The diagnostic performance of novel skin-based in-vivo tests for tuberculosis infection compared with purified protein derivative tuberculin skin tests and blood-based in vitro interferon-γ release assays: a systematic review and meta-analysis.

医学 结核菌素 结核分枝杆菌 免疫学 肺结核 病毒学 潜伏性肺结核 纯化蛋白衍生物 干扰素γ释放试验
作者
Maria Krutikov,Lena Faust,Vladyslav Nikolayevskyy,Yohhei Hamada,Rishi K Gupta,Daniela Maria Cirillo,Alberto Mateelli,Alexei Korobitsyn,Claudia M. Denkinger,Molebogeng X Rangaka
出处
期刊:Lancet Infectious Diseases [Elsevier BV]
标识
DOI:10.1016/s1473-3099(21)00261-9
摘要

Summary Background Novel skin-based tests for tuberculosis infection might present suitable alternatives to current tests; however, diagnostic performance of new tests compared with the purified protein derivative-tuberculin skin test (TST) or interferon-γ release assays (IGRA) needs systematic assessment. Methods In this systematic review and meta-analysis, we searched English (Medline OVID), Chinese (Chinese Biomedical Literature Database and the China National Knowledge Infrastructure), and Russian (e-library) databases from the inception of each database to May 15, 2019, (with updated search of the Russian and English databases on Oct, 20 2020) using terms “ESAT6” OR “CFP10” AND “skin test” AND “Tuberculosis” OR “C-Tb” OR “Diaskintest”. We included studies reporting on the performance of index tests alone or compared with a comparator. Inclusion criteria varied according to review objectives and performance outcome, but reporting of test cut-offs for positivity applied to study population was required from all studies. We used a hierarchy of reference standards for tuberculosis infection consistent with the 2020 WHO framework to evaluate diagnostic performance. Two authors independently reviewed the titles and abstracts for English and Chinese (LF and MK) and Russian studies (MK and VN). Study quality was assessed with QUADAS-2. Pooled random-effects estimates are presented when appropriate for total agreement proportion, sensitivity in microbiologically confirmed tuberculosis and specificity in cohorts with low risk of tuberculosis infection. This study is registered with PROSPERO, CRD42019135572. Findings We identified 1466 original articles, of which 37 (2·5%) studies, including 10 915 individuals (7111 Diaskintest, 2744 C-Tb, 887 EC, 173 DPPD), were included in the qualitative analysis (29 [78%] studies of Diaskintest, five [15%] studies of C-Tb, two [5%] studies of EC-skintest, and one [3%] study of DPPD). 22 (1·5%) studies including 5810 individuals (3143 Diaskintest, 2129 C-Tb, 538 EC-skintest) were included in the quantitative analysis: 15 (68%) of Diaskintest, five (23%) of C-Tb, and two (9%) of EC-skintest. Tested sub-populations included individuals with HIV, children (0–18 years), and individuals exposed to tuberculosis. Studies were heterogeneous with moderate to high risk of bias. Nine head-to-head studies of index test versus TST and IGRA permitted direct comparisons and pooling. In a mixed cohort of people with and without tuberculosis, Diaskintest pooled agreement with IGRA was 87·16% (95% CI 79·47–92·24) and 55·45% (46·08–64·45) with TST-5 mm cut-off (TST5 mm). Diaskintest sensitivity was 91·18% (95% CI 81·72–95·98) compared with 88·24% (78·20–94·01) for TST5 mm, 89·66 (78·83–95·28) for IGRA QuantiFERON, and 90·91% (79·95–96·16) for TSPOT.TB. C-Tb agreement with IGRA in individuals with active tuberculosis was 79·80% (95% CI 76·10–83·07) compared with 78·92% (74·65–82·63) for TST5 mm/15 mm cut-off (TST5 mm/15 mm). TST5/15mm reflects threshold in cohorts that applied stratified cutoffs: 5 mm for HIV-infected, immunocompromised, or BCG-naive individuals, and 15mm for BCG-vaccinated immunocompetent individuals. C-Tb sensitivity was 74·52% (95% CI 70·39–78·25) compared with a sensitivity of 78·18% (67·75–85·94) for TST5 mm/15 mm, and 71·67% (63·44–78·68) for IGRA. Specificity was 97·85% (95% CI 93·96–99·25) for C-Tb versus 93·31% (90·22–95·48) for TST 15 mm cut-off and 99·15% (79·66–99·97) for IGRA. EC-skintest sensitivity was 86·06% (95% CI 82·39–89·07). Interpretation Novel skin-based tests for tuberculosis infection appear to perform similarly to IGRA or TST; however, study quality varied. Evaluation of test performance, patient-important outcomes, and diagnostic use in current clinical algorithms will inform implementation in key populations. Funding StopTB (New Diagnostics Working Group) and FIND. Translations For the Chinese and Russian translations of the abstract see Supplementary Materials section.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
大模型应助wang采纳,获得10
刚刚
Ethanyoyo0917完成签到,获得积分10
1秒前
JJS完成签到,获得积分10
1秒前
汉堡包应助鑫儿采纳,获得10
2秒前
2秒前
踏实嚣完成签到 ,获得积分10
4秒前
4秒前
chenxilulu完成签到,获得积分10
5秒前
Jacky完成签到,获得积分10
5秒前
qi0625完成签到,获得积分10
6秒前
6秒前
7秒前
7秒前
yefeng完成签到,获得积分10
8秒前
复杂的兔子完成签到,获得积分10
8秒前
小彭陪小崔读个研完成签到 ,获得积分10
11秒前
12秒前
wang发布了新的文献求助10
12秒前
Adrenaline完成签到,获得积分10
12秒前
鱼吃完成签到,获得积分20
13秒前
15秒前
15秒前
悄悄睡觉完成签到 ,获得积分10
16秒前
way完成签到,获得积分10
17秒前
17秒前
苏子轩完成签到 ,获得积分10
18秒前
QY11完成签到,获得积分10
20秒前
跳跃的太君完成签到,获得积分10
20秒前
彭于晏应助shengwufenzi采纳,获得10
21秒前
lemon完成签到,获得积分10
23秒前
ymk发布了新的文献求助10
23秒前
曾泳钧完成签到,获得积分10
24秒前
cyj完成签到 ,获得积分10
25秒前
h41692011完成签到 ,获得积分10
25秒前
粥粥完成签到 ,获得积分10
26秒前
大陆完成签到,获得积分10
26秒前
sure完成签到 ,获得积分10
26秒前
xmx完成签到 ,获得积分10
28秒前
十年完成签到 ,获得积分10
29秒前
lynn完成签到,获得积分10
29秒前
高分求助中
Production Logging: Theoretical and Interpretive Elements 2700
Neuromuscular and Electrodiagnostic Medicine Board Review 1000
こんなに痛いのにどうして「なんでもない」と医者にいわれてしまうのでしょうか 510
The First Nuclear Era: The Life and Times of a Technological Fixer 500
Unusual formation of 4-diazo-3-nitriminopyrazoles upon acid nitration of pyrazolo[3,4-d][1,2,3]triazoles 500
岡本唐貴自伝的回想画集 500
Distinct Aggregation Behaviors and Rheological Responses of Two Terminally Functionalized Polyisoprenes with Different Quadruple Hydrogen Bonding Motifs 450
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 物理 生物化学 纳米技术 计算机科学 化学工程 内科学 复合材料 物理化学 电极 遗传学 量子力学 基因 冶金 催化作用
热门帖子
关注 科研通微信公众号,转发送积分 3671625
求助须知:如何正确求助?哪些是违规求助? 3228325
关于积分的说明 9779625
捐赠科研通 2938636
什么是DOI,文献DOI怎么找? 1610180
邀请新用户注册赠送积分活动 760547
科研通“疑难数据库(出版商)”最低求助积分说明 736093