Seegene's COVID-19 Self-Sample Collection Method 'ComboSwab' Approved for Use in Europe

Self-Collection of Specimens by Blood Test Subjects Under Medical Expert Supervision

[Asia Economy Reporter Kim Ji-hee] Seegene announced on the 24th that it has obtained the European CE-IVD (In Vitro Diagnostic Medical Device) certification to use 'ComboSwab,' which allows test subjects to collect their own specimens, for four types of COVID-19 diagnostic products. The applicable products include three that diagnose COVID-19 and its variants, and one that can simultaneously diagnose COVID-19 and influenza, totaling four types.

ComboSwab was devised to address the inconvenience of the existing PCR test specimen collection method for COVID-19 diagnosis, the 'nasopharyngeal swab method.' The nasopharyngeal swab method involves a medical professional scraping the mucous membrane deep inside the nose with a swab to collect the specimen. Since medical staff conduct the test one person at a time, the process takes considerable time. This inevitably leads to long waiting lines during large-scale testing. Additionally, during specimen collection, there is a risk of secondary infection to the tester or bystanders due to sneezing or other reactions from the test subject.

In contrast, ComboSwab is designed to allow test subjects to collect specimens themselves by swabbing inside their nose and mouth under the supervision of medical professionals. This enables specimen collection from many people simultaneously with fewer medical staff, significantly increasing testing capacity. It also reduces discomfort for test subjects, lowering resistance to testing.

The accuracy of test results is also high. Clinical trials comparing PCR tests conducted with specimens collected via the nasopharyngeal swab method and ComboSwab showed a 96.7% concordance rate for COVID-19 positive results, indicating equivalent levels. Countries such as the United States, the United Kingdom, and Singapore already use methods where test subjects collect specimens under medical supervision at designated locations.

Lee Min-cheol, head of Seegene's Life Science Research Institute, said, "Although ComboSwab is a self-collection method, it offers high accuracy and allows simultaneous collection of multiple specimens, making it suitable for situations requiring large-scale testing due to the spread of variants like Delta. Adding the convenience of ComboSwab to Seegene's multiplex technology-based diagnostic products will help increase global demand for Seegene's diagnostic reagents."

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