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The development of COVID-19 tests was a major public health priority during the early months of the COVID-19 pandemic.
In January 2020, scientists from China published the first genetic sequences of SARS-CoV-2 via GISAID, a program that normally handled genetic sequence data.Researchers around the world used that data to build molecular tests for the virus. Antigen- and antibody-based tests were developed later.
Even once the first tests were created, the supply was limited. As a result, no countries had reliable data on the prevalence of the virus early in the pandemic.The WHO and other experts called for ramping up testing as the best way to slow the spread of the virus. Shortages of reagent and other testing supplies became a bottleneck for mass testing in the EU, the UK and the US. Early tests also encountered problems with reliability.
Public Health England announced a test on the 10th,using a real-time RT-PCR (RdRp gene) assay based on oral swabs. The test detected the presence of any type of coronavirus, including specifically identifying SARS-CoV-2. It was rolled out to twelve laboratories across the United Kingdom on 10 February.
Scientists from China first released information on the viral genome on 11 January 2020,sending multiple genomic sequences to GISAID, an indispensable mechanism for sharing influenza genetic sequence data. That day the Malaysian Institute for Medical Research (IMR) produced "primers and probes" specific to a SARS-CoV-2 RT-PCR test. The IMR's materials were used to diagnose Malaysia's first patient on 24 January. BGI Group was one of the first companies to receive emergency use approval from China's National Medical Products Administration for a nucleic acid test.
The German nucleic acid testing protocol was published on the 17th. Another early PCR test was developed by Charité University hospital in Berlin, working with academic collaborators in Europe and Hong Kong, and published on the 23rd. It used rtRT-PCR, and formed the basis of 250,000 kits distributed by the World Health Organization (WHO).
In Russia, the first COVID‑19 test was developed by the State Research Center of Virology and Biotechnology VECTOR. Production began on 24 January.
In the US, the Centers for Disease Control and Prevention (CDC) developed its SARS-CoV-2 Real Time PCR Diagnostic Panel.The protocol became available on the 28th. One of three tests in early kits failed due to faulty reagents.
South Korean company Kogenebiotech's clinical grade, nucleic acid test (PowerChek Coronavirus) was approved by Korea Centers for Disease Control and Prevention (KCDC) on 4 February.
In Wuhan, BGI opened a makeshift 2000-sq-meter emergency detection laboratory named "Huo-Yan" (Chinese :火眼, "Fire Eye") on the 5th. It processed more than 10,000 samples/day. Construction required 5 days. The Wuhan Laboratory was followed by Huo-Yan labs in Shenzhen, Tianjin, Beijing, and Shanghai, in a total of 12 cities across China.[ citation needed ]
On 11 February, the test was approved by the Federal Service for Surveillance in Healthcare in Russia.
In the United States, the CDC refused to let other labs process tests that month, allowing an average of fewer than 100 samples/day to be processed.[ citation needed ] Tests using two components were not determined to be reliable until the 28th, and only then were state and local laboratories permitted to begin testing. The test was approved by the FDA under an EUA.[ citation needed ]
Due to limited testing, no countries had reliable data on the prevalence of the virus in their population.Testing variability distorts reported case fatality rates, which were probably overestimated in many countries due to sampling bias. Shortages of reagent and other supplies became a bottleneck for mass testing in the EU and UK and the US.
By 4 March, China reached 50,000 tests per day.A study examined 1070 samples from 205 Wuhan patients and reported varied sensitivity according to the methods and location of sample collection. Samples from bronchoalveolar lavage fluid specimens returned the highest sensitivity. The authors argued that CT scans showed even higher sensitivity.
US commercial labs began testing in early March. As of the 5th, LabCorp announced nationwide availability of COVID‑19 testing based on RT-PCR.Quest Diagnostics made nationwide testing available as of 9 March. US testing demand grew rapidly, causing backlogs of hundreds of thousands of tests at private US labs. Supplies of swabs and chemical reagents continued strained. On 25 May, the US required each state to take responsibility for meeting its testing needs. In March, the FDA issued EUAs for nucleic acid tests to Hologic (3/16), Abbott Laboratories (3/18), Thermo Fisher Scientific (3/19) Cepheid (3/21) and LabCorp (4/30).
On 12 March, Mayo Clinic announced a nucleic acid test.
On 16 March, the WHO called for ramping up testing programmes as the best way to slow the spread.Several European countries initially conducted more tests than the US. By 19 March, drive-in tests were offered in several large cities.
As of 22 March, according to the president of the Robert Koch Institute, Germany had capacity for 160,000 tests per week.As of 26 March, German Health Minister Jens Spahn estimated that Germany was conducting 200,000 tests per week. Germany has a large medical diagnostics industry, with more than a hundred testing labs that provided the technology and infrastructure to enable rapid increases in testing. Costs are borne by insurance when the test is ordered by a physician. As of the end of March at least 483,295 samples were tested and 33,491 (6.9%) had tested positive.
On 26 March, it was reported that 80% of test kits that Czechia purchased from China gave inaccurate results. million antibody-based test kits from China that were found to be inaccurate. China accused Czechia and Slovakia of incorrect use of those tests. Ateş Kara of the Turkish Health Ministry said the test kits Turkey purchased from China had a "high error rate".Slovakia purchased 1.2
Spain purchased test kits from Chinese firm Shenzhen Bioeasy Biotechnology Co Ltd, but found that results were unacceptable. The maker explained that the incorrect results may stem from failure to collect samples or use the kits correctly. On 27 March, the Spanish ministry switched to another vendor, Shenzhen Bioeasy.
By 31 March, the United Arab Emirates was testing more of its population per head than any other country.UAE implemented a combination of drive-through sample collection, and a mass-throughput laboratory from Group 42 and BGI. The lab conduced tens of thousands RT-PCR tests per day and was the first to be operational at that scale other than China.
By the month's end, testing had surpassed 200k/week.
The FDA gave an EUA for the US' first antibody test on the 2nd.
On 5 April, the U.S. subsidiary of China's BGI Group sent a proposal to the state of California offering to build in California, at cost ($10 million), the world's largest COVID-19 testing site, in two weeks, and train Americans to operate it. California's consultants recommended against it, because of the risk of security and commercial competition.
As of 7 April, the World Health Organization (WHO) had accepted two diagnostic tests for procurement under the Emergency Use Listing procedure (EUL).
On 13 April, Health Canada approved a nucleic acid test from Spartan Bioscience. Institutions may "test patients" with a handheld DNA analyzer "and receive results without having to send samples away to a [central] lab".
By the start of April, the United Kingdom was delivering around 10,000 swab tests per day.The British NHS announced that it was piloting a scheme to test suspected cases at home, to remove the risk of one patient infecting others at a hospital or disinfecting an ambulance used to transport a patient.
The UK purchased 3.5 million antibody test kits from China, but in early April 2020 announced these were not usable. On 21 April 2020, the Indian Council of Medical Research (ICMR) advised Indian states to stop using test kits purchased from China after receiving complaints from one state. Rajasthan health minister Raghu Sharma on 21 April said the kits gave only 5.4 percent accurate results.
Antibody survey results found from 2% to 30% positive.On preliminary data, WHO concluded that 2% to 3% of the world population had developed antibodies.
By month end, testing had surpassed 750k/week.
In May antibody tests were conducted on 5,603 major league baseball employees and 0.7% tested positive, showing that they had been infected. 70% of those who tested positive had had no symptoms. million tests per week for the week ending 17 May. This grew to 3.2 million by 14 June.The US was conducting an average of 2.5
Attempts to culture virus from upper respiratory specimens were largely unsuccessful when viral burden is low but detectable (i.e., cycle threshold values higher than 33–35).
On 1 May, Quotient Limited announced the CE Mark for its MosaiQ COVID-19 antibody test,designed as a serological disease screen specific to the Coronavirus. The test has a 100% sensitivity and 99,8% specificity claim.
On 3 May, Roche received an EUA for a selective ELISA serology test.
On 8 May, the FDA granted its first EUA for antigen test: "Sofia 2 SARS Antigen FIA" by Quidel Corp.
The FDA announced on 14 May a review of 15 adverse event reports about the Abbott ID Now device for low sensitivity.
On 21 May, researchers at Ben-Gurion University in Israel reported a one-minute coronavirus test with 90% accuracy, based on the "change in the resonance in the THz spectral range" shown by the coronavirus through THz spectroscopy.
Nearly two million antibody tests imported into Australia and costing $20 million were declared unusable.
In early May Harvard's Global Health Institute estimated that the US needed to test more than 900k per day.Other recommendations ranged up to 23m per day.
As of 24 May, countries that publicised their testing data had typically performed tests equal to 2.6 percent of their population, although no country had tested more than 17.3%.
On 29 May Siemens received an EUA for its anti-spike RBD-targeting serology test that it believes detects neutralizing antibodies.
By month end, testing had surpassed 1.4m/week.
In June, researchers announced a nucleic acid diagnostic test using reverse transcription-loop-mediated isothermal amplification (RT-LAMP), an existing technology used in pathogenic microorganism identification, genetically modified ingredients, tumor detection, and embryo sex identification. The test identified virus in samples of serum, urine, saliva, oropharyngeal swabs and nasopharyngeal swabs. Once commercialized the test has the potential to provide rapid (30-45 minute) diagnosis at point of care. The test was 100% selective and highly sensitive, detecting virus at a concentration of .06 fg/ml.
As of 14 June 2020, the percentage testing positive in the US as a whole had fallen below 5%.As of late June, test numbers crossed 600k/day.
On 6 November, the U.S. Food and Drug Administration (FDA) authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells.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 FDA granted Lucira Health emergency use authorization for the first US at-home rapid molecular diagnostic test. With a prescription from a healthcare provider, consumers can use the test kit to take a nasal swab then perform a 30-minute SARS-CoV-2 detection test at home.
On 15 December, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first over-the-counter (OTC) 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 fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual two years of age or older. The Ellume test uses a mid-turbinate nasal swab (sample is collected further back than the usual nasal swab, but not as far back as nasopharyngeal swabs, which are only appropriate for use by a trained health care provider) to detect certain proteins of the virus known as antigens. The Ellume test uses an analyzer that connects via bluetooth with a software application on a smartphone to help users perform the test and interpret results. Results are delivered in as little as 20 minutes to individuals via their smartphone.
On July 21, the U.S. CDC announced that, after December 31, 2021, it "will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel" and that the CDC encourages "laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses."
Abbott Laboratories is an American multinational medical devices and health care company with headquarters in Abbott Park, Illinois, United States. The company was founded by Chicago physician Wallace Calvin Abbott in 1888 to formulate known drugs; today, it sells medical devices, diagnostics, branded generic medicines and nutritional products. It split off its research-based pharmaceuticals business into AbbVie in 2013.
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a drug prior to approval. It does not constitute approval of the drug in the full statutory meaning of the term, but instead authorizes the FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security.
InBios International, Inc. is a medical diagnostic company based in Seattle that specializes in the design, development, and manufacture of immunodiagnostic devices for infectious diseases. The company was founded in 1996 and, since its inception, has developed several technologies useful in designing rapid and ELISA based immunodiagnostic assays. InBios offers a number of life science reagents, along with a portfolio of more than 25 diagnostic products, including FDA Emergency Use Authorization for COVID-19 products and FDA-cleared ELISA kits for Zika, dengue, and West Nile and rapid test kits for Chagas and leishmaniasis. InBios is GMP compliant, FDA registered, USDA licensed and ISO 13485:2016 certified.
DiaSorin is an Italian multinational biotechnology company that produces and markets in vitro diagnostics reagent kits used in immunodiagnostics and molecular diagnostics. The group was founded in 2000 and is headquartered in Saluggia, Italy. Its production is at several plants located in Europe and the United States: Saluggia and Gerenzano (Italy), Dietzenbach (Germany), Stillwater, Minnesota (US), Dartford (UK). The company is a constituent of the FTSE Italia Mid Cap index.
Quidel Corporation is a major American manufacturer of diagnostic healthcare products that are sold worldwide.
Cepheid is an American molecular diagnostics company. Its systems automate traditional nucleic acid tests. The tests can be used to identify and analyze pathogens and genetic disorders. Cepheid sells clinical tests for healthcare-associated infections, infectious diseases, sexual health, oncology and genetics.
Color is a population health technology company which provides genetic tests and analysis directly to patients as well as through employers. The product focuses on genes that indicate risk for heart disease, cancer, and that affect medication response.
Coronavirus disease 2019 (COVID-19) is a contagious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019. The disease has since spread worldwide, leading to an ongoing pandemic.
COVID-19 testing involves analyzing samples to assess the current or past presence of SARS-CoV-2. The two main branches detect either the presence of the virus or of antibodies produced in response to infection. Molecular tests for viral presence through its molecular components are used to diagnose individual cases and to allow public health authorities to trace and contain outbreaks. Antibody tests instead show whether someone once had the disease. They are less useful for diagnosing current infections because antibodies may not develop for weeks after infection. It is used to assess disease prevalence, which aids the estimation of the infection fatality rate.
Christian Heinrich Maria Drosten is a German virologist whose research focus is on novel viruses (emergent viruses). During the COVID-19 pandemic, Drosten came to national prominence as an expert on the implications and actions required to combat the illness in Germany.
COVID-19 drug development is the research process to develop preventative therapeutic prescription drugs that would alleviate the severity of coronavirus disease 2019 (COVID-19). From early 2020 through 2021, several hundred drug companies, biotechnology firms, university research groups, and health organizations were developing therapeutic candidates for COVID-19 disease in various stages of preclinical or clinical research, with 419 potential COVID-19 drugs in clinical trials, as of April 2021.
Viral disease testing is the use of a variety of testing techniques for a variety of purposes, including diagnosing conditions, assessing immunity and understanding disease prevalence. The primary approaches include DNA/RNA tests, serological tests and antigen tests.
A coronavirus breathalyzer is a diagnostic medical device enabling the user to test with 90% or greater accuracy the presence of severe acute respiratory syndrome coronavirus 2 in an exhaled breath. As of the first half of 2020, the idea of a practical coronavirus breathalyzer was concomitantly developed by unrelated research groups in the Singapore, United States, The Netherlands, Finland, Germany, Israel, England, Australia, Indonesia, Canada, Poland and United Kingdom.
COVID-19 testing in the United States can identify whether a person is infected with SARS-CoV-2, the virus which causes COVID-19. This helps health professionals ascertain how bad the epidemic is and where it is worst. The accuracy of national statistics on the number of cases and deaths from the outbreak depend on knowing how many people are being tested every day, and how the available tests are being allocated.
Casirivimab/imdevimab, sold under the brand name REGEN-COV, is an experimental medicine developed by the American biotechnology company Regeneron Pharmaceuticals. It is an artificial "antibody cocktail" designed to produce resistance against the SARS-CoV-2 coronavirus responsible for the COVID-19 pandemic. It consists of two monoclonal antibodies, casirivimab (REGN10933) and imdevimab (REGN10987) that must be mixed together. The combination of two antibodies is intended to prevent mutational escape. It is also available as a co-formulated product.
Truenat is a chip-based, point-of-care, rapid molecular test for diagnosis of infectious diseases. The technology is based on the Taqman RTPCR chemistry which can be performed on the portable, battery operated Truelab Real Time micro PCR platform. Truenat is developed and manufactured by Goa-based Molbio Diagnostics Private Limited.
Bamlanivimab is a monoclonal antibody developed by AbCellera Biologics and Eli Lilly as a treatment for COVID-19. The drug was granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in November 2020, and 950,000 doses have been bought by the US government as of December 2020. In April 2021, the EUA was revoked.
Curative, Inc. is a healthcare startup company best known for scaling COVID-19 testing and COVID-19 vaccinations during the COVID-19 pandemic. Headquartered in San Dimas, California, and operating throughout the United States, the company was founded in January 2020 by Fred Turner, Isaac Turner, and Vlad Slepnev to create new diagnostic tests for sepsis and to improve outcomes for sepsis patients. In response to an urgent, unmet need for COVID-19 test development and production in the United States, Curative rapidly shifted focus in March 2020. The company's research team developed a new test for SARS-CoV-2 that utilized oral swabs rather than nasopharyngeal swabs. The Curative test was designed with a scalable process and opportunities to reduce healthcare worker exposure risk and the amount of personal protective equipment (PPE) used. An independent manufacturing and supply chain model was adopted to avoid competing with existing COVID-19 test companies for limited supplies and laboratory capacity.
Bamlanivimab/etesevimab is a combination of two monoclonal antibodies, bamlanivimab and etesevimab, administered together via intravenous infusion as a treatment for COVID-19. Both types of antibody target the surface spike protein of SARS‑CoV‑2.
The United States' response to the COVID-19 pandemic with consists of various measures by the medical community; the federal, state, and local governments; the military; and the private sector. The public response has been highly polarized, with partisan divides being observed and a number of concurrent protests and unrest complicating the response.
the current shortages of laboratory consumables and reagents affect diagnostic capacity and hamper the epidemic response at the national and local levels. The laboratories have experienced delayed or missing deliveries of swabbing material, plastic consumables, RNA extraction and RT-PCR reagents, and PPE. This is affecting laboratories in all EU/EEA countries.
South Dakota, said that her state's public-health laboratory—the only lab doing COVID-19 testing in the state—had so much trouble securing reagents that it was forced to temporarily stop testing altogether. also noted critical shortages of extraction kits, reagents, and test kits
extract the virus's genetic material—in this case, RNA—using a set of chemicals that usually come in pre-assembled kits. 'The big shortage is extraction kits' There are no easy replacements here: 'These reagents that are used in extraction are fairly complex chemicals. They have to be very pure, and they have to be in pure solution'
After developing a test for the new virus by Jan. 10
Indeed, the rapid tests that arrived from China a few days ago do not really reliably detect the infection at an early stage.
None of the antibody tests ordered by the government is good enough to use, the new testing chief has admitted. Professor John Newton said that tests ordered from China.