SugenTech Proves Molecular Diagnostic-Level Accuracy in Clinical Results of COVID-19 Test Kit

[Asia Economy Reporter Hyunseok Yoo] SuzenTech announced on the 1st that its rapid diagnostic kit for the novel coronavirus infection (COVID-19) has been proven through clinical trial results to possess diagnostic accuracy comparable to that of 'molecular diagnostics'.

The COVID-19 antibody rapid diagnostic kit developed by SuzenTech, 'SGTi-flex COVID-19 IgG/IgM', underwent clinical trials at two major domestic hospitals immediately after its development. The clinical trial involved a total of 250 samples, including 100 positive patient samples and 150 negative patient samples. While most companies currently developing rapid diagnostic kits typically conduct in-house clinical trials with about 10 to 30 samples, SuzenTech recruited a large and diverse patient group and conducted clinical trials with major hospitals, resulting in a highly reliable sample size, according to the company.

The clinical trial results showed that SuzenTech's rapid diagnostic kit achieved 94% accuracy compared to molecular diagnostic methods. Sensitivity was 91%, and specificity was about 97%. Considering that rapid antibody diagnostic kits generally record about 80% accuracy, this represents a top-level accuracy. Consequently, SuzenTech's COVID-19 antibody diagnostic kit can quickly determine infection status within 10 minutes using just a drop of blood, and it possesses molecular diagnostic (RT-PCR) level accuracy that typically requires expensive equipment in specialized testing facilities, making it optimized for concurrent diagnostic use.

A company representative stated, "Some rapid diagnostic kit developers claim 100% accuracy after clinical trials for their COVID-19 rapid diagnostic kits, but they do not disclose clinical data, suggesting that they may have evaluated accuracy highly based on a limited number of samples. In contrast, SuzenTech's posted clinical results were conducted with a large-scale sample of 250 from two major hospitals, ensuring high reliability in clinical trial design, and they quantified diagnostic accuracy compared to molecular diagnostics, securing statistical accuracy."

A SuzenTech official added, "Recently, as accuracy issues with Chinese-made kits have emerged, inquiries from overseas parties regarding the accuracy of SuzenTech's rapid diagnostic kits have surged, prompting us to post clinical trial results on our English website. Like pregnancy test kits, just dropping a single drop of blood onto the diagnostic kit allows immediate results within 10 minutes, and the high accuracy has been proven, leading to a rapid increase in supply requests from abroad." He continued, "As related companies are gradually succeeding in developing diagnostic kits, overseas parties are already focusing on the accuracy and reliability of kits, so clinical results that can gain external credibility will become increasingly important."

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