Clinical evaluation of commercial nucleic acid amplification tests in patients with suspected sepsis

Clinical evaluation of commercial nucleic acid amplification tests in patients with suspected sepsis
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DOI:
10.1186/s12879-015-0938-4
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发表时间:
2015-04-28
影响因子:
3.7
通讯作者:
Karlsson, Diana
Karlsson, Diana
中科院分区:
医学3区
文献类型:
--
作者:
Ljungstrom, Lars;Enroth, Helena;Karlsson, Diana

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背景:脓毒症是一种严重的疾病,需要及时给予适当的抗生素治疗。血培养被认为是脓毒症病原学诊断的金标准,但其敏感性低,周转时间长。因此,出现了核酸扩增测试(NAAT)以缩短鉴定致病微生物的时间。本研究的目的是评估在日常实践中的临床效用在急诊科的两个商业NAAT在患者疑似sepsis.Methods:在六周的时间内,血液样本连续收集从所有成年患者入院的一般急诊科怀疑社区发病的败血症和静脉注射抗生素治疗。沿着常规的血液培养,对全血样本进行多重PCR(Magicplex(TM)),而来自血液培养瓶的部分用于通过基于微阵列的测定(Prove-it(TM))进行分析。病原学的意义,确定了两个传染病医生的临床表现和预期的致病性。结果:在382例疑似脓毒症,临床相关的微生物检测血培养42集(11%),多重PCR 37集(9.7%),和微阵列32集(8.4%)。虽然与血培养(kappa 0.50)中度一致,但多重PCR通过及时检测血培养阴性标本中的15个临床相关结果增加了诊断价值。结果的微阵列对应的血液培养(Kappa 0.90),但可在血液培养results.Conclusions:使用NAAT全血标本在辅助目前的文化为基础的方法提供了一个临床附加值,允许检测生物错过了血液培养。然而,应谨慎解释NAAT检测结果的病因学意义,因为高分析灵敏度可能会增加不一定与临床诊断相一致的结果。
Background: Sepsis is a serious medical condition requiring timely administered, appropriate antibiotic therapy. Blood culture is regarded as the gold standard for aetiological diagnosis of sepsis, but it suffers from low sensitivity and long turnaround time. Thus, nucleic acid amplification tests (NAATs) have emerged to shorten the time to identification of causative microbes. The aim of the present study was to evaluate the clinical utility in everyday practice in the emergency department of two commercial NAATs in patients suspected with sepsis.Methods: During a six-week period, blood samples were collected consecutively from all adult patients admitted to the general emergency department for suspicion of a community-onset sepsis and treated with intravenous antibiotics. Along with conventional blood cultures, multiplex PCR (Magicplex (TM)) was performed on whole blood specimens whereas portions from blood culture bottles were used for analysis by microarray-based assay (Prove-it (TM)). The aetiological significance of identified organisms was determined by two infectious disease physicians based on clinical presentation and expected pathogenicity.Results: Among 382 episodes of suspected sepsis, clinically relevant microbes were detected by blood culture in 42 episodes (11%), by multiplex PCR in 37 episodes (9.7%), and by microarray in 32 episodes (8.4%). Although moderate agreement with blood culture (kappa 0.50), the multiplex PCR added diagnostic value by timely detection of 15 clinically relevant findings in blood culture-negative specimens. Results of the microarray corresponded very well to those of blood culture (kappa 0.90), but were available just marginally prior to blood culture results.Conclusions: The use of NAATs on whole blood specimens in adjunct to current culture-based methods provides a clinical add-on value by allowing for detection of organisms missed by blood culture. However, the aetiological significance of findings detected by NAATs should be interpreted with caution as the high analytical sensitivity may add findings that do not necessarily corroborate with the clinical diagnosis.