Yonsei University's Department of Laboratory Medicine has conducted clinical research and published a paper (ASM Journal)
The medical device equipment inspection for GMP certification and KFDA approval has been completed by KTL
Project Details:
Performance parpameters for the prediction of positive urine culture in two subsets(overall and trained-species set) according to the tow cutoff values for positive urine culture
(June 1, 2019 - December 31, 2020, Ministry of Trade, Industry and Energy > Korea Institute for the Advancement of Technology)
2022' Conference Presentation on Researcher Clinical Results for UTI Analysis Equipment (Bacometer)
The study analyzed the same urine samples from a total of 263 patients using both the traditional culture method and the Bacometer.
When the infection threshold was set at 5,000 cfu/ml, the Bacometer demonstrated a sensitivity of 100% and a specificity of 98.3%, outperforming FDA-approved products. Additionally, the Bacometer reduced the testing time to 30 minutes, a significant improvement compared to the 24 hours required by traditional culture methods.
Table1. Performance parpameters for the prediction of positive urine culture in two subsets(overall and trained-species set) according to the tow cutoff values for positive urine culture
Testing Set(no.) | Cutoff (CFU/ml) | Accuracy (%) | Sensitivity (%) | Specificity(%) |
Overall(263) | 1,000 | 90.9 | 76.1 | 98.3 |
50,000 | 98.5 | 100.0 | 98.3 | |
Trained species(195) | 1,000 | 97.9 | 95.0 | 98.3 |
50,000 | 99.0 | 100.0 | 98.9 |
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