COVID-19 Coronavirus Tests
The US Centers for Disease Control and Prevention (CDC) Data Tracker reported about 280 million RT-PCR diagnostic tests, excluding antibody and antigen tests, have been performed to confirm SARS-CoV-2 virus infections.
The state of California leads the USA with 34,382,323 coronavirus tests performed, followed by New York (25,150,062), Florida (19,330,788), and Texas (17,277,484).
Overall, the data indicates a COVID-19 infection positivity rate of 9.24% as of January 22, 2021.
As of January 22, 2021, the U.S. Food and Drug Administration (FDA) authorized 319 coronavirus diagnostic tests, including 237 molecular tests, 69 antibody tests, and 13 antigen tests during 2020. Furthermore, 32 molecular authorizations can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter at-home antigen test.
The FDA has published a video explaining the different categories of tests in the fight against COVID-19 disease and issued the Coronavirus Testing Basics to provide information about the different types of tests available. Additionally, the Infectious Diseases Society of America published new Guidelines on the diagnosis of COVID-19: Serologic Testing.
And on January 8, 2021, the FDA issued an alert to clinical laboratory staff and providers that the FDA monitors the potential impact of coronavirus mutations, including an emerging variant from the United Kingdom known as the B.1.1.7. The FDA says false-negative results can occur with any molecular test for detecting SARS-CoV-2 if a mutation.
The FDA recently published A Closer Look at COVID-19 Diagnostic Testing to offer those who might purchase COVID-19 tests more technical information and resources. The COVID-19 tests most people discuss are RT-PCR, the nasal-swab test that detects viral RNA, and various antibody tests that detect if you have an immune response due to past exposure to the SARS-CoV-2, the betacoronavirus that causes COVID-19.
SARS-CoV-2 Diagnostic Test Panels
Diagnostic testing analyzes the qualitative detection of nucleic acid from the COVID-19 disease in upper and lower respiratory specimens such as nasal swabs, throat swabs, and, if possible, sputum collected from individuals who meet 2019-nCoV clinical and/or epidemiological criteria. Nucleic acid amplification tests are molecular tests that detect the virus's genetic material collected from the patient.
SARS-CoV-2 Serological Test
Antibody testing is an important step to tell if someone has been previously infected. It will provide more understanding of the coronavirus, including how long antibodies stay in the body and if they provide immunity. There is no identified advantage of assays whether they test for IgG, IgM, and IgG, or total antibody says the CDC. The serology or antibody test measures the number of antibodies present in the blood when the body responds to a specific infection, like SARS-CoV-2.
SARS-CoV-2 Combination Tests
The U.S. FDA assists healthcare providers in preparing for the 2020-2021 flu season during the COVID-19 pandemic by issuing emergency use authorizations for diagnostic tests to detect and differentiate the viruses that cause COVID-19 disease and influenza. While the seasonal Flu and COVID-19 are both contagious respiratory illnesses, but different viruses cause them, says the CDC.
CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay
Quest Diagnostics RC COVID-19 +Flu RT-PCR Test
Roche cobas® SARS-CoV-2 & Influenza A/B Test
BioFire Respiratory Panel 2.1
QIAstat-Dx Respiratory SARS-CoV-2 Panel
LabCorp COVID-19, influenza A, B, and RSV
Pixel by LabCorp™ COVID-19 Test Home Collection Kit
Cepheid Xpert® Xpress SARS-CoV-2/Flu/RSV rapid molecular diagnostic test for the detection of the viruses causing COVID-19, Flu A, Flu B, and RSV infections
GenMark Diagnostics's ePlex® Respiratory Pathogen Panel 2 test provides results in less than two hours for more than 20 viruses and bacteria that cause common and often serious respiratory infections, including COVID-19, influenza A and B, respiratory syncytial virus, and rhinovirus.
Note: If you think you have coronavirus disease 2019 (COVID-19) and need a test, contact your healthcare provider immediately. Or, contact your local health department regarding questions about testing. The FDA's COVID-19 Industry Hotline (1-888-INFO-FDA, press *) addresses questions on topics such as diagnostic testing.
January 2021 SARS-CoV-2 Diagnostic Test News
January 15, 2021 - United Biomedical, Inc. received U.S FDA Emergency Use Authorization for its COVID-19 antibody test, UBI SARS-CoV-2 ELISA.
January 15, 2021 - Eurofins announced the following initiatives to support health authorities’ variant detection and monitoring programs: Increasing, to more than 5,000 full genomes per day, the capacity for its ARTIC Next Generation Sequencing (NGS); The launch of NovaType, a SARS-CoV-2 RT-PCR assay, clinically validated for the identification of 1.1.7 and B.1.351 variants with a short turn-around time, ideal for retesting millions of positive samples to detect if the virus is the B.1.1.7 or B.1.351 variant; NovaType is already available as a Laboratory Developed Test (LDT) in Germany and will shortly be made available to the more than 50 Eurofins laboratories worldwide testing patients for COVID-19.
January 14, 2021 - California-based Thermo Fisher Scientific announced an extension of its SARS-CoV-2 GlobalAccess Sequencing Program to provide additional units of the Ion Torrent Genexus System* and Ion GeneStudio S5* Series sequencers at a subsidized price to further support global COVID-19 research and surveillance. As scientists continue to identify new strains of the SARS-CoV-2 virus, including the B.1.1.7 UK variant that studies suggest is more transmissible, genetic sequencing is being used to track these strains and new ones emerging, as well as to trace transmission patterns within communities.
January 13, 2021 - LexaGene Holdings, Inc. announced that it had initiated a program that uses the rapid configurability of the MiQLab™ system to investigate novel variants of SARS-CoV-2, the pathogen that causes COVID-19. LexaGene’s MiQLab can be easily configured to run tests for both coronavirus detection and strain identification as it is capable of screening for up to 27 genetic targets at once.
January 13, 2021 - The U.S. FDA published COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity.
January 13, 2021 - Wisconsin-based Promega announced labs performing the U.S. CDC Flu SC2 Multiplex Assay, a single test to diagnose infection caused by SARS-CoV-2, influenza A, or influenza B, can now use two Promega instruments and a Promega nucleic acid purification kit in the protocol. In a letter dated January 8, 2021, the US Food and Drug Administration authorized an amendment to the Emergency Use Authorization for the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay that adds the Maxwell® RSC 48 and Maxwell® CSC 48 instruments, along with the Maxwell® RSC Viral Total Nucleic Acid Purification Kit, as options for the test procedure.
January 12, 2021 - The US CDC announced it would require all air passengers entering the USA beginning January 26, 2021, to present a negative COVID-19 test, taken within 72 hours of departure.
January 12, 2021 - Review: The Sensitivity and Costs of Testing for SARS-CoV-2 Infection With Saliva Versus Nasopharyngeal Swabs. Saliva sampling seems to be a similarly sensitive and less costly alternative that could replace nasopharyngeal swabs to collect clinical samples for SARS-CoV-2 testing.
January 11, 2021 - California based AXIM® Biotechnologies, Inc. announced that it had released a preprint of its manuscript describing the development of ImmunoPass, the Company’s rapid point-of-care test that semi-quantitatively measures levels of neutralizing antibodies to COVID-19. AXIM’s ImmunoPass can serve as a convenient and effective testing option, as it has been proven to have 98 percent accuracy in detecting neutralizing antibodies using the benchmark of actual SARS-CoV-2 neutralization assays performed in a BSL3 laboratory. The advantages of AXIM’s ImmunoPass include that it uses only a single drop of blood, is smaller than the palm of a hand, highly portable, semi-quantitative, less expensive than a laboratory-based blood test, and can be used longitudinally to monitor increases and decreases in protective immunity after either natural infection or vaccine.
January 8, 2021 - Applied DNA Sciences, Inc. announced today that the U.S. FDA published a safety communication that identifies the Company’s Linea™ COVID-19 Assay Kit as one of only two tests marketed under the FDA’s Emergency Use Authorization that are potentially able to identify certain SARS-CoV-2 mutations, including a mutation found in the U.K. variant of SARS-CoV-2 (B.1.1.7). Identifying certain mutations can help identify samples that should be further characterized by genetic sequencing and can potentially assist with the early detection of new variants in patients, which may reduce the further spread of infection.
January 5, 2021 - Nirmidas Biotech, Inc. announced its second FDA Emergency Use Authorization for their COVID-19 rapid antibody IgG/IgM test, now available for point-of-care settings. The MidaSpot™ COVID-19 Antibody Combo Detection Kit uses a fingerstick serology test for detecting antibodies against the RBD antigen on the surface of the SARS-CoV-2 virus.
January 4, 2021 - Scentech-Medical announced it would test subjects vaccinated to map biomarkers specifically related to type IgM and IgG antibodies. The test to monitor antibody levels and type (which is being developed concurrently with the rapid breath test for coronavirus detection) will provide a quick indication of all vaccines' efficacy on the market. Moreover, such a test can indicate the immune system's response to various vaccine types.
January 1, 2021 - The U.S. CDC stated, 'To account for reduced antigen test accuracy, confirmatory testing with a nucleic acid amplification test (e.g., RT-PCR) should be considered after negative antigen test results in symptomatic persons and positive antigen test results in asymptomatic persons. Compared with real-time reverse transcription-polymerase chain reaction (RT-PCR) testing, the Sofia antigen test had a sensitivity of 80.0% and specificity of 98.9% among symptomatic persons; accuracy was lower (sensitivity 41.2% and specificity 98.4%) when used for screening of asymptomatic persons.
December 2020 SARS-CoV-2 Diagnostic Test News
December 30, 2020 - San Diego based Sorrento Therapeutics, Inc. announced that a Marketing Authorization Application has been submitted by its agents in Mexico to Comisión Federal para la Protección contra Riesgos Sanitarios, the health regulatory authority for Mexico, for its COVI-STIX rapid diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal samples of patients, "Inmunoensayo de flujo lateral para la detección cualitativa de la proteína nucleocápside del SARS-CoV-2".
December 24, 2020 - Albertsons Companies announced it has administered its first doses of the COVID-19 vaccine and is preparing for high consumer demand for immunizations through more than 1,700 pharmacy locations in the USA.
December 21, 2020 - Quest Diagnostics reported results of approximately 27 million COVID-19 molecular diagnostic tests to patients and providers in the United States since we began to provide these services in March 2020. The average turnaround time for molecular diagnostic testing is 2-3 days across all populations and 2 days for our priority population, including hospitalized patients, individuals in long-term care, and presurgical patients.
December 21, 2020 - Beroni Group announced that it had received notification from its European Authorized Representative, CMC Medical Devices & Drugs SL, that its newly developed SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) complies with the applicable essential requirements of the council directive 98/79/EEC in vitro diagnostics as amended.
December 18, 2020 - Beckman Coulter announced a new Access SARS-CoV-2 Antigen assay, the first cost-effective, high-quality, high-throughput COVID-19 test available in the USA volume, workflow, and scalable flexibility needed to help fight the COVID-19 pandemic. The Access SARS-CoV-2 Antigen assay has proven 93% Positive Percent Agreement within seven days post symptom onset and 100% Negative Percent Agreement. The Beckman Coulter antigen test results can be delivered in as little as 30 minutes on the organizations’ immunoassay analyzers, including the DxI 800, a high-throughput analyzer capable of processing 200 samples per hour.
December 16, 2020 - Study: Multicenter Evaluation of the Unyvero Platform for Testing Bronchoalveolar Lavage Fluid. The Unyvero LRT BAL Application provides accurate detection of common bacterial pneumonia agents and P. jirovecii. This panel's sensitivity and rapidity suggest a significant clinical value for choosing appropriate antibiotics and antibiotic stewardship.
December 16, 2020 - The BinaxNOW COVID-19 Ag Card Home Test is now authorized by the U.S. FDA for prescription use at home with self-collected nasal swab samples from individuals ages 15 years or older who are suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset. It is also authorized for use with adult-collected nasal swab samples from individuals ages 4 years or older.
December 15, 2020 - The U.S. FDA issued an emergency use authorization for the first over-the-counter fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects the SARS-CoV-2 virus's fragments from a nasal swab sample from any individual 2 years of age or older.
December 9, 2020 - The U.S. authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription. This product, which is authorized as the first COVID-19 direct-to-consumer (non-prescription) test system, allows an individual to self-collect a nasal swab sample at home and then send that sample for testing to LabCorp. Positive or invalid test results are then delivered to the user by a health care provider's phone call. Negative test results are delivered via email or an online portal.
December 8, 2020 - Liquid Diagnostics announced the development and successful CLIA validation of a home-collection assay for the quantitative testing of COVID-19 antibodies using saliva. It is now possible for individuals to monitor their COVID-19 antibodies' level over time without leaving home. This test utilizes the proprietary Amperial™ technology and measures IgG to the S1 domain of the SARS-CoV-2 Spike Protein. The test is classified as a Laboratory Developed Test. An emergency use authorization application has been filed and is awaiting U.S. FDA clearance.
December 7, 2020 - NOWDiagnostics, Inc. announced that study results for its ADEXUSDx® COVID-19 antibody test yielded encouraging test performance—providing a strong use case for the innovative diagnostic device, which was filed for Emergency Use Authorization from the U.S. FDA on May 29, 2020. The antibody test delivered 100% sensitivity and 100% specificity in a well-characterized 45 sample panel of COVID-19 positive and negative patient samples. The ADEXUSDx® COVID-19 Test is a rapid serology, a self-contained assay that measures the presence of SARS-CoV-2 antibodies and delivers lab-quality results in 15 minutes with no buffers, reagents, or additional equipment. The test requires only a drop of blood (either capillary blood from a simple fingerstick or 40 μL of venous whole blood, serum, or plasma) and has the potential to be deployed directly into homes and workplaces.
December 7, 2020 - Wellness 4 Humanity announced it had launched online sales for the first at-home COVID-19 testing kit to feature both a rapid antigen and RT-PCR saliva test, which are highly effective tests for determining active COVID-19 infections.
December 4, 2020 - The U.S. FDA issued authorization for the first diagnostic test for at-home collection of patient samples to detect both COVID-19 and influenza A and B. The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by suspected individuals of respiratory viral infection consistent with COVID-19 when a home collection is determined to be appropriate by an individual’s healthcare provider.
December 4, 2020 - In a new study published in the scientific journal Cell, the team from Gladstone, UC Berkeley, and UCSF has outlined the technology for a CRISPR-based test for COVID-19 that uses a smartphone camera to provide accurate results in under 30-minutes. They combined crRNAs targeting SARS-CoV-2 RNA to improve sensitivity and specificity and directly quantified viral load using enzyme kinetics. Integrated with a reader device based on a mobile phone, this assay has the potential to enable rapid, low-cost, point-of-care screening for SARS-CoV-2.
December 2, 2020 - Roche announced that its Elecsys® Anti-SARS-CoV-2 S antibody test had received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. The serology (blood) test can be used to measure the level of antibodies in people who have been exposed to the SARS-CoV-2 virus. The EUA in the USA follows the launch of the Elecsys® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark announced on 18 September. The new test targets antibodies directed against the region of the novel coronavirus known as the spike protein, specifically the area that enables the virus to bind to a host cell receptor required for the virus to enter the host cell.
December 1, 2020 - TCA/GENETWORx Labs today unveiled a breakthrough diagnostic Flu A-B/COVID-19/RSV combination test that provides patients with early detection of all three separate respiratory viruses with just one test sample. The TCA/GENETWORx Flu A-B/COVID Combo Test is a molecular diagnostic PCR test that detects two types of influenza viruses—influenza A and B—and differentiates them from RSV, and SARS-CoV-2, the virus that causes COVID-19. The Flu A-B/COVID Combo Test provided by GENETWORx has a 98 percent accuracy rate for influenza, 99 percent for COVID-19, and 96 percent for RSV.
November 2020 Coronavirus Diagnostic Development News
November 30, 2020 - The FDA Letter of Authorization has been revised to add the Mount Sinai COVID-19 ELISA IgG Antibody Test as an acceptable test to be used to qualify high and low titer COVID-19 convalescent plasma in the manufacture of COVID-19 convalescent plasma.
November 30, 2020 - Nationally, the surveillance indicators included in COVIDView have shown increases in SARS-CoV-2 virus circulation and associated illnesses and deaths in recent months. The percentage of specimens testing positive for SARS-CoV-2 has been increasing since September but decreased slightly during week #47 compared with week #46. During week #47, 3,769,481 specimens were tested for SARS-CoV-2 for diagnostic purposes, and 399,197 (10.6%) were positive. This is a decrease compared with week #46, during which 12.0% of specimens tested were positive. The percentages of specimens testing positive decreased among all age groups.
November 24, 2020 - Pennsylvania-based Rite Aid Corporation announced it is expanding its COVID-19 testing program to offer individuals 13 years of age and older no charge coronavirus testing services. Previously, testing was only available to 18 years of age or older. Currently operating 301 testing sites across 15 states, Rite Aid pharmacies have been on the front lines of the COVID-19 pandemic, partnering with Verily and its Baseline COVID-19 Testing Program to provide screening, scheduling, and return of results to participants for Rite Aid testing sites. BioReference Laboratories provides COVID-19 laboratory testing, while clinical oversight is provided by PWNHealth, a national clinician network that enables safe and easy access to diagnostic testing.
November 24, 2020 - Kantaro Biosciences, LLC received Emergency Use Authorization from the U.S. FDA for COVID-SeroKlir, its semi-quantitative SARS-CoV-2 IgG antibody test kit. Unlike other antibody tests, COVID-SeroKlir determines the presence and precise level of IgG antibodies and has a broad range of applications in the fight against COVID-19. Through a commercial partnership with Bio-Techne Corporation, the test kits are being manufactured at scale with a capacity of up to 10 million tests per month and the ability to scale up.
November 24, 2020 - New Jersey-based Quest Diagnostics reported the average Turnaround Time for COVID-19 high-quality molecular diagnostic testing increased to approximately 2-3 days, based on about 215,000 total testings per day.
November 24, 2020 - California based Fluidigm Corporation announced that the Central Drugs Standard Control Organisation in India had licensed importation and commercial sale of the Fluidigm® Advanta™ Dx SARS-CoV-2 RT-PCR Assay in that country for COVID-19 testing. The Fluidigm test is one of the first saliva-based tests for COVID-19 to be licensed in India.
November 23, 2020 - The U.S. government awarded an $11.6 million contract to Maine based Puritan Medical Products Company, LLC, to expand the domestic production capacity of Cue Sample Wands, the nasal swabs used exclusively with the COVID-19 cartridge-based molecular testing system developed and manufactured by Cue Health, Inc.
November 23, 2020 - Beckman Coulter launched its Access SARS-CoV-2 IgG II assay that measures a patient’s relative level of antibodies in response to a previous SARS-CoV-2 infection. This assay's new capabilities enable clinicians to establish a baseline to evaluate an individual’s immune response to the SARS-CoV-2 virus based on a numerical value and assess relative changes in an individual’s immune response to the virus time. The assay may also help researchers as they begin to understand the levels of IgG antibodies needed to be considered protective. And, the organization is filing for Emergency Use Authorization of the assay with the U.S. Food and Drug Administration and will immediately begin shipping assays to its customer base throughout the U.S. under Policy D. Beckman Coulter is also planning to make the assay available to markets accepting the CE Mark before the end of the year.
November 20, 2020 - During Week #46 of 2020, the CDC reported 3,435,511 specimens were tested for SARS-CoV-2 for diagnostic purposes, and 407,928 (11.9%) were positive. This is an increase compared with Week #45, during which 10.8% of specimens tested were positive. The percentages of specimens testing positively increased among all age groups.
November 17, 2020 - The U.S. Food and Drug Administration issued an emergency use authorization 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 intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.
November 10, 2020 - AnPac Bio-Medical Science Co., Ltd. announced the completion of an FDA EUA- SARS-CoV-2 (COVID-19) antibody test verification in its San Jose, California lab in November 2020 for the Roche Elecsys Anti Sars-COV-2 test, and is now capable of entering into the commercial testing stage. The Company also announced that COVID-19 antibody test equipment has also completed its Philadelphia la installation.
November 9, 2020 - Massachusetts based PerkinElmer, Inc. announced that EUROIMMUN had launched the Anti-SARS-CoV-2 QuantiVacTM ELISA to quantify IgG antibodies against the SARS-CoV-2 S1 antigen. The assay is available for countries accepting the CE mark, and the Company plans to file a request for this product with the U.S. FDA for Emergency Use Authorization. Dr. Wolfgang Schlumberger, CEO of EUROIMMUN, stated: “The EUROIMMUN assays, especially the S1-based tests, are important tools for pharmaceutical laboratories conducting clinical trials. Our assays can help to identify individuals who have been exposed to SARS-CoV-2 and may play a critical role in accurate evaluation of antibody status before and after infection, in antibody therapies, or vaccination programs.”
November 6, 2020 - The U.S. FDA authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection. The FDA issued an emergency use authorization (EUA) for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which specifically detects this type of antibody. The EUA was issued to GenScript USA Inc. for its cPass SARS-CoV-2 Neutralization Antibody Detection Kit.
November 2, 2020 - New Jersey-based Becton, Dickinson and Company (BD) announced the receipt of an order from the Dutch Ministry of Health for 9.2 million of its rapid, point-of-care, SARS-CoV-2 antigen tests for use on the BD Veritor™ Plus System, which detects SARS-CoV-2 in symptomatic patients in approximately 15 minutes. The first 1.2 million units will be delivered by mid-November 2020.
November 2, 2020 - California-based Alveo Technologies announced it had been awarded a grant to improve its performance and usability testing platform. If successful, advance the development and scale manufacturing of the company’s be—well™ COVID-19 test from the Bill & Melinda Gates Foundation. As the first of its kind platform, be.well™ is as accurate as a PCR test with all the benefits of an antigen test in terms of cost and accessibility that yields rapid test results.
November 1, 2020 - Hong Kong-based Prenetics told CNBC that its rapid coronavirus tests' accuracy is comparable to the “gold standard” of PCR testing. Prenetics tests were developed by researchers from Oxford University and used a loop-mediated isothermal amplification technique to return results in 30 minutes.
October 2020 Coronavirus Diagnostic Development News
October 29, 2020 - The University of Oxford announced it would take part in a new pilot scheme to assess the use of Lateral Flow Tests (LFTs), a new COVID-19 test designed to identify asymptomatic individuals infected with the virus. LFT is one of several new testing technologies for COVID-19 currently being trialed across the UK. It is hoped it will help identify those most at risk of spreading COVID-19, those who are infectious but not aware of this, and enable them to alter their behavior accordingly, thereby breaking the transmission chains and reducing the infection rate.
October 29, 2020 - Massachusetts based LabCentral announced it has partnered with BioLabs and E25Bio to launch the Cambridge Consortium for Rapid COVID-19 Tests. This new testing initiative aims to combine resources and validate fast, affordable diagnostic assays to provide SARS-CoV-2 screening for asymptomatic populations as part of a strategy for safely returning to work, school, or other aspects of daily life.
October 28, 2020 - Utah based Quansys Biosciences announced that the U.S. FDA had issued an Emergency Use Authorization for its laboratory-based IgG antibody test. A positive IgG antibody result identifies patients who have been exposed to the SARS-CoV-2 virus and, as part of their recovery, demonstrated an adaptive immune response. The Q-Plex™ SARS-CoV-2 Human IgG (4-Plex) Assay simultaneously detects human IgG antibodies that recognize the S1 and S2 subunits of the SARS-CoV-2 spike protein from the same sample. The S1 subunit is of particular interest as it contains the receptor-binding domain necessary for viral entry into human cells and the viral domain associated with neutralizing antibodies. The accuracy of testing for the S1 subunit alone was adequate for EUA requirements; nonetheless, adding the S2 subunit measurement to the clinical call increased accuracy to 97.4% sensitivity and 99.7% specificity.
October 27, 2020 - Agena Bioscience announced that its MassARRAY® SARS-CoV-2 Panel for the qualitative detection of the SARS-CoV-2 coronavirus had been granted Emergency Use Authorization (EAU) from the U.S. FDA. Clinical laboratories can process thousands of samples each day for less than $10 per sample running the assay on a single MassARRAY instrument, making it one of the highest throughput SARS-CoV-2 tests available under the EAU program.
October 26, 2020 - Truvian Sciences announced its submission of the Easy Check COVID-19 IgM/IgG™ Point-of-Care Antibody Test to the U.S. FDA for Emergency Use Authorization.
October 23, 2020 - In the USA, the overall percentage of respiratory specimens testing positive for SARS-CoV-2, the virus causing COVID-19, was 6.3% during week #42. At least one indicator used to monitor COVID-19 activity is increasing in eight of the ten HHS regions, and many regions report increases in multiple indicators.
October 22, 2020 - The World Health Organization approved antigen-based rapid diagnostic tests for the novel SARS-COV-2 coronavirus in Africa will significantly boost testing capacity and marks a game-changer in the continent’s fight against COVID-19.
October 21, 2020 - Spain based CerTest Biotec, along with Becton, Dickinson, and Company, announced that the VIASURE SARS-CoV-2 (N1 + N2) Real-Time PCR Detection Kit adapted for the BD MAX™ System has been CE marked* to the IVD Directive (98/79/EC).
October 21, 2020 - A new study published by Nature: The use of group testing on a massive scale to closely and continually monitor infection in a population, along with rapid and effective isolation of infected people, provides a promising pathway to the long-term control of COVID-19.
October 20, 2020 - The U.S. Department of Health and Human Services issued guidance under the Public Readiness and Emergency Preparedness Act authorizing qualified pharmacy technicians and State-authorized pharmacy interns to administer COVID-19 tests.
October 19, 2020 - Germany based Centogene N.V. announced that the U.S. FDA had issued Emergency Use Authorization (EUA) for ‘CentoSure,’ its latest SARS-CoV-2 RT-PCR test. The EUA permits this test's usage for individuals without any symptoms or suspicion of COVID-19, supporting widespread testing for the global population.
October 16, 2020 - The U.S. CDC reported the overall percentage of respiratory specimens testing positive for SARS-CoV-2 increased from 5.3% during week #40 to 5.4% during week #41. Percent positivity decreased slightly among those 18-49 years but increased among the other age groups. Regionally, the percentages of respiratory specimens testing positive for SARS-CoV-2 increased in Regions 5 (Midwest), 6 (South Central), 7 (Central), and 10 (Pacific Northwest) and decreased in the remaining (6) regions.
October 15, 2020 - Beckman Coulter announced that it was awarded funding by the Biomedical Advanced Research and Development Authority for a multi-center clinical trial to validate its Monocyte Distribution Width's ability hematology biomarker to aid in the rapid detection of Multisystem Inflammatory Syndrome in Children.
October 15, 2020 - Scientists from Oxford University’s Department of Physics have developed an extremely rapid diagnostic test that detects and identifies viruses in less than five minutes. The method, published on the preprint server MedRxiv, can differentiate with high accuracy SARS-CoV-2, the virus responsible for COVID-19, negative clinical samples, and other common respiratory pathogens such as influenza seasonal human coronaviruses.
October 14, 2020 - Texas Governor Greg Abbott, the Texas Education Agency, and the Texas Division of Emergency Management announced a COVID-19 Rapid Testing Pilot Program for Texas school systems. This program will help schools conduct rapid tests of district employees and students — with their parents' written permission — to mitigate the spread of COVID-19 on campuses.
October 13, 2020 - The US Department of Defense (DOD), on behalf of the U.S. Department of Health and Human Services (HHS), awarded an Other Transaction Agreement to Cue Health Inc., San Diego, California, to expand the U.S. production capacity of point-of-care COVID-19 tests. This industrial base expansion effort will allow Cue Health to increase production to 100,000 COVID-19 test kits per day by March 2021 and demonstrate this capacity by delivering six million COVID-19 tests to the U.S. Government to support the domestic COVID-19 response.
October 12, 2020 - Thermo Fisher Scientific Inc. introduced two new SARS-CoV-2 antibody tests: the Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA test and the Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test.
October 12, 2020 - Abbott announced that the U.S. FDA issued Emergency Use Authorization for its AdviseDx SARS-CoV-2 IgM lab-based serology test ARCHITECT® and Alinity™ platforms.
October 9, 2020 - The U.S. CDC reported the percentage of respiratory specimens testing positive for the SARS-CoV-2 coronavirus decreased from 5.2% during week #39 to just 4.9% during week #40.
October 8, 2020 - GenMark Diagnostics, Inc. announced it had received Emergency Use Authorization from the U.S. FDA for its ePlex® Respiratory Pathogen Panel 2 (RP2). In less than 2-hours, the test provides results for more than 20 viruses and bacteria that cause common and often serious respiratory infections, including COVID-19, flu, bronchitis, and the common cold.
October 2, 2020 - LabCorp announced that it is the first commercial laboratory to receive an Emergency Use Authorization from the U.S. FDA for a new, high-throughput method that uses heat and technology to extract RNA from samples collected for COVID-19 molecular testing.
September 2020 Coronavirus Diagnostic Development News
September 30, 2020 - To date, the U.S. FDA has authorized 263 coronavirus diagnostic tests under EUAs, which include 208 molecular tests, 51 antibody tests, and 4 antigen tests.
September 30, 2020 - Becton, Dickinson, and Company announced its rapid, point-of-care, SARS-CoV-2 antigen test for use on the BD Veritor™ Plus System had been CE marked to the IVD Directive (98/79/EC). The new test delivers results in 15 minutes. The company expects commercial availability of this new assay at the end of October for countries in Europe that recognize the CE mark.
September 29, 2020 - Cepheid announced it had received Emergency Use Authorization from the U.S. FDA for Xpert® Xpress SARS-CoV-2/Flu/RSV, a rapid molecular diagnostic test for the qualitative detection of the viruses causing COVID-19, Flu A, Flu B, and RSV infections from a single patient sample, with results delivered in approximately 36 minutes.
September 28, 2020 - The U.S. federal government announced it would begin distributing tens of millions of rapid coronavirus tests to US states. It urged governors to use them to reopen schools for students in kindergarten through 12th grade.
September 28, 2020 - The WHO announced it would provide 120 million rapid COVID-19 tests to low-and middle-income countries. Agreements between the Bill & Melinda Gates Foundation and test manufacturers Abbott and SD Biosensor make available innovative tests priced at a maximum of US$5, with the Global Fund committing an initial US$50 million to enable countries to purchase the new tests.
September 25, 2020 - The US FDA has amended the Emergency Use Authorization for the OraRisk COVID-19 RT-PCR test, allowing users of the device to be tested for coronavirus 2019 (COVID-19) via saline oral rinse collection.
September 24, 2020 - The U.S. FDA granted Emergency Use Authorization for Hologic’s Panther Fusion® SARS-CoV-2 test, which identifies the virus causing COVID-19. The assay is the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people.
September 24, 2020 - Comparative assessment of multiple COVID-19 serological technologies supports continued evaluation of point-of-care lateral flow assays in hospital and community healthcare settings.
September 23, 2020 - The U.S. FDA issued an emergency use authorization for the first serology (antibody) point-of-care test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection.
September 18, 2020 - Roche announced the launch of its Elecsys® Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. Roche has filed for Emergency Use Authorisation from the U.S. FDA.
September 17, 2020 - The FDA reissued the Emergency Use Authorization for the Abbott ID Now COVID-19 test.
September 17, 2020 - Visby Medical received Emergency Use Authorization by the U.S. FDA for a portable PCR COVID-19 test kit, the first company to do so, reported Reuters.
September 16, 2020 - NEJM editorial: Detection of SARS-CoV-2 with SHERLOCK One-Pot Testing.
September 15, 2020 - The U.S. FDA published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The tables show the Limit of Detection of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by the FDA.
September 15, 2020 - Innatoss Laboratories announced today the first neutralizing antibody testing service against SARS-CoV-2 for the public in Europe, using GenScript's cPass ™ SARS-CoV-2 Neutralization Antibody Detection Kit. The kit is the first in the world that enables rapid detection of neutralizing antibodies (NAbs), the specific antibodies present in the serum of COVID-19 patients responsible for clearing the viral infection.
September 14, 2020 - Imanis Life Sciences, LLC announced upcoming presentations about the development and validation of IMMUNO-COV™, the first scalable, quantitative neutralizing antibody test for COVID-19. In contrast to other antibody tests, the IMMUNO-COV assay specifically measures antibodies in the blood that can block infection by SARS-Co-V-2, the virus that causes COVID19.
September 10, 2020 - Accelerate Diagnostics announced that the U.S. FDA had issued an Emergency Use Authorization (EUA) for the individual BioCheck SARS-CoV-2 IgM Test Kit and the BioCheck SARS-CoV-2 IgG Test Kit. This announcement follows the recent EUA approval of the fully automated MS-Fast instrument and the BioCheck SARS-CoV-2 IgM and IgG Combo Test.
September 8, 2020 - LabCorp announced the launch of the first testing method to simultaneously detect COVID-19, influenza A / B, and respiratory syncytial virus (RSV). The single-panel test is available to patients through doctors, hospitals, and other authorized healthcare providers nationwide.
September 8, 2020 - QIAGEN announced plans to launch a rapid, portable test that can detect SARS-CoV-2 antigens in people with active infections in less than 15 minutes and process on average around 30 swab samples per hour using a small digital detection system. The Access Anti-SARS-CoV-2 Antigen Test is expected to become available in the fourth quarter of 2020.
September 7, 2020 - Avacta Group plc announced that it would launch an ELISA laboratory test for the SARS-CoV-2 spike protein to support global research efforts into the coronavirus that causes COVID-19. The Affimer-based ELISA test can detect the coronavirus spike protein in laboratory samples down to deficient concentrations. The Affimer-based ELISA test is also particular to the SARS-CoV-2 virus with no cross-reactivity against other closely related coronavirus spike proteins.
September 4, 2020 - Roche announced that the cobas® SARS-CoV-2 & Influenza A/B Test for use on the cobas® 6800/8800 Systems had received Emergency Use Authorization from the U.S. FDA for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B in patients suspected by their healthcare provider of having respiratory viral infection consistent with COVID-19 disease.
September 3, 2020 - ADMA Biologics, Inc. announced the launch of COVID-19 ImmunoRank Neutralization MICRO-ELISA, a proprietary, fully-validated ELISA assay for the detection of SARS-CoV-2 neutralizing antibodies in plasma and is intended for use as an aid to identify individuals who produce an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, and specifically for the detection of circulating SARS-CoV-2 neutralizing antibodies in human plasma of all immune globulin classes.
September 1, 2020 - Quest Diagnostics announced that it takes our responsibility seriously to promptly report laboratory data to public health authorities to aid pandemic response. Due to a technical issue, our reporting of a subset of public health COVID-19 test data to the Florida Department of Health was delayed. This subset involves nearly 75,000 of the approximately 1.4 million COVID-19 tests we had performed and reported to the state. We apologize for this matter and regret the challenge it poses for public health authorities in Florida. The issue has since been resolved. Importantly, the issue did not affect or delay the reporting of test results to providers and patients.'
September 1, 2020 - The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Convalescent Plasma for the Treatment of COVID-19. 'Although these data suggest that convalescent plasma with high antibody titers may be beneficial in non-intubated patients, uncertainty remains about the efficacy and safety of convalescent plasma due to the lack of a randomized control group and possible confounding in the Mayo Clinic’s EAP. '
September 1, 2020 - Roche announced that it would launch a SARS-CoV-2 Rapid Antigen Test, in late September, for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorisation to the U.S. FDA. The SARS-CoV-2 Rapid Antigen Test is used in point of care settings for both symptomatic and asymptomatic people.
August 2020 Coronavirus Diagnostic Development News
August 28, 2020 - The Lancet: Testing for responses to the wrong SARS-CoV-2 antigen?
August 27, 2020 - The U.S. Department of Health and Human Services and the Department of and Defense, and the Administration awarded a contract for $760 million to Abbott for delivery of 150 million rapid, Abbott BinaxNOW COVID-19 Ag Card Point of Care SARS-CoV-2 diagnostic tests to expand strategic, evidence-based testing in the USA.
August 26, 2020 - The U.S. FDA issued an emergency use authorization for the first antigen test. Results can be read directly from the testing card, similar to pregnancy tests.
August 26, 2020 - Abbott announced that the U.S. FDA issued Emergency Use Authorization for its BinaxNOW™ COVID-19 Ag Card rapid test to detect COVID-19 infection. It is highly portable, about the size of a credit card), affordable ($5), and provides 15 minutes. BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people to spread the disease to others.
August 24, 2020 - Beckman Coulter announced the launch of its Access SARS-CoV-2 Immunoglobulin M (IgM) assay. The new IgM antibody test demonstrated 99.9% specificity against 1,400 negative samples and 98.3% sensitivity at 15-30 days post-symptom onset. Beckman Coulter’s test is the only SARS-CoV-2 IgM assay that targets antibodies that recognize the receptor-binding domain (RBD) of the spike protein SARS-CoV-2 uses to bind to a human cell receptor. This is significant as antibodies that target the RBD can be neutralizing and prevent future infection by blocking the coronavirus from entering the cell.
August 21, 2020 - P-BEST was found in a study to provide an efficient and easy-to-implement solution for increasing testing capacity that can be easily integrated into diagnostic laboratories.
August 20, 2020 - Kroger Health announced expanding its COVID-19 testing offerings at more than 220 clinic locations by appointment for both symptomatic and asymptomatic patients. Kroger Health clinics, currently called The Little Clinic, are available in Arizona, Colorado, Georgia, Indiana, Kansas, Kentucky, Ohio, Tennessee, and Virginia.
August 20, 2020 - Quidel Corporation announced that labeling for Quidel’s Emergency Use Authorization for the Sofia® SARS Antigen FIA had been amended to include either nasal or nasopharyngeal swabs.
August 19, 2020 - The U.S. HHS issued 'Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests.'
August 19, 2020 - Fitbit study concludes that they can detect almost 50% of COVID-19 cases a day before enrollees in the study reported the onset of symptoms, and they do so with 70% specificity.
August 18, 2020 - The FDA issued the third Emergency Use Authorization for a COVID-19 antigen test for LumiraDX UK Ltd.’s LumiraDx SARS-CoV-2 Ag Test and authorized the test for use in high and moderate complexity laboratories certified Under the Clinical Laboratory Improvement Amendments (CLIA), as well as at the point-of-care operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
August 15, 2020 - The Yale School of Public Health's SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection, received U.S. FDA emergency use authorization.
August 14, 2020 - CDC Updated Isolation Guidance Does Not Imply Immunity to COVID-19 disease.
August 11, 2020 - LabCorp announced details of a no-charge antibody testing program in response to federal health authorities’ request to increase donations of COVID-19 blood plasma. For the next 3-months, LabCorp will perform the high-affinity antibody test at no-charge to patients, insurance companies, or the government. When patients receive other medically necessary blood tests as part of a medically necessary exam or treatment, this program enables providers to add the SARS-CoV-2 Antibodies Test to the same order, at no charge. The no-charge high-affinity antibody testing program will use the Roche Elecsys® Anti-SARS-CoV-2 and does not apply to other COVID-19 antibody tests, such as the IgG test.
August 11, 2020 - Celltrion Group announced plans to launch two rapid COVID-19 testing kits, SAMPINUTE™ COVID-19 Antigen MIA, to detect SARS-CoV-2 antigen DiaTrustTM COVID-19 IgG/IgM Rapid Test for detection of SARS-CoV-2 IgG/IgM antibody in the USA. Both tests deliver fast and reliable results, with over 90% sensitivity and specificity agreement.
August 10, 2020 - Quest Diagnostics reported approximately 11.2 million COVID-19 molecular diagnostic tests have been performed during 2020 and is now completing incoming specimens processing in about 2-3 days.
August 10, 2020 - Helix announced that it had received Emergency Use Authorization from the U.S. FDA for the HelixⓇ COVID-19 NGS Test, which is an amplicon-based next-generation sequencing test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens (nasopharyngeal swabs, oropharyngeal (throat) swab, mid-turbinate nasal swabs, and anterior nasal swabs) from individuals suspected of COVID-19 by their healthcare provider.
August 10, 2020 - XPhyto Therapeutics Corp. announced an update on its rapid COVID-19 (SARS-COV-2) screening test, near-term milestones, and commercialization pathway.
August 7, 2020 - FDA issued an Emergency Use Authorization to George Washington University Public Health Laboratory for its GWU SARS-CoV-2 RT-PCR Test. This molecular test is for use by health care providers for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (e.g., nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swabs) from individuals suspected of having contracted COVID-19.
August 6, 2020 - Charting a Rapid Course Toward Better COVID-19 Tests and Treatments, from the NIH Director's weekly blog.
August 5, 2020 - Thermo Fisher Scientific Inc. introduced a new highly automated, real-time PCR solution designed to analyze up to 6,000 samples in a single day to meet increasing global demand for COVID-19 disease testing. The high-throughput system enables laboratories to double or even triple their testing capacity.
August 5, 2020 - Fujirebio Diagnostics, Inc. announced the initiation of clinical testing needed for the submission of its new SARS-CoV-2 Antigen assay for Emergency Use Authorization from the U.S. FDA.
August 4, 2020 - The governors of 7 US states announced they had established an interstate compact to expand the use of rapid point-of-care antigen tests to slow the spread of COVID-19 disease.
August 4, 2020 - A new study by Yale University researchers shows that a new saliva test named SalivaDirect simplifies the test approach, avoids invasive sample collection, and the need for trained personnel to collect specimens.
August 3, 2020 - The Cleveland Clinic received FDA authorization for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP), oropharyngeal (OP) nasal swabs, and bronchoalveolar lavage, tracheal aspirate, and sputum from individuals suspected of COVID-19 by their healthcare provider.
August 1, 2020 - A Oxford University study of more than 9,000 healthcare workers suggested significant numbers of people were getting 'negative' test results, despite probably having had the SARS-CoV-2 coronavirus.
July 2020 Coronavirus Diagnostic Development News
August 1, 2020 - The U.S. FDA authorized two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual’s blood. Both Siemens, the ADVIA Centaur COV2G, and Attelica COV2G are known as “semi-quantitative” tests, meaning that they do not display a precise measurement but estimate the number of patients’ antibodies produced against infection with the virus that causes COVID-19 disease.
July 29, 2020 - Sorrento Therapeutics, Inc. announced it has entered into a licensing agreement with Columbia University ("Columbia") to a rapid, one-step diagnostic test that detects SARS-CoV-2 virus in as little as 30 minutes from a sample of saliva. Unlike other commercially available diagnostic products, the test developed by Columbia's team, to be marketed by Sorrento under the COVI-TRACE™ name, holds all of the testing materials in a single tube and requires no specialized laboratory equipment, making it easily deployable for point of care, on-site or potentially at-home testing. On June 16, 2020, a study evaluated the new test in 60 samples, including 30 samples with coronavirus and 30 without. The study found sensitivity and specificity of 97% and 100%, respectively, and the ability to detect as few as 1 or 2 copies of the SARS-CoV-2 virus in a microliter of saliva.
July 29, 2020 - Truvian Sciences announced that the U.S. FDA issued Emergency Use Authorization for the company’s Easy Check COVID-19 IgM/IgG™ antibody test. The test, which has been rigorously tested and validated by leading healthcare professionals and scientific experts at the University of California San Diego (UCSD) and the University of Chicago, exceeds the current EUA requirements for current COVID-19 antibody tests by delivering a sensitivity rate of 98.44 percent and a specificity of 98.9 percent.
July 29, 2020 - The US FDA posted frequently asked questions for patients and consumers about antibody (serology) testing during the COVID-19 public health emergency. A COVID-19 antibody test, also known as a serology test, is a blood test that can detect if a person has antibodies to SARS-CoV-2, the virus that causes COVID-19. COVID-19 antibody tests can help identify people who may have been infected with the SARS-CoV-2 virus or have recovered from the COVID-19 infection.
July 28, 2020 - The Advanced Medical Technology Association announced that COVID-19 molecular diagnostic tests' shipments reached 1 million per day for the week ending July 24th. Overall, about 80 million tests have been shipped in the USA during 2020.
July 27, 2020 - Bruker Corporation announced the FluoroType® SARS-CoV-2 plus next-generation 6-plex PCR assay for the precise detection of the SARS-CoV-2 virus causes the respiratory and systemic COVID-19 disease. This advanced CV19 infection assay showed 100% sensitivity and 100% specificity in two clinical trials.
July 26, 2020 - LabCorp announced it had performed approximately 8.5 million molecular tests since first making our COVID-19 test available in March. We can now process 180,000 tests per day with plans to increase capacity further. We have reduced the average time to deliver results to 2-3 days from specimen pickup with this additional capacity. For hospitalized patients, the average time for results is faster.
July 24, 2020 - The U.S. FDA reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization to include 2 new indications for use: testing for people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection and to allow pooled sample testing. The LabCorp test remains prescription-only and is authorized for human specimen collection either at home using the Pixel by LabCorp or other home sample collection kits authorized for use with LabCorp’s test or by a health care provider.
July 22, 2020 - Colorado University at Boulder researchers announced they had developed an RT-LAMP test for SARS-CoV-2 in raw saliva that takes about 45 minutes from sample to answer and requires only simple equipment.
July 21, 2020 - Bio-Techne Corporation announced that Exosome Diagnostics has completed validation testing for COVID-19 caused by the novel coronavirus (SARS-CoV-2) and now offers the ExoCovid-19 test for detection of the virus in patient samples. The ExoCovid-19 test will be performed in its CLIA-certified, CAP-accredited laboratory.
July 18, 2020 - The U.S. FDA reissued an emergency use authorization to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to 4 individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples.
July 14, 2020 - 3M and researchers at MIT announced they are testing a new rapid test that detects the virus. Accelerated research is underway to learn if a simple-to-use diagnostic device can produce highly accurate results within minutes and is feasible to mass manufacture. The test is in the Rapid Acceleration of Diagnostics Tech (RADx Tech) program, an aggressively-paced COVID-19 diagnostics initiative from the NIH’s National Institute of Biomedical Imaging Bioengineering.
July 10, 2020 - Decision Diagnostics Corp. announced it plans to provide a new single-use saliva testing kit option to its professional and individual use finger stick GenViro! COVID 19 Swift Kits designed to identify Covid-19 viral load. Test reporting for the GenViro! Finger-stick kits are currently producing results at 10.5 seconds, and initial testing completed on the saliva version of the kit should yield even faster results since the saliva testing will not require any sample correction.
July 8, 2020 - Decision Diagnostics Corp., through its subsidiary Pharma Tech Solutions, Inc., announced a distribution agreement for its GenViro! Covid-19 10.5 Second Swift Kit and other products with Global Swift Sensor Distribution represent the company's GenViro! And GenUltimate products on a non-exclusive but first-to-market basis in India, Sri Lanka, Singapore, Malaysia, Indonesia, Thailand, Vietnam, Nepal, Bangladesh, and Australia.
July 7, 2020 - Nasus Pharma announced data from a preclinical collaboration with the University of Virginia School of Medicine that demonstrated TaffiX®, the Company’s innovative nasal powder inhaler that effectively blocks viruses from reaching nasal mucosa, was able to block more than 99% of SARS-CoV-2 viruses.
July 7, 2020 - The U.S. HHS Launches ‘Surge’ COVID-19 Testing in Hotspot Jurisdictions in Florida, Louisiana, and Texas.
July 6, 2020 - Quest Diagnostics announced 'the average turnaround time for reporting test results is now 1 day for priority 1 patients and 4-6 days for all other populations. Over July, we will continue to ramp up our testing capacity from 115,000 last week to reach 150,000 molecular diagnostic tests a day.'
July 6, 2020 - The U.S. FDA issued an Emergency Use Authorization for a COVID-19 antigen diagnostic test, the Becton Dickinson Veritor System for Rapid Detection of SARS-CoV-2. This is the 2nd antigen test the FDA has authorized to detect SARS-CoV-2 antigens.
July 2, 2020 - The U.S. FDA issued a EUA for the 3rd diagnostic test to detect and differentiate the viruses that cause influenza and COVID-19 in individuals suspected of COVID-19.
July 1, 2020 - Kroger Health's COVID-19 Test Home Collection Kit will be available to frontline associates across Kroger's Family of Companies, based on medical need. In partnership with Gravity Diagnostics, a full-service clinical laboratory located in Covington, KY, Kroger Health plans to process up to 60,000 tests per week by the end of July 2020.
July 1, 2020 - Diagnostic accuracy of serological tests for COVID-19: systematic review and meta-analysis.
Today, July 1, 2020 - ProterixBio, Inc. announced completing a licensing agreement with the Massachusetts General Hospital for a COVID-19 serology assay. The assay was developed and validated by researchers at the Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard University, a joint venture of Harvard University, Massachusetts Institute of Technology, and Massachusetts General Hospital.
June 2020 Coronavirus Diagnostic Development News
June 30, 2020 - 155 Emergency Use Authorizations (EUA), which includes 130 molecular tests, 24 antibody tests, and 1 antigen test, have been issued by the U.S. FDA for diagnostic tests under the policies outlined in the COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
June 30, 2020 - Kroger Health COVID-19 Test Home Collection Kit approved by the U.S. FDA.
June 30, 2020 - T2 Biosystems, Inc. announced the completion of its COVID-19 molecular diagnostic test, the T2SARS-CoV-2 Panel. The test was developed by T2 Biosystems under a license agreement with the Center of Discovery and Innovation at Hackensack Meridian Health and is being commercially distributed after validation meeting requirements for an Emergency Use Authorization request to FDA.
June 29, 2020 - Beckman Coulter announced that its Access SARS-CoV-2 IgG assay had received Emergency Use Authorization from the U.S. FDA. Beckman Coulter has already shipped tests to more than 400 hospitals, clinics, and diagnostics laboratories in the USA. The company said it could deliver more than 30 million tests per month.
June 29, 2020 - Altimmune, Inc. announced it was awarded $4.7 million from the U.S. Army Medical Research & Development Command (USAMRDC) to fund its Phase 1/2 clinical trial T-COVID, an investigational intranasal immune modulator for the treatment of outpatients with early COVID-19 disease. As previously announced, patient enrollment in the T-COVID Phase 1/2 trial is expected to commence in the coming weeks, with data readout expected in the fourth quarter of 2020.
June 29, 2020 - LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel receives U.S. FDA EAU.
June 25, 2020 - PPD, Inc. has expanded its laboratory test portfolio by adding five new molecular, serology, and functional assays designed expressly for COVID-19 vaccine and therapy development programs. PPD’s new molecular assays utilize reverse transcriptase, polymerase chain reaction (RT-PCR), a versatile analysis technique that can help diagnose disease and measure gene expression, a valuable tool for viral infection studies. Specifically, these assays will detect SARS-CoV-2, the causative agent of COVID-19, and quantify the number of infectious particles to determine viral load.
June 16, 2020 - The U.S. Food and Drug Administration revoked the emergency use authorization of the Chembio Diagnostic System, Inc. (Chembio) DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test. Antibody tests, a type of serological test, can help provide information on a person’s and population’s exposure to COVID-19.
June 16, 2020 - The SAFER Sample Collection Kit is registered as a Class A medical device with the Health Sciences Authority of Singapore and is an easy-to-use saliva collection kit that comes with a bottle of stabilization fluid to be mixed with the sample at the point of collection, keeping viral RNA stable at room temperature for up to one week. The reagent used in Lucence’s SAFER Sample saliva collection kit inactivates SARS-CoV-2 within 45 seconds of sample collection.
June 15, 2020 - Ethos Laboratories has entered a strategic partnership with Genscript to offer the first quantitative surrogate Viral Neutralization Test to evaluate COVID-19 protective immunity in the USA. Tru-Immune measures and quantify the neutralizing capacity of antibodies against the SARS-CoV-2 virus. Unlike other tests currently on the market, Tru-Immune™ detects the presence and magnitude of neutralizing antibodies that prevent the COVID-19coronavirus's infectivity.
June 10, 2020 - The FDA issued an Emergency Use Authorization for Cue Health Inc.’s Cue COVID-19 Test for use at the Point of Care, that is, inpatient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
June 10, 2020 - For the duration of the relevant federal emergency declaration, pharmacists may order and administer tests that have been CLIA-waived or approved by the FDA. A test for which the FDA has issued an Emergency Use AuthorizationA is CLIA-waived and may be ordered and administered by pharmacists in Texas.
June 9, 2020 - The U.S. FDA issued an Emergency Use Authorization for the Illumina COVIDSeq™ Test, a high-throughput, sequencing-based, in vitro diagnostic (IVD) workflow enabling the detection of SARS-CoV-2. The end-to-end workflow extends the options available for labs to scale diagnostic testing.
June 8, 2020 - Phosphorus announced the U.S. FDA granted the Emergency Use Authorization request for its COVID-19 saliva test that features at-home sample collection. This is only the second at-home unsupervised saliva test approved by the FDA.
June 5, 2020 - Diagnostic tests (typically involving a nasopharyngeal swab) can be inaccurate in two ways. A false-positive result erroneously labels a person infected, with consequences. False-negative results are more consequential because infected persons — who might be asymptomatic — may not be isolated and can infect others.
June 4, 2020 - Roche announced that the U.S. FDA had issued a EUA for the Elecsys® IL-6 test. This test measures levels of the biomarker interleukin 6 (IL-6) and can be used to help identify patients with confirmed COVID-19 disease who could be at high risk of intubation with mechanical ventilation.
June 1, 2020 - Siemens Healthineers received Emergency Use Authorization from the FDA for its laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies, including IgM and IgG in blood. Test data demonstrated 100% sensitivity and 99.8% specificity. The total antibody test allows for identifying patients who have developed an adaptive immune response, indicating recent infection or prior exposure.
May 2020 Coronavirus Diagnostic Development News
May 28, 2020 - Quest Diagnostics announced that it had received EUA from the U.S. FDA for the Quest Diagnostics Self-collection Kit for COVID-19. The self-collection kit allows individuals to self-collect a nasal specimen at home or in a healthcare setting when appropriate by a healthcare provider.
May 23, 2020 - Interim Guidelines for COVID-19 Antibody Testing issued by the US CDC. "It cannot be assumed that individuals with truly positive antibody test results are protected from future infection," the CDC says in the updated guidelines. "Serologic testing should not be used to determine immune status in individuals until the presence, durability, and duration of immunity are established."
May 21, 2020 - Abbott announced an interim analysis of an ongoing multi-site clinical study in urgent care clinics that indicates its ID NOW COVID-19 rapid test shows strong agreement to lab-based molecular polymerase chain reaction (PCR) instruments. The interim results demonstrated ID NOW COVID-19 test performance is ≥94.7% in positive agreement (sensitivity) and ≥98.6% negative agreement (specificity) compared to two different lab-based PCR reference methods.
May 20, 2020 - GlaxoSmithKline’s consumer health unit announced an agreement with Mammoth Biosciences to develop a test that uses a technology commonly used in gene editing to detect novel coronavirus infections, reported Reuters. The test will use Mammoth’s CRISPR-based platform to identify the presence of viral RNA strands through a nasal swab and deliver results in less than 20 minutes, Mammoth said.
May 20, 2020 - Walmart and Quest Diagnostics announced that 7 Walmart stores across the state of New Jersey would open COVID-19 drive-thru testing sites beginning on May 22, 2020. The testing sites supported by NJ state and local officials will test adults who meet the testing criteria on who should be tested, including first responders, healthcare providers, and others with symptoms of COVID-19 and those in high-risk groups without symptoms.
May 15, 2020 - The U.S. FDA issued a EUA to Everlywell, Inc. for the Everlywell COVID-19 Test Home Collection Kit. Everlywell’s kit is authorized to be used by individuals at home who have been screened using an online questionnaire reviewed by a health care provider. This allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit.
May 14, 2020 - The U.S. FDA alerts the public to early data that suggest potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19. Specifically, the test may return false-negative results.
May 12, 2020 - LabCorp announced that its COVID-19 at-home collection test kit is now being offered to individuals nationwide who have symptoms consistent with COVID-19 infection and individuals without symptoms who may have been exposed to the virus.
May 11, 2020 - Abbott announced that the U.S. FDA issued Emergency Use Authorization for its SARS-CoV-2 IgG lab-based serology blood test on the Alinity™ I system. Abbott plans to ship nearly 30 million antibody tests globally in May across its ARCHITECT® and Alinity i™ platforms and will have the capacity for 60 million tests in June 2020.
May 9, 2020 - FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients. The EUA was issued late Friday to Quidel Corporation for the Sofia 2 SARS Antigen FIA.
May 8, 2020 - The U.S. FDA authorized the 1st diagnostic test with the option of using home-collected saliva samples for COVID-19 disease testing. Specifically, the FDA issued an emergency use authorization to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory-developed test. The new at-home saliva self-collection assay, developed by RUCDR in partnership with Spectrum Solutions and Accurate Diagnostic Labs, allows for broader screening than through the standard method using nose and throat swabs at testing locations requiring physical interactions with a healthcare professional.
May 5, 2020 - CRISPR-based research tool delivers results in an hour; researchers share protocol and kits to advance research and move toward clinical validation. A team of researchers at the McGovern Institute for Brain Research at MIT, the Broad Institute of MIT and Harvard, the Ragon Institute, and the Howard Hughes Medical Institute (HHMI) has developed a new diagnostics platform, STOP (SHERLOCK Testing in One Pot).
May 4, 2020 - Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy.
May 3, 2020 - Roche announced it's COVID-19 antibody test received FDA EUA and is available in markets accepting the CE mark. Roche’s SARS-CoV2 antibody test, which has a specificity greater than 99.8% and 100% sensitivity3 (14 Days post-PCR confirmation), can help assess patients’ immune response to the virus. As more is understood about immunity to SARS-CoV-2, the test may help assess who has built up immunity to the virus.
April 2020 Coronavirus Diagnostic Development News
April 28, 2020 - Quest Diagnostics announced individuals could purchase COVID-19 antibody testing for themselves online, without visiting a doctor's office.
April 26, 2020 - FDA issued Abbott Laboratories Inc. a new EUA for the SARS-CoV-2 IgG assay.
April 22, 2020 - Quest Diagnostics, the world's leading provider of diagnostic information services, announced that it has begun to perform antibody testing for coronavirus (COVID-19) using blood samples. Quest Diagnostics now provides healthcare providers in the USA access to COVID-19 antibodies and molecular diagnostic laboratory testing with the new service.
April 21, 2020 - The FDA re-issued the EUA for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.
April 16, 2020 - Paris-based Sanofi and Luminostics have signed an agreement to evaluate a collaboration on a unique self-testing solution for COVID-19. This collaboration aims to provide a consumer-based test that can detect the COVID-19 virus with high sensitivity and specificity from respiratory samples. The total time from specimen collection to results is expected in 30 minutes or less. It is based on Luminostics' unique technology that utilizes a consumer smartphone's optics, controlled by an iOS/Android app paired with an inexpensive adapter, combined with "glow-in-the-dark" nanochemistry and signal processing artificial intelligence.
April 15, 2020 - Abbott announced the launch of its third COVID-19 test, a lab-based serology blood test for the detection of the antibody IgG that identifies if a person has had the novel coronavirus SARS-CoV-2.
April 14, 2020 - The U.S. FDA announced it granted Emergency Use Authorization to Ortho Clinical Diagnostics’ total antibody assay for COVID-19—the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators. The VITROS Systems, already installed in more than 1,000 hospitals and reference labs in the U.S., are self-contained and do not require an external water source to run, offering lab placement flexibility.
April 13, 2020 - The U.S. FDA has granted emergency use authorization to Rutgers’ RUCDR Infinite Biologics and its collaborators for a new collection approach that utilizes saliva as the primary test biomaterial, the SARS-CoV-2 coronavirus. This is the first such approval granted by the FDA.
April 11, 2020 - CMS, together with the Departments of Labor and the Treasury, issued guidance to ensure Americans with private health insurance cover 2019 Novel Coronavirus (COVID-19) diagnostic testing and certain other related services, including antibody testing.
April 9, 2020- FirstWave Bio, Inc., announced plans to initiate a Phase 2a/2b study with FW-1022 in patients with COVID-19, beginning in mid-2020. With insights emerging into the crucial role of the gastrointestinal (GI) tract in COVID-19 severity and transmission, the company is accelerating the clinical development of FW-1022 to meet the urgent need for new strategies to combat the virus. FW-1022 is a proprietary oral formulation of Niclosamide, an FDA-approved anthelminthic drug with broad-spectrum antiviral properties currently listed on the WHO’s list of essential medicines.
April 7, 2020 - The FDA said, 'In the early days of an infection when the body’s immune response is still building, antibodies may not be detected. This is why tests that detect the body’s immune response should not be used as the sole basis to diagnose COVID-19 disease.
April 4, 2020 - The CDC's COVIDView weekly reported the national percentage of respiratory specimens testing positive for the SARS-CoV-2 coronavirus is an increasing trend and is now: 16.5% at public health laboratories and 8.8% at clinical laboratories.
April 3, 2020 - Ortho Clinical Diagnostics announced it is launching to market its SARS-CoV-2 (COVID-19/coronavirus) antibody test—the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack. Testing kits are expected to be available in a few weeks.
April 3, 2020 – The Eurofins’ U.S. Clinical Diagnostics network announced today that blood-based antibody testing for Coronavirus SARS-CoV-2 would begin Monday, April 6 at Boston Heart Diagnostics.
April 2, 2020 - Siemens Healthineers announced the availability of its molecular Fast Track Diagnostics SARS-CoV-2 Assay test kit used to aid in the diagnosis of infection by the SARS-CoV-2 virus that causes the COVID-19 disease. Test kits are already being shipped within the European Union for research use only to expedite availability. At the same time, the company continues to pursue Emergency Use Assessment and Listing from the WHO for clinical use.
April 1, 2020 - Aytu BioScience, Inc. announced that it had received its first Coronavirus Disease 2019 IgG/IgM Rapid Test shipment containing 100,000 tests from the manufacturer. The Company is now in the process of relabeling the test kits to comply with FDA requirements relating to the labeling of COVID-19 serology test kits and expects to begin filling current orders shortly thereafter.
April 1, 2020 - The US FDA issued an approval letter to Cellex for the first blood test that looks for antibodies against the novel coronavirus SARS-CoV-2 that causes COVID-19. This is different than assays that test for the presence of the virus.
March Coronavirus Diagnostic Development News
March 30, 2020 - CMS announced it would allow hospitals, laboratories, and other entities to perform tests for COVID-19 on people at home and in other community-based settings outside of the hospital. This will both increase access to testing and reduce risks of exposure. The new guidance allows healthcare systems, hospitals, and communities to set up testing sites exclusively to identify COVID-19-positive patients in a safe environment.
March 27, 2020 - Abbott announced that the U.S. FDA had issued Emergency Use Authorization for the fastest available molecular point-of-care test to detect novel coronavirus (COVID-19), delivering positive results in little as 5-minutes and negative results in 13-minutes. The test will run on the company's ID NOW™ platform, providing rapid results in a wide range of healthcare settings such as physicians' offices, urgent care clinics, and hospital emergency departments.
Mar. 26, 2020-- Henry Schein, Inc. announced the availability of an antibody rapid blood test, known as Standard Q COVID-19 IgM/IgG Rapid Test, intended to be administered at the point of care. The test delivers results within 15 minutes from a pinprick with no instrumentation required. Health care professionals can use the test results, along with a patient’s medical history, symptoms, and results of another relevant testing, to make informed decisions about patient treatment and care.
March 25, 2020 - A study led by UnitedHealth Group Research & Development and OptumCare clinicians has demonstrated that a simple, self-collected test effectively identifies COVID-19 infections as the current clinician-collected test. The study found tests using self-administered swab tests accurately detected COVID-19 in more than 90% of positive patients, consistent with the clinician-administered test. The US FDA has updated its guidance based on the UnitedHealth Group research, allowing patients nationwide to self-administer swab tests for COVID-19.
March 24, 2020 - Q2 Solutions announced its collaboration with the University of Texas Medical Branch to develop a novel assay for COVID-19 (SARS-CoV-2) tests, an essential tool for the rapid development of a Coronavirus vaccine. Once a viable assay is developed, Q2 Solutions labs will produce it for use in clinical trials to determine a COVID-19vaccine's effectiveness.
March 23, 2020 - Heat Biologics, Inc. reported collaborating with the University of Miami to develop a proprietary UM COVID-19 point-of-care diagnostic test. The new, patient-friendly test will require a simple pharyngeal throat swab to deliver on-the-spot results on a paper strip in under 30 minutes.
March 21, 2020 - Cepheid announced it had received Emergency Use Authorization from the U.S. Food & Drug Administration for Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test for the qualitative detection of SARS-CoV-2, the virus causing COVID-19. The test has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert® Systems worldwide, with a detection time of approximately 45 minutes.
March 20, 2020 - Daxor Corporation announced the first use of its BVA-100 test to guide volume treatment in a patient infected with the COVID-19 virus. The company also announced a clinical protocol for fluid guidance when utilizing the BVA-100 diagnostic test for COVID-19 patients. “The BVA-100 test has been shown in a prospective randomized control trial to reduce ICU mortality by as much as 66% and reduce ventilator days in populations suffering predominantly from respiratory distress and septic shock. Also, we believe our test can have a significant impact on patient triage and help guide the precise administration of scarce resources such as ventilators."
March 19, 2020 - LabCorp announced that it would perform more than 20,000 COVID-19 disease tests per day beginning March 20th. LabCorp is now performing COVID-19 testing at its labs in Phoenix, Ariz., Burlington, N.C., and Raritan, N.J.
March 18, 2020 - Abbott has received emergency use authorization from the FDA for its molecular test to identify SARS-CoV-2 coronavirus. The company is deploying 150,000 laboratory tests immediately in 18 states, including Illinois, California, New York, Massachusetts, and Washington. Abbott is scaling up production at its U.S. manufacturing location to reach capacity for one million tests per week by the end of March. The Abbott RealTime SARS-CoV-2 EUA test can be used on Abbott's molecular instrument, the m2000 RealTime System.
March 18, 2020 - Scientists from the University of Oxford’s Engineering Science Department and OSCAR have developed a rapid testing technology for the novel coronavirus SARS-CoV-2. The technology only requires a simple heat-block that maintains a constant temperature for RNA reverse transcription and DNA amplification, and the results can be easily read.
March 17, 2020 - Quest Diagnostics received emergency use authorization for its SARS-CoV-2 RNA, Qualitative Real-Time RT-PCR (“Quest SARS-CoV-2 rRT-PCR”) test for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens from individuals suspected of COVID-19 by their healthcare provider.
March 16, 2020 - LabCorp announced it is rapidly expanding its 2019 Novel Coronavirus (COVID-19) testing capacity and expects the ability to perform more than 10,000 tests per day by the end of the week and 20,000 tests per day by the end of March. The LabCorp 2019 Novel Coronavirus (COVID-19) NAA test is available for ordering by physicians or other authorized healthcare providers anywhere in the USA.
March 16, 2020 - Thermo Fisher Scientific Inc. announced that on March 13, 2020, the U.S. FDA issued an emergency use authorization (EUA) for its diagnostic test that can be used immediately by CLIA high-complexity laboratories in the U.S. to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19 disease. The authorized test uses Applied Biosystems TaqPath Assay technology and is designed to provide patient results within four hours of a sample being received by a lab. The estimated time-to-result also includes time for sample preparation and instrument analysis.
March 13, 2020 - The US FDA authorized the Roche cobas SARS-CoV-2 Test, the third Emergency Use Authorization granted for a diagnostic test during the USA's COVID-19 disease outbreak.
March 13, 2020 - Thermo Fisher Scientific Inc. announced that the U.S. FDA had issued an emergency use authorization for its diagnostic test that can be used immediately by CLIA high-complexity laboratories in the U.S. to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19, and not for any other viruses or pathogens.
March 12, 2020 - Co-Diagnostics, Inc. announced that Dr. Brent Satterfield, Ph.D., Chief Scientific Officer and co-founder of Co-Diagnostics, will address a meeting held by the Bipartisan Commission on Biodefense in Washington, D.C. on March 18, 2020. Co-Diagnostics was the first U.S. company to receive a CE-mark for a COVID-19 diagnostic test. The Company is currently shipping orders for its test to countries on 5 continents, including shipments to Italy.
March 12, 2020 - Twist Bioscience Corporation announced the availability of two synthetic SARS-CoV-2 RNA Controls. Positive controls provide quality control measures for the development, verification, and validation of diagnostic tests, including next-generation sequencings (NGS) and reverse transcription-polymerase chain reaction (RT-PCR) assay the limit of detection; and monitoring of day-to-day test variations.
March 10, 2020 - LabCorp announced its LabCorp 2019 Novel Coronavirus (COVID-19), NAA test, is available today, beginning at 6 p.m. ET, for ordering by physicians or other authorized healthcare providers anywhere in the U.S. The test detects the presence of the underlying virus (SARS-CoV-2) that causes COVID-19 and is used with patients who meet current guidance to evaluate infection with COVID-19.
March 10, 2020 – Premier Medical Laboratory Services announced their upcoming launch of Coronavirus (COVID-19) testing that will be available to hospitals and physician offices throughout the United States. Developed under CDC guidelines, PMLS’s COVID-19 test is undergoing FDA review for Emergency Use Authorization to begin testing patient samples as soon as validation is completed within the coming days.
March 9, 2020 - The CDC issued an update to the Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19).
March 8, 2020 - The CDC Health Alert Network Update CDCHAN-00429 highlights guidance and recommendations for evaluating and identifying patients who should be tested for COVID-19 that were shared on March 4, 2020, on the CDC COVID-19 website. It supersedes the guidance and recommendations provided in CDC’s HAN 428 distributed on February 28, 2020.
March 7, 2020 - The University of Washington lab reports a 5-7% positivity rate. The UW SARS-CoV-2 assay is a one-step Real-Time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal/oropharyngeal swabs. Results are for the identification of SARS-CoV-2 RNA. This University of Washington Department of Laboratory Medicine assay targets two distinct regions of SARS-CoV-2, the causative agent for COVID-19 disease, the RNA-dependent RNA polymerase gene, and the E gene.
March 6, 2020 - The CDC reported 72 state and local public health labs in 48 states and the District of Columbia have successfully verified and are currently using COVID-19 diagnostic tests. This CDC map includes states and territories with one or more laboratories that have successfully verified and are currently using COVID-19 diagnostic tests.
March 5, 2020 - Texas Governor Greg Abbott announced that the state now has the capacity to test for COVID-19. Six public health labs within Texas' Laboratory Response Network are now equipped to perform COVID-19 testing, with the remaining four being fully equipped in the coming days. On
March 5, 202,n March 5, 2020, Insurance Commissioner Mike Kreidler issued an emergency order to Washington health insurers requiring them to waive copays and deductibles for any consumer requiring testing (www.doh.wa.gov) for coronavirus COVID-19 disease.
March 5, 2020 - Quest Diagnostics announced it would launch a coronavirus (COVID-19) test service. The new test service aids the presumptive detection of nucleic acid in respiratory specimens of patients meeting CDC's clinical criteria for COVID-19 testing. The new test service will be provided as a laboratory-developed test, pending review by the FDA under emergency use authorization (EUA). The company will submit per FDA guidance within 15 days of clinical testing. The test is a molecular-based assay that detects viral RNA in respiratory specimens.
March 5, 2020 - California Orders Insurers To Waive Out-Of-Pocket Costs For Coronavirus Testing Amid Concerns Price Would Deter People: The California Department of Insurance and Department of Managed Health Care ordered all full-service commercial and Medi-Cal plans to “immediately reduce cost-sharing — including, but not limited to, co-pays, deductibles or coinsurance — to zero for all medically necessary screening and testing for COVID-19, including hospital, emergency department, urgent care and provider office visits where the purpose of the visit is to be screened and/or tested for COVID-19.”
March 2, 2020 - Longhorn Vaccines & Diagnostics announced today that the U.S. FDA has recommended that the company collaborate with diagnostic assay manufacturers to ensure that Longhorn’s PrimeStore MTM® is included as a transport device in Emergency Use Authorization (EUA) applications submitted to the FDA for research samples for the Coronavirus disease 2019 (COVID-19). The suggestion comes in conjunction with key actions to advance the development of novel Coronavirus medical countermeasures outlined by the FDA’s US Center for Devices and Radiological Health.
February Coronavirus Diagnostic Development News
February 29, 2020, the FDA issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus to achieve more rapid testing capacity in the USA. The new policy is for certain laboratories that develop and begin to use validated COVID-19 diagnostics before the FDA has completed a review of their Emergency Use Authorization (EUA) requests. The FDA can issue a EUA to permit the use, based on scientific data. FDA Commissioner Stephen M. Hahn, M.D., said: “We are not changing our standards for issuing EUAs. This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation.”
February 28, 2020 - The Chinese laboratory that first shared coronavirus genome with the world ordered to close for ‘rectification.’ No reason was given for the closure of the Shanghai facility, which released information about the virus ahead of authorities, reported SCMP.
February 27, 2020 - Duke-NUS Medical School in Singapore, researchers are among the front-runners to create a SARS-CoV-2 test. However, its assay must be validated before it is taken into production and deployed widely. The test was developed by a team led by Linfa Wang, an emerging disease specialist at Duke-NUS. In blood samples from recovered patients, the team identified antibodies targeting the spike protein that proved able to block the virus from killing cells in laboratory tests. In parallel, they created synthetic viral proteins that can detect those antibodies in a blood sample without using the live virus.
February 26, 2020 - QIAGEN announces worldwide shipments of QIAstat-Dx test kits for SARS-CoV-2. QIAstat-Dx Respiratory 2019-nCoV Panel rapidly differentiates novel coronavirus from 21 other pathogens implicated in serious respiratory syndromes.
February 26, 2020, a study from China shows chest CT demonstrates better sensitivity than the RT-PCR technique. Researchers at Tongji Hospital in Wuhan, China, concluded that CT should be used as the primary screening tool for COVID-19.
February 25, 2020, Anitoa Systems demonstrated a solution for the rapid on-site nucleic acid test of the 2019 novel coronavirus (2019-nCoV). Anitoa combines a high performance ultra-portable Real-Time Polymerase Chain Reaction (qPCR) instrument called Maverick with an innovative "one-step" reverse transcription qPCR (RT-qPCR) reagent for testing 2019-nCoV.
February 21, 2020, a practical “how-to” protocol for healthcare and public health professionals” was published by the WHO. This protocol was designed to determine viable virus presence and persistence on fomites in various locations where a COVID-19 patient is receiving care or isolate and understand how fomites may play a role in transmitting the virus.
February 20, 2020, the CDC published a page including interim guidance and resources for laboratory professionals working with specimens from persons under investigation (PUI) for coronavirus disease 2019 (COVID-19).
February 14, 2020, OSL started the dispatch of laboratory COVID-19 testing kits for 56 countries. As of 17 February, 37 shipments have been dispatched to 34 countries and 3 regional offices. Thee WHOcurrently says there are 15 laboratories identified to provide reference testing support for 2019-nCoV. The 2019-nCoV Realtime RTPCR test is reported to produce results in just 4 hours. On February 18, 2020, the WHO Situation Report #29 announced the WHO Operations Support and Logistics (OSL) continues to gather and assess Member States' needs for critical items.
February 4, 2020, the US FDA issued an emergency use authorization enabling the emergency use of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel. This FDA authorization allows the test at any CDC-qualified lab across the country. On February 5, 2020, the U.S. HHS announced opening an Easy Broad Agency Announcement to develop 2019-nCoV diagnostics and is now accepting abstract submissions for potential funding. The diagnostics must utilize platforms already cleared by the U.S. FDA, with a viable plan to meet the FDA's requirements to consider Emergency Use Authorization within 12 weeks of an award.
February 3, 2020 - Infection Prevention and Control Recommendations for Patients with Confirmed 2019 Novel Coronavirus (2019-nCoV) or Patients Under Investigation for 2019-nCoV in Healthcare Settings. This guidance is based on the currently limited information about 2019-nCoV related to disease severity, transmission efficiency, and shedding duration.
FDA Diagnostic Testing Information
NOTE: The information is sourced from organizations such as the CDC, NIH, WHO, and the Precision Vax news network and reviewed by Dr. Robert Carlson.