As of April 10, 2020, the number of U.S. SARS-CoV-2 coronavirus cases surpassed 500,000 with a death toll near 19,000. For over a century, coronaviruses were thought to only cause mild illnesses such as the common cold. With the outbreak of the 2002-03 SARS (severe acute respiratory syndrome) that was caused by SARS-CoV coronavirus, this concept was rapidly overturned, and as a result coronavirus research has geared up for the fast lane.
Coronaviruses are a family of large, single-stranded RNA viruses with size ranging from 26 to 32 kb. Like other viruses, coronaviruses proliferate by invading cells, manipulating the cells into making many copies of the virus, and infecting more cells. As an RNA virus, the coronavirus lacks error-repairing mechanisms during replication, and therefore, has a relatively high mutation rate resulting in rapid evolution.
At the 3′-end of the viral genome the four main structural proteins of coronavirus particles are encoded and include the nucleocapsid protein (N), membrane glycoprotein (M), small envelope protein (E), and spike protein(S) (Figure 1). Additionally, a subgroup of β-coronaviruses also contains a fifth structural protein, the hemagglutinin-esterase (HE). Among them, M and E proteins form a ball protecting the RNA genetic core, which is wrapped by N protein in a beads-on-a-string type conformation. S protein forms protrusions that can bind to certain receptors on target cells for infection and gives the virus a crown or corona-like shape, hence the name “coronavirus”.
Figure 1. Schematic diagram of coronavirus structure.
When detecting the SARS-CoV-2 in clinical and environmental samples, real-time reverse transcriptase polymerase chain reaction (RT-qPCR) is the gold standard. RT-qPCR can amplify and detect trace amounts of target viral RNA, making it sensitive for viral detection even days before symptoms show up. To aid in the global efforts for research and identification of the SARS-CoV-2, ScienCell developed a coronavirus detection kit (Cat #RX7038) by RT-qPCR, which recently received FDA Emergency Use Authorization (EUA). Importantly, our kit follows the latest CDC guidelines for detection of SARS-CoV-2. Included in the kit are two primer/probe sets (Cat #RX7038-N1 and RX7038-N2) that target the conserved regions of coronavirus nucleocapsid (N) gene, a Human RPP30 gene primer/probe set (Cat #RX7038-RP) that targets exon 1 of human RPP30 gene and serves as a control to assess specimen quality, a positive control (Cat #7038-Pos) consists of non-infectious viral RNA fragments spiked into human small airway epithelial cells and serves to ensure reagents and instruments are working properly. For more information on SARS-CoV-2 and its detection, please contact firstname.lastname@example.org.
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.