BiOptic Qexp-MDx Direct SARS-CoV-2 Detection System (CE-IVD)

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) belongs to the beta-coronavirus family, a group of single-positive-strand RNA viruses with envelopes. Coronavirus was named since its crown-like appearance observed under an electron microscope. They are infectious commonly between humans and animals. Currently, there are seven species known to infect humans: HCoV-229E, HCoV-NL63, HCoV-HKU1, HCoV-OC43, SARS-CoV, MERS-CoV, and SARS-CoV-2. According to the WHO announcement, the disease caused by SARS-CoV-2 is called COVID-19 (Coronavirus Disease-2019).

GLOBAL epidemic of SARS-CoV-2
As of Nov 29, 2021, there have been a total of 260,446,893 reported cases in 195 countries/regions, including 5,207,502 deaths. Since the genetic material of the virus is a single-stranded RNA, which is more likely to mutate while replication. Today, many mutant strains have appeared, include the more infectious variants: the United Kingdom (B.1.1.7), South Africa (B.1.351), Brazil (P.1),  and recently reported new mutant strain Omicron (B.1.1.529). Omicron has been listed as a variant of concern (VOC) by the WHO, as of Nov 28, at least 13 countries have reported more than 100 cases.

SYNDROME of COVID-19
The human SARS-CoV-2 were the results of infection by direct or indirect contact with secretions or droplets from carriers. According to WHO, the incubation period is about 1 to 14 days, and the carriers become infectious 2 days before symptoms. The symptoms include fever, dry cough, fatigue, shortness of breath, muscle aches, headaches, sore throat, etc. A few severe cases will have severe pneumonia, respiratory distress or organ failure, and even death. Nucleic acid testing is the first choice for testing (also have antigen test kit). Currently, supportive therapies are mostly used for treatment; life-sustaining treatment for severe cases.

3 STEPs complete diagnosis