Department of Family Medicine, Chang Gung Memorial Hospital, Taoyuan, and Chang Gung University College of Medicine, Taoyuan, Taiwan.
PLoS One. 2013 May 29;8(5):e62323. doi: 10.1371/journal.pone.0062323. Print 2013.
Blood culture is viewed as the golden standard for the diagnosis of sepsis but suffers from low sensitivity and long turnaround time. LightCycler SeptiFast (LC-SF) is a real-time multiplex polymerase chain reaction test able to detect 25 common pathogens responsible for bloodstream infections within hours. We aim to assess the accuracy of LC-SF by systematically reviewing the published studies.
Related literature on Medline, Embase, and Cochrane databases was searched up to October 2012 for studies utilizing LC-SF to diagnose suspected sepsis and that provided sufficient data to construct two-by-two tables.
A total of 34 studies enrolling 6012 patients of suspected sepsis were included. The overall sensitivity and specificity for LC-SF to detect bacteremia or fungemia was 0·75 (95% CI: 0·65-0·83) and 0·92 (95%CI:0·90-0·95), respectively. LC-SF had a high positive likelihood ratio (10·10) and a moderate negative likelihood ratio (0·27). Specifically, LC-SF had a sensitivity of 0·80 (95%CI: 0·70-0·88) and a specificity of 0·95(95%CI: 0·93-0·97) for the bacteremia outcome, and a sensitivity of 0·61 (95%CI: 0·48-0·72) and a specificity of 0·99 (95%CI: 0·99-0·99) for the fungemia outcome. High heterogeneity was found in the bacteremia outcome subgroup but not in the fungemia outcome subgroup.
LC-SF is of high rule-in value for early detection of septic patients. In a population with low pretest probability, LC-SF test can still provide valuable information for ruling out bacteremia or fungemia.
血培养被视为诊断败血症的金标准，但存在敏感性低和周转时间长的问题。LightCycler SeptiFast（LC-SF）是一种实时多重聚合酶链反应检测方法，能够在数小时内检测到 25 种引起血流感染的常见病原体。我们旨在通过系统评价已发表的研究来评估 LC-SF 的准确性。
检索 Medline、Embase 和 Cochrane 数据库，检索截止日期为 2012 年 10 月，纳入应用 LC-SF 诊断疑似败血症且提供了足够数据构建四格表的研究。
共纳入 34 项研究，共纳入 6012 例疑似败血症患者。LC-SF 检测菌血症或真菌血症的总体敏感性和特异性分别为 0.75（95%CI：0.65-0.83）和 0.92（95%CI：0.90-0.95）。LC-SF 的阳性似然比高（10.10），阴性似然比适中（0.27）。具体而言，LC-SF 检测菌血症的敏感性为 0.80（95%CI：0.70-0.88），特异性为 0.95（95%CI：0.93-0.97）；检测真菌血症的敏感性为 0.61（95%CI：0.48-0.72），特异性为 0.99（95%CI：0.99-0.99）。菌血症结果亚组存在高度异质性，但真菌血症结果亚组无异质性。
LC-SF 对早期发现败血症患者具有高度的纳入价值。在低预测试验概率的人群中，LC-SF 检测仍可为排除菌血症或真菌血症提供有价值的信息。
