Evaluation of the identification performance of MALDI-TOF MS Smart MS 5020 from Zhuhai DL Biotech

Matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) is a reliable technique, is rapid and precise in the identification of pathogens, and is essential in clinical microbiology laboratories. The aim of this project is to evaluate the identification performance of the MALDI-TOF MS Smart MS 5020 system (Zhuhai DL Biotech) by comparing the identification results with those of the MALDI-TOF MS Biotyper Microflex LT system (Bruker Daltonics). A total of 612 clinical isolates were analyzed in parallel: 494 routine species and 118 species not commonly isolated in routine practice, previously isolated and frozen in our hospital's strain collection. This collection included gram-negative bacteria, gram-positive bacteria, anaerobes, and fungi. Concordance at genus and species level identification was evaluated, and 16S rRNA gene sequencing was performed for strains unidentified or with discordant results. Both systems, Smart MS 5020 and Biotyper Microflex LT, achieved high identification rates (100% and 98.9%, respectively). The concordance between the systems was 98.9% at the genus level and 97.2% at the species level. Correct species-level identification was 96.9% for the Smart MS 5020 and 96.6% for the Biotyper Microflex LT. The MALDI-TOF MS Smart MS 5020 and Biotyper Microflex LT systems offer high efficacy in identifying a wide variety of clinical isolates, both demonstrating excellent performance.IMPORTANCEAccurate identification of microorganisms in clinical microbiology laboratories is essential for the effective diagnosis and treatment of patients. This study evaluates the performance of the Smart MS 5020 matrix-assisted laser desorption/ionization-time-of-flight mass spectrometry (MALDI-TOF MS) system in comparison to the widely used Biotyper Microflex LT system. As a new entrant to the market, independent validation of the Smart MS 5020 system is crucial for laboratories considering its implementation. By analyzing 612 clinical isolates, including both routine and rare species, this study provides valuable data on the concordance rates between the two systems. The results confirm the Smart MS 5020 high accuracy and reinforce the reliability of MALDI-TOF MS technology. The high concordance rate between the two systems establishes the Smart MS 5020 as a promising, cost-effective alternative for routine diagnostics. These results expand the evidence base on MALDI-TOF MS platforms and can inform procurement decisions in clinical laboratories worldwide.