Home Testing for COVID: Let’s Not Get Over-Enthused

The Recent Media Coverage:

In several recent articles (NY Times and Boston Globe among others), there was enthusiastic support for home testing for Covid as if it represented a risk free and quality mechanism for allowing social interaction.

Yes, home testing for COVID is an important tool for Americans to move forward from the Pandemic and yes, the Biden Administration plans to enable distribution of free tests across our nation.

Yes, there is a sizable role for home testing IF one understands what its results mean, including the possibility of false negatives and false positives. Also, home tests are only a part of what we need to improve COVID containment.

The media coverage and the Biden free distribution approach fail to recognize the need for a test user to have access to a physician, the capacity to arrange a second test to verify results and the ability to withstand the financial and psychological implications of quarantining. Read that again. Home tests are not complete answers.

And, and this is key: home testing is not risk free.

Home Test False Positives and Negatives:

Start with this reality. Home testing is not yet the gold standard for determining COVID. There are the possibilities of false negatives and false positives. Most of the articles were accurate about these home tests with the critical exception of a Globe article that stated that these home tests are 98% accurate. Not true, even based on the data produced by the test creators!

Yipes. There are false positives and false negatives.

False positives in particular concern me, most especially in view of the recall by Ellume of approximately 14,000 kits for yielding possible positive COVID results when, in reality, the person being tested was negative. The psychological implications of false positives is a topic skipped entirely in the articles/discussions of home testing.

With false positive results, there’s a need for a test user to have access to a physician, the capacity to arrange a second test to verify results and the ability to withstand the financial and psychological implications of quarantining. For those with false negatives (with zero symptoms), there remains the possibility of COVID’s presence, so reliance isn’t full proof. With symptoms and a negative result, there is again a need for a physician, a retest and quarantining too.

I recently experienced a false positive when I took an Ellume home test. I have been vaccinated; I was asymptomatic. I had worn two masks including an N-95 mask during the large wedding of my adopted son in a region of the US where the vaccination rate was 40%. Getting tested three days after arriving home seemed wise at the time.

When the Ellume home test showed I was positive, I did what was recommended by Ellume and the CDC. I immediately quarantined; I notified my doctor who suggested I take the molecular test ASAP to verify results, as she had been noticing false positives in asymptomatic, vaccinated individuals. I am over 65 too. I cancelled a planned outdoor dinner at my home; I notified close contacts including, of course, my romantic partner. Getting the PCP test and its results took a couple days. My work output was slowed down because I was so focused on my health.

I can report that I tested negative on the gold standard PCP test but in those intervening days, I was on edge and concerned. I waited for symptoms like one waits for water to boil. And I worried that every sneeze and cough and itch and stomach gurgle was a sign of COVID. I worried about my work, my close contacts, my wellness given my age.

I read about the Ellume home test recall after the just described scenario and received a recall notice from Ellume via email. That notice was so poorly worded that I had to re-read it. And I was struck by its lack of any sense of the impact of a false positive. The letter was addressed to “Customer;” it was signed “Ellume.” There was no address or email or phone number to call; there was a link to process a refund or obtain a replacement test. Yipes. And, they apologized for the “inconvenience.”

That word hardly suffices to describe what and I sure others experienced.

For those who are older, for those who need to work and for whom quarantine is costly, for those who struggle to find an available physician, for those who have trouble getting a gold standard PCP test, the recall (which Ellume labeled “urgent” ), the false positive was downright troubling; and if one had experienced loss or illness of others from COVID, the mistaken result could rightly be characterized as triggering and traumatic.

We Need Better Explanations:

We can do vastly better at explaining the tests, their results and the psychological consequences of false results. And, for the record, unlike the Ellume patient notification which, when measured in terms of readability, revealed scores on various established measuring devices that the notice was hard to read and required a 9th or 10th grade or college reading level, we need to provide information that is readable, in multiple languages and does NOT favor the elite population, which has easy access to further medical care.

I get the value of home tests. But surely, we can do better at identifying the possibility of false results and the psychological and health risks they present.

I worry that we are so focused on restoring “normal” and a post-COVID era that we are ignoring psychological wellbeing of home test takers. That is a failure we need to acknowledge and remedy ASAP.