C-Tb 皮肤试验诊断儿童和 HIV 感染成人结核分枝杆菌感染：一项 3 期试验。
C-Tb skin test to diagnose Mycobacterium tuberculosis infection in children and HIV-infected adults: A phase 3 trial.
机构信息
Department of Vaccine Development, Statens Serum Institut, Copenhagen, Denmark.
Department of Infectious Diseases Immunology, Statens Serum Institut, Copenhagen, Denmark.
出版信息
PLoS One. 2018 Sep 24;13(9):e0204554. doi: 10.1371/journal.pone.0204554. eCollection 2018.
BACKGROUND
C-Tb, an ESAT-6/CFP-10-based skin test, has similar sensitivity for active TB compared to tuberculin skin test (TST) and QuantiFERON-TB-Gold-In-Tube (QFT). However, data are limited in children and HIV-infected persons.
METHODS
Asymptomatic South African contacts <5 years (n = 87; HIV-uninfected), or symptomatic individuals of all ages presenting to clinics with suspected TB (n = 1003; 30% HIV-infected) were recruited from eight South African centres. C-Tb and TST were allocated to either forearm double blinded. Samples for QFT were collected in parallel, and test-positivity rates were compared.
RESULTS
In participants with microbiologically confirmed TB (n = 75; 45% HIV-infected) sensitivity of C-Tb, TST and QFT were similar (72% versus 75% versus 73%; p>0.5). All 3 tests had similar positivity rates in HIV-infected participants with active TB, however, positivity rates were reduced when CD4 counts were <100 cells/μL. In participants where active TB was excluded (n = 920), C-Tb (41%), TST (43%), and QFT (44%) also had similar test-positivity rates. Among asymptomatic contacts aged below five, 32% (28/87) tested positive with C-Tb and 32% (28/87) with TST (concordance 89%). Overall, C-Tb and TST showed a similar safety profile.
CONCLUSION
C-Tb was safe and showed similar test-positivity rates, compared to TST and QFT, in children and HIV-infected persons with active or latent M. tuberculosis infection. These data inform the utility of C-Tb in clinical practice.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01642888. EudraCT 2011-005078-40.
背景
C-Tb 是一种基于 ESAT-6/CFP-10 的皮肤试验，其对活动性结核病的敏感性与结核菌素皮肤试验（TST）和 QuantiFERON-TB-Gold-In-Tube（QFT）相似。然而，在儿童和 HIV 感染者中的数据有限。
方法
来自南非 8 个中心的无症状 5 岁以下南非接触者（n=87；HIV 未感染者）或因疑似结核病就诊的所有年龄段的症状患者（n=1003；30%HIV 感染者）纳入研究。C-Tb 和 TST 分别分配至前臂进行双盲。同时采集 QFT 样本，并比较试验阳性率。
结果
在经微生物学证实患有结核病的参与者（n=75；45%HIV 感染者）中，C-Tb、TST 和 QFT 的敏感性相似（72% 与 75% 与 73%；p>0.5）。在 HIV 感染者中，所有 3 种检测方法在活动性结核病中均具有相似的阳性率，然而，当 CD4 计数<100 个/μL 时，阳性率降低。在排除活动性结核病的参与者（n=920）中，C-Tb（41%）、TST（43%）和 QFT（44%）也具有相似的检测阳性率。在年龄<5 岁的无症状接触者中，32%（28/87）的 C-Tb 检测结果阳性，32%（28/87）的 TST 检测结果阳性（一致性 89%）。总的来说，C-Tb 与 TST 具有相似的安全性，在活动性或潜伏性结核分枝杆菌感染的儿童和 HIV 感染者中，与 TST 和 QFT 相比，具有相似的检测阳性率。这些数据为 C-Tb 在临床实践中的应用提供了依据。
试验注册
ClinicalTrials.gov NCT01642888。EudraCT 2011-005078-40。
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