Non-Specific, But Still Helpful, Results
Marketed IVDs at the time I am writing do not detect bird flu specifically. They detect flu generally, including (we suspect) bird flu, and others, but don’t tell you what type it is. A few tests do provide different subtypes from today’s bird flu though, and The CDC is already making clear that subtype testing can be useful in avoiding the pandemic overload at the CDC.
The FDA lists these tests as running cleared A/H1 and other subtype tests:
- Applied BioCode, Inc. BioCode CoV-2 Flu Plus Assay
- BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ)
- GenMark Diagnostics, Inc. ePlex Respiratory Pathogen Panel 2
- Luminex Molecular Diagnostics, Inc. NxTAG Respiratory Pathogen Panel + SARS-CoV-2
- QIAGEN GmbH QIAstat-Dx Respiratory SARS-CoV-2 Panel
- Applied BioCode, Inc. BioCode Respiratory Pathogen Panel (RPP)
- Biocartis NV Idylla Respiratory (IFV-RSV) Panel
- Biofire Diagnostics, LLC BioFire Respiratory Panel 2.1 (RP2.1)
- BioFire Diagnostics, LLC FilmArray Pneumonia Panel, PLUS and TORCH
- BioFire Diagnostics, LLC BIOFIRE SPOTFIRE Respiratory (R) Panel and Sore Throat Panel
- GenMark Diagnostics, Inc. eSensor Respiratory Viral Panel (RVP)
- GenMark Diagnostics, Inc. ePlex Respiratory Pathogen (RP) Panel
- Luminex Corporation Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
- Luminex Molecular Diagnostics, Inc. NxTAG Respiratory Pathogen Panel
The CDC is careful to say that these tests do not detect bird flu; however, they can be useful in a triaging of what samples to send to avoid the CDC from becoming overloaded:
CDC requests commercial laboratories continue to send the following specimens to PHLs as soon as possible for further testing and characterization.
- Influenza A positive specimens that are subtype negative on tests designed to provide an influenza subtyping result (ex. Biofire) and confirmed upon retest.
- Influenza A positive specimens that are subtype influenza A(H1) and not influenza A(H1)pdm09 on tests designed to provide an influenza subtyping result and confirmed upon retest.
Tests Providing a Flu-Positive/Negative, But No Subtype Information
As mentioned there are plenty of influenza tests marketed, and the expectation is that Influenza A tests will perform in at least detecting bird flu as “flu,” but not specifying the subtype. Brands with standard influenza A testing products include: Sekisui, Abbott, Everlywell, Cepheid, Hologic, Revvity, Pfizer, Roche, and Princeton Biotech, to name a few.
There should be a supply of both molecular and antigen influenza tests. Now, that doesn’t eliminate concerns about other items and eventual manufacturing crunches if there is not sufficient help from the federal government. But during the pandemic, other problems emerged – healthcare worker shortages, PPE for workers, swabs, and finally tests themselves. These factors are hard to predict should a pandemic reach COVID-level proportions, but presumably are better. For instance:
- PPE: The CDC is a bit more ready than in the past in terms of advice on preserving PPE and setting triages of mask and respirator use at facilities – https://www.cdc.gov/niosh/topics/pandemic/conserving.html
- Swabs: In terms of swab manufacturing – using stereolithography to 3D print testing swabs is indicated to offer the safest, most efficient method to fulfill the short-term supply chain resilience needs.
- Flu Test Development: The federal government through BARDA, the Biomedical Advanced Research and Development Authority, has been supporting various flu test efforts – https://globalbiodefense.com/2023/04/20/aptitude-awarded-up-to-54m-barda-funding-for-at-home-diagnostics/
- EUA Approvals: The FDA has procedures in place for a future pandemic and has hinted they will use more 3rd party approvals for EUAs that can rapidly approve test products, without having to completely give up oversight.
These reflect that we would be at least in better shape, if not optimal shape for a pandemic that might arrive. Until such time as vaccines and medications can pick up the slack (research and development for H5N1 mrNA-based vaccines is underway), the testing industry stands ready.
