Multicenter evaluation of an innovative fully-automated molecular diagnostics system.

IF 4.4 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Clinical chemistry and laboratory medicine Pub Date : 2026-09-29 DOI:10.1515/cclm-2026-0879

Yaping Ren, Chao Chen, Weizhong Wang, Zhengquan Yang, Zhonggang Fang, Ying Yu, Zhongyuan Xiang

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引用次数: 0

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.

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一个创新的全自动分子诊断系统的多中心评估。

目的：评估新型全自动分子诊断系统Molecision®R8的分析性能，以及其多重检测能力和与不同类型分析物和样品的兼容性。方法：根据相关标准对精密度、检出限和线性度进行评价。将Molecision®R8与两种市售系统Sansure和Hybribio进行方法比较，每种系统使用四种检测方法-乙型肝炎病毒（HBV） RNA、沙眼衣原体（CT） DNA、解脲支原体（UU） DNA和淋病奈瑟菌（NG） DNA。结果：R8具有良好的分析性能，实验室内变异系数(CV)≤1.55 %，检出率为100 %，线性关系强，相关系数为0.9998。在molecular®R8和Sansure系统的HBV RNA比较中，Passing-Bablok回归的斜率和截距的95% %置信区间分别为1和0，Bland-Altman分析的平均偏差为-0.05 lg IU/mL。R8与Hybribio系统在CT DNA、UU DNA和NG DNA检测上的符合率均在95 %以上，但UU DNA的符合率为阴性。结论：该试剂在多种分析物和样品类型中均具有良好的分析特性。R8在临床常规应用中与其他PCR平台具有较强的一致性，证实了其临床安全性和有效性。molecular®R8具有样品-结果-输出的工作流程，可以进一步提高临床分子实验室的效率。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical chemistry and laboratory medicine 医学-医学实验技术

CiteScore

11.30

自引率

16.20%

发文量

306

审稿时长

3 months

期刊介绍： Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!