Estonian Researchers Develop Unique Coronavirus Rapid Test

The University of Tartu and SelfDiagnostics, a medical equipment supplier, have developed a SARS-CoV-2 rapid molecular test that allows detecting the viral RNA (one of the three major biological macromolecules that are essential for all known forms of life, along with DNA and proteins) at a lower price and a greater resource efficiency; the test allows identifying infection on the spot in less than an hour.

The current method regularly used for virus identification is PCR, polymerase chain reaction, where the nucleic acid is amplified in stages at different temperatures. This method regularly presumes purification of the nucleic acids from the sample.

The PCR method is, however, time-consuming and requires complex laboratory equipment, special facilities and trained staff. This makes current testing relatively expensive and resource intensive. From the patient point of view, current centralised testing has two major drawbacks, significant delay in the results (usually days) and uncomfortable or even painful sampling of the nasopharynx.

Identifying the infection within 45 minutes

The University of Tartu researchers and Estonian-German company SelfDiagnostics have now developed a coronavirus rapid test that allows identifying the infection within 45 minutes.

The test is based on the isothermal amplification of nucleic acids, meaning that the presence of viral RNA is determined at a constant temperature. This means there is no need for large laboratory equipment or conditions and the test can be performed on-site or at the point of the patient care. Clinical studies indicate that the accuracy of the novel molecular rapid PCR test is similar to that of central laboratories.

According to Katrin Krõlov, the lead of the R&D activities, the test aims to get an accurate diagnostic result at the site of patient care. “Above all, the test is a faster and a more affordable alternative to current testing system,” Krõlov said. “For example, if you are travelling by plane, it is not very helpful if you are informed that you were on the same flight with a corona-positive person a couple of days after the flight. The rapid test, however, would allow identifying the infected people before boarding.”

A single-use mini-laboratory

Ülo Langel, a professor of molecular biotechnology, explained that the rapid test allows expanding testing in the regions where the fast diagnosing of the coronavirus is vital. “The testing should be diffused and close to the patient. The bigger goal is to allow people test themselves without burdening the healthcare system. It would save valuable time in diagnosing fast spreading infection, where current testing system meets the limit,” Langel said.

SelfDiagnostics has been developing different diagnostic products for the past ten years. According to its CEO, Marko Lehes, they have successfully modified a previously developed infection rapid test to detect both the SARS-CoV-2 virus and influenza viruses. “The rapid test has the accuracy of a laboratory with the size of a human palm. We can say that it is basically a single-use mini-laboratory,” Lehes said.

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U of Birmingham Scientists Develop New COVID-19 Test That Gives Positive Result in Minutes

A new COVID-19 test that reduces testing time from 30 minutes to less than five and delivers accurate results has been developed by researchers at the University of Birmingham.

The researchers believe their method could deliver a test that is not only fast but also sufficiently sensitive. The test does not require samples to be treated at high temperatures, and it can be performed using standard laboratory equipment, making it readily deployable.

A preprint paper (yet to be peer reviewed) describing the new process has been published on MedRxiv in which the researchers demonstrate the rapidity and sensitivity of their method using patient sample RNA provided by Public Health England. 

Professor Tim Dafforn from the University’s School of Biosciences commented: “We have designed a new method for testing that combines the ease of use and speed of lateral flow testing with the inherent sensitivity of an RNA test.  It features reagents that can be used in existing point of care devices and meets the need for testing in high throughput, near-patient, settings where people may be waiting in line for their results.” 

The most accurate COVID-19 tests currently in use require detecting viral RNA - the most common of these use a technique called PCR (polymerase chain reaction). The PCR test is a two-step process, which involves first converting to the RNA to DNA and then ‘amplifying’ the material many times over.

The new Birmingham test simplifies the method to a single step and uses an alternative amplification method called EXPAR (Exponential Amplification Reaction). This technique uses very short, single strands of DNA for the replication process, which can be completed in a matter of minutes, making a significant reduction in the overall time needed to produce results.

The entire test can be run on standard laboratory equipment at lower temperatures compared to PCR tests, which require higher temperatures to separate out strands of DNA as part of the amplification process.

University of Birmingham Enterprise has filed a patent application covering this novel method for amplifying RNA sequences, and its use for detecting RNA in a sample. 

The researchers, made up of cross-disciplinary team from the University of Birmingham’s School of Biosciences, School of Chemistry and the Institute of Cancer and Genomic Sciences, anticipate that further development work could lead to a simple handheld test being developed which could give ‘on the spot’ results.

Professor Jim Tucker, from the University’s School of Chemistry says: “The EXPAR technique has been tried and tested over several years, but we’ve been able to apply it in a new way to detect COVID-19. This is an extremely promising approach to developing a rapid, accurate test which could increase NHS testing capability by up to five times.”

The research is funded by a BBSRC doctoral training scheme, the Midlands Integrative Biosciences Training Partnership (MIBTP). The team are currently applying for funding from UK Research and Innovation to develop the test for NHS laboratories.

Professor Andrew Beggs, from the University's Institute of Cancer and Genomic Sciences, says: “More rapid testing will allow us to unlock near patient testing, getting people safely back to work and controlling outbreaks when they happen. The development of the EXPAR test will allow us to produce more tests that can rapidly diagnose COVID-19”

While the method was developed specifically to reduce testing time and increase testing throughput in COVID-19 testing, in the long-term, the use of the EXPAR technology is expected to extend to other RNA-based viruses and infectious agents such as bacteria, as well as other diseases including cancer. 

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Bruker Introduces MBT Sepsityper® Kit US IVD for Rapid Identification of > 400 Microorganisms from Positive Blood Cultures

Bruker Corporation announced US FDA clearance and the US launch of the MBT Sepsityper Kit US IVD for rapid microbial identification of more than 425 microorganisms from positive blood cultures on the MALDI Biotyper CA System.

Dr. Wolfgang Pusch, Executive Vice President Microbiology & Diagnostics at Bruker Daltonics, stated: “This represents an order of magnitude increase in the number of microorganisms that can be identified rapidly from positive blood cultures in suspected bacterial or fungal sepsis cases compared to targeted PCR detection. This could make the MBT Sepsityper Kit US IVD a nearly universal, rapid sepsis identification solution for clinical microbiology. We expect this affordable fast assay to benefit large numbers of patients, as it comes at a fraction of the cost of expensive syndromic panels with limited species coverage. Faster identification can assist infectious disease physicians and pharmacists in switching sepsis patients to appropriate antibiotics or antifungals for local or hospital infection patterns, which reduces costs, length of ICU stays and could save lives.”

The MBT Sepsityper Kit US IVD enables the rapid identification of many microorganisms from positive blood culture bottles. Harvested microorganisms are processed, and then identified using the FDA-cleared MALDI Biotyper CA System, with a reference library that covers 425 different gram-negative and gram-positive bacterial species and groups, as well as yeasts, including Candida auris, an emerging pathogen for hospital-acquired candidiasis.

The MBT Sepsityper Kit US IVD workflow typically takes less than 30 minutes from a positive blood culture bottle alert to identification. It can save up to 24 hours in time-to-result (TTR) for many identifications, versus additional agar plate culturing, and a further 8–12 hours for biochemical identification after agar plate culturing. The MBT Sepsityper Kit US IVD workflow does not test for resistance or antibiotic susceptibility. It rapidly identifies the microbial species once the blood culture system has detected microbial growth.

Mr. Ike Northern, Director of Infectious Disease Testing and Immunology at the CompuNet Clinical Laboratory in Dayton, Ohio, explained: “I think a lot of laboratories are realizing that they need to use MALDI-TOF MS technology for microbial identification. Many are now making this investment when they recognize the long-term patient and cost benefits. The MBT Sepsityper Kit US IVD will be the next step for a lot of clinical microbiology laboratories. Many are currently using multiplex PCR tests, but once you have the MALDI Biotyper instrument, it is more cost-effective to use the MBT Sepsityper Kit US IVD for fast identification than PCR syndromic panels.” (*)

Rapid testing from positive blood cultures is gaining increasing interest in the clinical microbiology community due to high mortality and morbidity rates in sepsis and septic shock. Sepsis impacts an estimated 30 million patients worldwide every year, many of whom die or suffer permanent health issues. Survival rates can be increased by rapid initiation of an appropriate antibiotic therapy (http://www.worldsepsisday.org). Developed for use with Bruker's U.S. FDA-cleared MALDI Biotyper CA System, the MBT Sepsityper Kit US IVD is intended to simplify and speed up identification of microorganisms directly from positive blood cultures of sepsis patients.

Dr. Elisabeth C. Shearon, the Medical Director at Alverno Laboratories in Hammond, Indiana, commented: “Rapid (MBT) Sepsityper identification has become instrumental in terms of our patient care. Especially in critically ill patients, the improved turn-around-time allows disease specific treatment which conserves health-care resources and, most importantly, improves patient outcomes.” (*)

Currently, guidelines call for physicians to treat septic patients quickly with broad-spectrum antibiotics with the goal of switching to a more targeted therapy once the infecting organisms have been identified and/or any antibiotic resistances have been determined. The MBT Sepsityper Kit US IVD can improve this process by providing rapid microbial identifications to help clinical microbiologists, treating physicians, and patients alike.

Dr. Steven D. Burdette, the Chief of Infectious Diseases at the Miami Valley Hospital in Dayton, Ohio added: “The MBT Sepsityper kit data has allowed us to adjust antibiotic therapy according to our local antibiogram. This, at times, has allowed us to narrow or stop certain antibiotic treatments while in other cases, it has allowed us to escalate antibiotic coverage pending sensitivity data. It has become a crucial tool for our Antimicrobial Stewardship team.” (*)

* All quoted early adopters have self-validated the research-use-only (RUO) version of the MBT Sepsityper kit prior to FDA-clearance of the MBT Sepsityper Kit US IVD.

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New COVID-19 Test from Turkey Can Be A Game-Changer

The new nanotechnology-based diagnostic system can detect the COVID-19 virus within 10 seconds with a swab taken from the mouth.

The system, is called Diagnovir and developed within the infrastructure of Bilkent UNAM, the joint work of Dr. Bülend Ortaç and his team, Bilkent Holding and E-A Technology operating in Bilkent Cyberpark Technology Development Zone.

It is an optically based diagnostic and identification system that changes the color of the glow in the presence of the virus, thus detecting viruses with high selectivity.

In this system, pathogens are detected within 10 seconds by dynamically receiving a fluorescent signal via a pathogen detection chip developed specifically for a biosensor device.

Physiologist Dr. Ali Aytaç Seymen, the researcher at Bilkent UNAM, said that after saliva sample taken from the mouth. If the sample is positive, the system shows it in about 10 seconds and if it is negative, it analyzes longer and shows results in 20 – 30 seconds.

After the sample taken from the patient, it is mixed with a special solution, dropped on the pathogen detection chip, and if there is a pathogen in the environment by the biosensor device, the presence of pathogens with high accuracy is detected by taking the fluorescent signal.

Taking saliva samples from the mouth instead of taking swab samples from deep areas such as the oropharynx and nasopharynx will also make the use of the system preferable.

Unlike the commonly used PCR tests, the system is not based on sample replication, but on detecting the presence or absence of the virus with advanced optical methods.

In the system, optical and electronic modules that provide both precise virus detection and high selectivity in detection, as well as high-level biotechnology and material science knowledge are used. The system has shown 99% success in virus detection in pre-clinical studies conducted so far.

We believe that the system will be widely used in Turkey and in the world as a fast and reliable virus detection method. Therefore, the necessary infrastructure investments for the mass production of this biosensor system have already started. The mass production phase is planned to start within an estimated 2 months, right after completing the necessary permissions from Ethics Committee Turkey Pharmaceuticals and Medical Devices Agency (TİTCK) within the shortest time. Accordingly, it will be possible to contribute to the control of the pandemic and to significantly relieve social life.

In order to protect the intellectual rights of this innovation, patent applications of the system have been made recently.

The system has high export potential. All marking, certification, and accreditation steps that will pave the way for domestic and international sales have also started.

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Israeli Scientists Roll Out 15-Minute Covid-19 Tests

The nationwide vaccination campaign has taken Israel by storm. However, even if the entire population is quickly vaccinated against the coronavirus (Covid-19), additional tests will still be needed for many months. Health officials will still need to quickly map out where infected individuals or populations are located, verify that people are indeed healthy, follow new chains of infection, or test those who’d like to fly overseas. Waiting 48 or even 72 hours for test results harms the test’s effectiveness, and can occasionally deem the results irrelevant. Traditional tests look for the continuous presence of viral RNA coronavirus material in a sample taken from cells obtained from the nasal passages or throat and can take between one and three hours to analyze the concentration of viruses from a sample. Further delays are caused by bottlenecks in the testing labs. Since the outbreak of the pandemic, repeated attempts have been made to speed up the process, and now it seems as though one Israeli scientist has achieved a potential gamechanger.

Various types of rapid tests have already been presented over the past year. The diagnostic test offered by U.S. diagnostic manufacturing company Quidel, was perhaps the most notable, and its Sofia test was later adopted by the Israeli Ministry of Health. Tests such as those don’t look for the actual presence of RNA or other genetic viral material in the infected individual, rather they deduce whether a person is a viral carrier based on other metrics, such as locating the existence of viral proteins related to the coronavirus

Calibrating old technology for rapid testing

The new method is based on rapidly testing coronavirus samples by using the PCR method, which makes millions of copies of DNA samples, allowing scientists to zoom in on a small portion of DNA and analyze it in detail, enabling them to fine-tune their results. Those responsible for the breakthrough include Dr. Amos Danielli and his laboratory technicians at the Faculty of Engineering at Bar-Ilan University. For the past eight months, his team has been working on calibrating MagBiosense technology and adjusting it so that it may be used for rapid Covid-19 testing.

Today, coronavirus samples are taken from supposed infected individuals and the material undergoes a series of chemical manipulations, whose job is to prepare them for an analysis conducted by PCR machines, or quantitative PCR instruments, using a light sensor. After the genetic material, or RNA, is extracted from the sample, it is mixed with a special chemical solution that knows how to spot viral RNA and separate it from the rest of the sample.

The RNA is reverse-transcribed into complementary DNA using the reverse transcriptase enzyme, and multiple DNA strands are encouraged by a specific chemical to multiply rapidly, making a great mass of genetic information, helping scientists zoom in on the minute information, where a specially-equipped light sensor can easily spot individual viral proteins. In addition, the chemical solution is filled with fluorescent molecules that are able to attach to the viral genetic information and “color” it with phosphorescent material that emits light or phosphorescence when a laser is shined upon it. The sensor in the PCR machine knows how to sense light and thereby identify the virus in a sample.

Danielli and his team added additional materials to this ‘chemical salad’ which gives the molecules in the solution a magnetic charge as well. An electromagnet is affixed to the PCR machine so that in real-time the genetic information will be collected and drawn closer to the sensors. In that way, Danielli explains, the identification of Covid-19 in a sample can be much quicker and test a greater amount of genetic information - which is created by the machine - much earlier in the testing process. This in turn allows researchers to determine with high proficiency whether the individual is infected or not 

“It’s like attracting fireflies”

“Think of it like fireflies,” Danielli told Calcalist. “If you see two or three fireflies flying around the room, you won’t be able to spot them. But if you have several concentrated in one spot, you’ll be able to locate them easily. We look at how much light is emitted in the solution, and the amount of light increases at every PCR step, or as the machine’s sensor doubles the amount of genetic information. But if the amount of genetic material that the solution was started with was too sparse, it will take more time to create a large amount of information that the light sensors can detect. We are just helping the sensor do its job and attracting the ‘fireflies’ to it.” He thinks the technology that his lab is developing can successfully shorten the diagnostic testing time, cutting it down from an hour or an hour and a half to just 15 minutes.

The MagBiosense device, (which is the bread and butter of the magnetic biological sensing field), was developed by Danielli’s lab 15 years ago during the course of his doctorate studies, to be used by the agricultural industry and a company he registered in the U.S. (and later sold the technology) to detect diseases in farm livestock. Its first use for human research, however, was conducted four years ago as part of the ongoing struggle against the Zika virus which broke out in Brazil in 2016. With the outbreak of the coronavirus pandemic, Danielli began to adapt the device so that it could be used to identify coronavirus material as part of a collaboration with the Department of Laboratories at the Ministry of Health. During the study, which was conducted at Bar-Ilan University, 274 samples were taken, 140 of which yielded negative-Covid results, while 134 cases were found to be infected with the virus. In 100% of the cases, the results of the MagBiosense test were identical to that of the standard PCR tests, with a typical test taking around 30 minutes.

Now, technological application has reached a point where it can be recruited for easing the bottleneck conditions in diagnostic testing laboratories. Danielli’s testing device was approved by the Administration for the Development of Weapons and Technological Infrastructure, which recommended that the Ministry of Health purchase the technology for widespread use in public laboratories. Danielli believes that the technology has an even greater potential due to its rapid test result time, and can be utilized in places like airports, border crossings, or potential Covid-hotspots with an abundance of travelers, like Eilat or the Dead Sea.

This all joins the long line of Israeli developments in the Covid sector in recent months, which are all looking to optimize diagnostic testing. Prof. Gabby Sarusi at Ben-Gurion University of the Negev is working on developing a rapid exhalation test that analyzes a person’s breath, similar to the breath-analyzer used by the Israel Police to detect drunk drivers’ breath by analyzing the electrical charge emitted from their air flow. The startup LessTests joined the Technion Institute of Technology, and developed a more efficient management of diagnostic testing by mixing several coronavirus tests together and using algorithms to analyze the results and conduct mass testing. During the first few months of the pandemic, the Tel Aviv-based company, ImpactLabs engineered a robot that can quickly analyze Covid-19 samples without human contact. Those two examples could help shorten the long wait time and relieve bottleneck conditions in the testing process.

Source: CTech 

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Inexpensive and Rapid Tests can Distinguish Between Chagas Disease Parasites

A new rapid diagnostic test that can differentiate between different strains of Chagas disease parasite could lead to a widespread testing program.

Researchers from Imperial College London, the University of Kent, the London School of Hygiene and Tropical Medicine, and the charity TroZonX17 have developed a blood test that can identify the main types of parasite that cause Chagas disease, which affects eight million people primarily in Latin America.

This rapid diagnostic test (RDT) could be performed cheaply and quickly using a small sample of blood. The details of the test are published in Scientific Reports.

Chagas disease affects some of the poorest areas of Latin America and is increasingly becoming a global health threat. The disease is transmitted via a 'kissing bug' that carries the parasite Trypanosoma cruzi. Left untreated, the parasitic infection can permanently damage the heart, nervous system or intestines and lead to lifelong disability and death.

However, the initial symptoms are usually mild, which makes early detection difficult without a diagnostic test; the World Health Organization estimates that as few as one percent of cases are detected. Existing tests are expensive, and no point-of-care rapid tests can differentiate between the six principal groups of the parasite, which tend to vary by geographical region.

Changing the picture

Co-author Professor Stuart Haslam, from the Department of Life Sciences at Imperial, said, "Chagas is a devastating disease that is historically difficult to tackle. Our new test could dramatically change that picture, helping control a disease that currently runs unchecked through millions of people."

Similar to the various color-coatings found on Smarties and M&Ms, slightly different sugars (or glycoproteins) decorate the surface of the various strains of the T. cruzi parasite. During infection, the T. cruzi glycoproteins contribute to alerting the human immune system. The immune system then labels the glycoprotein as a threat and raises antibodies that target it. The new test design allows detection of antibodies that recognize the different glycoproteins.

Study co-author and TroZonX17 CEO, Barrie Rooney, said: "We made a synthetic, glycosylated antigen that mimicked a T. cruzi strain-specific glycoprotein and, in collaboration with research scientists in Latin America, we tested the antigens on their archived blood samples. In this pilot study, the antigen identified the people who carried the corresponding specific strain of the T. cruzi parasite."

Expanding to other diseases

Having single tests to distinguish different strains paves the way for future research on the relationship between disease prognosis and the different strains of T. cruzi infection.

The technique used could also be applicable to a wide range of other diseases, according to co-author Professor Haslam: "Our work clearly shows the importance of the glycosylation of the synthetic antigens used in Chagas disease diagnostics. This is an important lesson for improving diagnostics for other infectious diseases, including COVID-19."

Development of new tests for diagnosing Chagas disease in the early stages, when treatment would be most effective, has remained complicated for so long, in part, because affordable diagnostics for neglected diseases are not attractive profit-making opportunities for large companies.

TroZonX17 will now use the new specific antigens to support development of a fuller range of affordable RDTs for widespread access to strain-specific diagnosis, even in very remote locations.

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NUI Galway receives Grant to develop Handheld Device for Rapid COVID-19 Testing

Researchers from NUI Galway and the University of Wyoming have received a grant of €199,720 from the Health Research Board to develop a handheld device for rapid detection of SARS-CoV-2, the virus that causes COVID-19. The device, which they aim to have available early next year, will also test for antibodies to the virus in human samples.

The test device is already being sold and the research team are currently developing a COVID test to work with it in order to produce and distribute large quantities within a short period of time. The rapid test will be capable of being administered by anyone, such as airport officials or school principals.

Professor Gerard Wall, of Microbiology, College of Science and Engineering and SFI Research Centre for Medical Devices (CÚRAM) at NUI Galway, is leading the research along with Professors Patrick Johnson and Karen Wawrousek from the University of Wyoming’s Department of Chemical Engineering.

Professor Wall will employ a laboratory-based technique that mimics the human immune response “in vitro”, or in a test tube, to produce antibody fragments for use in the detection of the virus. The antibody fragments will enable high sensitivity and reproducibility of the device and can be produced in large quantities in bacterial cells.

Professors Johnson and Wawrousek will attach the antibody fragments to nanoparticles for incorporation into a hand-held, battery-operated device that will carry out rapid detection of the virus using a laser, in approximately 15 minutes.

Professor Gerard Wall, NUI Galway, said: “Rapid detection of the virus on-site will allow potentially infectious people to be identified so that decisions on isolation and treatment can be made immediately. There are clear applications for this type of device in airports, workplaces or schools, among other locations.”

Professor Patrick Johnson, University of Wyoming, said: “Our test will have higher sensitivity than other rapid tests and will not require any sample preparation. The idea is to have an accurate, portable, on-site test with results within 15-20 minutes. This will allow rapid answers while the person is still present, enabling immediate intervention and treatment.”

Samples can be collected from saliva, nasal swab or blood. The samples will then be placed in glass vials and inserted into hand-held instruments, called Raman spectrometers, for analysis.

The project team plans to use Raman spectrometers developed by entrepreneur Keith Carron, CEO of Metrohm Raman in Laramie, Wyoming and will work with Noah Hull, Microbiology Laboratories manager at the Wyoming Public Health Laboratory to validate the assay against known positive and negative samples.

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SEKISUI Diagnostics Announces Launch of the OSOM® Ultra Plus Flu A&B Test in Europe

SEKISUI Diagnostics announces it has received CE Marking (Conformité Européenne) for the OSOM® Ultra Plus Flu A&B Test and has begun marketing in Europe.  

The test utilizes traditional lateral flow technology with performance near or exceeding sensitivity of other reader-based tests without using an instrument. It is intended for the qualitative detection of influenza type A and type B nucleoprotein antigens directly from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection.  

"The CE Marking of the OSOM® Ultra Plus Flu A&B Test expands our flu portfolio allowing us to provide a more accurate rapid influenza test kit to many different institutions in more countries. The WHO acknowledges that rapid influenza testing can have important case management implications, specifically allowing the use of influenza antivirals. Other benefits may include the isolation, clustering and analysis of confirmed cases to help prevent outbreaks in the hospital setting and the reduction of the inappropriate use of antibiotics," said Robert Schruender, President and CEO of SEKISUI Diagnostics. "Accurate diagnosis of influenza is critical to rule in or rule out the flu and can help guide healthcare professionals when trying to diagnose other respiratory infections.  This is especially important in our current situation where SARS-CoV-2 Tests are still not widely available.  We are proud to be able to provide another diagnostic tool which can help protect patients and our communities."  

SEKISUI Diagnostics offers solutions to address the varying needs of customers to help improve patient outcomes, maximize clinical efficiencies, and reduce operational budgets. "Reflecting on the unprecedented respiratory season last year, we have seen the value of tests that can respond to high volume clinical demand no matter where testing occurs," said David Morris, PhD, Sr. Product Manager. "Rapid, point-of-care testing continues to be an essential tool in the healthcare system's ability to respond to surges in testing demand and to reduce the spread of respiratory infections." 

Testing patients provides valuable information to clinicians that enables treatment decisions and reduces the risk of prescribing unnecessary antivirals, antibiotics or allows them to be referred on for more extensive testing if needed.  

About SEKISUI Diagnostics: 

SEKISUI Diagnostics is a global diagnostics company committed to improving patient's lives by providing innovative medical diagnostics to physicians and laboratories through a global commercial network.  Product lines include clinical chemistry and coagulation systems/ reagents, rapid test kits and point-of-care systems as well as enzymes and specialty bio-chemicals.  

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FDA Authorizes First COVID-19 Test for Self-Testing at Home

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.

“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only. 

The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus. Positive results indicate the presence of SARS-CoV-2. Individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection.

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19. A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic. Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “We look forward to proactively working with test developers to support the availability of more at-home test options.”

An important component to successful at-home testing is the ability to efficiently track and monitor results. As noted in this EUA, prescribing health care providers are required to report all test results they receive from individuals who use the test to their relevant public health authorities in accordance with local, state and federal requirements. Lucira Health, the test manufacturer, has also developed box labeling, quick reference instructions and health care provider instructions to assist with reporting.

Diagnostic testing remains one of the pillars of our nation’s response to COVID-19. The FDA continues its public health commitment to pursue new approaches that help make critical tests available to more Americans through EUA authority. 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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