To win this war and save American lives, we need an at-home sampling and processing blood test, and we need it soon.
BOSTON, MASSACHUSETTS, UNITED STATES, March 31, 2020 /EINPresswire.com/ — There was justifiable excitement when Abbott announced a new 5-minute test for COVID-19, the disease caused by the novel coronavirus. More rapid and widespread testing at point-of-care will do much to help us win this war.
Ultimately, though, hospital-based or office-based testing devices, like Abbotts, aren’t going to make a big-enough dent in this battle. Only at-home sample collecting and processing will truly help us get our arms around this enormously difficult to defeat new enemy and defeat it.
In my earlier article, I outlined a 3-step plan to save lives. The third, and arguably most important, step of that plan is the rapid wide-scale deployment of a fully at-home blood test for COVID-19. In this article, I will more fully explain why this is so critical, and so doable, financially, technologically and psychologically.
WE ALREADY HAVE A PROTOTYPE UNDER WIDESPREAD USE
Can you imagine a diabetic going to the hospital four times a day, 365 days a year, to get his or her blood-sugar level tested? Because diabetics need frequent, easy-to-use blood tests, the market responded with an at-home sampling AND processing kit that helps millions of American diabetics manage their condition fully at-home.
Without this tool, it is safe to assume that many diabetics would be flying blind, living their lives at the whims of an invisible killer – much as we are today with the coronavirus.
The 5-minute Abbott test is a game-changer, to be sure. The President, the FDA, and private business should be applauded for expediting its development and approval.
But touting it as a patient/consumer-centered test is misleading. It’s only a “5-minute test” if you live at a hospital or doctor’s office. For many Americans, particularly those who rely on public transportation, the start-to-finish testing process could actually consume at least four-and-a-half hours.
This, obviously, is an impractical and psychologically intolerable amount of time for most Americans, if you want them to test themselves (and others) every time they seek entry back into their “virus-free” homes. Yet, this would be the price they would have to pay, daily, if they went back to work at their plant or office.
If you were a soldier in a foxhole, would it be reasonable to expect you to spend four hours every time you need to get a bullet to fire your next round?
HERE'S EXACTLY WHAT WE NEED
What we need to win the war as soon as possible is a test kit having ALL of the following features:
1. Very fast results: If we plan to keep our homes a virus-free safe haven, we need to be able to quickly test anyone who seeks entry into it. This means we need super-fast (no longer than 15-minutes, and preferably 5-minutes) sampling and processing, combined, i.e. as fast as the current finger-prick blood sugar testing.
2. Mobile: So we can use it at home or on the road.
3. Convenient: Easy-to-carry and low-profile, so that it can be kept in the average entry way.
4. Ease-of-use: A simple finger prick should do it. The current nasal- and throat-swabs are difficult to do correctly (meaning a high, very dangerous, false-negative rate) and painful for the patient.
5. No time, energy, or transportation costs: Quick, easy, and at-home.
6. Low-aggregate costs: No personnel or labs needed to sample or interpret results.
7. No prior-authorization needed: Nobody should need an order from their doctor to quickly learn if they have COVID-19. Test can be done any time, day or night.
8. High-quality and “idiot-proof”: No medical – or even high school – degree needed.
9. Safe and effective: Proven repeatedly over many years of use.
10. Highly accurate: Very low error rate, especially dangerous false-negative rate
THREE COMPANIES READY TO ROLL
I personally know of three companies that, if soon they receive adequate funding for further development, manufacturing, and distribution, and robust regulatory support, can very quickly help us accomplish the goal of having a large-scale at-home-test program that could meet these requirements, nationwide.
Why are all of those features of great importance? Because, if the tests aren’t widely and aggressively used, we won’t come close to being able to save, by my count, 50,000 American lives. It would be like performing D-Day with only 1,000 soldiers, instead of 156,000.
Gen. Eisenhower didn’t do it, and I don’t believe President Trump will either. He is looking for “The One Big Thing,” a knock-out punch.
Based on my decades of experience in the health sciences, including previously serving as the Principal Deputy Commissioner of the U.S. Food and Drug Administration, I know that at-home-sample-collection and processing, which will help us accomplish aggressive testing in enormous numbers, is the only way we are going to win this war.
This is doable. We just need our leaders to make this Phase I of my plan happen, very, very soon.
The Hon. John Norris is an FDA Former Principal Deputy Commissioner, a Harvard Former Health Policy and Management Faculty Member, a Massachusetts Former Chairman of the Clinical Laboratory Regulation Reform Commission, and Chairman of FDTH Regulatory Affairs Strategies, as well as an inventor-entrepreneur and frequent drug, device, Healthcare-IT, clinical lab, and hospital-system visionary, innovator, advisor, and board member. He can be reached at firstname.lastname@example.org.
FDTH Regulatory Affairs Strategies
email us here
Source: EIN Presswire