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Coronavirus was initially identified in the Guangdong province of southern China in November 2002. Known by the name, severe acute respiratory syndrome coronavirus (SARS-CoV) is thought to be an animal virus that emerged from bats and became epidemic by affecting 26 countries and further resulting in more than 8,000 cases in 2003.
Middle East respiratory syndrome coronavirus (MERS-CoV) infection was first reported in September 2012 in Saudi Arabia. Till date, nearly 2,500 cases of this type of infection has been reported in 27 countries in a near the Arabian Peninsula. In addition, the largest outbreak of MERS-CoV outside this peninsular region occurred in the Republic of Korea in 2015.
And now, with the outbreak of pneumonia of unknown aetiology in Wuhan City, Hubei Province, China, COVID-19, also known as SARS-CoV2 has emerged as a pandemic infection, as declared by the World Health Organization (WHO).
Initially, an express test to identify the novel coronavirus was developed in the Chinese city of Wuxi, eastern Jiangsu Province by the National Institute for Communicable Disease Control and Prevention. It was observed that the diagnostic kit delivered results in 8-15 minutes and reported to be highly sensitive, easy-to-use, and easily transportable. After the virus had spread to other parts of the world, a number of countries such a South Korea, the U.S., and Russia managed to develop diagnostic kits as they received genome of the new virus.
The 2019-novel coronavirus (2019-nCoV) real-time reverse transcription (RT) PCR diagnostic panel, provided by the Centers for Disease Control and Prevention (CDC) in the U.S., is a test intended for the qualitative detection of nucleic acid from the 2019-nCoV in upper and lower respiratory specimens such as nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) collected from individuals who meet 2019-nCoV clinical and/or epidemiological criteria. The criteria include clinical signs and symptoms associated with 2019-nCoV infection, contact with a probable or confirmed 2019-CoV case, and history of travel to geographic locations where positive cases have been detected.
The diagnostic kit provided by CDC is a molecular in-vitro diagnostic test that aids in the detection and diagnosis 2019-CoV and is based on widely used nucleic acid amplification technology. Moreover, the product contains oligonucleotide primers and dual-labelled hydrolysis probes (TaqMan) and control material used in real-time RT-PCR for the in-vitro qualitative detection of 2019-nCoV RNA in respiratory specimens. Also, the diagnostic tests can only be performed by trained laboratory personnel who are proficient in performing RT-PCR assays.
Furthermore, in India, on March 24th, 2020, a Pune-based molecular diagnostic company, Mylab Lifesolutions Pvt. Ltd., became the first Indian company to granted validation for its COVID-19 diagnostic test kits, or RT-PCR, by the Drug Controller of India, after the validation from the National Institute of Virology. With the rapid increase in the total number of COVID-19 cases, across the globe, the need for rapid and reliable diagnostics are increasing, thereby, boosting the demand for coronavirus diagnostic kits, significantly.
Furthermore, the companies actively providing the diagnostic kits to test the presence of coronavirus infection, in individuals showing clinical symptoms include, MoBiTec GmbH, Siemens Healthineers, CerTest BIOTEC, altona Diagnostics GmbH, Mylab Lifesolutions Pvt. Ltd., and F. Hoffmann-La Roche Ltd.