In Vitro Diagnostic Industry in China - Molecular Diagnosis Analyzers and Reagents V

Innovative Products

The following innovative products have obtained the registration certificate of regulatory authorities for the first time in the industry based on the technology platform, and are open to the whole market as the benchmark. Only some representative products are listed.

1. Molecular Diagnostic Instruments

1.1 Nucleic Acid POCT

The UC0102 Nucleic Acid amplification and detection system (Certificate No.: G.X.Z.Z. 20,193,221,026) of Ustar Biotechnology (Hangzhou) Ltd. (hereinafter referred to as “Ustar”) is the first approved instrument for point-of-care testing (POCT) in China. At present, the reagents supporting the instrument are all based on crossing priming amplification (CPA). Independent detection reaction, which can effectively avoid cross-contamination between samples, and the operation is sample. Just add the sample to the reaction tube after pretreatment, and the subsequent detection process can be completed automatically in this instrument.

The reaction tube is divided into three segments: the lysis zone, the elution zone, and the amplification zone. When the tube is inserted into the instrument, the instrument first heats the lysis zone of the tube, so that the nucleic acid in the sample is released into the solution, and then adsorbed by the magnetic beads. The magnetic beads and nucleic acid are dragged from the lysis zone by the magnet through the hydrophobic layer to the cleaning area. The impurities on the magnetic beads in the cleaning area are removed by the elution solution, and the magnetic beads and nucleic acids are dragged by the magnetic steel through the hydrophobic layer to reach the large-scale system for nucleic acid extraction and PCR tests; the extraction, system preparation, and amplification are completed in one amplification zone. The nucleic acid in the amplification zone is eluted by the elution buffer, and the eluted nucleic acid and reagent start to react at the amplification zone by temperature control. At the same time, the fluorescent probe binds to the specific amplification zone to produce a fluorescent signal. After detecting the signal, the instrument generates an amplification curve, CT value, and detection result.

In 2020, the NMPA approved additional four nucleic acid real-time detection instruments, namely, Galaxy Nano PCR cycler (Registration No.: G.X.Z.Z. 20,203,220,597), Universal Nano PCR cycler (Registration No.: G.X.Z.Z. 20,203,220,012) of igenesis Biotechnology (Shanghai) Co., Ltd. (hereinafter referred to as “igenesis”), the iponatic Portable Molecule Workstation of Sansure Biotech Inc. (Registration No.: G.X.Z.Z. 20,203,220,419), and Universal Pro automatic PCR analysis system (Registration No.: G.X.Z.Z. 20,203,220,825). These instruments need to be used with fluorescent PCR reagents. The amplification reaction of igenesis Galaxy nano is carried out in the Galaxy smart box. The smart box contains nucleic acid extraction reagents, and the PCR reagents need to be added separately.

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