{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T05:03:50Z","timestamp":1789621430552,"version":"build-2803163510"},"reference-count":25,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T00:00:00Z","timestamp":1789084800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100010425","name":"Tri-Service General Hospital","doi-asserted-by":"publisher","award":["TSGH-D-115108"],"award-info":[{"award-number":["TSGH-D-115108"]}],"id":[{"id":"10.13039\/501100010425","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100010425","name":"Tri-Service General Hospital","doi-asserted-by":"publisher","award":["TSGH-D-115112"],"award-info":[{"award-number":["TSGH-D-115112"]}],"id":[{"id":"10.13039\/501100010425","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100010425","name":"Tri-Service General Hospital","doi-asserted-by":"publisher","award":["TSGH-D-115111"],"award-info":[{"award-number":["TSGH-D-115111"]}],"id":[{"id":"10.13039\/501100010425","id-type":"DOI","asserted-by":"publisher"}]},{"award":["TSGH-D-115108"],"award-info":[{"award-number":["TSGH-D-115108"]}],"id":[{"id":"https:\/\/ror.org\/007h4qe29","id-type":"ROR","asserted-by":"publisher"}]},{"award":["TSGH-D-115112"],"award-info":[{"award-number":["TSGH-D-115112"]}],"id":[{"id":"https:\/\/ror.org\/007h4qe29","id-type":"ROR","asserted-by":"publisher"}]},{"award":["TSGH-D-115111"],"award-info":[{"award-number":["TSGH-D-115111"]}],"id":[{"id":"https:\/\/ror.org\/007h4qe29","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Antibiotics"],"abstract":"<jats:p>Background\/Objectives: Prompt identification of bloodborne pathogens and their antimicrobial resistance is critical for effective sepsis management. Direct molecular testing of blood offers faster results than blood culture; however, its clinical utility has been limited by suboptimal sensitivity and procedural complexity. This study evaluated an automated rapid multiplex PCR assay (BPID\u00ae system) and compared its performance with gold-standard methods. Methods: This was a preliminary, single-centre diagnostic-agreement study. Forty-three whole-blood samples were collected from patients with suspected bloodstream infection at Tri-Service General Hospital, Taipei, Taiwan, between January 2025 and January 2026, and were analysed. Three molecular methods and two culture-based methods were compared: the BPID\u00ae system, a Qiagen\u00ae-based workflow, the BioFire\u00ae FilmArray\u00ae BCID2 panel, blood culture, and MALDI-TOF MS identification. Positive percent agreement (PPA) was calculated at the organism level against a composite reference standard. Analytical sensitivity (limit of detection, LoD) was assessed in whole blood spiked with serial dilutions of ten reference organisms. Results: The composite reference standard yielded 47 reference-positive organisms across 42 samples. The BPID\u00ae system achieved a PPA of 95.74% (95% CI, 85.8\u201398.8), numerically similar to the post-culture BCID2 panel (93.62%; p = 1.00, exact McNemar test), and higher than the Qiagen\u00ae workflow (72.34%; p = 0.001), blood culture (72.34%; p = 0.007), and MALDI-TOF MS (74.47%; p = 0.013). In a sensitivity analysis using a composite reference standard from which the index test was excluded, 46 organisms remained reference-positive and the PPA of the BPID\u00ae system was 95.65% (44\/46; 95% CI, 85.5\u201398.8), again numerically similar to the BCID2 panel (93.48%; p = 1.00). For antimicrobial resistance determinants covered by both panels, the BPID\u00ae system reproduced the BCID2 determinant profile in all 16 specimens in which such a determinant was reported (100%), versus 10 of 16 specimens (62.5%) for the Qiagen\u00ae method. Confirmed LoD values for the BPID\u00ae system were 0.67\u201320.81 CFU\/mL, an 8.8- to 24.3-fold improvement over the Qiagen\u00ae method (6.51\u2013224.61 CFU\/mL). Conclusions: The automated BPID\u00ae system substantially improves PCR-based diagnostic sensitivity for bacteremia and, by operating directly on whole blood, removes the culture-incubation step that post-culture molecular panels require. Because the study was not designed as an equivalence or non-inferiority trial and evaluated only 43 specimens, the similar agreement observed for the BPID\u00ae system and the BCID2 panel should not be interpreted as demonstrated equivalence; these findings should be regarded as a preliminary clinical evaluation requiring confirmation in larger multicentre studies that also enrol culture-negative and uninfected controls.<\/jats:p>","DOI":"10.3390\/antibiotics15090896","type":"journal-article","created":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T17:14:59Z","timestamp":1789146899000},"page":"896","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Analytical and Clinical Evaluation of a Fully Automated Direct-from-Whole-Blood Multiplex PCR Assay Using Large-Volume Reverse Elution for Rapid Bloodstream Infection Diagnosis"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-2948-2049","authenticated-orcid":false,"given":"Chi-Sheng","family":"Tai","sequence":"first","affiliation":[{"name":"Graduate Institute of Medical Science, National Defense Medical University, Taipei City 11490, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hsing-Yi","family":"Chung","sequence":"additional","affiliation":[{"name":"Division of Clinical Pathology, Department of Pathology, Tri-Service General Hospital, National Defense Medical University, Taipei City 11490, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tai-Han","family":"Lin","sequence":"additional","affiliation":[{"name":"Division of Clinical Pathology, Department of Pathology, Tri-Service General Hospital, National Defense Medical University, Taipei City 11490, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chih-Kai","family":"Chang","sequence":"additional","affiliation":[{"name":"Division of Clinical Pathology, Department of Pathology, Tri-Service General Hospital, National Defense Medical University, Taipei City 11490, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cherng-Lih","family":"Perng","sequence":"additional","affiliation":[{"name":"Division of Clinical Pathology, Department of Pathology, Tri-Service General Hospital, National Defense Medical University, Taipei City 11490, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hung-Sheng","family":"Shang","sequence":"additional","affiliation":[{"name":"Division of Clinical Pathology, Department of Pathology, Tri-Service General Hospital, National Defense Medical University, Taipei City 11490, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ming-Jr","family":"Jian","sequence":"additional","affiliation":[{"name":"Division of Clinical Pathology, Department of Pathology, Tri-Service General Hospital, National Defense Medical University, Taipei City 11490, Taiwan"},{"name":"Graduate Institute of Pathology and Parasitology, National Defense Medical University, Taipei City 11490, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,9,11]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"200","DOI":"10.1016\/S0140-6736(19)32989-7","article-title":"Global, Regional, and National Sepsis Incidence and Mortality, 1990\u20132017: Analysis for the Global Burden of Disease Study","volume":"395","author":"Rudd","year":"2020","journal-title":"Lancet"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1181","DOI":"10.1007\/s00134-021-06506-y","article-title":"Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021","volume":"47","author":"Evans","year":"2021","journal-title":"Intensive Care Med."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1589","DOI":"10.1097\/01.CCM.0000217961.75225.E9","article-title":"Duration of Hypotension before Initiation of Effective Antimicrobial Therapy Is the Critical Determinant of Survival in Human Septic Shock","volume":"34","author":"Kumar","year":"2006","journal-title":"Crit. 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