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Development of COVID-19 tests

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Development of COVID-19 tests

The COVID-19 transmission is rapid and occurs via inhalation of respiratory droplets or aerosol particles contaminated with SARS-CoV-2. The viral deposition occurs on mucous membranes of nose, mouth, or eyes via sprays and splashes; or direct contact with hands contaminated with SARS-CoV-2 either by respiratory fluids or by touching surfaces contaminated with the virus. Evidence from studies suggests that SARS-CoV-2 aerosols can stay viable in air for about 3 hours, have a half-life of about 1 hour and can survive for more time on steel and plastic while compared to cardboard and copper. Hence, developing a therapy against COVID-19 was progressing at a pandemic speed, yet there is no effective therapy approved by food and drug administration (FDA). Vaccines seem promising and currently include Pfizer-BioNTech vaccine, Moderna vaccine, Oxford/AstraZeneca vaccine, and the Janssen vaccine. But all of these therapeutic strategies cannot offer complete protection against COVID-19 paving way for epidemiological approaches to break the chain of disease transmission. In such an approach, diagnostics is the most crucial tool helping to identify the disease cases leading to isolation as well as contact tracing, thereby preventing other people from coming in contact with the patients or their recent contacts.

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 virological.org, a "hub for prepublication data designed to assist with public health activities and research". 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 country had reliable data on the prevalence of 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 10 January 2020,. 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.

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