比较两种诊断性试验方法检测CDI感染率和并发症出现率
作者 ： Yves Longtin ,Sylvie Trottier ,Gilles Brochu ,Bianka Paquet-Bolduc ,Christophe Garenc ,Vilayvong Loungnarath ,Catherine Beaulieu ,Danielle Goulet ,Jean Longtin期刊名称：Clin Infect Dis
发表时间：2012-09-27
索引：Clin Infect Dis.2012 Oct 19;2012-9-25.
背景： 大部分艰难梭状芽胞杆菌感染(CDI)监控项目既没有明确说明使用的诊断方法，也没有对感染率进行分层。本研究使用2种有效的诊断方法，对医疗相关的CDI (HA-CDI)的发生率和并发症出现率进行评估。
方法：本前瞻性队列研究中的患者在2010年8月1日到2011年7月31日之间进行了艰难梭状芽胞杆菌检查。所有样本都使用了以下两种检测方法进行平行测试：针对毒素B基因tcdB 的商业化PCR试剂盒和检测谷氨酸脱氢酶和毒素A、B的三步酶免疫试验及细胞培养细胞毒性试验(EIA/CCA)。使用单因素泊松回归对CDI发生率比进行计算。
结果：在总共95 750患者住院日中共检测了1321份粪便样本，用PCR检测了85例HA-CDI，用EIA/CCA 检测了56例HA-CDI(P = .01)。PCR法总检出率为8.9每10000患者住院日（95%置信区间, 7.1–10.9），而EIA/CCA法为5.8每10000患者住院日(95% CI, 4.4–7.4，P = .01)。PCR法和EIA/CCA法的检出率比为1.52 (95% CI, 1.08–2.13; P = .015)。PCR法诊断CDI的总并发症出现率为27% (23/85)而EIA/CCA法为39% (22/56)(P = .16)。与PCR法和EIA/CCA法联用检测相比，单用PCR法诊断会产生更低可能的并发症出现率（分别为39%和3%; P < .001）
结论：用PCR法去取代EIA/CCA法可以提升超过一半的CDI检出率。诊断方法的标准化可以有助于医院之间的比较。
北京协和医学院麦毓麟翻译，北京协和医学院张麟审核
Background. Most Clostridium difficile infection (CDI) surveillance programs neither specify the diagnostic method to be used nor stratify rates accordingly. We assessed the difference in healthcare-associated CDI (HA-CDI) incidence and complication rates obtained by two validated diagnostic methods.Methods. Prospective cohort study of patients for whom a C. difficile test was ordered between 1 August 2010 and 31 July 2011. All specimens were tested in parallel by a commercial polymerase chain reaction (PCR) assay targeting toxin B gene tcdB, and a three-step algorithm detecting glutamate deshydrogenase and toxins A and B by enzyme immunoassay and cell culture cytotoxicity assay (EIA/CCA). CDI incidence rate ratios were calculated using univariate Poisson regression.Results. 1321 stool samples were tested during a period totalling 95,750 patient-days. 85 HA-CDI cases were detected by PCR and 56 cases by EIA/CCA (P=0.01). The overall incidence rate was 8.9 per 10,000 patient-days (95% CI, 7.1-10.9) by PCR and 5.8 per 10,000 patient-days (95% CI, 4.4-7.4) by EIA/CCA (P=0.01). The incidence rate ratio comparing PCR and EIA/CCA was 1.52 (95% CI, 1.08-2.13; P=0.015). Overall complication rate was 27% (23/85) when CDI was diagnosed by PCR and 39% (22/56) by EIA/CCA (P=0.16). Cases detected by PCR only were less likely to develop a complication of CDI compared with cases detected by both PCR and EIA/CCA (3% vs. 39%, respectively; P<0.001).Conclusion. Performing PCR instead of EIA/CCA is associated with a >50% increase in the CDI incidence rate. Standardization of diagnostic methods may be indicated to improve inter-hospital comparison. 学习了，PCR法对CD的检出率更高
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