The US Centers for Disease Control and Prevention (CDC) published data that indicates there have been 65,756,307 tests to confirm if a person has a SARS-CoV-2 infection, which is the betacoronavirus causing COVID-19 disease. As of August 7, 2020, the national infection rate was about 9%.
On July 29, the FDA posted updated FAQs about COVID-19 antibody testing, also known as a serology test, which is a blood test that can detect if a person has antibodies to SARS-CoV-2, the betacoronavirus that causes COVID-19 disease. 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.
And, the CDC issued Interim Guidelines for COVID-19 Antibody Testing in Clinical and Public Health Settings. Antibody or serology tests detect if the person’s blood contains antibodies to coronavirus.
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.
> > COVID-19 Tests Now Available < <
And, the U.S. 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 and the steps involved in obtaining results.
- 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," or "NAAT" tests are molecular tests that detect the virus's genetic material collected from the patient. These FDA-authorized NAAT tests for SARS-CoV-2 based on the currently available data, we believe are highly accurate. This means that a positive or a negative result from a NAAT test is likely to be true.
- Currently, 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 is responding to a specific infection, like SARS-CoV-2. This means the test detects the body's immune response to the infection caused by the virus rather than detecting the virus itself.
- In the early days of a SARS-CoV-2 infection when the body's immune response is still building, antibodies may not be detected.
Tests Detecting Both COVID-19 and Influenza Viruses
The U.S. FDA is assisting healthcare providers to prepare for the 2020-2021 flu season during the COVID-19 pandemic by issuing an emergency use authorizations for diagnostic tests for detection and differentiation of the viruses that cause COVID-19 disease and influenza:
- CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay
- BioFire Respiratory Panel 2.1
- QIAstat-Dx Respiratory SARS-CoV-2 Panel
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.
August 2020 Coronavirus Diagnostic Development News
August 12, 2020 - To date, the U.S. FDA has authorized 210 coronavirus diagnostic tests under EUAs, which include 173 molecular tests, 37 antibody tests, and 2 antigen tests. FDA issued new Emergency Use Authorizations to LumiraDx UK Ltd., for its LumiraDx SARS-CoV-2 RNA STAR, and Biomeme, Inc., for its Biomeme SARS-CoV-2 Real-Time RT-PCR Test.
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 are receiving 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 for detection of SARS-CoV-2 antigen, and 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 has 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 the pathway to commercialization.
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 have 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 samples 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), and 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 tests from Siemens, the ADVIA Centaur COV2G and Attelica COV2G, are what are known as “semi-quantitative” tests, meaning that they do not display a precise measurement, but estimate the number of a patient’s 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") for the rights 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 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 shipments of COVID-19 molecular diagnostic tests 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 launch of the FluoroType® SARS-CoV-2 plus next-generation 6-plex PCR assay for the highly specific detection of the SARS-CoV-2 virus, which causes the respiratory and systemic COVID-19 disease. In two clinical trials, this advanced CV19 infection assay showed 100% sensitivity and 100% specificity.
July 26, 2020 - LabCorp announced it has performed approximately 8.5 million molecular tests since first making our COVID-19 test available in March, and we are now able to process 180,000 tests per day with plans to increase capacity further. With this additional capacity, we have reduced the average time to deliver results to 2-3 days from specimen pickup. 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 have 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, the 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 and 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, who will 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 the month of 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 for the detection of SARS-CoV-2 antigens.
July 2, 2020 - The U.S. FDA issued a EUA for the 3rd diagnostic test for detection and differentiation of 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.
July 1, 2020 - ProterixBio, Inc. today 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 which is 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 set forth 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 validation 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 has 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 is able to 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 of 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 aid in the diagnosis of disease and give a measure of gene expression, making it 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 infectivity of the COVID-19 coronavirus.
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 an Emergency Use Authorization has been issued by the FDA 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 so far 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 has 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 the identification of patients who have developed an adaptive immune response, which indicates recent infection or prior exposure.
May 2020 Coronavirus Diagnostic Development News
- May 28, 2020 - Quest Diagnostics announced that it has received EUA from the U.S. FDA for the Quest Diagnostics Self-collection Kit for COVID-19. The self-collection kit is for individuals to self-collect a nasal specimen at home or in a healthcare setting when determined to be appropriate by a healthcare provider.
- May 23, 2020 - Interim Guidelines for COVID-19 Antibody Testing issued bu 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 is established."
- May 21, 2020 - Abbott announced today an interim analysis of an ongoing multi-site clinical study in urgent care clinics that indicates its ID NOW COVID-19 rapid test is showing strong agreement to lab-based molecular polymerase chain reaction (PCR) instruments. The interim results are demonstrating ID NOW COVID-19 test performance is ≥94.7% in positive agreement (sensitivity) and ≥98.6% negative agreement (specificity) when 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 will open COVID-19 drive-thru testing sites beginning on May 22, 2020. The testing sites, which are 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 that is 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 is alerting 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 the company's 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 called 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 to assess who has built up immunity to the virus.
April 2020 Coronavirus Diagnostic Development News
April 28, 2020 - Quest Diagnostics announced individuals can purchase COVID-19 antibody testing for themselves, online, without visiting a doctor's office.
April 26, 2020 - FDA issued to 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. With the new service, Quest Diagnostics now provides healthcare providers in the USA access to COVID-19 antibody as well as molecular diagnostic laboratory testing.
April 21, 2020 - The FDA re-issued the EUA for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of 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. The goal of this collaboration is 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 the range of 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, in combination 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 labs 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 for 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 have coverage of 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 that is 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 will 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 while 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 has 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 will 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 for the purpose of identifying COVID-19-positive patients in a safe environment.
March 27, 2020 - Abbott announced that the U.S. FDA has issued Emergency Use Authorization for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as 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 results of the test, 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 is as effective in identifying 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, which is 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 the effectiveness of a COVID-19 vaccine.
March 23, 2020 - Heat Biologics, Inc. reported that it is 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 has 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 the release of 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. In addition, 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 will be able to 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 for the identification of 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 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 which 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 COVID-19 disease outbreak in the USA.
- March 13, 2020 - Thermo Fisher Scientific Inc. announced that the U.S. FDA has 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 for diagnostic tests including both next-generation sequencings (NGS) and reverse transcription-polymerase chain reaction (RT-PCR) assays; determination of 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 for use with patients who meet current guidance for evaluation of 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.
- March 5, 2020 - On 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 will 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) which 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 in order 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 an 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 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, although its assay has to 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 having to use 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 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 isolated, and to understand how fomites may play a role in the transmission of 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. Currently, the WHO 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 the needs of Member States 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 use of the test at any CDC-qualified lab across the country. On February 5, 2020, the U.S. HHS announced the opening of an Easy Broad Agency Announcement for the development of 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 requirements for the FDA 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 available about 2019-nCoV related to disease severity, transmission efficiency, and shedding duration.
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FDA Diagnostic Testing Information
NOTE: The information is sourced from organizations such as the CDC, NIH, WHO, and the Precision Vax news network and has been reviewed by Dr. Robert Carlson.