Abbott's Alinity m Molecular Diagnostic System Receives China's Class III Registration Certificate Three Years After Its Debut
Abbott
Diagnostic and pharmaceutical product manufacturers
In September, the National Medical Products Administration approved the registration of Abbott's Alinity m automated nucleic acid analysis system in China, officially granting it market approval (Registration No. 20243220544).
Alinity m made its debut in China at the 4th CIIE in 2021 and obtained certification three years later, demonstrating Abbott's high registration efficiency.
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ALINITY M System is a fully integrated automated molecular diagnostics analyzer that uses real-time fluorescent quantitative PCR technology. ALINITY m drives laboratory transformation in the following ways:
ReadiFlex Technology - Abbott's proprietary technology that enables true random access (completed without affecting turnaround time or throughput)
Universal Sample Rack — No sample sorting required, simplifies front-end workflow, up to 12 racks, 144 samples
To optimize sample extraction, RNA and DNA specific extraction and purification reagents have been developed to achieve better PCR performance while reducing manual handling time.
Within ~8 hours, there are 75 opportunities to start a new test - including STAT samples, with the time to first result being <115 minutes, and obtaining 300 results within 8 hours.
A maximum of 20 test items can be performed at one time.
ALINITY M System Offers a Wide Range of Testing Options, Such as Multiplex SARS-CoV-2, Influenza A, Influenza B, and RSV Testing.
In China, the supporting reagents that have been listed include: Abbott RealTime HIV-1 Kit (PCR-fluorescence method) for the determination of Human Immunodeficiency Virus Type 1 nucleic acid, Abbott RealTime HCV (PCR-fluorescence method) for Hepatitis C Virus nucleic acid testing, and Abbott RealTime High Risk HPV (fluorescence PCR method) for Human Papillomavirus nucleic acid genotyping detection.
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