Aenium started clinical trials with the Spanish authorities on April 25, 2020, and performed hundreds of clinical comparisons with commercial nasal swabs. In the clinical trials, RNA was processed by one-step RNA real-time PCR using two kits RT-PCR (BGI) and ref. RR064A (Takara) to detect SARS-CoV-2. Both nasal swabs included an endogenous control, obtaining positive results compared with the same clinical trials over other certified conventionally manufactured commercial swabs. Aenium and Burloak developed a RNA-free nasal swab with specific laboratory-tested parameters.
Rapid Manufacturing Systems contributed to the mass production vision of offering market value for the nasal swabs industrialization. Based on this success, more products are in the pipeline (e.g. pediatric nasal swabs).
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