No test is perfect. We can certainly strive for perfection, but perfection is not a proper criterion for the development or use of a test. As a physician, two golden rules have guided my past practice. Number one, don’t order a test unless you plan to do something different depending on its result (lots of examples where doing a test on a person with low likelihood of a condition led us down a long, and sometimes dangerous, rabbit trail of further testing and procedures that ultimately harmed and did not help the patient). Number two, always understand the limitations of any test you order, to understand what it can tell you, what it doesn’t tell you and how it may be either a false positive (the test says you have a condition, but you don’t) or a false negative (the test says you don’t have a condition, but you do).
Antibody testing for the novel coronavirus is an exciting development and holds great promise in the future (and, I don’t think it is a distant future – I would not be surprised if we got answers to our questions later this year). These tests are new, being studied and we still have many unanswered questions that are critical to be answered before we change our lives based on their results.
A number of people have been touting that antibody testing can “get people back to work and give them back the lives that they were hoping for.” This may very well come true. It is not true today.
So, given a push for antibody testing, but given warnings from others, how should Idaho employers think about whether they should require employees to have antibody tests?
- If those pushing you to do antibody testing are making false claims, beware. To me, if someone makes false claims, that undermines their credibility. That doesn’t mean they can’t be right about other things, but beware and be extra skeptical. What are some of the false claims I have heard thrown around?
- That an antibody test is “FDA-approved.” As of today, there are no novel coronavirus antibody tests that are FDA-approved. There are four tests that have received Emergency Use Authorizations (EUA) as of the time of this writing, and then others that are being offered pursuant to notification without an EUA. FDA-approved has a special meaning and implies some rigorous review. EUAs and notifications have not gone through this extensive review.
- That a test is “100% accurate”. I cannot think of a single test we have that is 100% accurate. We don’t require and shouldn’t require 100% accuracy in making medical decisions, but like the old saying, “if something sounds too good to be true, it probably is.” Again, this doesn’t mean that a test being pushed is not a good test, but it is one more thing I weigh when I am considering the credibility of someone trying to get me to buy or do something. As, a physician, I have never ordered a test that is 100% accurate, but I know what the limitations to a test are that I am doing and I advise my patients accordingly when I explain their test result to them.
- The test has 100% sensitivity and 100% specificity. I am not a statistician, but I don’t think this is even possible. You could certainly have a test that is 100% sensitive or 100% specific, but I don’t believe a test could be both. Again, it doesn’t mean it is not a good test, but it is an additional factor to weigh when you consider whether you can trust this particular source of information on the test. Again, I don’t require that a test I order is 100% sensitive and 100% specific, but as the person who will interpret the test and explain it to my patient, I need to understand where the test may suggest my patient has a condition that I don’t think they have or doesn’t have a condition that I think they do have.
- I am not an expert on immunology or virology, but I do know enough to ask questions and I know when I can’t get answers to my questions or those answers don’t make sense or the answers I get can be fact-checked and readily disproven, that I am going to be a bit distrustful and probably not get reassurance without the advice of experts. Most employers are not going to be experts in these areas, either. So, what can you do?
- Have your HR or medical advisors check the guidance of the World Health Organization, the CDC or your local public health department. If they are cautioning against taking this step, you should too. Further, the FDA does provide some helpful advice and has issued warnings that you will want to be aware of before using antibody testing for employment-related decisions.
- Read what experts without conflicts of interest are saying in the press and media.
- There are many reasons why local experts will not speak out publicly about misinformation. If you do see an expert, or even a non-expert but someone who is knowledgeable, speaking out and expressing concern, you should be extra diligent in asking probing questions and seeking validation of claims being made before you make your own decision as to engage in the testing.
- Consult with experts, but make sure that these experts do not have conflicts of interest. Some of the biggest proponents of antibody testing for purposes not recommended by authorities and other experts are those who have a conflict of interest and stand to gain by publicity, funding or direct sales of the testing. A conflict of interest does not mean that someone is not being truthful or doesn’t have a great product, but we need to keep in mind that sometimes conflicts of interest do influence how someone portrays a product and may not create the incentives for the person to be fully transparent and give all the necessary qualifications for their statements. We just need to do extra diligence when someone is asking us to change a practice or buy something when we know that they stand to gain from those decisions.
- Realizing that I am not an expert and likely your business does not have expertise in this area, it may not be prudent to enter into a debate with someone who professes to be over the facts or the science behind the test. Instead, my biggest flashing red light goes off when someone recommends something that they themselves are not doing. So, four simple questions to ask the person pushing the test.
- Do you or your company benefit in any way if people purchase the testing you are advocating?
- If a doctor or a clinic are promoting an antibody test as a way to “get people back to work and give them back the lives that they were hoping for,” then I would ask them to show you the evidence that they are using the antibody test for themselves and their employees for that purpose. If someone tests negative, do they not permit them to come to work or care for patients who potentially have COVID? If the physician or employee does test positive, are they allowing the person to be put in higher risk situations than those who test negative? Are you imposing a lower level of infection prevention procedures for those who test positive? Are you prioritizing PPE to those who test negative and relaxing the PPE protections for those who test positive? After each question, ask why or why not.
- Most often, insurance companies do not provide coverage for tests that are not proven and that are used for purposes that the government does not approve of. I would ask, which insurance companies are providing coverage for this testing and if so, can you provide me with the evidence?
- In those cases where someone suggests that a test is perfect and is 100% accurate, I would ask then why hasn’t the FDA approved it (when you are told that it is FDA-approved, ask for them to show you that evidence from the FDA) and why are the WHO, CDC and State public health authorities recommending against it instead of actively promoting the test?
- As I mentioned at the beginning of my blog post, I don’t order a test unless it may change my management of a patient. Otherwise, why would you put the patient through the discomfort of the test, the time associated with getting the test, the risks that a test may cause and the cost of the test? So, I would ask the same thing of employers. If you are requiring your employees to get a test, then answer the following questions for yourself:
- What will I do differently if my employee tests positive? Will I put them in higher risk activities than those who test negative? Will I try to conserve PPE or other equipment and lessen the protection that I offer to these employees? If you are not going to change their work assignment or change their protection or procedures, why are you spending the money for a test, assuming that you are either paying for your employee to be tested or your company’s health plan is?
- What will I do differently if my employee tests negative? By the way, unless your company provides health care, we think (we don’t know, but this could be an area where the use of antibody testing could be useful) that at most, 10 percent of Idahoans have been infected. Many think it could be considerably lower. So, if at least 90 percent of your workforce has a negative antibody test, does that mean you are not going to allow them back to work? Are you going to take additional safety measures if you do allow them to return to work? If you aren’t going to do anything different, why are you putting your employees through the time, effort and potentially cost of getting tested?
- If my company decides not to allow persons who test negative to return to work, what liability are we assuming for potential employee discrimination or other claims related to conditioning the ability to work on a test that is not approved by the FDA or supported for this use by health authorities? Obviously, liability could be minimized by continuing to pay employees who you don’t allow to return to work, but can you sustain this? Can you run your business with less than 10 percent of your workforce? And, to the extent you furlough employees without pay who are not testing positive, could employees ultimately become so desperate that they decide to purposefully put themselves as risk in an attempt to become infected and subsequently have a passing test that will allow them to return to work?
- Finally, just as a physician would, an employer requiring a test or using the test to make employment-related decisions should ask themselves, what does a positive test mean? Unfortunately, most lay persons believe that a positive antibody test means they are immune. We have reason to believe that is likely to be the case and we certainly hope that is true, but we simply don’t know and anyone who tells you that they can assure you that your employees are immune based solely on the results of this antibody test should be added to the list of people you remain skeptical of. We may have the evidence before long that this may indeed be true. But, it would be reckless to make that assumption today. Just ask that person if they tested positive, would they be willing to take a direct challenge with the virus to confirm they are immune?
I understand that we want to reopen the economy and get back to work. I want the same thing. Ironically, I am proposing that people get back to work sooner at lower cost than those who are proposing we use the antibody testing to get back to work. What we do know is that the infection prevention recommendations work – social distancing, covering coughs and sneezes, washing hands, working form home when feasible, avoid non-essential travel, avoiding large groups of people, wear a face covering out in public, etc.
I am saying that if your business is open or can open and you can implement these measures, bring your employees back to work today. And, I have been saying this since April 15. There is no reason that your employees need to wait until they can schedule an antibody test, get to a clinic that can get the sample, send the sample to an out-of-state lab, get the results back and there is no reason that you or the employee need to incur these costs. If they can work today with a positive antibody test, they could have been working since April 15 without the antibody test. I can’t imagine what an employer or the employee should do differently whether they have a positive or negative antibody test. (Well, actually I can, but it means keeping the antibody positive person off work longer – note, there is a period of time when people are possibly still shedding virus after they start producing IgG. In fact, knowing that the employee is IgG positive and allowing them to return to work immediately, may also create liability.)
Obviously, this is a fast-changing environment. We are learning more about the virus and making technological advances every day. At some point in the near future, my advice is likely to change – when we can get accurate facts and have the data to support those facts. In the meantime, let’s not spend money that we are not going to get value for, and let’s not imagine that these tests tell us something they don’t and inadvertently put people at risk of serious, and sadly sometimes fatal, illness.