SugenTech, COVID-19 Antibody Test Kit... "US Clinical Trial Proves 100% Sensitivity, 99% Specificity"

[Asia Economy Reporter Hyunseok Yoo] SuzenTech's novel coronavirus disease (COVID-19) antibody rapid diagnostic kit 'SGTi-flex IgM/IgG' recently demonstrated final clinical performance with 100% sensitivity (ability to identify positives as positive) and 99% specificity (ability to identify negatives as negative) in performance evaluations conducted in the United States for the U.S. FDA's Emergency Use Authorization (EUA).

SuzenTech announced on the 28th that in the performance evaluation conducted by the U.S. National Cancer Institute (NCI), the sensitivity was 100% (30 clinical samples), and in clinical trial institutions in the U.S., the specificity was 99% (121 clinical samples), showing higher accuracy. These results are higher than the clinical trial results conducted in Korea, which showed 94% sensitivity (163 clinical samples) and 98% specificity (360 clinical samples).

This clinical trial was conducted as part of the process for obtaining FDA approval for the antibody diagnostic kit. The NCI, responsible for accuracy testing by the FDA, initially conducted an experiment with significant errors, prompting the company to perform a retest. SuzenTech submitted these results to the FDA and decided to undergo the U.S. NCI evaluation again.

A SuzenTech official stated, "In the performance evaluation conducted by the U.S. NCI, specificity was assessed using specimen samples not originally intended for the company's intended use, resulting in a 90% specificity for IgM antibodies (100% specificity for IgG antibodies), causing significant errors. This clinical trial verified the accuracy," adding, "The clinical results have been submitted to the FDA, and through consultation with the U.S. FDA, we decided to undergo the U.S. NCI evaluation again."

He continued, "Although the results conducted by NCI had significant errors, FDA regulations require that retest results be posted on the website, which could lead to misunderstandings that SuzenTech's diagnostic kit failed to receive approval," and added, "If the retest proceeds, EUA approval is expected within a month, and once the retest results are available, the FDA will revise and post the clinical results."

In the U.S., antibody rapid diagnostics are used more for confirming immunity and determining the possibility of returning to daily life rather than for judging infection status, so demand is high amid the prolonged COVID-19 situation. SuzenTech has already completed consultations with several U.S. diagnostic device distributors and plans to begin mass supply immediately upon EUA approval.

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