Abbott's Fully Automated Nucleic Acid Analysis System Alinity m Receives China Market Approval

Source: IVDdaily

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.

ALINITY M System is a fully integrated automated molecular diagnostics analyzer that utilizes 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 processing time.

• Within ~8 hours, there are 75 opportunities to start a new test - including STAT samples,Time to first result <115 minutes, 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: Human Immunodeficiency Virus Type 1 Nucleic Acid Quantitative Detection Kit (PCR-Fluorescence Method) Abbott RealTime HIV-1 Kit, Hepatitis C Virus Nucleic Acid Detection Kit (PCR-Fluorescence Method) Abbott RealTime HCV, and Human Papillomavirus Nucleic Acid Genotyping Detection Kit (Fluorescence PCR Method) Abbott RealTime High Risk HPV.