Here's how the FDA looks at home-based Antigen testing.
"This latest FDA authorization is for an antigen test, which is a new type of diagnostic test designed for rapid detection of the virus that causes COVID-19. Each category of diagnostic test has its own unique role in the fight against this virus. PCR tests can be incredibly accurate, but running the tests and analyzing the results can take time. One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes. However, antigen tests may not detect all active infections, as they do not work the same way as a PCR test. Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR tests. This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection. With this in mind, negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative.
Antigen tests are also important in the overall response against COVID-19 as they can generally be produced at a lower cost than PCR tests and once multiple manufacturers enter the market, can potentially scale to test millions of Americans per day due to their simpler design, helping our country better identify infection rates closer to real time.
This May 20, 2020 press announcement was titled: Coronavirus (COVID-19) Update: FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients.
The FDA "authorizes" a product for use. It indicates citizens are not allowed to do use a medical product unless they have prior permission from the government who determines whether is is not only safe enough for us to use but whether they know for sure that it will be effective. The FDA policy is to prevent anything that has not been proven safe and effective to be used by citizens but that doesn't consider the costs of cent rating on safety and effectiveness.
The underlying issue
The testing controversy indicates a much deeper, broader issue. It concerns two methods by which we attempt to advance the common good. The one is by centralize government to ensure the safety of citizens while the secondtesting controversy indicates a much deeper, broader issue. It concerns two opposing methods by which we attempt to advance the common good. The one is by centralized government such as the FDA to ensure the safety of citizens while the second depends on the intelligence of the free activity of citizens with all its warts and evils.
Permission Society
The idea of prior government approval indicates a framework some have called the "Permission Society". It means that a powerful agency does not allow citizens to choose to use something unless the agency decides for the citizen that what they are doing is proven safe and effective. It puts citizens in the role of children who must be protected and not allowed to make choices for themselves. It is an oriented relationships, and it is oriented by a top down imposition of rules and enforcement. It is paternalism (the bad kind) that does not respect the autonomy or activity organized by people. It establishes and parent/child relationship between government officials and citizens.
We can imagine all kinds of horrible things that might happen to citizens but much of that never happens in an 'unfettered' market because citizens collectively have far more intelligence than does a single government agency. Can we allow people unfettered access to food purchases even though no one has approved the use of each food? Can we allow people to develop an automobile and sell it? Can we allow people to form a charter school? Can we allow electronic market transactions? In every one of these cases, all kinds of natural regulators spring in response to bad products.
For example there are largely no government standards and prohibitions for most of the transactions of products sold on Amazon. How can these transactions work? Bad products are very effectively regulated naturally by return policies, Amazon guarantees, user reports, and customer ratings. Bad products are very effectively regulated naturally and almost in real-time by return policies, Amazon guarantees, consumer ratings, and user reports. Furthermore this information is all transparent and instantaneously available. Furthermore these powerful incentives to develop a good product mean the producers must constantly redesign and improve products even though the new designs do not come from the consumer,ers. They only select and respond to a new product, not design it. That freedom to develop and market products creates a dynamic process of advanced ent driven by invention and market testing.
Of all the areas of societal concern, the pandemic demands the rapid innovation of solutions, many solutions tested all at once. The government agencies recognize how they slow down and even block innovation by admitting to emergency provision of special authorizations before a product has gone though all its required phases. This slow pace is not that of the rapid inventions and improvements of marketplace technology. Government agencies are cautious, careful, and slow.
And government agencies are immune to customer feedback. They don't and can't care since their goal is to make sure each product is safe and effective, and they proudly state that exclusive contraption on safety and effectiveness in their mission statements.
Comparing Costs and Benefits
There is another way to look at the issue of decentralization and empowerment of citizens, that of considering costs and benefits. The benefit of knowing only safe and effective products and testing are allowed to be used by the public comes with the cost of the loss of benefit that rapid innovation and free activity can produce. We can imagine all kinds of horrible things might happen to citizens if they are allowed to do dangerous things like take unproven drugs or use inaccurate virus test kits. Those appear to be costs but they are vague and certainly not founded in research. But the benefits of freeing citizens to conduct their own decentralized testing such as by parents who will have the $1 test strips that gives them results in 15 minutes, would be the immediate detection of a contagious person. By isolating immediately, the transmission rate of the various would plummet. That lowering of effective R is the benefit to the common good.
Compare that to effectiveness of the centralized control of approved testing method that is costly, centrally administered, with its lengthy times for results, and with its attendant requirement for hiring a huge number of trackers once an infected person is identified days later. On the one hand, then, is empowering citizens by allowing decentralized, easy, cheap testing but which will miss some early cases with small viral loads. It allows schools to open and gives parents immediate benefits. Widespread decentralized, antigen testing would lower the effective R which would serve the common good by stopping viral transmission of the CoV-2 virus. It has considerable benefit at the cost of missing a small percentage of people with small viral loads at the beginning of their infection.
For the common good we must compare the current effectiveness of testing and lockdown to the effectiveness of decentralized testing to stopping transmission and freeing societal activity to move toward normal activity. Do we attempt to manage the virus at great cost by centralized government command and control or we we free and empower citizens to identify and respond?
(Bad) Government as Prior Restraint
The notion of prior restraint in human relationships depends on at least two things for it to be sustained. The first is fear. The second is the belief in a child-like citizenry who cannot be allowed to manage their own lives and choices and who must be protected and taken care of.
Progress depends not on fear but on science and technology. The advancement of society in overcoming its problems depends not on the framework that infantilizes citizens by a supposedly omniscient agency to which we give unfettered power but on the massive amount of collective intelligence at work in free activities of invention, and testing by unfettered exchange that tests ideas and products. Certainly we must deal with evil but government enforcement of government rules is a poor, weak means to a just and caring society.
(Cross posted to Developmental Philosophy)
