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QFT-Plus:在变异性方面更胜一筹?——对德国具有移民背景学生进行系列检测时新一代IGRA的评估

QFT-Plus: a plus in variability? - Evaluation of new generation IGRA in serial testing of students with a migration background in Germany.

作者信息

Knierer J, Gallegos Morales E N, Schablon A, Nienhaus A, Kersten J F

机构信息

University Medical Center Hamburg-Eppendorf (UKE), Center of Excellence for Health Services Research in Nursing (CVcare), Hamburg, Germany.

University Medical Center Hamburg-Eppendorf (UKE), Center of Excellence for Health Services Research in Nursing (CVcare), Hamburg, Germany ; Institute for Statutory Accident Insurance and Prevention in the Health and Welfare Services (BGW), Principles of Prevention and Rehabilitation Department (GPR), Hamburg, Germany.

出版信息

J Occup Med Toxicol. 2017 Jan 5;12:1. doi: 10.1186/s12995-016-0148-z. eCollection 2017.

Abstract

BACKGROUND

Currently available Interferon-gamma release assays (IGRAs) show a considerable variability in serial testing for latent tuberculosis infection (LTBI). This study offers first results for the new generation IGRA QuantiFERON-TB Gold Plus (QFT-Plus) introduced in 2015 in comparison with its predecessor QuantiFERON-TB Gold In-Tube (QFT-GIT) from serial testing of students with a migration background at German universities.

METHODS

Forty-one students were selected from a previous study. All students with a positive IGRA were asked and 11 agreed to participate in this cohort study. Additionally 30 students with negative IGRA results were selected by chance. Weekly testing with QFT-Plus and QFT-GIT was performed in all individuals over a 4-week period. IGRA variability was evaluated by calculating conversion and reversion rates.

RESULTS

From 41 participants a total number of 163 serial measurements were analyzed for each IGRA, leading to 122 possible IGRA changes each. QFT-Plus had four conversions and two reversions leading to a conversion rate of 4.3% (4 of 93 possible conversions, 95% CI 1.4-11.3%) and reversion rate of 6.9% (2 of 29 possible reversions, 95% CI 1.2-24.2%). QFT-GIT had 2 conversions and 1 reversion causing slightly lower rates with 2.2% conversions (2 of 91, 95% CI 0.4-8.5%) and 3.2% reversions (1 of 31, 95% CI 0.2-18.5%). Inconsistent IGRA results occurred in 4 subjects for QFT-Plus (8 stable positives, 29 stable negatives) and in 2 subjects for QFT-GIT (9 stable positives, 30 stable negatives). Agreement between the two IGRAs was 95.1% ( = 0.89). Variance attributed to the individuals was low (QFT-Plus: ICC = 0.88).

CONCLUSION

This study confirms occurrence of conversions and reversions for the new QFT-Plus in serial testing of a high-risk cohort in a low-incidence setting with improbable new TB contact during the study. QFT-Plus conversion and reversion rates were slightly higher than for the QFT-GIT but overall they were lower for both IGRAs than in other studies that investigated IGRA variability.

摘要

背景

目前可用的干扰素-γ释放试验(IGRAs)在潜伏性结核感染(LTBI)的系列检测中显示出相当大的变异性。本研究首次给出了2015年推出的新一代IGRA QuantiFERON-TB Gold Plus(QFT-Plus)的结果,并将其与其前身QuantiFERON-TB Gold In-Tube(QFT-GIT)进行比较,该比较基于对德国大学中有移民背景的学生的系列检测。

方法

从先前的一项研究中选取41名学生。所有IGRA检测呈阳性的学生均被邀请,其中11名同意参与这项队列研究。此外,随机选取30名IGRA检测结果为阴性的学生。在4周时间内,对所有个体每周进行一次QFT-Plus和QFT-GIT检测。通过计算转换率和逆转率来评估IGRA的变异性。

结果

对41名参与者,每种IGRA共分析了163次系列测量结果,每种IGRA分别有122次可能的结果变化。QFT-Plus有4次转换和2次逆转,转换率为4.3%(93次可能转换中的4次,95%CI 1.4 - 11.3%),逆转率为6.9%(29次可能逆转中的2次,95%CI 1.2 - 24.2%)。QFT-GIT有2次转换和1次逆转,转换率略低,为2.2%(91次中的2次,95%CI 0.4 - 8.5%),逆转率为3.2%(31次中的1次,95%CI 0.2 - 18.5%)。QFT-Plus有4名受试者出现IGRA结果不一致(8例稳定阳性,29例稳定阴性),QFT-GIT有2名受试者出现结果不一致(9例稳定阳性,30例稳定阴性)。两种IGRA之间的一致性为95.1%(κ = 0.89)。个体引起的方差较低(QFT-Plus:组内相关系数ICC = 0.88)。

结论

本研究证实在低发病率环境下对高危队列进行系列检测时,新的QFT-Plus会出现转换和逆转情况,且在研究期间不太可能有新的结核接触。QFT-Plus的转换率和逆转率略高于QFT-GIT,但总体而言,两种IGRA的这些比率均低于其他研究中调查IGRA变异性时的比率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d1e1/5216544/e0a6815d7992/12995_2016_148_Fig1_HTML.jpg

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