中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2010年
12期
1139-1144
,共6页
何英%陆学东%李海静%孟淑芳%汤一苇
何英%陸學東%李海靜%孟淑芳%湯一葦
하영%륙학동%리해정%맹숙방%탕일위
梭菌,难辨%聚合酶链反应%免疫酶技术%评价研究
梭菌,難辨%聚閤酶鏈反應%免疫酶技術%評價研究
사균,난변%취합매련반응%면역매기술%평개연구
Clostridium difficile%Polymerase chain reaction%Immunoenzyme techniques%Evaluation studies
目的 比较分析用于美国医院临床微生物实验室的5种艰难梭菌感染检测方法 ,从中选择1种适于早期诊断艰难梭菌感染的灵敏、特异、简单、快速及经济的实验方案.方法 对174份临床送检的腹泻患者粪便标本同时用TGC、Premier Toxin A&B EIA(A/B-EIA)、C.Diff Quick Chek Complete(D-EIA)、BD GeneOhm Cdiff assay(BD-PCR)和实验室发展的PCR(LD-PCR)方法 进行艰难梭菌的检测.以金标准TGC法作为参比标准,评价各种检测方法 的敏感度、特异度、阳性预测值、阴性预测值.结果 TGC法检测174份腹泻患者大便标本,艰难梭菌感染的阳性率为13.8%(24/174).与TGC法比较,4种检测方法 的敏感度、特异度、阳性预测值、阴性预测值分别为:A/B-EIA 62.5%、99.3%、93.8%、94.3%;D-EIA 66.7%、98.7%、88.9%、94.9%;BD-PCR 83.3%、98.7%、90.9%、97.4%;LD-PCR 79.2%、93.3%、65.5%、96.6%.所有标本中,至少1种方法 检测为阳性的标本共计34份,其中15份标本5种方法 检测结果 均为阳性.D-EIA法检测结果 中,18份标本GDH及毒素A/B均为阳性,23份仅GDH阳性,133份GDH及毒素A/B均为阴性.18份D-EIA检测阳性标本全部与BD-PCR检测结果 一致,16份与TGC法检测结果 一致.24份TGC阳性标本中,有22份包括在41份GDH抗原呈阳性的标本中.D-EIA检测为假阴性的8份标本中,4份BD-PCR检测为阳性.根据本实验结果 ,D-EIA与BD-PCR相结合的二步法检测方案灵敏度、特异度、阳性预测值、阴性预测值分别为83.3%、98.7%、90.9%、97.4%.结论 从技术角度评价,以BD-PCR法为最优.结合D-EIA与BD-PCR的二步法检测方案,是对临床送检标本进行艰难梭菌感染检测的灵敏、特异、简便、快速、经济的检测方案.
目的 比較分析用于美國醫院臨床微生物實驗室的5種艱難梭菌感染檢測方法 ,從中選擇1種適于早期診斷艱難梭菌感染的靈敏、特異、簡單、快速及經濟的實驗方案.方法 對174份臨床送檢的腹瀉患者糞便標本同時用TGC、Premier Toxin A&B EIA(A/B-EIA)、C.Diff Quick Chek Complete(D-EIA)、BD GeneOhm Cdiff assay(BD-PCR)和實驗室髮展的PCR(LD-PCR)方法 進行艱難梭菌的檢測.以金標準TGC法作為參比標準,評價各種檢測方法 的敏感度、特異度、暘性預測值、陰性預測值.結果 TGC法檢測174份腹瀉患者大便標本,艱難梭菌感染的暘性率為13.8%(24/174).與TGC法比較,4種檢測方法 的敏感度、特異度、暘性預測值、陰性預測值分彆為:A/B-EIA 62.5%、99.3%、93.8%、94.3%;D-EIA 66.7%、98.7%、88.9%、94.9%;BD-PCR 83.3%、98.7%、90.9%、97.4%;LD-PCR 79.2%、93.3%、65.5%、96.6%.所有標本中,至少1種方法 檢測為暘性的標本共計34份,其中15份標本5種方法 檢測結果 均為暘性.D-EIA法檢測結果 中,18份標本GDH及毒素A/B均為暘性,23份僅GDH暘性,133份GDH及毒素A/B均為陰性.18份D-EIA檢測暘性標本全部與BD-PCR檢測結果 一緻,16份與TGC法檢測結果 一緻.24份TGC暘性標本中,有22份包括在41份GDH抗原呈暘性的標本中.D-EIA檢測為假陰性的8份標本中,4份BD-PCR檢測為暘性.根據本實驗結果 ,D-EIA與BD-PCR相結閤的二步法檢測方案靈敏度、特異度、暘性預測值、陰性預測值分彆為83.3%、98.7%、90.9%、97.4%.結論 從技術角度評價,以BD-PCR法為最優.結閤D-EIA與BD-PCR的二步法檢測方案,是對臨床送檢標本進行艱難梭菌感染檢測的靈敏、特異、簡便、快速、經濟的檢測方案.
목적 비교분석용우미국의원림상미생물실험실적5충간난사균감염검측방법 ,종중선택1충괄우조기진단간난사균감염적령민、특이、간단、쾌속급경제적실험방안.방법 대174빈림상송검적복사환자분편표본동시용TGC、Premier Toxin A&B EIA(A/B-EIA)、C.Diff Quick Chek Complete(D-EIA)、BD GeneOhm Cdiff assay(BD-PCR)화실험실발전적PCR(LD-PCR)방법 진행간난사균적검측.이금표준TGC법작위삼비표준,평개각충검측방법 적민감도、특이도、양성예측치、음성예측치.결과 TGC법검측174빈복사환자대편표본,간난사균감염적양성솔위13.8%(24/174).여TGC법비교,4충검측방법 적민감도、특이도、양성예측치、음성예측치분별위:A/B-EIA 62.5%、99.3%、93.8%、94.3%;D-EIA 66.7%、98.7%、88.9%、94.9%;BD-PCR 83.3%、98.7%、90.9%、97.4%;LD-PCR 79.2%、93.3%、65.5%、96.6%.소유표본중,지소1충방법 검측위양성적표본공계34빈,기중15빈표본5충방법 검측결과 균위양성.D-EIA법검측결과 중,18빈표본GDH급독소A/B균위양성,23빈부GDH양성,133빈GDH급독소A/B균위음성.18빈D-EIA검측양성표본전부여BD-PCR검측결과 일치,16빈여TGC법검측결과 일치.24빈TGC양성표본중,유22빈포괄재41빈GDH항원정양성적표본중.D-EIA검측위가음성적8빈표본중,4빈BD-PCR검측위양성.근거본실험결과 ,D-EIA여BD-PCR상결합적이보법검측방안령민도、특이도、양성예측치、음성예측치분별위83.3%、98.7%、90.9%、97.4%.결론 종기술각도평개,이BD-PCR법위최우.결합D-EIA여BD-PCR적이보법검측방안,시대림상송검표본진행간난사균감염검측적령민、특이、간편、쾌속、경제적검측방안.
Objective To evaluate five detection methods for the laboratory diagnosis of Clostridium difficile infection in the hospitals of USA, and explore a sensitive, specific, accuracy and rapid regimen for the early diagnosis of Clostridium difficile infection. Methods A total of 174 stool specimens submitted to the clinical microbiology laboratory for Clostridium difficile testing were separately tested by five methods including toxigenic culture (TGC), Premier Toxin A&B EIA( A/B-EIA), C. Diff Quick Chek Complete( DEIA), BD G eneOhm Cdiff assay(BD-PCR) and Laboratory-developed PCR(LD-PCR). The gold standard of TGC was used as a reference criterion, and the sensitivity, specificity, positive predictive value ( PPV )and negative predictive value (NPV) of A/B-EIA, D-EIA, BD-PCR and LD-PCR assays were determined. Results Among the 174 specimens studied, 24 were defined as true positives for Clostridium difficile infection by TGC assay, giving a positive rate of 13.8% (24/174). In comparison to the standard,the sensitivity, specificity, PPV and NPV were 62.5%, 99.3%, 93.8% and 94.3% for A/B-EIA;66.7%, 98.7%, 88.9% and 94.9% for D-EIA; 83.3%, 98.7%, 90.9% and 97.4% for BD-PCR;79.2%, 93.3%, 65.5% and 96.6% for LD-PCR. Among all tested specimens, 34 were positive by atleast one of five methods, and of which 15 were concordant by all five methods. The D-EIA results were divided into three groups depending on results of GDH and (or) toxins A/B: 18 were positive for both GDH and toxins A/B, 23 were positive for only GDH, and 133 were negative for both GDH and toxins A/B. Of 18 positive specimens by D-EIA assay, all were concordant with results of BD-PCR assay and 16 were agreement with results of TGC assay. Twenty-two of 24 positive specimens by TGC assay were included in 41 specimens that were positive for GDH. Among eight false negative specimens by D-EIA assay, four were differentiated as positive results by BD-PCR. According to the present study, the sensitivity, specificity,PPV and NPV of a two-step detection algorithm in combination with D-EIA and BD-PCR assays were 83.3%, 98.7%, 90.9% and 97.4%, respectively. Conclusions From the point of technological evaluation, BD-PCR is preferable. A two-step detection algorithm combining D-EIA with BD-PCR is proposed for the laboratory diagnosis of Clostridium difficile infection. This algorithm has demonstrated an excellent sensitivity and specificity, as well as decreased test turnaround time and test cost.
