Shuwen Biotech Receives CE-IVD Mark for its SARS-COV-2 RT-PCR Kit

Feb, 2021 - by CMI

Shuwen Biotech, a China-based biotech diagnostic company that offers diagnosis screening test kits & services to improve prediction, prevention, and diagnosis & treatment of various diseases, received the CE-IVD Mark for its SARS-COV-2 RT-PCR Kit.

The Covid-19 pandemic has led to devastating effects on both public life and the economy of various countries. The novel coronaviruses are viruses that, in humans, cause serious illness such as pneumonia, encephalitis and meningitis. There are a lot of different types of novel coronavirus and all are responsible for a variety of different syndromes. The most common symptoms of novel coronaviruses are high fever, malaise, vomiting, diarrhea and abdominal pain. Novel coronaviruses are generally transmitted from one person to another through bodily fluids such as blood, saliva, vaginal secretions and through the air.

Public health laboratories can determine if a person has a novel coronavirus by testing samples obtained from the throat, nose and armpit. According to the World Health Organization, globally, as of 5:33pm CET, 4 January 2021, there have been 83,910,386 confirmed cases of COVID-19, including 1,839,660 deaths. Such scenario has prompted various countries to scale up production and escalate faster delivery of COVID-19 testing kits. In line with the strategy, Shuwen received clearance from the relevant Chinese government agency for export of the kit to Europe and other territories recognizing CE certification.

The kit detects nucleic acids from the novel coronavirus in upper and lower respiratory specimens. The main feature of the kit is the real-time reverse transcription PCR. The kit is compatible with several real-time PCR platforms such as, Rotor-Gene Q, QuantSudio Dx, ABI 7500, SlAN-96S, ABI 7500Fast, LightCycler 480II, Cobas Z480, and CFX96. It can detect active infections from nasal, nasopharyngeal and oropharyngeal swab specimens. In another achievement, Shuwen Biotech recently received the China National Medical Products Administration approval for its patent-protected Preeclampsia Detection Kit, a rapid non-invasive urine-based point-of-care test for the detection of preeclampsia, a pregnancy complication.