TAIPEI (CNA) — A technical cooperation effort between Taiwan and Denmark has produced a testing device for the COVID-19 coronavirus that shows the results in just 12 minutes, but it is still in the clinical trial stage, Taiwan’s Ministry of Science and Technology announced Wednesday.
The device, dubbed ViroTrack COVID-19 IgM/IgG, was developed by a joint startup BluSense Diagnostics, with funding from Taiwan, the ministry said while unveiling the test kit at a press event.
All it requires is one drop of blood (30 ul) from the patient, and the ViroTrack can produce a result within 12 minutes, indicating whether the person is carrying the virus or has recovered from a COVID-19 infection, the ministry said.
In an initial clinical trial last week, 15 blood samples were tested at Hvidovre Hospital in Denmark, and performance of the device was 90 percent in terms of both sensitivity and specificity, according to BluSense Diagnostics.
Further clinical trials will be conducted next week at Italian hospitals, with the aim of obtaining certification in the European Union in May and releasing the device on the Taiwan market by June, the company said.
ViroTrack is portable and easy to use, which makes it suitable for COVID-19 screening at ports of entry, Deputy Science and Technology Minister Shieh Dar-bin (謝達斌) said at the press event, adding that he hopes it can be supplied to countries that have limited testing capacity.
The device will be also be valuable in contact tracing in communities to identify asymptomatic patients, according to BluSense Executive Vice President Jessie Sun (孫偉芸).
ViroTrack works by checking the human antibodies immunoglobulin M (IgM) and Immunoglobulin G (IgG) to determine the stage of infection, according to BluSense Diagnostics Chairman Filippo Bosco.
IgM is the largest human antibody and usually the first to appear in the response to initial exposure to an antigen, while IgG is the most prolific and acts as protection against bacterial and viral infection.
In COVID-19 cases, IgM appears around the 4th day of the infection, which means it can indicate suspected cases, while IgG shows up on the 10th day or later, giving an indication of whether the patient has been infected or is recovering, Bosco said.
With the help of those indicators, medical professionals can determine whether a patient has recovered and can be discharged from the hospital, which is much more efficient than the current polymerise chain reaction (PCR)-based tests, he said.
At present, PCR and antibody testing are the main forms of COVID-19 testing globally, while ViroTrack uses blood serum, according to Shieh.
BluSense Diagnostics, a startup jointly funded by Taiwan and Denmark, has its biochemical research base in Copenhagen and its hardware and software development and research center, as well as a manufacturing plant, in Taoyuan, northern Taiwan.