WellsBio Receives Approval for Tsutsugamushi Diagnostic Kit... "100% Sensitivity and Specificity"

WellsBio Tsutsugamushi Diagnostic Kit. [Photo by WellsBio]

[Asia Economy Reporter Lee Gwan-joo] WellsBio, a subsidiary of Access Bio, announced on the 22nd that it has obtained domestic approval for the 'careGENE™ Scrub Typhus Real-time PCR kit,' which can diagnose infection with the Orientia tsutsugamushi bacterium.

This kit is an in vitro diagnostic medical device that helps confirm infection by detecting the specific gene of the Orientia tsutsugamushi bacterium in whole blood samples from patients suspected of scrub typhus infection using real-time polymerase chain reaction (Real-time PCR).

Results can be confirmed within 80 minutes after the test begins, improving diagnostic testing efficiency. Clinical trials conducted domestically showed both sensitivity and specificity at 100%, proving excellent clinical performance.

WellsBio plans to launch this product within this month and will actively supply it to domestic medical institutions. Additionally, by obtaining CE certification currently in preparation, the company plans to accelerate entry into overseas diagnostic markets such as Europe.

A WellsBio representative stated, "Scrub typhus has initial symptoms very similar to COVID-19 and influenza, so the accuracy of diagnostic tests is even more emphasized," adding, "We hope this product, which considers not only the accuracy but also the efficiency of scrub typhus diagnosis, will significantly contribute to the domestic quarantine system."

Scrub typhus is an acute febrile illness transmitted by larvae of chigger mites carrying the Orientia tsutsugamushi bacterium. It is a Class 3 legally designated infectious disease with the highest number of patients among mite-borne infectious diseases. After an incubation period of 1 to 3 weeks, sudden chills, fever, and headache begin, followed by cough, vomiting, muscle pain, abdominal pain, and pharyngitis, accompanied by rash and eschar (scab).

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