T-Track-CMV 和 QuantiFERON-CMV 检测在预测肾移植受者 CMV 再激活中的保护作用。

T-Track-CMV and QuantiFERON-CMV assays for prediction of protection from CMV reactivation in kidney transplant recipients.

机构信息

Institute for Transfusion Medicine, University Hospital Essen, University of Duisburg-Essen, Essen, Germany; Institute for Virology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.

Department of Nephrology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.

出版信息

J Clin Virol. 2018 Aug;105:91-96. doi: 10.1016/j.jcv.2018.06.009. Epub 2018 Jun 12.

DOI:10.1016/j.jcv.2018.06.009

PMID:29936407

Abstract

BACKGROUND

Assays detecting CMV-specific cell-mediated immunity (CMI) may support the current management of CMV infection in solid-organ transplant (SOT) recipients, by allowing a better risk assessment and adjusting antiviral treatment.

OBJECTIVES

The primary endpoint was the performance of two tests measuring CMV-specific interferon-gamma production, both approved for commercial use in clinical settings. Secondarily, we determined a cut-off for the cellular immune response, which protects against CMV reactivation/infection.

STUDY DESIGN

Thirty kidney transplant (KTx) patients were stratified according to their CMV-IgG status pre-transplantation (Tx) and were divided into two groups: pre-emptive (donor-/recipient+, donor+/recipient+) and prophylaxis (donor+/recipient-). An ELISpot (T-Track-CMV) was performed at month 1 post-Tx (pre-emptive group) and end of prophylaxis and one month thereafter (prophylaxis group). An ELISA (QuantiFERON-CMV) was performed every 2-4 weeks (pre-emptive) or monthly (prophylaxis), in parallel to the CMV viral load (PCR).

RESULTS

A good positive agreement was obtained between the QuantiFERON-CMV or T-Track-CMV and the CMV-IgG (kappa = 0.839 and 0.824, respectively). A cut-off of 19.5 spot forming units (SFU)/200,000 lymphocytes for the T-Track-CMV IE-1 (AUC = 0.802, sensitivity 45%, specificity 100%) and 495 SFU/200,000 lymphocytes for the T-Track-CMV pp65 (AUC = 0.617, sensitivity 11%, specificity 100%) was defined to assess protection against reactivation. The QuantiFERON-CMV performed modestly (AUC = 0.477, cut-off 85.1 IU/ml).

CONCLUSIONS

The QuantiFERON-CMV and T-Track-CMV enable the functional assessment of CMV-specific CMI in KTx recipients. In combination with CMV viral load monitoring, T-Track-CMV results could stratify patients at risk of CMV reactivation/infection.

摘要

背景

检测 CMV 特异性细胞介导免疫（CMI）的检测方法可以通过更好地评估风险和调整抗病毒治疗来支持实体器官移植（SOT）受者的 CMV 感染管理。

目的

主要终点是两种检测 CMV 特异性干扰素 - γ产生的测试的性能，这两种测试均已获得商业批准，可用于临床环境。其次，我们确定了防止 CMV 再激活/感染的细胞免疫反应的截止值。

研究设计

根据移植前（Tx）的 CMV-IgG 状态，将 30 名肾移植（KTx）患者分层，并分为两组：抢先（供体-/受体+，供体+/受体+）和预防（供体+/受体-）。在 Tx 后 1 个月（抢先组）和预防结束后 1 个月进行 ELISpot（T-Track-CMV）。在抢先组中，每 2-4 周进行一次 ELISA（QuantiFERON-CMV），在预防组中每月进行一次，同时进行 CMV 病毒载量（PCR）检测。

结果

QuantiFERON-CMV 或 T-Track-CMV 与 CMV-IgG 之间获得了良好的正相关性（kappa 值分别为 0.839 和 0.824）。T-Track-CMV IE-1 的 19.5 个斑点形成单位（SFU）/200,000 个淋巴细胞和 T-Track-CMV pp65 的 495 SFU/200,000 个淋巴细胞的 cutoff 值分别为 19.5 SFU/200,000 个淋巴细胞（AUC=0.802，灵敏度 45%，特异性 100%）和 495 SFU/200,000 个淋巴细胞（AUC=0.617，灵敏度 11%，特异性 100%），用于评估预防再激活的效果。QuantiFERON-CMV 的表现中等（AUC=0.477，cutoff 值为 85.1 IU/ml）。