You are here: Home / News / COMPANY / Development of COVID-19 tests

Development of COVID-19 tests

Views: 0     Author: Site Editor     Publish Time: 2023-03-24      Origin: Site

COVID-19 spreads rapidly and occurs through inhalation of respiratory droplets or aerosol particles contaminated with SARS-CoV-2. The virus occurs on the mucous membranes of the nose, mouth, or eyes through spray and splash; or through direct contact with SARS-CoV-2-contaminated hands through respiratory fluids or contact with virus-contaminated surfaces.Research evidence shows that SARS-CoV-2 aerosols can survive in the air for about 3 hours, with a half-life of about 1 hour, and survive longer on steel and plastic than on cardboard and copper.As a result, the development of treatments for COVID-19 is progressing at pandemic speed, but there are no effective treatments approved by the Food and Drug Administration (FDA).Vaccines appear promising and currently include the Pfizer-BioNTech vaccine, Moderna vaccine, Oxford/AstraZeneca vaccine and Janssen vaccine.But none of these therapeutic strategies can provide complete protection against COVID-19,paving the way for an epidemiological approach to break the chain of disease transmission.In this approach, a diagnosis is the most important tool to help identify cases of the disease leading to isolation and contact tracing to prevent others from coming into contact with the patient's closest contacts.Developing a COVID-19 test was a major public health priority during the early months of the COVID-19 pandemic.In January 2020, Chinese scientists released the first SARS-CoV-2 genetic sequence through GISAID,a program that typically handles genetic sequence data.Researchers around the world used this data to create molecular tests for the virus. Antigen and antibody-based tests were later developed.Even with the first tests created, the supply is limited.As a result, no country has reliable data on the prevalence of the virus early in the pandemic.The World Health Organization and other experts have called for increased testing as the best way to slow the spread of the virus.The shortage of reagents and other testing supplies has become a bottleneck for large-scale testing in the European Union, the United Kingdom, and the United States.Early testing also encountered reliability issues.

2020

January COVID-19 tests

Public Health England announced a test on the 10th using a buccal swab-based real-time RT-PCR (RdRp gene) detection method.The test detects the presence of any type of coronavirus, including specific recognition of SARS-CoV-2. It launched on 10 February in 12 laboratories across the UK.Chinese scientists first released information about the virus genome on January 11, 2020,sent multiple genome sequences to GISAID, an integral mechanism for sharing influenza genetic sequence data.That day, the Institute of Medica Research Malaysia (IMR) produced "primers and probes" for a SARS-CoV-2 RT-PCR test.Materials from the IMR were used to diagnose the first patient in Malaysia on 24 January.BGI Group was one of the first companies to obtain an emergency use license for nucleic acid testing from the State Drug Administration of China.The German nucleic acid testing plan was announced on the 17th. Another earlier PCR test was developed by the Charité University Hospital in Berlin in collaboration with academic collaborators in Europe and Hong Kong and published today. It uses rtRT-PCR and forms the basis of a kit of 250,000 distributed by the World Health Organization (WHO).In Russia, the first COVID 19 test was developed by the National Virology and Biotechnology Research Center VECTOR. Production began on January 24.In the United States, the Centers for Disease Control and Prevention (CDC) developed a SARS-CoV-2 real-time PCR diagnostic panel.The agreement is available on the 28th.One of the three tests in the early kit failed due to a problem with the reagents

February

The Korean company Kogenebiotech's clinical-grade nucleic acid test (PowerChek Coronavirus) was approved by the Korea Centers for Disease Control and Prevention (KCDC) on February 4.On the 5th, Huada Gene opened a temporary emergency testing laboratory covering an area of 2,000 square meters in Wuhan, called "Huoyan".It processes more than 10,000 samples per day.Construction took 5 days.The Wuhan lab is followed by Huoyan Labs in Shenzhen, Tianjin, Beijing, and Shanghai, for a total of 12 cities in China.On February 11, the test was approved by the Russian Federal Health Care Surveillance Service.In the U.S., the CDC refused to allow other labs to process tests that month, allowing an average of fewer than 100 samples per day.A test using two components was not determined to be reliable until the 28th, and state and local labs were not allowed to begin testing until then.The test is FDA-approved under the EUA.

March

Because of limited testing, no country has reliable data on the prevalence of the virus in its population.Test variability distorts reported case fatality rates, and many countries may overestimate case fatality rates due to sampling bias.The shortage of reagents and other supplies has become a bottleneck for large-scale testing in the European Union and the United Kingdom [8] and the United States.By March 4, China reached 50,000 tests per day.A study examined 1070 samples from 205 Wuhan patients and reported varying

sensitivities depending on the method and location of sample collection. Samples from bronchoalveolar lavage fluid samples returned the highest sensitivity.The authors suggested that CT scans showed higher sensitivity.U.S. commercial labs began testing in early March. As of the 5th, LabCorp announced the nationwide availability of its RT-PCR-based COVID 19 test.Quest Diagnostics began testing nationwide on March 9.Demand for testing in the United States has grown rapidly, resulting in a backlog of hundreds of thousands of tests in private U.S. laboratories. Supplies of swabs and chemicals continue to be tight.On May 25, the United States held states accountable for meeting their testing needs.In March, FDA issued notifications to Hologic (3/16), [40] Abbott Laboratories (3/18), Thermo Fisher Scientific (3/19) Cepheid (3/21) for EUA for nucleic acid detection and LabCorp (4/30).On March 12, the Mayo Clinic announced the implementation of nucleic acid testing.On March 16, the World Health Organization called for increased testing programs as the best way to slow the spread.Several European countries initially conducted more tests than the United States.Through March 19, drive-through testing was offered in several large cities.As of March 22, according to the director of the Robert Koch Institute, Germany had the capacity to conduct 160,000 tests per week.As of March 26, 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 laboratories providing the technology and infrastructure to rapidly increase testing.When a doctor orders a test, the cost is covered by the insurance.As of the end of March, at least 483,295 samples had been tested, of which 33,491 (6.9%) were positive.On March 26, it was reported that 80% of the test kits the Czech Republic purchased from China had inaccurate results.Slovakia purchased 1.2 million antibody-based test kits from China, which were found to be inaccurate.China accused the Czech Republic and Slovakia of using these tests incorrectly.Ateş Kara of the Turkish Ministry of Health stated that the test kits purchased by Turkey from China have a "high error rate". Spain bought the kits from the Chinese company Shenzhen Baiyi Biotechnology Co. Ltd.,but found the results unacceptable. Inaccurate results may result from failure to collect samples correctly or to use the kit correctly, the manufacturer explained. On March 27, Spanish authorities switched to another supplier, Shenzhen Boyi.By March 31, the United Arab Emirates had tested more people per capita than any other country. [60] The UAE implemented a combination of drive-thru sample collection and high-throughput laboratories from Group 42 and BGI.The laboratory performs tens of thousands of RT-PCR tests per day, and is the first laboratory operating at this scale outside of China.By the end of the month, testing has exceeded 200k/week.