中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2012年
8期
702-705
,共4页
倪丽丽%罗柳林%景玲杰%张军%陈晋
倪麗麗%囉柳林%景玲傑%張軍%陳晉
예려려%라류림%경령걸%장군%진진
分枝杆菌,结核%核酸扩增技术%结核,肺
分枝桿菌,結覈%覈痠擴增技術%結覈,肺
분지간균,결핵%핵산확증기술%결핵,폐
Mycobacterium tuberculosis%Nucleic acid amplification techniques%Tuberculosis,pulmonary
目的 评估RNA恒温扩增实时荧光检测技术(SAT)在临床痰液标本结核分枝杆菌检测中的价值.方法 对2011年9至12月上海市肺科医院230例临床确诊肺结核患者和78例其他呼吸系统疾病患者的痰液分别用SAT法、BD960培养法、罗氏培养法和集菌涂片法同时进行检测.SAT法与BD960培养法结果不符标本,再用结核分枝杆菌核酸扩增荧光体外检测试剂盒(PCR-TB)进行检测,同时对BD960培养阳性菌株和SAT扩增产物进行扩增及测序,对菌种进行鉴定.采用x2检验比较SAT法与上述3种方法对结核病患者的阳性检出率.结果 以BD960培养法作为金标准(剔除BD960培养法中有7份污染菌),则SAT方法的敏感度为90.5％( 95/105),特异度为84.2％( 165/196),阳性预测值为75.4％ (95/126),阴性预测值为94.3％( 165/175).SAT法与BD960培养法结果符合率为86.4％( 260/301).223份临床确诊的肺结核患者痰标本SAT法、BD960培养法、罗氏培养法和涂片法的阳性检出率分别为56.5％( 126/223)、45.7％( 102/223)、41.7％( 93/223)和37.2％( 83/223),SAT法显著高于其他3种方法,差异有统计学意义(x2=4.087,P＜0.05).结论 SAT技术用于结核分枝杆菌实验室诊断具有特异度高、敏感度好,操作简便、快速,污染率低的特点,有望成为实验室诊断的新方法.
目的 評估RNA恆溫擴增實時熒光檢測技術(SAT)在臨床痰液標本結覈分枝桿菌檢測中的價值.方法 對2011年9至12月上海市肺科醫院230例臨床確診肺結覈患者和78例其他呼吸繫統疾病患者的痰液分彆用SAT法、BD960培養法、囉氏培養法和集菌塗片法同時進行檢測.SAT法與BD960培養法結果不符標本,再用結覈分枝桿菌覈痠擴增熒光體外檢測試劑盒(PCR-TB)進行檢測,同時對BD960培養暘性菌株和SAT擴增產物進行擴增及測序,對菌種進行鑒定.採用x2檢驗比較SAT法與上述3種方法對結覈病患者的暘性檢齣率.結果 以BD960培養法作為金標準(剔除BD960培養法中有7份汙染菌),則SAT方法的敏感度為90.5％( 95/105),特異度為84.2％( 165/196),暘性預測值為75.4％ (95/126),陰性預測值為94.3％( 165/175).SAT法與BD960培養法結果符閤率為86.4％( 260/301).223份臨床確診的肺結覈患者痰標本SAT法、BD960培養法、囉氏培養法和塗片法的暘性檢齣率分彆為56.5％( 126/223)、45.7％( 102/223)、41.7％( 93/223)和37.2％( 83/223),SAT法顯著高于其他3種方法,差異有統計學意義(x2=4.087,P＜0.05).結論 SAT技術用于結覈分枝桿菌實驗室診斷具有特異度高、敏感度好,操作簡便、快速,汙染率低的特點,有望成為實驗室診斷的新方法.
목적 평고RNA항온확증실시형광검측기술(SAT)재림상담액표본결핵분지간균검측중적개치.방법 대2011년9지12월상해시폐과의원230례림상학진폐결핵환자화78례기타호흡계통질병환자적담액분별용SAT법、BD960배양법、라씨배양법화집균도편법동시진행검측.SAT법여BD960배양법결과불부표본,재용결핵분지간균핵산확증형광체외검측시제합(PCR-TB)진행검측,동시대BD960배양양성균주화SAT확증산물진행확증급측서,대균충진행감정.채용x2검험비교SAT법여상술3충방법대결핵병환자적양성검출솔.결과 이BD960배양법작위금표준(척제BD960배양법중유7빈오염균),칙SAT방법적민감도위90.5％( 95/105),특이도위84.2％( 165/196),양성예측치위75.4％ (95/126),음성예측치위94.3％( 165/175).SAT법여BD960배양법결과부합솔위86.4％( 260/301).223빈림상학진적폐결핵환자담표본SAT법、BD960배양법、라씨배양법화도편법적양성검출솔분별위56.5％( 126/223)、45.7％( 102/223)、41.7％( 93/223)화37.2％( 83/223),SAT법현저고우기타3충방법,차이유통계학의의(x2=4.087,P＜0.05).결론 SAT기술용우결핵분지간균실험실진단구유특이도고、민감도호,조작간편、쾌속,오염솔저적특점,유망성위실험실진단적신방법.
Objective To evaluate the clinical value of the isothermal RNA amplification assay (SAT) for detection of Mycobacterium tuberculosis in sputum samples.Methods Sputum specimens from 230 patients with diagnosed tuberculosis and 78 cases of other respiratory diseases during September to December 2011 were detected using SAT,BD960 culture,LowenStein-Jensen( L-J ) culture and concentrated smear simultaneously.The samples with different results between SAT and BD960 culture were tested by Mycobacterium tuberculosis PCR fluorescence diagnosis kits.Strains were identified by amplification and sequencing the BD960 culture-positive isolates and SAT amplification products.Positive detection rate of SAT and other three methods for patients with tuberculosis were compared by chi-square test.Results Using the results of BD960 culture as the golden standard (7 cases of pollution bacteria in BD960 culture was rejected ),the sensitivity,specificity,positive predictive value,and negative predictive value of SAT was 90.5％ (95/105),84.2％ (165/196),75.4％ (95/126),94.3％ (165/175),respectively.The agreement rate of SAT and BD960 culture was 86.4％ (260/301).For 223 tuberculosis patients,the positive detection rate of SAT,BD960 culture,L-J culture and concentrated smear was 56.5％ ( 126/223 ),45.7％ ( 102/223 ),41.7％ ( 93/223 ) and 37.2％ ( 83/223 ) respectively.The positive detection rate of SAT is significantly higher than the other three methods (x2 =4.087,P ＜ 0.05 ).Conclusion SAT,as a new technology for laboratory diagnosis of TB,has high specificity and sensitivity.The operation is fast and simple,and the pollution rate is low.It is a promising laboratory diagnosis method.
