February 9, 2021

Biotech company Tonix Pharmaceuticals has received guidance from the FDA allowing it to develop a skin test for Covid-19 that can detect whether someone has previously been infected and also whether the person currently has T Cell immunity. T Cells are one of the most important defences against infections, and are often more long-lasting that antibodies.

The test, known as TNX-2100, uses molecules called synthetic peptides applied to the forearm to determine. After 48 hours, the skin response will indicate both a past infection and the state of T cell immunity. It should even be able to determine whether the immunity is due to a vaccine or to a past infection.

Other tests for past Covid infections look for antibodies. But antibodies can fade over a relatively short time frame, whereas T Cells can be very long-lived. So a T Cell test such as TNX-2100 should more accurately show a person's Covid-19 history. It could also be used to determine if a booster shot of vaccine is needed.

Tonix, based in Chatham, New Jersey, received guidance from the FDA that it believes will allow it to complete development of the skin test in a way likely to win eventual FDA approval.

Tonix is also developing a Covid-19 vaccine that can create T cell immunity lasting years, perhaps even decades.

December 22, 2020

For the first time, people will be able to buy a Covid-19 test at a nearby store without a prescription, administer the test at home, and quickly see the result. The U.S. FDA recently approved the test, which is made by Ellume, an Australian diagnostics company.

Other home Covid tests have been approved, but they require either a prescription or people to send the test samples to a remote lab and wait days before receiving the results.

The Ellume Covid-19 Home Test can be used on children as young as two, as well as adults. It uses a nasal swab, but does not require the swab be inserted deep in the nasal cavity. The user mixes the swab with some liquid solution, and the results appear about 15 minutes later.

The test is a so-called antigen test, which looks for proteins that are part of SARS-CoV-2, the virus that causes Covid-19, rather than looking for genetic material, as many other tests do. Ellume conducted a trial that indicates a 96% accuracy rate for the test.

Ellume estimated the retail cost of the test kit will be about $30. The company is working to scale up production quickly, planning to make at least 100,000 test kits a day within a month, and could reach one million a day by June 2021.

December 17, 2020

Stanford scientists have developed a rapid, low-cost Covid test that can be done at home, with easy-to-read results in thirty minutes. The tests use saliva only, with no need for uncomfortable nasal swabs.

The test kits should be easy to manufacture at large scale, even "tens of millions" per day, according to Dr. Manu Prakash, one of the lead scientists. He also estimates a cost per test kit as low as $5. These factors, plus the fact that electricity isn't needed to carry out the test, could make it a key tool in fighting the pandemic worldwide.

The team is assembling about 10,000 test kits to be used in a trial to measure its accuracy and confirm its usability. The test uses boiling water and a manual device to amplify any RNA fragments of SARS-CoV-2, the virus that causes Covid-19, which can then be detected using other parts of the test kit.

Dr. Prakash and his colleagues designed a key component of the kit to act as a centrifuge to process the sample, one that costs only a few dollars of materials, instead of lab-level centrifuges which can cost hundreds or thousands of dollars.

He is part of Stanford's Bioengineering Department, which is affiliated with both the schools of Medicine and Engineering.

November 28, 2020

The US FDA has approved a rapid at-home test for Covid-19, the first such home test to be approved. The test, from California-based Lucira Health, takes 30 minutes to produce a result.

Under the FDA approval, via an Emergency Use Authorization (EUA), a patient needs a prescription from a doctor to get the All-In-One Test Kit.

Lucira said that the kit tests for the presence of genetic material from SARS-CoV-2, the virus that causes Covid-19, and is more accurate than antigen tests, which look for proteins associated with the virus.

The user takes a sample using a nasal swab, then stirs the swab in a vial that is provided as part of the test kit. Within 30 minutes, a green light will appear to indicate a positive or negative result.

Lucira said that preliminary results showed that the test is accurate 94% of the time, and also that negative results are 98% accurate. Further clinical studies are ongoing.

Other at-home Covid tests require the sample be sent to a lab for processing.

October 20, 2020

In a study comparing the new rapid, $5 test for Covid-19 to the more established - and slower and more expensive - tests that use the PCR method to detect a Covid infection, the rapid tests were almost as accurate and may have caught all the highly infectious cases.

The study used the new BinaxNOW test from Abbott Labs, which produces a result in just 15 minutes.

The scientists from the University of California at San Francisco (UCSF) went to a public transit station and tested 878 local riders with both the rapid test and the traditional PCR test, and compared the results. Out of 16 people who had high levels of the virus according to the PCR test, 15 of them had positive results from the rapid test, showing that the rapid test caught over 90% of the highly infectious cases.

The BinaxNOW test is an antigen test, and is designed to detect people with high levels of the SARS-CoV-2 virus, which causes Covid-19. Those with such high levels are the most likely to pass the infection to others, so detecting such people quickly can be a great tool to limit the spread of Covid.

There have been many complaints that the standard PCR tests are too slow to be helpful in real life situations - people often have to wait several days or longer to get the test results. With a rapid test, someone can know if it is safe to proceed to the office, to school, or with their travel plans for the day.

October 13, 2020

The U.S. government has awarded funding for a trial of rapid test for MIS-C, a rare but potentially deadly effect of Covid-19 in children. The test, called Monocyte Distribution Width (MDW), was developed by Beckman Coulter, a division of Danaher Corporation.

The MDW test measures the sizes of monocytes, a type of white blood cell. A high variation in the sizes is a signal of a systemic infection such as MIS-C.

MIS-C stands for Multisystem Inflammatory Syndrome in Children. Occasionally children who have contracted Covid-19 have developed MIS-C. The condition is not considered dangerous if caught early, but can be fatal if not promptly or correctly diagnosed. Thus a reliable test that can distinguish MIS-C from other illnesses with similar symptoms will be a key tool in protecting children from Covid.

The trial is being funded by BARDA, the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services. It will be conducted by Beckman Coulter in partnership with several academic and health care centers, including Massachusetts General Hospital (MGH).

October 5, 2020

Just in time for flu season, diagnostics company Cepheid has received FDA approval for a rapid, 4-in-1 test that can detect both Covid-19 and various flu strains.

Since the symptoms of Covid and flu overlap, testing will be crucially important for health care providers to know whether a patient is infected with the flu or with SARS-CoV-2, the virus that causes Covid-19.

The test uses a single sample from a patient to determine the presence of the coronavirus or the flu, in just 36 minutes. The test operates on the GeneXpert system from Cepheid that is often deployed at point-of-care locations, such as hospitals and even some care homes.

The system uses PCR testing to detect genetic sequences that identify a pathogen. It has high accuracy, according to Cepheid. The testing system can be configured to detect other infectious diseases as well, such as Strep, MRSA, and tuberculosis.

The FDA granted Emergency Use Authorization (EUA) for the test, and Cepheid said it will start shipping it to customers very soon.

September 26, 2020

United Airlines announced it will roll out rapid Covid-19 tests to passengers headed to Hawaii from San Francisco. The tests can give results in 15 minutes.

Hawaii has a 14-day quarantine requirement for all passengers arriving from the mainland. But after working with the state government, United says that passengers receiving a negative test shortly before their flight will not have to go into quarantine.

United is using the rapid tests made by Abbott Labs, and they will first be deployed at San Francisco International Airport (SFO), where there are daily flights to Hawaii. Passengers will also have the option of using a mail-in test within 72 hours of their flight.

The rollout of rapid testing has the potential to solve multiple problems. Hawaii depends on the tourism industry, but the pandemic and associated quarantines have slashed arrivals; using rapid tests, quarantines can now be avoided. And airlines need to convince passengers of the safety of air travel. Negative Covid tests by all passengers could go a long way to making potential travelers feel safe.

Other airlines and airports are likely to announce rapid testing programs soon.

September 24, 2020

A new test in Finland can detect Covid-19 infection in only 10 seconds, and all it takes is a few sniffs by a dog. The specially trained dogs are available at Helsinki Airport, where travelers can choose to be tested.

Coronavirus testing has been a perpetual problem since the pandemic started. The canine test addresses one of the biggest problems: the long delays that are common between testing and getting the results, which often takes several days at least. It also improves another common complaint: Current testing is also physically uncomfortable in most cases, requiring insertion of a long nasal swab.

In the current implementation of the dog-based test, arriving passengers wipe their necks to collect sweat. The dogs sniff the wipes, and can detect the presence of Covid in just 10 seconds or less. In that case, the passenger is directed to a health center in the airport.

Dogs have an extremely sensitive sense of smell, and are commonly used to detect drugs and other contraband at arrival areas of airports. Using dogs to detect illness has been an active area of research, and Covid is just the latest disease that can be detected by trained dogs.

There is some evidence that the dogs are better than standard PCR tests at detecting SARS-CoV-2, the virus that causes Covid-19, in presymptomatic or asymptomatic people.

Dogs are unlikely to become infected with the virus, and in the rare cases when they have contracted Covid, have not developed symptoms and have not spread it to others.

If enough dogs can be trained, the canine tests may later be rolled out to schools, hospitals, shopping malls, and other public places.

August 27, 2020

The FDA gave emergency approval to a new, rapid Covid-19 test from Abbott Labs. The test can determine the presence of SARS-CoV-2, the virus that causes Covid-19, in just 15 minutes.

Not only is the test quick, but it is also cheap. Abbott says it will sell the test for only $5, and plans to produce 50 million per month, starting in October. The test is called BinaxNOW, and is sold in a card-type form factor.

The test uses a nasal swab, and can be processed on the spot, rather than being sent to a remote lab. It is an antigen test, which looks for actual pieces of the virus.

This type of test may not be as accurate as the PCR-based tests which are sent to labs and look for the virus's genetic code. But PCR-based tests have been plagued with delays so long that some question their effectiveness. Abbott says the new test is has 97.1% sensitivity, and 98.5% specificity; those are the two values by which the accuracy of such tests is measured.

A rapid, low-cost test has the potential to greatly improve control of the pandemic even without a vaccine. People could be tested upon entrance to, say, an office building or an airport, and only allowed entry upon a negative test result.

The test results can be displayed on a mobile app being provided by Abbott.

August 15, 2020

The FDA has a Covid-19 test that uses only saliva from the patient, a much more comfortable collection than the nasal swabs that are the common testing method. The test also requires less chemical reagents than other tests, so should be better able to scale to large volumes.

The test, called SalivaDirect, was developed by scientists at the Yale School of Public Health. The saliva samples are sent to a lab, where results are available after approximately three hours of processing.

The reduced number of reagents involved also makes SalivaDirect a low-cost Covid test, and the Yale scientists estimated that labs could charge as little as $10 per tested sample.

The combination of easier collection and low cost could mean much wider testing availability, if the tests are scaled up to high volumes. The accuracy of the results appear similar to that of tests using nasal swabs.

During development, the Yale team used the test on NBA players and staff to confirm it worked as quickly and accurately as intended.

July 13, 2020

A test that detects the presence of the coronavirus that causes Covid-19 is under development by a partnership between scientists at 3M and MIT.

The goal is a test that can accurately determine the presence of the virus "within minutes", 3M said. It should also be capable of being manufactured in mass quantities. The test would be administered at point-of-care, and would produce results without needing to be sent to a lab for processing.

Such a rapid-response test could be a major improvement in the ability of local governments to monitor and control Covid-19 outbreaks.

The MIT team is let by Prof. Hadley Sikes, from the Dept. of Chemical Engineering. His research includes work on cellulose-based protein tests, which could be used in tests for SARS-CoV-2, which causes Covid-19.

The project has received $500,000 in funding from the NIH via a program known as RADx Tech.

May 7, 2020

A team of scientists has developed a test for the virus causing Covid-19 that is based on the gene-editing technology known as Crispr. The current tests are based on a different technology known as polymerase chain reaction (PCR).

The researchers, based at the Broad Institute in Massachusetts, said that new tests would be cheaper and faster than the existing tests. The bill of materials would cost only about $6, and the tests could be performed in about one hour, they say.

The team has published the design for the test, but it has not yet undergone thorough review and implementation.

Cheaper and faster tests for Covid-19 can help widespread testing become a norm, and make testing a bigger part of determining appropriate policies for social distancing and business reopening.

April 26, 2020

A genetic test for the virus causing Covid-19 has been launched that can be processed at very high volumes - even up to tens of thousands per day. The test can also use saliva-based samples, which can be collected more easily than the existing tests that use nasal swabs.

The new test was launched by RUCDR Infinite Biologics, part of Rutgers University in New Jersey, working in partnership with Accurate Diagnostic Labs. Saliva testing allows people to gather their own samples, rather than to go to a testing site where trained health workers gather samples based on nasal swabs.

Andrew Brooks, COO of RUCDR, said, "Saliva testing will help with the global shortage of swabs, and will not require health care professional to collect samples".

April 16, 2020

Medical giant Abbott Labs announced a new test to determine if someone has been previously exposed to the virus that causes Covid-19 and may thus have some immunity from a new infection. This type of test looks for antibodies that the immune system uses to fight an infection by SARS-CoV-2, the virus behind Covid-19.

Abbott is being very aggressive in ramping up the tests. It says it can ship as many as one million tests this week, a total of 4 million in April, and 20 million by June.

Serology tests, as antibody tests are more formally known, can reveal past exposure to a virus, even if a person never showed any symptoms. They are different from tests that look for the virus itself to determine if a person is suffering from a current, active infection.

Antibody tests can reveal the extent of immunity to Covid-19 in a population, and thus guide policy regarding normalizing behavior. This particular test detects the IgG antibody, which tends to persist in the body for a significant time after exposure.