Çavuşoğlu Cengiz, Durusoy Raika, Yaşar Melike, Kayın Münevver
Ege University Faculty of Medicine, Department of Medical Microbiology, Izmir, Turkey.
Mikrobiyol Bul. 2017 Apr;51(2):115-126. doi: 10.5578/mb.53842.
The aims of this study were to evaluate the sensitivity of QuantiFERON®-TB Gold in Tube (QFT) test and its agreement with the tuberculin skin test (TST), to investigate possible factors associated with indeterminate QFT test results and to explore the relationship between latent tuberculosis infection (LTBE) prevalence and the rate of tuberculosis (TB) cases in our region. 1455 cases with QFT test performed in Ege University Faculty of Medicine Hospital between 2013 and 2015 were included in the study and simultaneously TST results of 268 of 1455 cases were reached. TST results were evaluated according to both ≥ 10 mm and ≥ 15 mm cut-off values. The QFT results of the cases were compared according to their gender, age groups and clinical characteristics with chi-square test. Stratified analyses were also conducted according to age groups. Multivariate logistic regression was used to analyse factors associated with QFT positivity and indeterminate QFT results. Cohen's kappa was used to test the agreement between QFT and TDT, overall and stratified according to age groups. Among 1455 cases, 396 (27.2%) were QFT positive and 120 (8.2%) had an indeterminate QFT result. When the indeterminate results were excluded, QFT positivity was found as 29.7%. The highest indeterminate results were determined among 0-4 year-old and ≥ 65 year-old groups as 17.6% and 12.1%, respectively and lowest among the 55-64 age group as 4%. The comparison of the cases without any cellular immunity defect and the patients with hematologic malignancies or immune deficiency and patients under immunosuppressive treatment had two and 2.44 times more indeterminate QFT results, respectively. Among 268 cases with TST results reached, QFT positivity was 30.6%; 38.1% for TST ≥ 10 mm and 25.7% for TST ≥ 15. After the exclusion of indeterminate results, the agreement between QFT and TST ≥ 10 mm was 71.3% for positive cases and 75.5% for negative cases. The highest agreement between QFT and TST ≥ 10 mm was in the age group 35-64 and lowest in the age group ≥ 65. Among 43 culture-positive cases, 32 had QFT positive, six negative and five indeterminate results. When indeterminate results were excluded, the sensitivity of thetest was 84.2% (32/38) among culture-positive active TB cases. TST results were available for 17 of the culture-positive cases, among them QFT sensitivity was 76.5% (13/17), TST sensitivity 70.6% (12/17) and the sensitivity of both tests was 88.2% (15/17). The ratio of QFT positivity has increased as the age increased. Interestingly, QFT positivity was higher among females than males in the 15-34 age group and higher among males in the 35-64 age group. The rates of QFT positivity were lower among immunocompromised patients. When QFT and TST positivities were compared with the rate of TB cases among age groups, QFT positivity was observed as parallel to the rate of TB cases. In conclusion, although the sensitivity of QFT was higher than TST, it was found that it could not be considered as a gold standard in LTBE diagnosis. As active TB cases originate from the LTBE pool, QFT test results might be considered a better indicator of active TB development risk.
本研究的目的是评估管内QuantiFERON®-TB Gold(QFT)检测的敏感性及其与结核菌素皮肤试验(TST)的一致性,调查与QFT检测结果不确定相关的可能因素,并探讨本地区潜伏性结核感染(LTBI)患病率与结核病(TB)病例发生率之间的关系。纳入了2013年至2015年在伊兹密尔艾杰大学医学院医院进行QFT检测的1455例病例,同时获取了1455例病例中268例的TST结果。根据≥10 mm和≥15 mm的临界值评估TST结果。采用卡方检验根据病例的性别、年龄组和临床特征比较QFT结果。还根据年龄组进行了分层分析。使用多变量逻辑回归分析与QFT阳性和QFT结果不确定相关的因素。采用Cohen's kappa检验QFT与TDT之间的一致性,总体及按年龄组分层进行检验。在1455例病例中,396例(27.2%)QFT阳性,120例(8.2%)QFT结果不确定。排除不确定结果后,QFT阳性率为29.7%。0至4岁组和≥65岁组的不确定结果最高,分别为17.6%和12.1%,55至64岁年龄组最低,为4%。无任何细胞免疫缺陷的病例与血液系统恶性肿瘤或免疫缺陷患者以及接受免疫抑制治疗的患者相比,QFT结果不确定的情况分别多2倍和2.44倍。在获得TST结果的268例病例中,QFT阳性率为30.6%;TST≥10 mm时为38.1%,TST≥15时为25.7%。排除不确定结果后,QFT与TST≥10 mm之间阳性病例的一致性为71.3%,阴性病例为75.5%。QFT与TST≥10 mm之间的一致性在35至64岁年龄组最高,在≥65岁年龄组最低。在43例培养阳性病例中,32例QFT阳性,6例阴性,5例结果不确定。排除不确定结果后,培养阳性的活动性结核病例中该检测的敏感性为84.2%(32/38)。17例培养阳性病例有TST结果,其中QFT敏感性为76.5%(13/17),TST敏感性为70.6%(12/17),两种检测的敏感性为88.2%(15/17)。QFT阳性率随年龄增加而升高。有趣的是,15至34岁年龄组女性的QFT阳性率高于男性,35至64岁年龄组男性的QFT阳性率更高。免疫受损患者的QFT阳性率较低。当将QFT和TST阳性率与各年龄组的结核病病例发生率进行比较时,发现QFT阳性率与结核病病例发生率平行。总之,尽管QFT的敏感性高于TST,但发现其在LTBI诊断中不能被视为金标准。由于活动性结核病例源自LTBI群体,QFT检测结果可能被视为活动性结核发生风险的更好指标。