Product Certification Completed Within This Month... Priority Overseas Supply of 2 Types

"Confirmed Infection Within 20 Minutes" Celltrion to Launch COVID-19 Diagnostic Kit in July View original image


[Asia Economy Reporter Cho Hyun-ui] Celltrion announced on the 16th that it will complete certification of its COVID-19 diagnostic kit products within this month and begin overseas supply.


Celltrion plans to launch an antigen point-of-care test (POCT) that can deliver results within 20 minutes in July, developed jointly with the diagnostic kit specialist company 'VIVV'. This product, which incorporates Celltrion's proprietary COVID-19 antibody-antigen technology to enhance sensitivity, is scheduled to complete certification within this month.


POCT is a diagnostic device that uses portable equipment to test specimens directly at the clinical site and confirm results immediately, featuring higher sensitivity than rapid diagnostic tests (RDT) that are visually identified. The antigen POCT jointly developed by Celltrion and VIVV offers the advantage of antigen diagnostic kits that can detect early-stage infected patients who have not yet formed antibodies, while simultaneously providing the rapidity of existing rapid diagnostic kits and the high sensitivity of molecular diagnostics.


A Celltrion official explained, "Recent prototype tests showed over 95% sensitivity compared to RT-PCR (reverse transcription polymerase chain reaction) within 20 minutes, achieving the highest level of completeness among existing COVID-19 related rapid diagnostic devices."


Additionally, Celltrion will supply COVID-19 antibody rapid diagnostic kits (RDT), which are in high demand in European and U.S. markets, overseas under the Celltrion brand this month through a partnership with the domestic diagnostic kit specialist company 'Humasis', which developed the product.


Antibody RDTs have the advantage of allowing easy testing of many patients at a low cost. Since sensitivity appears from about one week after onset when antibody formation becomes active, they are widely used in medical institutions for purposes such as confirming discharge of recovered patients. Celltrion plans to continue joint development of the RDT platform with Humasis, supplying not only improved antibody RDTs with higher sensitivity using Celltrion's proprietary antibody-antigen technology but also antigen RDTs.


Celltrion intends to prioritize supplying these products to countries where public diagnostic infrastructure is relatively weak compared to Korea or where efforts to return to normal life during the pandemic are accelerating for economic recovery.



A Celltrion official stated, "Alongside the ongoing successful development of therapeutics, we are on the verge of global supply of diagnostic kit products through productive collaboration with specialized companies. While contributing to the global effort to end COVID-19, we will continue to explore various ways to leverage advanced technologies of domestic diagnostic device companies for the joint development of Celltrion and the diagnostic industry."


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

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