WellsBio Obtains Domestic Approval for Severe Fever with Thrombocytopenia Syndrome Diagnostic Kit

WellsBio, a subsidiary of Access Bio, announced on the 8th that it has obtained domestic approval for a genetic diagnostic reagent capable of detecting infection with the Severe Fever with Thrombocytopenia Syndrome (SFTS) virus.

WellsBio's diagnostic reagent for Severe Fever with Thrombocytopenia Syndrome.
[Photo by WellsBio]

The "Caregen SFTS Virus RT-PCR Kit," approved this time by WellsBio, is an in vitro diagnostic medical device that helps diagnose the disease by detecting the SFTS virus gene in human blood samples using real-time reverse transcription polymerase chain reaction (real-time RT-PCR).

The company explained that clinical trials conducted domestically showed both sensitivity and specificity at 100%, enhancing the accuracy and efficiency of diagnostic testing. Additionally, the test is precisely designed to detect the virus even when only 25 RNA copies are present per test.

SFTS is a newly emerging infectious disease first identified in China in 2009 and whose cause was determined in 2011. It is a Class 3 legally designated infectious disease transmitted by Haemaphysalis longicornis and Haemaphysalis flava ticks carrying the SFTS virus. The main symptoms include fever and gastrointestinal symptoms such as loss of appetite, abdominal pain, nausea, vomiting, and diarrhea. A total of 1,334 SFTS patients were reported and notified in South Korea between 2013 and 2020. Since 2017, approximately 200 to 250 patients have been reported annually.

Since no preventive vaccine or antiviral treatment has been developed for SFTS to date, avoiding tick bites is the best preventive measure. If symptoms are suspected, it is essential to visit the nearest medical institution promptly for early testing.

A WellsBio representative stated, "Abnormal findings detected through blood tests of patients with Severe Fever with Thrombocytopenia Syndrome can also be observed in other diseases, so confirmation must be made through the detection of the causative virus gene." He added, "WellsBio's diagnostic reagent is a product that considers not only high accuracy but also efficiency, and it will greatly contribute to the domestic quarantine system."

WellsBio, a subsidiary of Access Bio, is a specialized diagnostic product development and manufacturing company established in 2013 with the purpose of developing next-generation diagnostic products.

This content was produced with the assistance of AI translation services.