快速免疫色谱实验可凝肺结核病人的评价

目的 评价基于结核分支杆菌３９ＫＤａ等五种抗原的快速免疫色谱实验（澳大利亚ＩＣＴ－ＴＢ）对可疑肺结核的临床诊断价值。方法 以初诊可疑肺结核患者１２５例为受试对象，同时做痰涂片、培养，血清ＩＣＴ－ＴＢ以及胸片检查。结果 总的敏感性为４５％、特异性为１００％。结论 此试验不能完全代替痰涂片抗酸染色检查，但二者联合使用，可使敏感性提高到６３．６％     

肺结核病患者痰涂片及痰培养检测结果分析

目的 分析肺结核患者痰涂片及痰分离培养抗酸杆菌检验情况,为确诊和控制结核病提供科学诊断依据。方法 2008-06/2011-05四川省双流县结核病门诊就诊的可疑肺结核（可疑者）2 418例及化疗期间肺结核患者（治疗者）649例,总计3 067例,分别对每例就诊者进行痰涂片和培养检测。结果 3 067例就诊者中查出抗酸杆菌阳性777例,总阳性率为25.33%（777/3067）,其中痰涂片阳性（涂阳）524例,痰培养阳性（培阳）651例,阳性率分别为17.09%和21.23%。2 418例可疑者涂阳383例,培阳619例,阳性率分别为15.84%（383/2418）和25.60%（619/2418）,培阳高于涂阳,差异有统计学意义（P〈0.01）。649例肺结核治疗者涂阳141例,培阳32例,阳性率分别21.73%（141/649）和4.93%（32/649）,涂阳高于培阳,差异有统计学意义（P〈0.01）。结论 可疑肺结核者痰培阳高于涂阳,而肺结核治疗者涂阳高于培阳,痰涂片抗酸杆菌检测特异性高而敏感性低,分离培养敏感性、特异性均较高。     

血T-SPOT.TB联合肺泡灌洗液TbDNA检测对诊断肺结核的应用价值

目的分析血T-SPOT.TB联合肺泡灌洗液(BALF)Tb DNA检测对肺结核诊断的价值。方法选择2013.3~11月86例疑似肺结核患者,经确诊后分为肺结核组46例、肺炎组40例,均行T-SPOT.TB、BALF-Tb DNA、BALF涂片、痰涂片、PPD、结核抗体检测,对各检测结果进行对比,并行T-SPOT.TB与BALFTb DNA联合检测与单用检测、涂片法、PPD、结核抗体对比分析。结果血T-SPOT.TB、BALF-Tb DNA敏感性分别为84.8%、80.4%,特异性分别为80.0%、77.5%,两者联合检测敏感性为100.0%,阳性预测值为97.1%,阴性预测值为100.0%,与单用检测对比,差异有统计学意义(P0.05),与涂片法、PPD、结核抗体对比,存在显著差异(P0.01)。结论血T-SPOT.TB与BALF-Tb DNA联合检测提高了肺结核的诊断阳性率,弥补对方不足,减少肺结核的漏诊、误诊,是一个有前途的检测方法。     

免疫学检测联合痰涂片和痰培养检测在活动性肺结核临床诊断中的价值

目的 分析结核感染T细胞斑点试验(T-SPOT.TB)、结核抗体、痰涂片与痰培养联合检测在活动性肺结核诊断中的临床意义。方法 收集2014年1月至2019年12月北京结核病控制研究所门诊收治的疑似活动性肺结核患者715例,最终诊断为活动性肺结核患者412例(肺结核组),非结核病患者303例(非结核组)。715例患者均行T-SPOT.TB检测、结核抗体检测及痰涂片、痰培养检查;以临床诊断结果为标准,分析4种方法单独及联合检测的临床意义。结果 肺结核组患者中,T-SPOT.TB阳性检出率为83.7%(345/412);非结核组患者中,T-SPOT.TB阳性检出率为20.8%(63/303);两组阳性检出率差异有统计学意义(χ²=2.823,P=0.000)。T-SPOT.TB对活动性肺结核检测的敏感度、特异度、阳性预测值、阴性预测值和准确度分别为83.7%(345/412)、79.2%(240/303)、84.6%(345/408)、78.2%(240/307)、81.8%[(345+240)/715];4种方法联合诊断的敏感度、特异度、阳性预测值、阴性预测值和准确度分别为93.7%(386/412)、50.8%(154/303)、72.1%(386/535)、85.6%(154/180)、75.5%[(386+154)/715]。T-SPOT.TB检测、结核抗体检测及痰涂片、痰培养检查的ROC曲线下面积(AUC)分别为0.815、0.575、0.593、0.715,四项联合检测的AUC为0.894。结论 T-SPOT.TB检测的敏感度、阴性预测值较好,T-SPOT.TB检测联合结核抗体、痰涂片和痰培养检测的敏感度、AUC较高,联合检测可提高对肺结核的诊断效能。     

第三次痰涂片检查在摩尔多瓦和乌干达结核病诊断中的有效性

地点:摩尔多瓦和乌干达分别有24和30个结核病(TB)显微镜检查实验室.目的:评价第3次痰涂片检查对确诊1例增加的TB病例所需的工作量.方法:采用实验室登记回顾性研究,通过第3次痰涂片检查确定TB患病率和增加的病例数,TB病例来源于摩尔多瓦和乌干达的疑诊患者,这2个地区可以提供用于确诊1例增加的TB病例所需的检查数量.结果:在摩尔多瓦有9%(1141/12525),在乌干达有20%(7280/36054)的疑诊病例通过至少1次阳性痰涂片确诊为TB病例.通过第3次检查得到的增加病例比例在摩尔多瓦是4%,在乌干达为3%.为了通过第3次痰涂片检查而确诊1例增加的TB病例,在摩尔多瓦需检查273张涂片(95%可信区间200-389)、乌干达需检查175张涂片(95%可信区间153-222),平均确诊时间分别为11d(8～16)和7d(6～9).结论:在这2个国家,第3次痰涂片检查对诊断痰涂片阳性TB是无效的.     

T细胞斑点试验与痰涂片检查在成人不同年龄段肺结核诊断中的结果分析

目的 对比分析结核感染T细胞斑点试验(T-SPOT.TB)及痰涂片检查在成人不同年龄段肺结核诊断中的临床意义。方法 选取2018年3月至2019年12月在海南省文昌市人民医院就诊的650例疑似肺结核患者资料进行回顾性分析,将入选者按照世界卫生组织年龄分段进行分组,青年组(18～44岁)296例、中年组(45～59岁)144例及老年组(≥60岁)210例。所有患者行T-SPOT.TB及痰涂片检查,比较在不同年龄段肺结核患者中两种检查方法的检测阳性率。利用ROC曲线判断T-SPOT.TB试验中A抗原、B抗原在不同年龄段肺结核患者的诊断价值;分析T-SPOT.TB在成人不同年龄段肺结核的诊断效能。结果 ①在不同年龄组中T-SPOT.TB检测阳性率明显高于痰涂片法,差异均有统计学意义(P<0.05)。②在不同年龄段中T-SPOT.TB检测的灵敏度和准确度间比较,差异有统计学意义(P<0.05);T-SPOT.TB对青年组、中年组、老年组的诊断灵敏度分别为92.72%、79.81%、64.52%,两两比较差异均有统计学意义(P<0.0166);T-SPOT.TB对老年组的诊断准...     

T-SPOT.TB联合基因芯片检测在老年肺结核诊断中的应用

目的 观察结核菌感染T细胞斑点试验(T-SPOT.TB)与基因芯片检测联合使用对老年肺结核的诊断价值.方法 选择300例老年高度疑似肺结核的患者作为研究对象,全部患者接受T-SPOT.TB检测、基因芯片检测、痰培养、痰涂片,并将痰培养与涂片结果作为金标准,计算T-SPOT.TB检测、基因芯片检测单独使用及联合使用诊断老年肺结核的灵敏度、特异度、阳性预测值、阴性预测值,并计算其Kappa值,分析各检测方法与金标准的一致性.结果 300例老年高度疑似肺结核患者采集标本300份,均为痰样本,经培养与涂片检测后结果显示,检出结核分枝杆菌者165例,阳性率为55.00%.将痰培养与涂片结果作为金标准,T-SPOT.TB检测、基因芯片检测单独及联合用于老年肺结核诊断的灵敏度、特异度、阳性预测值、阴性预测值分别为84.24%、68.89%、76.80%、78.15%;86.06%、91.85%、92.81%、84.35%;96.97%、76.30%、83.33%、95.37%;各检测方法单独检测及联合检测用于老年肺结核诊断与金标准的一致性Kappa值分别为0.537、0.773、0.751.结论 T-SPOT.TB联合基因芯片检测可以明显提高二者单独使用的灵敏度及阴性预测值,减少老年肺结核早期漏诊,且与金标准有较好的一致性,可考虑将其作为老年肺结核早期主要筛查诊断方法.     

痰液标本结核分支杆菌RNA恒温扩增检测及临床应用

目的探讨实时荧光核酸恒温扩增检测法（SAT）在肺结核患者实验诊断中的应用。方法设计特异性引物和探针,建立并优化SAT检测体系,对131例临床确诊并接受治疗的肺结核患者、73例非结核性肺部感染者痰液标本中的结核分支杆菌（TB）RNA进行检测,并与PCR法检测TB DNA,痰培养法、痰涂片抗酸染色法检测TB的结果进行比较。结果 131例肺结核患者痰液标本中,SAT对TB检出率为52.67%,高于痰培养法（39.69%,P=0.035）和痰涂片抗酸染色法（35.11%,P=0.004）;以PCR法为参考标准,SAT的灵敏度、特异度、阳性预测值、阴性预测值依次是95.38%、90.91%、91.18%、95.24%。结论 SAT检测痰液标本中TB RNA灵敏度高,特异性强,操作简便、快速,具有临床推广应用价值。     

两份痰标本代替三份痰标本涂片法的可行性研究

目的 探讨在可疑肺结核病例中能否用两份痰标本涂片法代替三份痰标本涂片法.方法 对1002例可疑肺结核病例的三份痰标本(即时痰、夜间痰、清晨痰)分别进行直接涂片、萋-尼尔逊氏抗酸染色和光学显微镜镜检.结果 即时痰+夜间痰+清晨痰组与夜间痰+清晨痰组的结核阳性率无显著性差异.结论 即时痰不能提高结核阳性率,在可疑肺结核患者中可以用夜间痰+清晨痰两份标本涂片法代替原方案即时痰+夜间痰+清晨痰的三份标本涂片法.     

对脓血样痰标本第二次查痰提高涂阳肺结核病人发现的研究

目的评价肺结核病人痰标本首次检查3个痰全部为阴性者而痰标本性状为脓样、血样痰、重新留取标本进行第二次检测,以提高痰菌检出的阳性率。方法采用直接厚涂片萋-尼氏法抗酸染色显微镜检对2422例肺结核病人痰标本中的脓血样痰进行第二次检测。结果2007年肺结核及可疑症状者查痰人数为1177,初次痰检阳性人数阳性检出率为11.4%,年度阳性检出率为12.4%,由于第二次查痰阳性率提高了1%。而2008年查痰人数为1245,初次痰检阳性人数阳性检出率为12.3%,年度阳性检出率13.3%,阳性率也提高了1%。结论首次检查3个痰全部为阴性的脓血样标本、进行第二次查痰,进一步提高涂阳肺结核病人的发现,达到控制肺结核传染源目的。     

A minimum 5.0 ml of sputum improves the sensitivity of acid-fast smear for Mycobacterium tuberculosis

Detection of acid-fast bacilli (AFB) by sputum smear supports treatment decisions with pulmonary tuberculosis (TB), but smear sensitivity for Mycobacterium tuberculosis is only approximately 45 to 75%. In an effort to increase sensitivity, smears were prepared using a minimum sputum volume of 5.0 ml. Sensitivity of smears during a 39-mo period (n = 1,849) using >/= 5.0 ml of sputum was 92. 0%, significantly greater (p < 0.001) than a sensitivity of 72.5% in a previous 24-mo period (n = 3,486) when all specimens were processed regardless of volume. All new cases of TB (n = 18) were smear-positive with >/= 5.0 ml of sputum before treatment, and all were receiving antituberculosis drugs at hospital discharge. In contrast, significantly fewer new cases of TB (14 of 26, p = 0.002) were positive before treatment when smears were prepared using sputum of any volume, and significantly fewer of these new TB cases (18 of 26, p = 0.03) were receiving treatment at hospital discharge. The eight cases without treatment were smear-negative. These results indicate that acid-fast smear using >/= 5.0 ml of sputum increases sensitivity for M. tuberculosis and accelerates treatment of TB.     

全血检测特异性抗结核抗体对结核病快速诊断价值的研究

目的了解全血检测特异性抗结核抗体(LAM-IgG)对结核病快速诊断的价值.方法采受试者手指血20μL用金标试剂盒直接检测LAM-IgG.结果 125例涂阳肺结核抗体阳性检出率为92.0%;267例涂阴肺结核抗体阳性检出率为78.3%;94例陈旧性肺结核抗体阳性检出率为 75.5%;36例肺外结核抗体阳性检出率为83.3%;315例非结核抗体阳性检出率为47.6%.本试验灵敏度为82.7%(324/392),特异度为52.4%(165/315).结论全血快速检测抗结核抗体较血清检测更方便,灵敏度高,但特异度较低,不能作为涂阴肺结核的最终诊断,此项检查可作为涂阴肺结核的辅助诊断和结核可疑者的筛选手段以及肺外结核的诊断指标之一.     

T-SPOT.TB在肺结核合并糖尿病患者诊断中的价值分析

目的 研究分析在肺结核合并糖尿病患者中采用结核杆菌T细胞斑点实验(T-SPOT.TB)诊断的价值影响.方法 通过抽签选出于2017年10月—2019年4月期间收治的60名非肺结核合并糖尿病患者作为该次研究的一号组,同时选取同时期在该院确诊的60例患有肺结核合并糖尿病的患者作为该次研究的二号组.对两组患者统一实施结核杆菌...     

结核抗体lgG/lgM检测在肺结核和肺外结核中的诊断价值

目的 探讨异种血清抗体检测技术在结核病诊断中的应用价值。方法 采用IgG/IgM抗体试剂盒分别检测102例结核病患者(包括73例肺结核和29例肺外结核)、223例其他肺部疾病患者和100例对照者结核感染情况,以临床诊断为标准评价该方法的敏感度和特异性,同时分别与痰菌培养及痰涂片平行检验的结果作比较,统计学分析采用χ²检验。结果 结核抗体IgG/IgM检测结核病患者的敏感度为74.51%、特异度为91.64%。结核抗体IgG/IgM检测肺结核和肺外结核的敏感度分别为82.19%、55.17%,肺内和肺外结核的敏感度差异有统计学意义(P＜0.05),结核抗体lgG/IgM检测结核患者阳性检出率明显高于痰培养法和痰涂片法(P<0.05)。102例结核病患者年龄段分组分析,少年组和老年组检出率分别为58.33%、36%,远低于青年组和中年组的96.15%和89.74%。不同年龄组间进行卡方比较分析显示,P＜0.05,差异有统计学意义。425例标本中,共发现8例非结核分枝杆菌,其中6例胞内分枝杆菌, 2例脓肿分枝杆菌,lgG/lgM抗体检测均为阴性。结论 IgG/IgM血清抗体检测肺内、外结核具有快速方便、经济和较高的敏感度,适合用于临床结核筛查。     

Value of smear and PCR in bronchoalveolar lavage fluid in culture positive pulmonary tuberculosis.

At present, further investigations are needed in patients with suspected pulmonary tuberculosis (TB) and either negative sputum smear or without sputum. The aim of the present study was to analyse the yield of bronchoalveolar lavage fluid (BALF) smear and PCR in patients with confirmed pulmonary TB. Patients with a positive culture for Mycobacterium tuberculosis complex in sputum or BALF were analysed over 5 yrs. In total, 90 out of 230 (39%) patients with culture-positive pulmonary TB had a positive sputum smear, and 120 patients underwent bronchoscopy. BALF smear was positive in 56 (47%), BALF PCR in 93 (78%) patients, and BALF smear and/or PCR was positive in 83%. In total, 71 patients who underwent bronchoscopy and had complete clinical records were further analysed. BALF (smear or Mycobacterium tuberculosis complex-PCR) allowed a rapid diagnosis in 10 (59%) out of 17 patients who had a negative sputum smear, and 49 (91%) out of 54 patients without sputum production. Of these 71 patients, 12 (17%) were only culture positive. Rapid diagnosis of pulmonary TB by smear and/or PCR was made in 190 out of 210 patients (90%) in sputum or BALF. In conclusion, combined use of bronchoalveolar lavage fluid smear and Mycobacterium tuberculosis complex-PCR has a good diagnostic yield in patients with sputum smear-negative tuberculosis or without sputum production.     

Cost-effectiveness of novel diagnostic tools for the diagnosis of tuberculosis

SETTING: The potential cost-effectiveness of improved diagnostic tests for tuberculosis (TB) in resource-limited settings is unknown. OBJECTIVE: To estimate the incremental cost-effectiveness of a hypothetical new point-of-care TB diagnostic test in South Africa, Brazil and Kenya. DESIGN: Decision-analysis model, adding four diagnostic interventions (sputum smear microscopy, new test, smear plus new test and smear plus TB culture) to a baseline of existing infrastructure without smear. RESULTS: Adding sputum smear was estimated to be more cost-effective (incremental cost per disability-adjusted life year [DALY] of $86 [South Africa], $131 [Brazil], $38 (Kenya]) than a new TB diagnostic with 70% sensitivity, 95% specificity and price of $20 per test ($198 [South Africa], $275 [Brazil], $84 [Kenya]). However, compared to sputum smear, smear plus new test averted 46-49% more DALYs per 1000 TB suspects (321 vs. 215 [South Africa], 243 vs. 166 [Brazil], 790 vs. 531 [Kenya]), at an incremental cost of $170 (Kenya) to $625 (Brazil) per DALY averted. Cost-effectiveness was most sensitive to the specificity and price of the new test, the baseline TB case detection rate and the discount rate. CONCLUSION: Novel diagnostic tests for TB are potentially highly cost-effective. Cost-effectiveness is maximized by high-specificity, low-cost tests deployed to regions with poor infrastructure.     

Role of Gene Xpert in smear negative pulmonary tuberculosis

BackgroundTuberculosis is a major health problem contributing to significant morbidity and mortality. Early diagnosis and treatment is the key for TB control. Sputum microscopy is a rapid and inexpensive test but due to low and variable sensitivity, many cases can be missed. Culture is considered to be the gold standard but is time consuming. Gene Xpert is a novel and rapid cartridge based nucleic acid amplification test (CBNAAT) that can be used for prompt diagnosis.AimTo compare the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of Gene Xpert with culture in diagnosing tuberculosis in sputum smear negative patients.MethodsThe study is a prospective observational study conducted from December 2017 to January 2019 on 189 patients, who were sputum smear negative but had signs and symptoms suggestive of tuberculosis. Their respiratory samples were taken (either sputum or bronchoalveolar lavage) and sent for Gene Xpert. The results were compared with culture, which was taken as the gold standard, and diagnostic accuracy was assessed.ResultA total of 189 patients were included in the study. In 25 patients sputum was taken and in 164 patients BAL was taken (which included 22 patients in whom sputum Gene Xpert was negative but there was high clinical suspicion of tuberculosis). The sensitivity, specificity, PPV and NPV of Gene Xpert in diagnosing smear negative pulmonary tuberculosis was found to be 96.3%, 81.3%, 87.5% and 94.2% respectively.ConclusionGene Xpert can be used as a rapid diagnostic tool in patients who are sputum smear negative but have clinical features highly suggestive of tuberculosis. It additionally helps in detecting rifampicin resistance. But every Gene Xpert positive case does not necessarily mean an active disease, therefore, past history of tuberculosis along with radiological signs of disease activity are to be considered. In case of negative Gene Xpert but high clinico-radiological suspicion of TB, patients should be followed up on regular intervals, while awaiting their culture.     

Integration of microscopy and serodiagnostic tests to screen for active tuberculosis.

SETTING: University of California San Diego Medical Center, USA. OBJECTIVE: To create a simple screening strategy for tuberculosis (TB) that includes antibody detection assays to improve the accuracy of microscopic examination of sputum for acid-fast bacilli (AFB smear). METHODS: Serum samples were obtained from 190 patients suspected of having active TB. TB diagnosis was established by Mycobacterium tuberculosis culture. HIV status was determined by commercial serologic tests. IgG antibody levels were measured by ELISA using purified M. tuberculosis antigens. Data from 130 randomly selected patients were used to develop a screening strategy; data from the remaining 60 patients were used for validation. RESULTS: AFB smear had 70% sensitivity and 88% specificity. In algorithms integrating single or multi-antigen ELISA with AFB smear and HIV results, the sensitivity improved over each test alone. The algorithm that included a four-antigen ELISA (38 kDa antigen, lipoarabinomannan, MPT-64 and glutamine synthase) had a sensitivity of 93% and a specificity of 76%. Compared to AFB smear, the sensitivity of the algorithm was significantly higher, while the specificity was not statistically different. CONCLUSION: This study demonstrates that a screening strategy can be created by integrating multi-antigen ELISA with AFB smear and HIV testing.