The United States faced an acute shortage of reliable Covid-19 tests when the Pandemic hit. It was the nation's first major Pandemic failure, blinding health experts and the public to the spread of the coronaviruses and allowing the pathogen to spread across the country. For most of 2020 it required waiting hours just to be tested and then wait a week or more for results.
Hundreds of millions of rapid, at- home tests are pouring into the American market every month. The federal government is giving out free tests, Americans are trading tips on social media, and children are spitting into collection tubes at school.
Treatments and cures are usually the most important developments in medicine, but the Pandemic has shown the importance of diagnostics. Knowing early, knowing fast and doing something about it is the first line of defense against disease.
Over the last two years, a group of researchers at Emory and other Atlanta institutions has played a key role in getting Covid tests into the hands of Americans.
We were able to answer the question, "Do these tests work?" by looking at their eyes and hands.
Over 200 colleagues, including physicians, engineers, biochemists and more, have worked late nights and early mornings to speed up the development of new tests and ensure that existing products can detect Omicron.
The Atlanta team has been absolutely heroic, said Bruce Tromberg, director of the N.I.H.
The work that the Atlanta team has done shows how much research is needed to get a test right. The model provided by the team's work could help us be better prepared for future Pandemics and could lead to a new era of at- home diagnosis.
Dr. Tromberg said that the new mechanism for moving many of the technologies from the blackboard to the bedside is a result of the Pandemic.
On a rainy February morning, Shelton sat in his mother's car in a church parking lot in Atlanta, feeling congested and achy. He was at the drive-through testing site for a standard P.C.R. test when a researcher asked if he would like to help evaluate a new Covid test.
He was eager to help. He sat in the passenger seat with a bunch of stuff on his lap. He carefully swirled the swab in each nostril after reading the instructions.
He told the researcher that the instructions had been easy to follow and that his results were negative in 15 minutes.
The study would help the F.D.A. decide whether to approve the product, which was already available abroad.
The goal is to bring those tests into the American market.
Dr. Lam has a youthful energy that fills every room he enters and he wears black-frame glasses. When his son had terrible ear infections, he and a colleague invented a device that allowed parents to take pictures of their children's eardrums and doctors to diagnose them remotely.
Oliver Brand, an engineer at Georgia Tech, and Dr. Greg Martin, a pulmonologist and critical care doctor, collaborated with Dr. Lam to establish a diagnostic research center. The mission of the Atlanta Center for Microsystems was to help companies, scientists and inventors develop high-tech diagnostic devices that could be used outside the laboratory.
The N.I.H.-funded center was open barely a year when Covid arrived.
The N.I.H. worked closely with the Atlanta researchers. The Atlanta center was enlisted by the agency to play a key role in the new N.I.H. initiative, which was created in the spring of 2020.
Dr. Tromberg said that the applications poured in by the hundreds.
The Atlanta team was asked to answer the question.
On a recent afternoon, Leda Bassit and Anuradha Rao demonstrated the process in a quiet second-floor laboratory, where an assortment of at- home test strips and cartridges was arrayed on a bench. In the early days of the Pandemic, the women spent a lot of time in the Biosafety Level 3 laboratory, growing live coronaviruses and using it to test the tests.
Over the last two years, the team amassed tens of thousands of patient samples in the basement freezer farm, a small, windowless room that holds rows of frost-encrusted appliances and was named for characters from the movie.
The scientists often make highly concentrated viral slurries from patient samples pulled, in a blast of frigid air.
To assess the sensitivity of a single product, they test it with viral samples at a range of concentrations, using the same components that consumers would receive and following the same instructions.
Dr. Bassit used a small blue test tube to get a bit of concentrated viral solution out of a small pipette and onto a nasal swab. She put a thin test strip on the tube and twirled the swab in it. Within minutes, two pink lines appeared across the strip.
The scientists took pictures and recorded results 75 or 80 times per product. The most sensitive tests turned positive even when the virus was not very strong.
Products that performed well in the lab were evaluated at local Covid testing sites where people could volunteer to provide extra samples.
Julie Sullivan, chief operating officer for the Atlanta RADx, said that some saliva tests missed a lot of real-world infections.
Sarah Farmer, managing director of Georgia Tech, said that researchers assessed the user-friendliness of each product.
The data played a big part in the development of the test-tube stand, after researchers noticed that users could not set the liquid-filled, round-bottomed tube down on a table. He said that the company hopes to use what it learns to design other consumer-friendly tests.
To find tests that could be scaled up quickly, the researchers rated the technology readiness of each test. They were not mature enough to succeed on this measure.
They looked for manufacturing problems by taking each test apart. Some products were too complex to be produced by the millions, while others were too slapdash.
Companies adjusted their products in response to the scientists. The feedback the Atlanta team gave the companies allowed them to change their platforms and make them really successful.
The first over-the-counter Covid test made by the Australian company Ellume was authorized by the F.D.A. by late 2020.
We thought we were done. We had to restart after the Alpha variant took off.
Small pieces of the virus are looked for in covid tests. Antigen tests usually contain antibodies that bind to the virus's surface.
The shape of the proteins can be changed by the virus, making it harder for the antibodies to bind and generate false negatives. In January of 2021, the Atlanta researchers began working with the N.I.H. and F.D.A. to test dozens of authorized products against new variant.
The tests appear to be performing better in the real world than they did in the lab, despite initial concerns about their sensitivity.
The scientists are prepared to repeat the process if there is a new variant.
When the Biden administration announced plans to make at- home tests more accessible, the researchers helped to speed up F.D.A. authorization of products that can be produced in volume.
Dr. Michael Mina is the chief science officer for e Med, which sells at- home tests. The onus is usually on test developers to collect their own data and navigate the regulatory process.
He said that the federal government and scientists in Atlanta have created a better model for vetting products and getting them into consumers.
Thirty-nine manufacturers have received 40 F.D.A. authorizations for Covid tests, including seven over-the-counter products, which have been evaluated by the Atlanta team.
The category of at- home diagnostics has been accelerated by the RADx program.
The Atlanta scientists tackled some basic research questions, such as whether children can reliably swab themselves and whether people should use their throats instead of their noses.
Some of the team's biochemists are predicting the future. The method for programming human cells was developed by them. Each cell has a different version of the same antigen on its surface.
Researchers can add one of the antibodies used in commercial tests to this collection of cells with a fluorescent marker. The cells that give off the weakest fluorescent signals have not bound tightly to the antibody, which means that they have a different type of virus.
"We can do binding experiments on all variants at the same time," said Eric Ortlund, a researcher at the Emory University School of Medicine.
The approach the team hopes to apply to other viruses, including influenza, could also help companies design more robust tests from the beginning, selecting antibodies that are less likely to be rendered useless by a few small mutations.
Some test manufacturers have received funding to add flu detection to their tests.
Some of the technologies that didn't make it to market, such as breath-based diagnostics, received feedback and investment that could speed their development.
Think about all the things NASA did to get to the moon.
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