Coronavirus Diagnostic Tests
Coronavirus Diagnostic Tests
As of March 27, 2020, all 50 states and the District of Columbia have successfully verified COVID-19 diagnostic tests and are offering various testing services. Contact your state health department regarding questions about testing.
Furthermore, the leading national commercial lab testing services businesses (Abbott, Co-Diagnostics, Lab Corp, Roche, Thermo Fischer Scientific, Quest Labs) began offering SARS-CoV-2 coronavirus diagnostic services. These diagnostic testing firms and numerous hospital systems, offer local testing services throughout the USA.
The FDA said on March 26, 2020, under the COVID-19 laboratory-developed test policy, the FDA has been notified by more than 100 laboratories. To date, 17 emergency use authorizations have been issued by the FDA for nation-wide use.
Coronavirus Diagnostic Testing Overview
Most testing for COVID-19 disease is currently done on viral genetic material from nose and throat swabs, using a workhorse tool of molecular biology known as reverse transcription-polymerase chain reaction (RT-PCR). The test works by amplifying a specific genetic sequence in the virus.
Short complementary sequences known as primers help to get the copying started. But PCR can only detect viruses while it is present in a person. It doesn’t reveal much about a resolved infection. It’s also known to sometimes produce false positives if reagents in a lab become contaminated.
March Coronavirus Diagnostic Development News
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.
Qualifying Potential COVID-19 Disease Patients
- Healthcare providers should contact their local/state health department immediately to notify them of patients with fever and lower respiratory illness who traveled to China within 14 days of symptom onset.
- The CDC recommends collecting and testing upper respiratory (nasopharyngeal AND oropharyngeal swabs), and lower respiratory (sputum, if possible)) for those patients with productive coughs. The induction of sputum is not indicated. Specimens should be collected as soon as possible once a PUI is identified, regardless of the time of symptom onset.
- State and local health departments who have identified a PUI should immediately notify the CDC’s Emergency Operations Center (EOC) at 770-488-7100 to report the PUI and determine whether testing for 2019-NCoV at CDC is indicated. The EOC will assist local/state health departments to collect, store, and ship specimens appropriately to CDC, including during after-hours or on weekends/holidays.
FDA Diagnostic Testing Information
- The FDA also added additional updates to its COVID-19 Diagnostics FAQ.
NOTE: The information is sourced from the US CDC and has been reviewed by Dr. Robert Carlson on March 24, 2020.
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