Technologies

ERA Technology：

Enzymatic Rapid Amplification (ERA ) Technology is a new type of innovative and novel qpcr technologyg, which is global leading and independent intellectual property isothermal nucleic acid amplification technology developed by R&D team of Suzhou GenDx. ERA uses advanced Molecular Design, Directed Evolution, Affinity Mathematics and other technical means in the field of antibody pharmacy to transform and mutate specific enzymes from bacteria, viruses and bacteriophages. Following that, screening of functional mutants and optimizing of the combinations are conducted. The core recombination isothermal amplification system was obtained. The method was applied for Chinese patents and international patents (Application No.: 201910262085.3; PCT201910262085.3). The method can specifically amplify trace target DNA fragments at low temperature (25-42℃). At the optimal temperature of 37-45℃, the amplification process only takes 5-20 minutes. Its low temperature adaptability and sensitivity have made significant breakthroughs and reached the international advanced level.

Nucleic acid rapid release technique：

The core principle of GenDx Nucleic Acid Rapid Extraction Reagent relies on an enzymatic-chemical synergistic lysis system utilizing specific enzymes, denaturants, and chaotropic salts to rapidly disrupt the hydrogen bonding networks and hydrophobic interactions within cell walls/membranes, while simultaneously inhibiting nuclease activity. This is combined with reverse adsorption technology to achieve efficient nucleic acid release and purification.Through the cleavage of covalent bonds (e.g., peptide bonds, ester bonds) in membrane structures and the disruption of histone-DNA intermolecular forces, nucleic acids are liberated. This process irreversibly denatures proteins that inhibit amplification and degrades nucleic acid-binding proteins via enzymatic and chemical actions, thereby reducing impurity interference. Additionally, reducing agents disrupt the disulfide bonds of RNase, further suppressing its activity.The lysate mixture is then passed through resins and filtration devices that effectively adsorb and precipitate proteins and other organic molecular impurities, thereby purifying nucleic acids and removing multiple inhibitory components.

Highlights：

1. Rapid and User-Friendly Operation: Results are delivered within 10-20 minutes from sample to completion, with minimal user input.

2. Ultra-High Sensitivity: Achieves detection limits as low as 1-10 copies of target nucleic acid.

3. Robust Inhibition Resistance: Samples require minimal preparation and can be directly used in reactions, resisting common inhibitors.

4. Isothermal Amplification: Operates at a constant temperature between 37°C and 45°C, reducing reliance on specialized equipment and enabling broad compatibility with basic thermal cyclers.

5. Closed-Tube Detection: Eliminates aerosol contamination risks through integrated reaction and detection in a single closed system, ensuring safe and reliable results.

ERA offers a fast, accurate, and accessible solution for biological nucleic acid testing.

Comparison of techniques：