Internal Medicine, Angiology and Arteriosclerosis Diseases Section, Department of Clinical and Experimental Medicine, University of Perugia, Perugia, Italy.
J Clin Microbiol. 2012 Apr;50(4):1285-8. doi: 10.1128/JCM.06793-11. Epub 2012 Feb 8.
Early identification of causative pathogen in sepsis patients is pivotal to improve clinical outcome. SeptiFast (SF), a commercially available system for molecular diagnosis of sepsis based on PCR, has been mostly used in patients hospitalized in hematology and intensive care units. We evaluated the diagnostic accuracy and clinical usefulness of SF, compared to blood culture (BC), in 391 patients with suspected sepsis, hospitalized in a department of internal medicine. A causative pathogen was identified in 85 patients (22%). Sixty pathogens were detected by SF and 57 by BC. No significant differences were found between the two methods in the rates of pathogen detection (P = 0.74), even after excluding 9 pathogens which were isolated by BC and were not included in the SF master list (P = 0.096). The combination of SF and BC significantly improved the diagnostic yield in comparison to BC alone (P < 0.001). Compared to BC, SF showed a significantly lower contamination rate (0 versus 19 cases; P < 0.001) with a higher specificity for pathogen identification (1.00, 95% confidence interval [CI] of 0.99 to 1.00, versus 0.94, 95% CI of 0.90 to 0.96; P = 0.005) and a higher positive predictive value (1.00, 95% CI of 1.00 to 0.92%, versus 0.75, 95% CI of 0.63 to 0.83; P = 0.005). In the subgroup of patients (n = 191) who had been receiving antibiotic treatment for ≥24 h, SF identified more pathogens (16 versus 6; P = 0.049) compared to BC. These results suggest that, in patients with suspected sepsis, hospitalized in an internal medicine ward, SF could be a highly valuable adjunct to conventional BC, particularly in patients under antibiotic treatment.
早期识别脓毒症患者的病原体对于改善临床结局至关重要。SeptiFast（SF）是一种基于 PCR 的商用脓毒症分子诊断系统，主要用于血液科和重症监护病房的住院患者。我们评估了 SF 与血培养（BC）相比在 391 例疑似脓毒症患者中的诊断准确性和临床实用性，这些患者住院于内科病房。在 85 例（22%）患者中确定了病原体。SF 检测到 60 种病原体，BC 检测到 57 种病原体。两种方法的病原体检测率无显著差异（P = 0.74），甚至在排除 9 种仅由 BC 分离且未包含在 SF 主列表中的病原体后，差异仍无统计学意义（P = 0.096）。与单独使用 BC 相比，SF 与 BC 的联合应用显著提高了诊断率（P < 0.001）。与 BC 相比，SF 污染率显著降低（0 例与 19 例；P < 0.001），对病原体鉴定的特异性更高（1.00，95%置信区间[CI]为 0.99 至 1.00，与 0.94，95%CI 为 0.90 至 0.96；P = 0.005），阳性预测值更高（1.00，95%CI 为 1.00 至 0.92%，与 0.75，95%CI 为 0.63 至 0.83；P = 0.005）。在已接受≥24 小时抗生素治疗的患者亚组（n = 191）中，SF 比 BC 鉴定出更多的病原体（16 种与 6 种；P = 0.049）。这些结果表明，在住院于内科病房的疑似脓毒症患者中，SF 可以作为传统 BC 的一种非常有价值的辅助手段，尤其是在接受抗生素治疗的患者中。
