Testing

Testing

CRISPR-Based Tests

Developing rapid and accurate tests with the gene editing technology CRISPR

Tests based on new technologies, such as the Nobel prize-winning gene editing technology CRISPR, are expected to be the next generation of rapid, affordable diagnostic testing. The first commercially available paper-strip CRISPR-based test, “Feluda”, was approved in India in October 2020. Developed by local scientists at New Delhi’s Council of Scientific and Industrial Research’s constituent lab and manufactured by Tata Sons, the Feluda test costs less than $10 and provides results in less than an hour; an analysis of 2,000 patient samples demonstrated 96% sensitivity and 98% specificity. 

In the United States, the FDA granted its first-ever CRISPR-related emergency use authorization (EUA) for a CRISPR-based diagnostic test known as “Sherlock”. The Sherlock diagnostic technology (Specific High-sensitivity Enzymatic Reporter unLOCKing) was developed by MIT and Harvard researchers and manufactured by Sherlock Biosciences. While the EUA was limited to high-complexity laboratory processing, development is underway for a simplified paper-based version of the Sherlock diagnostic test. The group has created the site STOPCovid.science to advocate for further development of rapid at-home or point-of-care diagnostic testing.

Potential Contacts: Tata Sons; Sherlock Biosciences 

Related Ideas: Rapid Antigen Tests

Rapid Antigen Tests

Inexpensive, rapid antigen tests have the potential to be mass-produced and widely available for daily population testing

A growing number of experts are calling for a new testing strategy: mass-production of rapid antigen tests. Antigen tests are faster and cheaper than PCR-based alternatives, some costing between $1-5 and providing results in less than 20 minutes. While antigen tests have received pushback for their relatively lower sensitivity, advocates emphasize the ability of these tests to identify cases during peak periods of infectiousness. Rapid identification and targeted isolation of the most infectious cases could thereby help to reduce community transmission.

Rapid antigen testing has been regularly employed in India, where it accounts for 30% of testing and has helped to significantly improve testing capacity. The Indian Council of Medical Research (ICMR) has approved three different types of antigen tests (MyLab Discovery Solutions, SD Biosensor, Vishat Diagnostics) for use in India, all of which must be administered by trained medical professionals. Due to low sensitivity, the ICMR recommends a combined testing approach, by having negative antigen test results confirmed by a PCR test. 

In Uganda, Dr. Misaki Wayengera and his team at Makerere University are developing the STDS-Agx (swab tube dipstick antigen agglutination) COVID-19 test kit, which provides results within one to two minutes. They aim to have the product validated and available by the end of September.

In the United States, the FDA has approved four different antigen tests (Quidel, BD, LumiraDX, Abbott) for emergency use authorization as of September 2020; these tests are all required to be administered by a trained medical professional, and three involve costly specialized equipment to analyze results. Such equipment can be found in doctors’ offices and nursing homes.  The federal government announced an initiative to distribute 150 million of Abbott’s BinaxNOW rapid antigen test kits to schools and vulnerable populations.

An all-volunteer group created the site RapidTests.org to advocate for widely available, inexpensive paper-strip rapid antigen tests to be self-administered at home. This effort, led by epidemiologist Dr. Michael Mina, argues that the convenience and low cost of such paper-strip tests would allow for frequent, even daily, testing of large populations, and making it possible to immediately identify cases that are infectious. Several US-based companies, such as 3M and E25Bio, have been developing these types of rapid antigen tests. However, the FDA has not yet approved these types of tests, citing concerns for the sensitivity of paper-strip tests.

While the WHO initially released guidance in April advising against the clinical use of rapid antigen tests, they later published updated interim guidance providing general recommendations for the use of rapid antigen tests with expected performance parameters (≥ 80% sensitivity, ≥ 97-100% specificity). In late September, a global partnership involving the WHO, Global Fund, and organizations such as the Bill and Melinda Gates Foundation announced plans to manufacture and distribute 120 million affordable rapid antigen tests for low- and middle-income countries.

Potential Contacts:

Organizations:  MyLab Discovery Solutions; SD Biosensor; Vishat Diagnostics; Quidel; BD; LumiraDX; Abott; 3M; E25Bio

Individuals: Dr. Misaki Wayengera, Makerere University; Dr. Michael Mina, Harvard School of Public Health

Related Ideas: City-wide Testing; Pop-Up Mobile Testing Sites

America Needs to Radically Rethink Our COVID-19 Testing Approach, Time, July 29, 2020 

Rapid, $1 COVID-19 Tests Exist. Why Can’t We Get Them?, Vox, August 27, 2020 

‘Breakthrough’ COVID-19 Tests Are Currently Cheap, Fast—and Not Very Accurate, Scientific American, May 7, 2020

Rapid Screening Tests That Prioritize Speed Over Accuracy Could be Key to Ending the Coronavirus Pandemic, The Conversation, August 14, 2020 

Rapid Antigen Test Now 30% of India’s Testing Load, The Hindu, August 4, 2020

List of Companies/Vendors of Rapid Antigen Test Kits for COVID-19 Validated/Being Validated By ICMR, Indian Council of Medical Research, August 14, 2020 

Centre Tells States: Do RT-PCR to Catch False Negatives After Rapid Antigen Test, The Indian Express, September 11, 2020 

Ugandan Scientists Develop Quick, Low-Cost COVID-19 Test Kits, Cornell Alliance for Science, April 13, 2020

Individual EUAs For Antigen Diagnostic Tests For SARS-CoV-2, U.S. Food and Drug Administration 

Trump Administration Announces Initiative For More and Faster COVID-19 Testing in Nursing Homes, U.S. Department of Health and Human Services, July 14, 2020 

Trump Announces Plan to Ship 150 Million Rapid Coronavirus Tests, The New York Times, September 28, 2020

The Plan That Could Give Us Our Lives Back, The Atlantic, August 14, 2020 

Press Conference With Michael Mina, Harvard T.H. Chan School of Public Health, June 1, 2020 [Podcast with in-depth explanations of the science and status of rapid antigen tests] 

Failing the Coronavirus-Testing Test, Harvard Magazine, August 3, 2020

The Push to Deploy At-Home Antigen Tests for COVID-19, The Scientist, August 17, 2020

MIT Team Collaborates with 3M to Develop Rapid COVID-19 Test, MIT News, July 14, 2020 

Cambridge Biotech Seeks OK For Coronavirus Test That Delivers Results in 15 Minutes, Boston Globe, March 31, 2020 

Fast Coronavirus Tests: What They Can and Can’t Do, Nature News, September 16, 2020

Advice on the Use of Point-Of-Care Immunodiagnostic Tests For COVID-19, World Health Organization, April 8, 2020 

Antigen-Detection in the Diagnosis of SARS-CoV-2 Infection Using Rapid Immunoassays, World Health Organization, September 11, 2020 

Global Partnership to Make Available 120 Million Affordable, Quality COVID-19 Rapid Tests For Low- and Middle-Income Countries, World Health Organization, September 28, 2020

Additional Sources:

Your Coronavirus Test is Positive. Maybe It Shouldn’t Be, The New York Times, August 29, 2020 

A Next-Generation Coronavirus Test Raises Hopes and Concerns, WBUR News, April 30, 2020 

A Cheap, Simple Way to Control the Coronavirus, The New York Times, July 3, 2020 

‘It’s Kitchen Sink Time’: Fast, Less-Accurate Coronavirus Tests May Be Good Enough, The New York Times, August 6, 2020

Coronavirus Antigen Tests: Quick and Cheap, But Too Often Wrong?, Science Magazine, May 22, 2020

Beat COVID Without a Vaccine, The Wall Street Journal, October 1, 2020

Drive-Through Testing

Testing people while seated in their cars is safer, faster, and cheaper than testing them inside medical facilities

Testing people in drive-through centers, with people seated in their cars, is safer, faster, and cheaper than testing them in hospitals. Cars may be disinfected on the way out. Results can be sent to patients by text message or email.

The drive-through method began in South Korea in February; this Korean journal article details the original concept and design. This video from WION shows the system in use around the world. The idea has spread to several countries, including Rwanda and the United States, where a searchable national list of all such testing sites is updated regularly. 

Potential Contacts: Rwanda Biomedical Center

Related Ideas: Testing Booths; Pop-Up Mobile Testing Sites

Testing Booths

Pressurized plastic or glass booths can make Covid-19 testing safer, cheaper, and faster.

For congested areas where drive-through testing is infeasible, Yangji hospital in South Korea developed pressurized, clear-plastic testing booths with rubber gloves inserted through walls that let staff take nasal samples without any contact with patients. This practice makes testing safer, faster, and cheaper, and sharply reduces use of scarce PPE. This journal article details the design and implementation of the original Korean testing booths.

Inspired by the Korean design, Boston-based Massachusetts General Hospital and Healthcare Innovation Partners LLC collaborated to develop their own testing booths, and are working with manufacturers for commercial distribution. A similar booth was launched at the Gleneagles Hospital in Singapore, developed by the Singaporean company Esco Aster.

Potential Contacts:

Organizations: Yangji Hospital; MGH Springboard Studio; Healthcare Innovation Partners LLC; Gleneagles Hospital; Esco Aster

Individuals: Dr. Kristian Olson and Dr. Paul Currier (Mass General Hospital), Sam Foster (Healthcare Innovation Partners, Booth Manufacturer)

Related Ideas: Drive-Through Testing; Pop-Up Mobile Testing Sites

Pop-Up Mobile Testing Sites

Rapid development of mobile testing laboratories to expand testing capacity

To quickly augment COVID-19 testing in a district of Beijing, a temporary mobile testing lab was built using an air-inflated structure placed within a sports venue to address the city’s growing demand for nucleic acid tests. Developed in collaboration by BGI Genomics and Etopia, the inflatable laboratories are designed with innovative ventilation systems to ensure a clean environment. Separate module components reduce assembly costs and improve mobility.  The lab accommodates 14 automated testing machines and is capable of running 10,000 tests per day.

Potential Contacts: BGI Genomics; Etopia

Related Ideas: Leveraging Speed; Tech-Based Social Distancing; Drive-Through Testing; Testing Booths; City-wide Testing; Rapid Hospital Construction

Drones for Remote Testing

Drones can be used to transport samples between urban centers and rural clinics to speed up testing

Since mid-April, over 1,000 health facilities in Ghana have used drones to transport coronavirus test samples to the national laboratories in Accra and Kumasi. The drones, supplied by US-based startup Zipline, can fly about 100 miles on each trip at 60 mph. As a result, rural clinics in Ghana shave hours, even days, off their wait time for test results. Deliveries have also expanded beyond testing to include PPE, blood products, vaccines, etc. Zipline has partnered with Rwanda since 2016 to deliver blood products and chemotherapy agents to rural clinics, but Ghana appears to be the first country to harness this technology for COVID-19 testing. In the US, three drone companies, including Zipline, are expanding their drone delivery programs to include testing in North Carolina – one of the first states to utilize drones in this capacity.

Potential Contacts: Zipline

City-Wide Testing

City-wide testing using high-throughput testing, organization, and compliance, can provide a complete picture of COVID-19 infections in a specific location.

In large cities worldwide, expanded testing capacity has presented the opportunity to test entire populations. Wuhan, China is the preeminent example. Following a months-long lockdown, Wuhan’s 11 million people were required to be tested for COVID-19. The campaign, which launched on May 14, succeeded in its goal and found 300 asymptomatic carriers. Daily testing capacity was increased from 300,000 to 1 million, partly through the use of batch testing, where samples from multiple people are pooled. Those who refused testing risked their government-issued health QR codes being downgraded from green to yellow or red, which would limit their access to shops, work, and transit. A similar initiative was launched in Mudanjiang in China’s Heilongjiang province.

In September, Hong Kong launched a week-long free universal testing initiative, aiming to test at least 5 million of its 7.5 million residents. However, the initiative was highly criticized and disrupted by political tensions, as pro-democracy activists encouraged the public to boycott the testing program, citing concerns of Chinese influence and inaccurate testing methods.

Related Ideas: Batch/Pooled Testing; Individual QR Codes

Batch/Pooled Testing

Pooling test samples can conserve diagnostic testing kits and speed up testing

In an effort to test 11 million citizens, officials in Wuhan, China, rolled out a plan that would allow laboratories to conserve on testing supplies. By pooling together samples and testing in batches, scientists conserved valuable diagnostic tests and successfully tested nearly 10 million people in 19 days. Typically, each batch pooled samples from five people.

Batch testing, originally used during World War II to test soldiers for syphilis, allows scientists to use fewer tests on more people. For example, 100 swabs are divided into 5 groups of 20 swabs. If only one batch of 20 swabs comes back positive, then that group of people can be retested, reducing the number of tests from 100 to 25. Batch testing works best in populations with a low prevalence of COVID-19, typically when 10% or less expected to be infected. This may be an effective method for long-term surveillance but not in the context of a flare-up.

Scientists in Germany, Israel, and the U.S. are pursuing strategies to expand batch testing. German researchers, spearheaded by the Institute of Medical Virology at Goethe University in Frankfurt, have developed a procedure to dramatically increase testing capabilities. In Rwanda, researchers have created a mathematical algorithm to refine the process of pooled testing to determine optimal batch size; they are working to develop the model into a software that can be used by other laboratories.

By July 2020, the U.S. was looking to roll out pooled testing. Memphis was the first U.S. city to include pooled testing in its response strategy, with the local government advised by Dr. Manjoj Jain, an Adjunct Professor of Epidemiology at Emory University (see contact info below).

Potential Contacts: Dr. Manoj Jain (Adjunct Professor of Epidemiology, Emory University); Sandra Ciesek (Institute of Medical Virology)

Related Ideas: City-wide Testing