By Fineline Cube 
China-based Dynamiker Biotechnology (Tianjin) Co., Ltd. announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Aspergillus nucleic acid detection kit (fluorescent PCR method). This marks the first product from Dynamiker Bio’s molecular diagnostics platform to gain regulatory approval.
Significance of the Approval
The kit is specifically designed for the early, rapid, and precise diagnosis of invasive aspergillosis. It enables fast and accurate detection of specific nucleic acid fragments of Aspergillus species in bronchoalveolar lavage fluid (BALF) samples, delivering results within just 2 hours after sampling.
Technical Performance
The kit demonstrates exceptional performance with a sensitivity of 96.67% and specificity of 99.02%, making it a reliable tool for the diagnosis of Aspergillus infections.-Fineline Info & Tech