Clinical chemistry and laboratory medicine · 2026
Multicenter evaluation of an innovative fully-automated molecular diagnostics system.
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Ren Yaping, Chen Chao, Wang Weizhong, Yang Zhengquan, Fang Zhonggang, Yu Ying, Xiang Zhongyuan
Аннотация
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.
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.