The Covid-19 test supply chain is not yet ready for omicron

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Case surge By the highly spreadable omicron variant The U.S. Covid-19 testing capabilities have been pushed to the limit.Rapid antigen test is out of stock In many pharmacies, and String for PCR test Stretching around the blocks of American cities. As more people go on vacation and fuel new outbreaks, this problem may get worse, and at this time new testing supplies from the federal government are expected to arrive.

Covid-19 is spreading so fast that by early February, the U.S. may need to conduct 3 to 5 million tests per day, which is far more than The country is currently underway, according to Internal modeling From the Ministry of Health and Human Services.With the reduction of test supplies, some Local Officials urged the Biden administration to cite National Defense Production Act, A law during the Korean War that allowed the president to order private companies to produce certain products in an emergency.To help solve the shortage problem, the White House Said earlier on Tuesday It will ship as many as 500 million free tests directly to American households in the next few weeks.

The supply crunch for testing may seem sudden, but it has actually been brewing for several months. Limited federal investment, slow regulatory approval procedures, and continued shortages of raw materials and workers have hindered test manufacturing. With people flocking to buy fast Covid-19 tests before Christmas and New Year trips, these issues are now being staged, and the tests required far exceed what the system can provide.These tests are also expensive, with typical costs ranging from More than $10.

“These factors together create a perfect storm,” Lindsay DawsonThe deputy director of HIV policy at the Kaiser Family Foundation told Recode. “The test seems to be more difficult to conduct than it was three or four days ago.”

Test is broken

This Gold standard The PCR test used to diagnose Covid-19 involves healthcare professionals Wipe your nose The sample is then sent to the laboratory for molecular testing. It usually takes a day for the laboratory to report the results to the patient. These tests are now in high demand, and the waiting time for some test appointments may exceed several hours. In addition, many laboratories are currently flooded with samples, which delays the results for several days, making them practically useless.

The continuous delay in PCR results is an important reason for quick tests at home, such as BinaxNOW, QuickVue and Ellume, Should become the main way for many people to be tested. You can purchase these tests at the pharmacy counter or order online. The test kit includes foam swabs, chemical reagents and cards or cartridges. To perform a test, you need to wipe the inside of your nose to collect a sample, mix the sample with reagents, and insert the swab into a card or box to detect the presence of certain proteins called antigens. It only takes about 15 minutes to get the result.Although these tests are not as accurate as PCR tests, which look for genetic characteristics of the virus, they are A reasonable choice When the PCR test is not available.

There are also several companies that provide home molecular testing kits, which are as accurate as PCR testing, but they are not cheap.A company called Detect sells starter kits with a test and a reusable hub for Approximately 75 USD, The additional test is 49 dollars. Cue Health’s home molecular testing is even more expensive.Reusable reminder reader Cost $249, A pack of three tests is 225 dollars. There are also home PCR tests that use saliva, but these usually require the patient to send the sample back to the laboratory for processing, and the cost is about $100.

There are several reasons why these rapid antigen tests have suddenly become so scarce.Workplace and school Many available quick tests were purchased in bulk Earlier this year, they accelerated their reopening efforts.At the same time, the distributor is Reserve materials To take advantage of the spread of omicron. More and more people seek rapid testing before traveling during winter vacation, which further reduces supply.

But the root cause of this shortage can actually be traced back to the beginning of the pandemic, when the White House prioritized vaccine development rather than testing.The Trump administration has invested heavily in the development of new vaccines Operating warpage speed, The Biden administration’s pandemic strategy is mainly focused on distributing these vaccines across the country.

At the same time, the Food and Drug Administration Very slow to evaluate and approve over-the-counter rapid tests. These tests Was originally classified as a medical device, Which means they must meet strict requirements. According to reports, two years after the pandemic, only 14 self-administered antigen tests were authorized for emergency use. Arizona State University Database.

Among these tests, the BinaxNow rapid antigen test from Abbott Laboratories accounts for approximately 75% of US retail sales.Abbott’s test dominance attracted Some criticism After ProPublica Report Tim Stenzel, director of the FDA’s Office of Diagnostic Tests and Evaluation, previously worked at Abbott and Quidel, another company that has been approved for Covid-19 testing. Abbott and Quidel are actually the first two companies that the FDA allows large-scale production of over-the-counter tests, but last month, The agency says It will give priority to approving faster tests to help the ongoing reopening work and prepare for the upcoming holidays.

Test manufacturing has also lost momentum because Vaccination curbed the infection rate In summer.The venue began to require a vaccination certificate to enter, and the CDC announced that the vaccinated person does not need to Periodic inspection. Realizing that Covid-19 testing will no longer be a hot commodity, popular rapid test manufacturers are preparing to reduce their production scale. These companies are now scrambling to start again.

“I can tell you that we see unprecedented demand for BinaxNOW, and we are sending them as quickly as possible,” Abbott’s Director of Public Affairs for Rapid Diagnostics, John Kowal, told Recode. “Although the summer public health guidance caused the rapid testing market to plummet, we have never stopped testing.”

However, it is not easy to quickly improve the manufacturing level. Ellume is an Australian company that produces Covid-19 rapid test products. September said This demand is already 1,000 times its original forecast.The testers were not spared either Global supply chain crisis, anyone.Shortage Foam swabs, mechanical, electronic productAnd the special paper used for test cards slowed down the speed of test manufacturing.

Labor shortage is also a challenge. Orasure conducted a quick test called InteliSwab, but failed to recruit enough employees Employees at the Pennsylvania plant to meet demand. And BD, it sells one Home test called Veritor, In its warning November Annual Notice to Investors Ongoing supply chain issues, including transportation issues and component availability, could harm its entire business.

Fix is ​​coming-slow

This fall, the Biden administration introduced a more aggressive testing strategy.White house spent $3 billion in total Promote the manufacture of rapid test products.The Biden administration also Targeted insurance The company bears the cost of over-the-counter rapid testing, although the guidance may not be until January 15 and Will not apply retrospectivelyThe policy also cannot help people who do not have private insurance.The Ministry of Health and Human Services stated in October that it would spend 70 million USD Help introduce more tests to the U.S. market, focusing on tests that can be manufactured on a large scale.

The US government’s approach is in sharp contrast with foreign policies.For example, in the UK, the Covid-19 test is Free distribution, And the government Send tools to people’s homes If they cannot get the exam through school or work.Covid-19 test is free in Germany Between March and October.

Nevertheless, the White House Say The country “is expected to quadruple the supply of rapid home tests we conducted in late summer.” This seems ambitious.Australian test manufacturer Ellume only plans to start production in a new factory Manufacturing plant in Maryland this monthThe company plans to produce 70 million tests per month by the end of December, including tests ordered by the federal government. Abbott stated that it should achieve the same goal by January. iHealth Labs obtained emergency use authorization for its over-the-counter tests just last month and stated that it can produce 200 million tests per month Start next year.

But the number of people who tested positive is Grow up day by day, Which means that the number of people exposed to Covid-19 who need to be tested is also increasing. At present, it is not clear whether sufficient tests have been conducted at the right place and time to contain the spread of Covid-19 in the United States. After all, if there are enough rapid tests, people can perform regular self-tests so that new cases can be detected faster and the virus can spread more slowly.

at the same time…

Expected shortage. Walgreens and CVS told Recode that the demand for testing far exceeds the supply, and some of their pharmacies will be out of stock. You don’t have to go to a few stores in person, but you can check if the tests are available on the websites of many pharmacies, although they may not always be up-to-date. Keep in mind that you may be subject to inventory restrictions. Walgreens currently only allows customers to purchase four Covid-19 test products at once.In any case, if you need to test at home, you should Buy The first one you see.

There are also social media accounts and local news sites that track test availability in different communities, and people may share information on community Facebook groups and Nextdoor pages.You should also pay attention to the buying guide, like this One from “Wired”, With updated links to online sales test locations.When looking for supplies, watch out for crooks Impersonating a government agency and Require prepayment of test fees.

Even if you are eager to purchase a rapid test, you can still perform PCR testing at your local pharmacy, urgent care clinic, or mobile testing center. Some of these facilities may also provide rapid testing, so you should ask if PCR and rapid testing are performed at the same time when you go.

In the next few weeks, there will be more free testing options. The Biden government has distributed many of the rapid tests it purchased to community centers and clinics, which may distribute the tests for free. The White House plans to create a new website that people can use to request free home testing from the federal government. Local governments may also conduct tests.

However, the test may not be found.If you think you have Covid-19, you should isolate and check if necessary treat May be available. But it may not be certain.Unfortunately, this means that now is a good time to adapt Pandemic uncertainty.

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