Multicenter evaluation of an innovative fully-automated molecular diagnostics system

Abstract

Abstract Objectives To evaluate the analytical performance of a novel fully-automated molecular diagnostics system Molecision® R8, together with its multiplex testing capability and compatibility with different types of analytes and samples. Methods Precision, limit of detection (LoD) and linearity were evaluated based on respective guidelines. Method comparisons were conducted between Molecision® R8 and two commercially available systems Sansure and Hybribio, using four assays for use with each system - hepatitis B virus (HBV) RNA, Chlamydia trachomatis (CT) DNA, Ureaplasma urealyticum (UU) DNA, and Neisseria gonorrhoeae (NG) DNA. Results Molecision® R8 demonstrated excellent analytical performance: within-lab coefficient of variation (CV) was ≤1.55 %, with 100 % detectable rates at claimed LoD and strong linearity with correlation coefficient of 0.9998. In HBV RNA comparison between Molecision® R8 and Sansure system, the 95 % confidence interval of the slope and the intercept in Passing-Bablok regression contained 1 and 0 respectively, and mean bias was −0.05 lg IU/mL in Bland-Altman analysis. Over 95 % agreement rates were found between R8 and Hybribio system in CT DNA, UU DNA and NG DNA detection, except for the negative agreement rate of UU DNA. Conclusions Excellent analytical characteristics were verified in various analyte and sample types for Molecision® R8. Clinical safety and effectiveness of R8 were substantiated by its strong consistency with other polymerase chain reaction (PCR) platforms in routine clinical use. With sample-in-result-out workflow, Molecision® R8 could further improve the efficacy of clinical molecular laboratories.