Siemens Healthineers Obtains MFDS Approval for COVID-19 Virus IgG Antibody Test

Siemens Healthineers' SARS-CoV-2 IgG antibody test (sCOVG).

[Asia Economy Reporter Lee Gwanju] Siemens Healthineers Korea announced on the 24th that it has received approval from the Ministry of Food and Drug Safety for the COVID-19 virus (SARS-CoV2) IgG antibody test (sCOVG) product.

Siemens Healthineers' ‘SARS-CoV2 IgG’ test is designed to detect IgG antibodies against the spike protein, which acts as a mediator when the virus invades the human body.

With this product approval, Siemens Healthineers has obtained authorization for both the total antibody test (COV2T) and the IgG antibody test (sCOVG), targeting the spike protein antigen.

The total antibody test (COV2T), which was already approved by the Ministry of Food and Drug Safety in April last year, detects both IgM and IgG antibodies present in the blood, helping to identify asymptomatic infections or confirm virus infection without prior diagnosis, thus aiding early response during the pandemic.

The IgG antibody test (sCOVG) selectively measures only IgG, which is maintained for a longer period compared to IgM, and is expected to play an important role in long-term quarantine guidelines and vaccination-related policies.

Siemens Healthineers' IgG antibody test can be utilized across various equipment groups depending on the size of the laboratory. Using the Atellica Solution immunoassay analyzer, which can process 440 tests per hour, the first test result can be obtained in just 25 minutes.

Myungkyun Lee, CEO of Siemens Healthineers Korea, stated, “Siemens Healthineers is the only company supplying both the IgG antibody test (sCOVG) and the spike protein-based total antibody test (COV2T), and will continue to contribute to Korea’s long-term COVID-19 quarantine guidelines and response measures.”

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