{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T15:55:04Z","timestamp":1790610904783,"version":"4.1.0"},"reference-count":21,"publisher":"Walter de Gruyter GmbH","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_cclm-2026-0879_abs_001\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>\n                      To evaluate the analytical performance of a novel fully-automated molecular diagnostics system Molecision\n                      <jats:sup>\u00ae<\/jats:sup>\n                      R8, together with its multiplex testing capability and compatibility with different types of analytes and samples.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-0879_abs_002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Precision, limit of detection (LoD) and linearity were evaluated based on respective guidelines. Method comparisons were conducted between Molecision\n                      <jats:sup>\u00ae<\/jats:sup>\n                      R8 and two commercially available systems Sansure and Hybribio, using four assays for use with each system - hepatitis B virus (HBV) RNA,\n                      <jats:italic>Chlamydia trachomatis<\/jats:italic>\n                      (CT) DNA,\n                      <jats:italic>Ureaplasma urealyticum<\/jats:italic>\n                      (UU) DNA, and\n                      <jats:italic>Neisseria gonorrhoeae<\/jats:italic>\n                      (NG)\u00a0DNA.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-0879_abs_003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Molecision\n                      <jats:sup>\u00ae<\/jats:sup>\n                      R8 demonstrated excellent analytical performance: within-lab coefficient of variation (CV) was\u00a0\u22641.55\u202f%, with 100\u202f% detectable rates at claimed LoD and strong linearity with correlation coefficient of 0.9998. In HBV RNA comparison between Molecision\n                      <jats:sup>\u00ae<\/jats:sup>\n                      R8 and Sansure system, the 95\u202f% confidence interval of the slope and the intercept in Passing-Bablok regression contained 1 and 0 respectively, and mean bias was\u00a0\u22120.05 lg IU\/mL in Bland-Altman analysis. Over 95\u202f% 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\u00a0DNA.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-0879_abs_004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      Excellent analytical characteristics were verified in various analyte and sample types for Molecision\n                      <jats:sup>\u00ae<\/jats:sup>\n                      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\n                      <jats:sup>\u00ae<\/jats:sup>\n                      R8 could further improve the efficacy of clinical molecular laboratories.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/cclm-2026-0879","type":"journal-article","created":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T14:55:46Z","timestamp":1790607346000},"source":"Crossref","is-referenced-by-count":0,"title":["Multicenter evaluation of an innovative fully-automated molecular diagnostics system"],"prefix":"10.1515","author":[{"given":"Yaping","family":"Ren","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine , The Second Xiangya Hospital of Central South University , Changsha , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chao","family":"Chen","sequence":"additional","affiliation":[{"name":"Institute of In\u00a0Vitro Diagnostics Technology at Snibe Diagnostic , Shenzhen New Industries Biomedical Engineering (Snibe) Co. Ltd. Shenzhen , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weizhong","family":"Wang","sequence":"additional","affiliation":[{"name":"Laboratory Medicine Center, Department of Clinical Laboratory, Zhejiang Provincial People\u2019s Hospital, Affiliated People\u2019s Hospital , Hangzhou Medical College , Hangzhou , Zhejiang , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhengquan","family":"Yang","sequence":"additional","affiliation":[{"name":"Laboratory Medicine Center, Department of Clinical Laboratory, Zhejiang Provincial People\u2019s Hospital, Affiliated People\u2019s Hospital , Hangzhou Medical College , Hangzhou , Zhejiang , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhonggang","family":"Fang","sequence":"additional","affiliation":[{"name":"Institute of In\u00a0Vitro Diagnostics Technology at Snibe Diagnostic , Shenzhen New Industries Biomedical Engineering (Snibe) Co. Ltd. Shenzhen , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine) , Hangzhou , China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhongyuan","family":"Xiang","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , The Second Xiangya Hospital of Central South University , Changsha , China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2026,9,29]]},"reference":[{"key":"2026092814554317963_j_cclm-2026-0879_ref_001","doi-asserted-by":"crossref","unstructured":"Asokan, S, Choudekar, A, Jagadeesan, A, SM, R, Ali, A, Napte, SU, et al.. Molecular diagnostics in clinical microbiology: advances, applications, and future directions. 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