When you think about getting tested for COVID-19, you’re most likely picturing two types of tests: the at-home rapid antigen tests you can buy at the drugstore and the PCR test where the results are processed by a lab. What you’re probably less familiar with are at-home molecular tests that you can buy online.
In a nutshell, these at-home molecular tests combine the accuracy of PCR tests with the convenience of antigen tests. It’s a potent combination, as it reduces the chances of a self-test delivering a false negative result. That, in turn, can help people plan with a greater degree of certainty. It’s a big reason why companies like Google provide these tests to their workers as part of return to office plans. Currently, the FDA has authorized three OTC at-home molecular tests: Cue Health, Detect, and Lucira Health. However, when I polled friends, family, and co-workers, none were aware that this was an option — and some weren’t sure about the difference between molecular and antigen tests to begin with. If these tests are so convenient and accurate, why isn’t everyone using them? How come more people haven’t heard about them?
Hint: they’re expensive. The Cue Health tests that Google gives its workers require you to buy a separate hub. That device, plus a three-pack of tests, costs $444. That number doesn’t even include extra fees to verify your results for travel. And yet, Cue, Detect, and Lucira all claim their tests are accessible for the average person. We tried all three to find out how well these tests worked, what their limitations are, and what scenarios these pricey tests might be worth shelling out for.
What are the different types of COVID-19 tests?
There are two types of COVID-19 tests: antigen tests and molecular tests.
Antigen tests are probably the ones you’re most familiar with. They look for proteins on the surface of the virus and can deliver results in as little as 15 minutes. While you can get an antigen test from a healthcare provider, you can also buy an at-home kit from your local pharmacy. Some familiar brands include the Abbott BinaxNOW COVID-19 Antigen Self Test, iHealth COVID-19 Antigen Rapid Test, and QuickVue At-Home OTC COVID-19 Test. These tests are affordable and convenient but aren’t as accurate as a molecular test. That’s because if you’re early on in an infection, you may get a false negative as you don’t have enough of the virus in your system yet.
Molecular tests use a different method to detect a virus. Instead of looking for proteins, they search for snippets of the virus’s genetic material and make copies of those snippets until there are enough for a test to detect. They’re also known as nucleic acid amplification tests (NAATs). They can catch much lower levels of a virus than antigen tests. That also means they can sometimes tell if you’re infected before there’s enough virus in your nose to get picked up by an antigen test.
PCR tests, which are considered the gold standard, fall under this category. So do the OTC molecular tests made by Cue, Detect, and Lucira. However, it’s important to note that these at-home tests are not the same as PCR tests. That’s because they use different amplification methods.
To amplify bits of virus, PCR tests need specialized lab equipment that cycles through higher and lower temperatures. This process can take several hours and currently requires trained technicians. That’s why you can’t always get your PCR results on the same day.
But Cue, Detect, and Lucira’s tests use a process that can amplify genetic material at one steady temperature — which can be done via a small machine that you can store in your home.
Essentially, OTC at-home molecular tests matter because they can deliver results that are as accurate as a lab-run test sooner and faster — without needing to actually send a swab to a lab. The Lucira test, for example, delivers results in 30 minutes or less. Cue’s test delivers results in about 20 minutes. The Detect test takes about an hour.
Say you’ve received notice that you’ve recently been exposed to COVID-19 but aren’t showing symptoms yet. Compared to an at-home antigen test, an OTC molecular test could more reliably tell you whether you’ve been infected. That higher degree of accuracy also reduces the need for confirmation testing to rule out false negatives and could potentially save you time and money as a result. The potential benefits are multifold — the main issue is accessibility.
Are these tests easy to use? How much do they cost?
Cue, Detect, and Lucira’s tests are all easy to use. If you can take an antigen test, you shouldn’t have any problems taking one of these at-home molecular tests. Like antigen tests, the general process requires you to take a nasal swab and stir it in a sample vial. The difference is that, once you’ve collected your sample, you place it in a little machine that handles the amplification process.
Of the three, Lucira’s test is the most straightforward. It’s also the only one that doesn’t require you to download an app to use it. After you’ve collected your sample and placed the vial in the machine, you can leave it to do its thing for a half hour. However, Lucira’s tests are single-use and cost $75 per test. The machine component itself isn’t reusable — you toss that into the trash once you’re done. Also, you can’t store your testing history in an app like the other two tests. Instead, you take a photo of your test unit alongside a QR code with your kit’s serial number. For “verified” results, there’s a separate QR code for using the LUCI test reporting portal. All that does is create a record of your test results that can then be presented at events, conferences, school, etc.
Whether it’s accepted is another story.
OTC molecular COVID-19 tests
Device | Price | Number of tests per pack | How long per test? | Reusable hub? |
---|---|---|---|---|
Device | Price | Number of tests per pack | How long per test? | Reusable hub? |
Cue | $249 for Cue Reader, $65 per test; starter bundle (1 reader and 3 tests) for $444; subscriptions also available for $39.99 and $74.99 | 3–10 | 20min | Yes |
Detect | $39 for hub, $49 per test; starter bundle (1 hub and 1 test) for $85 | 1 | 75min | Yes |
Lucira | $75 | 1 | 30min | No |
Unlike Lucira, Cue and Detect have opted to create reusable machines that are sold separately from the actual tests. That’s certainly more eco-friendly, but it also means you’re investing more into a product ecosystem upfront. The Detect Hub costs $39, while a test costs $49. There’s also a starter kit bundle that includes the hub and one test for $85. Meanwhile, the Cue Reader retails for $249, and an individual test costs $65. You can also opt for a Cue Plus membership, which gets you a discount on the Cue Reader and tests as well as an allotment of tests per year. There are two levels: Cue Plus Essential, which costs $39.99 monthly for 10 tests, and the Cue Plus Complete, which is $74.99 for 20 tests.
Detect might be the most affordable of the three tests, but its process is the lengthiest and takes about 75 minutes from start to finish. It’s not hard. It feels like conducting a science experiment in your living room. The entire process is painless since the Detect app gives you a video walkthrough and automatically sets timers so you don’t forget to check results. That said, it is the most complicated of the three options. For instance, one step requires you to check if a reagent bead dissolves, while a few others have you forcefully flick vials to make sure the liquid inside adequately sinks to the bottom before you insert the sample into the hub. Unlike Lucira and Cue’s tests, you still have to decipher lines to see if you’re positive or negative. However, it’s easier to interpret since the app walks you through that process as well.
Cue’s process splits the difference between Lucira and Detect. It requires you to create a Cue account, pair the Reader over Bluetooth to your phone, and possibly update the Reader’s firmware before you can get started. But, once you’ve collected your sample, all you have to do is follow along with the on-screen prompts. It basically entails sticking the test cartridge in the reader, taking a nasal swab, and waiting for the results to appear on your phone.
How accessible are these tests?
Long story short, anyone can buy these tests. You don’t have to work for a big organization to get your hands on one. Cue, Detect, and Lucira all have easy to navigate websites where you can order the tests and have them shipped to your home. (Lucira’s tests are also available on Amazon.) However, the sticker shock for a single test is jarring when you compare them to rapid antigen self-tests, which usually retail for around $15 to $25 for a pack of two. Sometimes, you can even find at-home antigen tests for as little as $10. The US government is also sending households up to eight rapid tests for free.
At first glance, it seems like these at-home molecular tests are meant to be exclusive tools for the wealthy. But, when I questioned Cue, Detect, and Lucira about their pricing, each company’s spokesperson emphasized that accessibility was the main point of their tests.
Lucira co-founder Debkishore Mitra tells The Verge that its test was purposefully made to be one-time use only. According to Mitra, these tests were designed so that people without reliable internet or smartphones could open a box and get an accurate test. The idea was to also ensure that people wouldn’t need to buy a separate piece of equipment — everything would be contained in a single box. Cue and Detect, however, require that you at least have a smartphone running iOS or Android as well as separately purchase a hub. Mitra also noted that the price of rapid antigen tests may not be the most accurate comparison.
“On average, a PCR test costs $130,” says Mitra, defending the price of a Lucira kit. “So from that perspective, to be within the PCR molecular accuracy range, we consider ourselves to be fairly accessible.”
Detect co-founder and chief strategy officer Owen Kaye-Kauderer defends the higher cost as part of a larger toolkit for at-home COVID testing. “Antigen tests definitely have their time and place. If you’re testing every day, most families can’t afford to test with molecular tests every single day,” says Kaye-Kauderer. “I would think of molecular tests as a valuable tool in an arsenal.”
Kaye-Kauderer went on to explain that, in some situations, the cost may even out. Because antigen tests are more susceptible to false negatives, you may have to take multiple tests or even a PCR test to confirm a negative result. For example, if you have symptoms and test negative on an antigen test, the CDC recommends following it up with a molecular test or “serial antigen testing that is performed every 2-3 days while symptomatic.” In this scenario, even though antigen tests are more affordable overall, Kaye-Kauderer argues one $49 Detect test with a higher accuracy rate would mean you wouldn’t need to take multiple antigen tests over several days to confirm that negative result. He thinks most people would be best served by a mix of rapid antigen and at-home molecular tests.
Each company’s representatives told me it’s possible to get partially or fully reimbursed for at-home molecular tests. However, they weren’t able to name specific plans, providers, or policies that would definitively cover these tests. That, they said, is a side effect of the byzantine US healthcare system. Essentially, everyone has to call up their own healthcare provider and find out for themselves. Maybe you’ll get covered — maybe you won’t.
I tried to figure out whether my insurance provider, Cigna, would cover an at-home molecular test. There wasn’t a clear answer. Cigna’s COVID-19 billing guidance says that through July 14th, up to eight diagnostic OTC and at-home COVID tests are covered every month. However, another Cigna policy page specifies that molecular tests are covered if they’re billed by an accredited healthcare provider or lab. Cigna also says that it does not cover OTC tests for non-diagnostic purposes, like employment or travel. So, if I buy an at-home molecular test online to have on hand for a variety of scenarios, will it be covered? I won’t know until I actually file a claim.
Whether you consider these tests accessibly priced will depend on how you plan to use them. If you want to rely on antigen tests 90 percent of the time and keep one $75 Lucira test for certain situations — many people could afford that. Depending on how often you need to test, Detect and Cue’s pricier systems may also start to make financial sense. That said, it’d be hard to rely on at-home molecular tests alone unless you’re lucky enough that someone else — say, your employer — foots the bill.
Can these tests be used for travel or events?
Sometimes.
The good news is these at-home molecular tests can be used as proof of a negative result for school, events, and travel. The bad news is there’s no standard policy. Some places will accept them, but some won’t. You’ll have to check ahead of time.
For international travel, some countries’ health regulatory agencies may not accept at-home molecular tests as proof. You’ll also have to check with each individual airline you’re taking. For example, I’ll be flying to South Korea later this year, and, as of this writing, at-home molecular tests aren’t an option. While these at-home molecular tests are considered acceptable by the CDC, FDA, and several other countries for travel, the Korean embassy explicitly states that “all forms of self-administered tests are not valid regardless of test type.”
Even if the tests are accepted, using them for travel will cost you even more. To use at-home molecular tests for travel, CDC requirements say that the test must be administered with a telehealth service that provides real-time supervision “through an audio or video connection.” That telehealth provider must then provide a report confirming your identity, the test result, when your test specimen was collected, the name of the entity issuing your result, and the type of test. Cue, Detect, and Lucira all offer this service for an extra price. For Cue, you must be a Cue Plus Complete subscriber. Meanwhile, Detect offers a $20 add-on service. Lucira offers its free Luci Pass service for verified results for personal use, but you can need $20 video observations via Azova for travel.
As for events, this will depend on an individual event space or building’s policies. While working on this article, I had to attend an event at a building where proof of a negative PCR test was required for entry. Even though I explained to my contact that at-home molecular tests offer similar accuracy to PCR tests, I was still told none of these tests would be accepted. It didn’t matter that I could provide verified results. It was a PCR test or bust.
When should you opt for an OTC molecular test?
There are some specific scenarios where an OTC molecular test is preferable to antigen tests or even traditional PCRs.
Despite the lack of standardized COVID-19 travel protocols, these tests can potentially save frequent travelers time and money — so long as they do their due diligence ahead of time. This is especially true if you’re making the same trips over and over for business. Not only are the tests portable but also telehealth proctoring sessions can be scheduled last minute without you having to scramble to get to an in-person PCR testing location. If you travel abroad, it also eliminates the need to figure out where you’re going to get tested in a foreign country.
They’re also a good option in the enterprise space. It’s no surprise that Cue, Detect, and Lucira each told me they count businesses and hospitals among their clientele. Cue spokesperson Shannon Olivas told The Verge that the company has delivered 6 million tests and 30,000 readers to 20 states through a contract with the Department of Defense. That translates to over 2,000 schools, 17 state public health departments, and 50 correctional facilities. Cue also counts Google, the MLB, Johns Hopkins, the NBA, and Mayo Clinic among its enterprise customers.
Meanwhile, Lucira’s Mitra says the company counts Air Canada among its clients for employee testing. It also serves government agencies and healthcare systems, including the National Oceanic and Atmospheric Administration, Sutter Health, and Cleveland Clinic.
But these tests could also benefit average consumers when you need to be certain above all else. For example, if you’re visiting a high-risk family member for the holidays. In this instance, a false negative on an antigen test carries higher stakes. It’s very possible that you may get a negative result on an antigen test because you have a low viral load early on during an infection. A molecular test’s higher sensitivity can provide extra peace of mind.
There’s another scenario when early detection via at-home molecular tests would be preferable: it could help more people qualify for time-specific treatments.
While clinical trials show COVID-19 antiviral Paxlovid can reduce hospitalization and death from COVID by 89 percent, it must be taken within five days of symptom onset. As a result, the potentially life-saving antiviral is underutilized. In this instance, having an at-home molecular test on hand could be useful for immunocompromised individuals who would most benefit from Paxlovid. That was the idea behind a recent partnership between Detect and healthcare provider Carbon Health. Now, people using Detect’s system can easily access antivirals like Paxlovid through its app the same day they test positive.
What is the future of these tests? Will they be more affordable?
Cue, Detect, and Lucira all told me they have plans for these at-home tests beyond COVID-19. Detect and Lucira both told The Verge they’re setting their sights on a combined COVID-19 and flu test. Meanwhile, all three identified other illnesses, such as strep throat or sexually transmitted infections, as other potential future tests.
“We’re already in the middle of development of a whole suite of new products in the infectious disease space,” says Eric Kauderer-Abrams, Detect co-founder and chief technology officer. He also emphasized that the tests would all work with a new lower-cost hub.
“We are the lowest cost at-home molecular test on the market. I think within the next couple of months, we’ll be in a position to make that cost gap between where we are and the antigen test smaller,” says Kauderer-Abrams. However, he concedes that gap is unlikely to completely disappear with this current generation. That’ll be more likely with Detect’s second-generation product.
Lucira’s Mitra also notes that the company is making efforts to scale up and reduce costs. Meanwhile, Cue Health’s Olivas told The Verge that the company permanently reduced the price of its monthly memberships and tests by $10 to help more people afford Cue’s platform.
Of course, a future where everyone could afford these tests would be ideal. But that’s not where we’re at. Even so, it’s impossible to issue a blanket statement about whether these tests are worth the extra money. That depends on your individual circumstances, how frequently you need to test, and how much you prioritize accuracy. It’s an unsatisfying answer, but it’s also the truth.
Photography by Victoria Song / The Verge
Source: https://www.theverge.com/2022/6/3/23141813/molecular-covid-19-test-otc-pcr-fda