Distinguishing COVID-19 and Flu Diagnosis Results
"Supply Contract to Be Finalized"
[Asia Economy Reporter Myunghwan Lee] SuzenTech announced on the 7th that it has received manufacturing approval from the Ministry of Food and Drug Safety for a combo rapid diagnostic product that can simultaneously test for COVID-19 and influenza.
According to SuzenTech, most of the previously approved diagnostic kits for simultaneous COVID-19 and influenza testing were either duo products combining two separate products or combo products that detect three viruses simultaneously on a single strip. In these cases, the test results were generally all indicated by red lines.
In contrast, SuzenTech's new combo product (SGTi-flexM COVID-19 & Flu A/B Ag) incorporates nanotechnology, allowing differentiated interpretation of test results. By applying nanobeads of various colors, the results for each virus and the control line are distinguished in blue and red, enhancing visibility and ease of interpretation.
The accuracy showed sensitivities of 90.9%, 96.6%, and 93.0% for COVID-19 and influenza types A and B, respectively. The specificity for all three viruses was 100%.
A SuzenTech representative stated, "In a situation where it is difficult to distinguish between influenza virus and COVID-19 suspected patients, leading to a 'twindemic' phenomenon, the newly approved product is expected to assist in diagnosing single or simultaneous infections of COVID-19 and influenza with a single test." They added, "We are currently in close consultation with major domestic pharmaceutical companies to ensure smooth product supply and plan to finalize sales and supply contracts soon."
Meanwhile, the Ministry of Health and Welfare established the 'Simultaneous Testing Reimbursement Criteria for Influenza A·B Virus Antigens and SARS-CoV-2 Antigens' through an administrative notice on the 26th of last month. The reimbursement criteria have been applied since the 1st of this month. Medical institutions are expected to be able to conduct combo kit diagnostic tests for patients exhibiting symptoms of influenza or COVID-19 and claim reimbursement accordingly.
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