Catholic University of Korea, Seoul St. Mary's Hospital has developed a new diagnostic system to quickly diagnose hepatitis within 20 minutes using a small amount of blood.
Blood is a useful resource in emergency situations or at medical institutions that do not have the large diagnostic equipment, considering it can be used immediately for tests without the need for any preprocessing such as mixing in a centrifuge.
|St. Mary's Professors Oh Eun-jee (left) and Han Kyung-ja|
The team, led by St. Mary's Professors Oh Eun-jee and Han Kyung-ja of the Department of Laboratory Medicine, worked with Korean biotechnology firm Boditech Med to develop the Automated Fluorescent Immunoassay System (AFIAS), a small diagnostic device that accurately detects hepatitis B and C. The study was published in the Annals Laboratory Medicine.
According to the paper, researchers compared the diagnostic performance of AFIAS with that of automated chemiluminescent immunoassays (CLIAs) to evaluate usability. The study showed AFIAS sensitivity to be 99.8 percent while specificity was 99.3 percent for the HBsAg test. The diagnostic system also garnered 100.0 percent for the anti-HBs tests, and a 98.8 percent and 99.1 percent for the anti-HCV tests.
Boditech Med's AFIAS is an automatic immunoassay analyzer that analyzes blood using an optical module capable of detecting high-sensitivity fluorescent materials and body fluids. It is a small device that can be simultaneously inspected and read on the spot.
|Automated Fluorescent Immunoassay System (AFIAS)|
"Research related to the recent rapid identification of various diseases, such as cancer and stroke, with a drop of blood, is accelerating, and the rapid identification of hepatitis B and C," Professor Oh Eun-jee said. "In the case of small and medium-sized hospitals, it is possible to increase the convenience of diagnosis and increase the early diagnosis by lowering the cost."
The immunodiagnostic device obtained the fourth-grade approval, the highest safety grade of the medical device safety, from the Ministry of Food and Drug Safety.