For the detection of COVID-19 and the Severe Acute Respiratory Syndrome 2 coronavirus, it is possible to perform tests based on the polymerase chain reaction (PCR), nucleic acid test and the enzyme-linked immunosorbent assay (ELISA) for the detection of specific antibodies.
One of the first PCR tests was developed at the University Hospital of Charité, Berlin, in January 2020, using real-time polymerase chain reaction (RT-PCR) and formed the basis of 250,000 kits that the World Organization of Health went on to distribute. A South Korean company called Kogenebiotech developed a PCR-based SARS-CoV-2 detection kit called PowerCheck Coronavirus on January 28, 2020. It looks for the "E" gene, which is shared by all beta coronaviruses and the SARS-CoV-2 specific RdRp gene. Other companies in the country, such as Solgent and Seegene, also developed their versions of detection kits called the DiaPlexQ and Allplex 2019-nCov Assay, respectively, in February 2020. In China, BGI was one of the first companies to receive approval from emergency use of the National Medical Devices Administration to organize a PCR-based SARS-CoV-2 detection kit. In the United States, the Centers for Disease Control and Prevention (CDC) developed the RT-PCR Diagnostic Panel of the New Coronavirus (2019-nCoV) which was made available to public health laboratories by the International Reagent Resource, internal agency of the CDC. One of three genetic tests in older versions of the kits projected inconclusive results and a traffic jam in Atlanta; the tests, which used two components, were deemed reliable on February 28, 2020, allowing state and local laboratories to quickly complete the analysis. The test was then approved by the Food and Drug Administration under an emergency use authorization. US commercial laboratories also began testing. On March 5, 2020, LabCorp announced the nationwide availability of COVID-19 testing based on RT-PCR. Quest Diagnostics similarly released the national COVID-19 test on March 9, 2020. No limitation on the amount of testing performed was stipulated; collection and processing of specimens must be performed in accordance with the requirements of the Centers for Disease Control and Prevention. On March 12, 2020, the Mayo Clinic reported having developed a test to detect COVID-19 infection. As of March 2020, Hoffmann–La Roche received FDA approval to create a test that could be run within 3.5 hours, allowing a machine to run approximately 4,128 tests in a 24-hour period.
On February 28, 2020, another South Korean company named PCL submitted a request to the South Korean Ministry of Food and Drug Safety to enable the use of its RT-PCR-based detection kit. The company claims that the antibody-based material can make a diagnosis in up to 10 minutes. On March 8, 2020, Taiwan's Academia Sinica announced the world's first monoclonal antibody that specifically binds to the nucleocapsid protein (protein N) of the new coronavirus, was successfully generated and tested in just 19 days. If the rapid immunological test kit can be successfully developed and manufactured based on this antibody, it will be very useful for detecting SARS-CoV-2 within 15 to 20 minutes, just like a rapid influenza test.
The Expify Respiratory test, owned by IDbyDNA, is a Metanogenomic nucleic acid analysis test that can identify more than 900 respiratory pathogens, including the SARS-CoV virus strain