Clinical microbiology is one of the key disciplines for the diagnosis and treatment of infectious diseases. It can provide pathogen-based evidence for the diagnosis and treatment of clinical infectious diseases, monitor antimicrobial resistance in medical institutions at all levels, and prevent and control nosocomial infections.

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Recently, Mindray conducted a clinical trial at West China Hospital of Sichuan University, a top university hospital in mainland China, to evaluate the clinical performance of the Mindray Automated Identification and Antimicrobial Susceptibility Analysis System (referred to as "AF-600") in terms of the accuracy of clinical strain identification and antimicrobial susceptibility.

The results of the trial showed that the AF-600 was consistent and equivalent to other well-known similar products in terms of clinical performance. The trial covered over 90% of bacterial species, with an identification accuracy of over 95% and antimicrobial susceptibility accuracy (CA, EA) exceeding 95%. These results demonstrate that the AF-600 is safe and effective for clinical use, and can meet the clinical needs.

A rigorous validation protocols

This clinical trial was designed and formulated in accordance with the requirements of the "Guidelines for the Design of Clinical Trials of Medical Devices", CLSI M52, and Cumitech 31A, which required the selection of registered and reputable similar products in China for comparison. The same sample is tested on two detection systems in a random order. To eliminate potential operator bias, the trial uses a synchronous blind test method. This involves the random placement and numbering of all clinically collected samples by the trial unit, with blind test operators and evaluators. The trial unit will unblind and compare the sample results

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This clinical trial included a total of 400 clinical strains, all of which were included and none of which were excluded. The 400 strains represented 66 species and 25 genera, including 150 Gram-negative rods, 125 Gram-positive cocci, 50 Gram-negative cocci, 32 Gram-positive rods, and 43 yeast-like fungi.

An outstanding clinical performance

1. General accuracy of bacterial identification

This test covers more than 90% of the bacterial species detected clinically, and the identification accuracy is >95%. Meets the requirements of "WS/T 807-2022 Performance Verification of Clinical Microbial Culture, Identification and Drug Susceptibility Testing Systems" (identification accuracy is more than 90%).

2. General accuracy of bacterial antimicrobial susceptibly testing

This test covers more than 90% of clinically detected bacterial species, with CA and EA exceeding 95%. Meets the requirements for drug sensitivity accuracy of "WS/T 807-2022 Performance Verification of Clinical Microbial Culture, Identification and Drug Susceptibility Testing Systems" (both CA and EA are ¡Ý90%, VMD and MD are ¡Ü3%).