三种分子生物学诊断技术对结核病诊断价值的比较
삼충분자생물학진단기술대결핵병진단개치적비교
A study of the value of three molecular diagnostic techniques in the diagnosis of tuberculosis
  • 万方数据
    中华结核和呼吸杂志 중화결핵화호흡잡지
    Chinese Journal of Tuberculosis and Respiratory Diseases
    2015年 9期 680-685 ,共6页

    黄芳%党丽云%孙惠平%杨翰%邬霞

    황방%당려운%손혜평%양한%오하

    结核,肺%检测技术 結覈,肺%檢測技術
    결핵,폐%검측기술
    Tuberculosis,pulmonary%Test technology
    目的 评估实时荧光RNA恒温扩增检测(SAT)、分枝杆菌核酸检测(TB-NTM-PCR)及多色巢式荧光定量PCR(Xpert MTB/RIF)法对结核病诊断的价值.方法 收集2014年4-7月西安市结核病胸部肿瘤医院收治的确诊为肺结核患者的痰标本共378份,同时采用痰直接抗酸染色镜检、SAT、TB-NTM-PCR及MTB 960快速液体培养和Xpert MTB/RIF法对标本进行检测.以MTB 960快速液体培养及痰直接抗酸染色镜检结果为金标准,分析SAT法、TB-NTM-PCR法及Xpert MTB/RIF法对MTB的检出率.采用x2检验比较3种分子生物学检测方法的阳性率.结果 SAT、TB-NTM-PCR及Xpert MTB/RIF法检测的总体阳性率分别为37.6％(142/378)、37.8％ (143/378)和53.4％(202/378);涂阳培阳时,SAT、TB-NTM-PCR及Xpert MTB/RIF法检测的阳性率分别为84.6％ (77/91)、91.2％ (83/91)和96.7％(88/91),3种检测方法的阳性率比较差异有统计学意义(P =0.018 2);涂阴培阳时,SAT、TB-NTM-PCR及Xpert MTB/RIF法检测的阳性率分别为61.9％ (60/97)、44.3％(43/97)和80.4％(78/97),3种检测方法的阳性率比较差异有统计学意义(P ＜0.000 1);涂阴培阴时,SAT、TB-NTM-PCR及Xpert MTB/RIF法检测的阳性率分别为1.6％(3/185)、6.5％(12/185)和16.8％(31/185),3种检测方法的阳性率比较差异有统计学意义(P=0.018);涂阳培阴时,SAT、TB-NTM-PCR及Xpert MTB/RIF法检测的阳性例数分别为3/5、5/5及5/5例.以MTB 960快速液体培养和痰直接抗酸染色涂片镜检为金标准,3种检测方法中Xpert MTB/RI法的敏感度(87.6％,163/186)及阴性预测值最高(88.5％,185/209)且漏诊率最低(12.4％,24/193);SAT法特异度(98.2％,214/218)及阳性预测值最高(97.2％,138/142)且误诊率最低(1.8％,4/218).以960药敏试验结果为金标准,Xpert MTB/RIF法耐药检测的正确率为95.48％(148/155),敏感度为95.5％(128/134),特异度为95.2％ (20/21).结论 SAT、TB-NTM-PCR和Xpert MTB/RIF法对结核病的诊断均具有良好的辅助作用;Xpert MTB/RIF法无论对涂阳或涂阴肺结核均具有良好的检出率.
    목적 평고실시형광RNA항온확증검측(SAT)、분지간균핵산검측(TB-NTM-PCR)급다색소식형광정량PCR(Xpert MTB/RIF)법대결핵병진단적개치.방법 수집2014년4-7월서안시결핵병흉부종류의원수치적학진위폐결핵환자적담표본공378빈,동시채용담직접항산염색경검、SAT、TB-NTM-PCR급MTB 960쾌속액체배양화Xpert MTB/RIF법대표본진행검측.이MTB 960쾌속액체배양급담직접항산염색경검결과위금표준,분석SAT법、TB-NTM-PCR법급Xpert MTB/RIF법대MTB적검출솔.채용x2검험비교3충분자생물학검측방법적양성솔.결과 SAT、TB-NTM-PCR급Xpert MTB/RIF법검측적총체양성솔분별위37.6％(142/378)、37.8％ (143/378)화53.4％(202/378);도양배양시,SAT、TB-NTM-PCR급Xpert MTB/RIF법검측적양성솔분별위84.6％ (77/91)、91.2％ (83/91)화96.7％(88/91),3충검측방법적양성솔비교차이유통계학의의(P =0.018 2);도음배양시,SAT、TB-NTM-PCR급Xpert MTB/RIF법검측적양성솔분별위61.9％ (60/97)、44.3％(43/97)화80.4％(78/97),3충검측방법적양성솔비교차이유통계학의의(P ＜0.000 1);도음배음시,SAT、TB-NTM-PCR급Xpert MTB/RIF법검측적양성솔분별위1.6％(3/185)、6.5％(12/185)화16.8％(31/185),3충검측방법적양성솔비교차이유통계학의의(P=0.018);도양배음시,SAT、TB-NTM-PCR급Xpert MTB/RIF법검측적양성례수분별위3/5、5/5급5/5례.이MTB 960쾌속액체배양화담직접항산염색도편경검위금표준,3충검측방법중Xpert MTB/RI법적민감도(87.6％,163/186)급음성예측치최고(88.5％,185/209)차루진솔최저(12.4％,24/193);SAT법특이도(98.2％,214/218)급양성예측치최고(97.2％,138/142)차오진솔최저(1.8％,4/218).이960약민시험결과위금표준,Xpert MTB/RIF법내약검측적정학솔위95.48％(148/155),민감도위95.5％(128/134),특이도위95.2％ (20/21).결론 SAT、TB-NTM-PCR화Xpert MTB/RIF법대결핵병적진단균구유량호적보조작용;Xpert MTB/RIF법무론대도양혹도음폐결핵균구유량호적검출솔.
    Objective To evaluate the diagnostic value of real-time fluorescent RNA isothermal amplification detection technology (simultaneous amplification and testing,SAT),Mycobacterium nucleic acid detection (PCR-fluorescence probe)method (TB-NTM-PCR) and Xpert MTB/RIF detection in the diagnosis of tuberculosis.Methods A total of 378 sputum specimens from pulmonary tuberculosis patients were collected between April to July 2014 in Xi' an Thoracic Tumor and Tuberculosis Hospital.The specimens were detected by 5 methods at the same time including acid-fast stain,SAT method,TB-NTM-PCR method,TB 960 rapid liquid culture and Xpert MTB/RIF.The sensitivity and specificity of SAT method,TB-NTM-PCR method and Xpert MTB/RIF were calculated according to the results of TB 960 rapid liquid culture and staining.The difference among all the 3 methods was analyzed by Chi-squared test.Results The positive rate of SAT-TB,TB-NTM-PCR and Xpert MTB/RIF were 37.6％ (142/378),37.8％ (143/378)and 53.4％ (202/378),respectively.In specimens both positive for acid-fast stain and culture,the positive rate of SAT method was 84.6％ (77/91),that of TB-NTM-PCR was 91.2％ (83/91),and that of Xpert MTB/RIF was 96.7％ (88/91),the difference being significant (P =0.018 2).In specimens negative for acid-fast stain but positive for culture,the positive rate of SAT method was 61.9％(60/97),that of TB-NTM-PCR was 44.3％ (43/97),and that of Xpert MTB/RIF was 80.4％ (78/97),the difference being significant (P ＜ 0.000 1).In specimens both negative for acid-fast stain and culture,the positive rate of SAT method was 1.6％ (3/185),that of TB-NTM-PCR was 6.5％ (12/185),and that of Xpert MTB/RIF was 16.8％ (31/185),the difference being significant (P =0.018).In specimens positive for acid-fast stain but negative for culture,the number of positive samples of SAT,TB-NTM-PCR and Xpert MTB/RIF were 3 (3/5),5 (5/5),and 5 (5/5),respectively.With the result of TB 960 rapid liquid culture and staining as the reference,Xpert MTB/RIF showed the highest sensitivity of 87.6％ (163/186),the minimum rate of missed diagnosis of 12.4％ (24/193),and the highest negative predictive value of 88.5％ (185/209);SAT-TB showed the highest specificity of 98.2％ (214/218),the minimum rate of misdiagnosis of 1.8％ (4/218),the highest positive predictive value of 97.2％ (138/142).With the result of TB 960 rapid liquid culture as the reference,the sensitivity and the specificity of Xpert MTB/RIF were 95.52％(128/134) and 95.24％ (20/21).The accordance rate of Xpert MTB/RIF and TB 960 rapid liquid culture was 95.48％ (148/155).Conclusion The 3 molecular detection methods showed good results for the auxiliary diagnosis of tuberculosis.Xpert MTB/RIF had the best performance both in smear positive and negative specimens and it can detect rifampicin related rpoB gene mutations at the same time.
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