The anniversary no one wanted
Volume 7, Issue 10 | March 8, 2023
In This Issue
First COVID Antigen test granted FDA marketing clearance
Warning: False-negative skin tests for food allergy
Norovirus status: 12-month high
Remote patient monitoring still growing
Bird flu in China
New and Noteworthy
This week, we dedicate the issue to the memory of those who have lost their lives or loved ones to COVID-19. You can also find a brief roundup of Quick Hits below.
Sensitive & Specific will take a hiatus next week. We’ll see you on March 22.
Food for Thought
Three years. An anniversary for an event that no one wanted and only a well-informed few expected. Three years of tears and frustration. The numbers sadly speak for themselves: Globally, 6.8 million people died. In the US - 1.1 million souls gone. The US remains in the top 5% of the most-affected countries in deaths per capita (Peru is number one).
Case numbers are much more complex now, as under-reporting is rampant. That’s especially true in the US, where at-home tests are the primary vehicle for diagnosis and awareness of the nation’s centralized reporting system for those tests is lacking (not to mention any interest in reporting). CDC reports show 103 million cases as of today. We know that the real number is higher. How high? During the first 18 months of the pandemic, the CDC estimated that only one in four cases were reported. Once the at-home test explosion happened, unreported numbers started rising. We estimate that only one in eight cases were reported in 2022. Today, as at-home tests dominate, PCR labs close, and many are experiencing at least their second bout of COVID, the number could be one in 15. We’ve seen estimates that are even higher, up to one in 20.
This year, to honor those who lost their lives and those who lost loved ones, we will look at what COVID has taught us - what we now know that will help improve health and save lives in the future.
The Sensitive & Specific Seven “Successes” from COVID
Diagnostics: Knowledge and awareness soared.
Telehealth: It works - and it’s easy.
Industry Cooperation: Companies put deals together in days instead of months.
Vaccine Development: From discovery to doses in less than a year. 13 billion administered since.
Push for Clean Indoor Air: We need it not just for health, but for education and productivity, too.
Remote Work: For those whose tasks permit it, it has increased personal flexibility and added hours to the day.
Wastewater Testing: Sampling sewers supports viral surveillance - seamlessly.
Our number-one realistic hope for the future (accepting that a peaceful, disease-free world is off the table) is that decision-makers, large and small, remember the lessons of COVID. It may be naïve to hope that governments in challenging economic times spend money today to prevent potential threats tomorrow. But, disease is one threat that governments can’t negotiate away. The only hope is mitigation: Testing, containment and treatment.
Quick Hits
FDA announced that Sofia 2 SARS Antigen+ FIA test by Quidel has been granted De Novo authorization for marketing clearance. This test, a Point of Care test with prescription required, is the first antigen test to receive marketing clearance through the traditional premarket review process (not the EUA process).
Skin tests for food allergies are known for false positives - now FDA warns potentially life-threatening false negatives can occur too. Investigating reports of adverse events, including anaphylaxis, has led the agency to require warning labels on all food allergen extracts used for skin testing. The labels now ask clinicians to consider confirming negative skin tests with follow up serology (blood) testing. Of course, serology tests use food allergens too, but likely not the exact same extracts.
Cases of norovirus are at a 12-month high, according to CDC data. However, these levels are within the normal range for this time of year, according to a spokesperson from the agency. Wash your hands.
Use of remote patient monitoring continues to grow, even though in-person clinician visits have resumed, according to a new report analyzing insurance claims. Blood-pressure and diabetes monitoring are the leading uses, with cardiologists and primary-care clinicians the top users.
China has reported a second recent case of the strain of bird flu that has been spreading worldwide. Both cases involved people who had direct contact with poultry.