InfectID-BSI 性能评估：一种从全血中直接检测与脓毒症相关的病原体的快速定量 PCR 检测方法。
Performance evaluation of InfectID-BSI: A rapid quantitative PCR assay for detecting sepsis-associated organisms directly from whole blood.
机构信息
Microbio Ltd., Translational Research Institute, Brisbane, Queensland 4102, Australia.
Microbio Ltd., Translational Research Institute, Brisbane, Queensland 4102, Australia; Queensland Health, Brisbane, Queensland, Australia.
出版信息
J Microbiol Methods. 2023 Aug;211:106783. doi: 10.1016/j.mimet.2023.106783. Epub 2023 Jul 12.
BACKGROUND
Bloodstream infections (BSIs) (presence of pathogenic organism in blood) that progress to sepsis (life-threatening organ dysfunction caused by the body's dysregulated response to an infection) is a major healthcare issue globally with close to 50 million cases annually and 11 million sepsis-related deaths, representing about 20% of all global deaths. A rapid diagnostic assay with accurate pathogen identification has the potential to improve antibiotic stewardship and clinical outcomes.
METHODS
The InfectID-Bloodstream Infection (InfectID-BSI) test is a real-time quantitative PCR assay, which detects 26 of the most prevalent BSI-causing pathogens (bacteria and yeast) directly from blood (without need for pre-culture). InfectID-BSI identifies pathogens using highly discriminatory single nucleotide polymorphisms located in conserved regions of bacterial and fungal genomes. This report details the findings of a patient study which compared InfectID-BSI with conventional blood culture at two public hospitals in Queensland, Australia, using 375 whole blood samples (from multiple anatomical sites, eg. left arm, right arm, etc.) from 203 patients that have been clinically assessed to have signs and symptoms of suspected BSI, sepsis and septic shock.
FINDINGS
InfectID-BSI was a more sensitive method for microorganism detection compared with blood culture (BacT/ALERT, bioMerieux) for positivity rate (102 vs 54 detections), detection of fastidious organisms (Streptococcus pneumoniae and Aerococcus viridans) (25 vs 0), detection of low bioburden infections (measured as genome copies/0.35 mL of blood), time to result (<3 h including DNA extraction for InfectID-BSI vs 16 h-48 h for blood culture), and volume of blood required for testing (0.5 mL vs 40-60 mL). InfectID-BSI is an excellent 'rule out' test for BSI, with a negative predictive value of 99.7%. InfectID-BSI's ability to detect 'difficult to culture' microorganisms re-defines the four most prevalent BSI-associated pathogens as E. coli (28.4%), S. pneumoniae (17.6%), S. aureus (13.7%), and S. epidermidis (13.7%).
INTERPRETATION
InfectID-BSI has the potential to alter the clinical treatment pathway for patients with BSIs that are at risk of progressing to sepsis.
背景
血流感染（BSI）（病原体在血液中存在）发展为败血症（由机体对感染的失调反应导致的危及生命的器官功能障碍）是一个全球性的重大医疗问题，全球每年有近 5000 万例败血症相关死亡病例，占全球总死亡人数的约 20%。一种具有准确病原体鉴定能力的快速诊断检测方法有可能改善抗生素管理和临床结局。
方法
InfectID-血流感染（InfectID-BSI）检测是一种实时定量 PCR 检测方法，可直接从血液（无需预培养）中检测 26 种最常见的引起 BSI 的病原体（细菌和酵母）。InfectID-BSI 通过位于细菌和真菌基因组保守区域的高度区分单核苷酸多态性来鉴定病原体。本报告详细介绍了一项患者研究的结果，该研究在澳大利亚昆士兰州的两家公立医院将 InfectID-BSI 与常规血培养进行了比较，使用了 375 份来自 203 名患者的全血样本（来自多个解剖部位，例如左臂、右臂等），这些患者的临床评估有疑似 BSI、败血症和感染性休克的体征和症状。
结果
与血培养（BacT/ALERT，bioMerieux）相比，InfectID-BSI 对微生物的检测更敏感（阳性率为 102 比 54 次检测），可检测到难培养的病原体（肺炎链球菌和嗜水气单胞菌）（25 比 0），可检测到低生物负荷感染（以每 0.35 毫升血液的基因组拷贝数衡量），结果时间（<3 小时，包括用于 InfectID-BSI 的 DNA 提取，而血培养为 16 小时至 48 小时），以及检测所需的血量（0.5 毫升比 40-60 毫升）。InfectID-BSI 是一种出色的 BSI“排除”检测方法，阴性预测值为 99.7%。InfectID-BSI 检测“难以培养”微生物的能力重新定义了四种最常见的 BSI 相关病原体，即大肠杆菌（28.4%）、肺炎链球菌（17.6%）、金黄色葡萄球菌（13.7%）和表皮葡萄球菌（13.7%）。
解释
InfectID-BSI 有可能改变有发展为败血症风险的 BSI 患者的临床治疗途径。
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