The impact of HIV infection and CD4 cell count on the performance of an interferon gamma release assay in patients with pulmonary tuberculosis.

The impact of HIV infection and CD4 cell count on the performance of an interferon gamma release assay in patients with pulmonary tuberculosis.
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DOI:
10.1371/journal.pone.0004220
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发表时间:
2009
期刊:
影响因子:
3.7
通讯作者:
Andersen AB
Andersen AB
中科院分区:
综合性期刊3区
文献类型:
--
作者:
Aabye MG;Ravn P;PrayGod G;Jeremiah K;Mugomela A;Jepsen M;Faurholt D;Range N;Friis H;Changalucha J;Andersen AB

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在结核病和艾滋病毒流行环境中,结核病特异性干扰素伽玛释放分析(IGRAs)的表现还没有得到充分的记录。这项研究评估了Quantiferon TB-Gold In-Tube(QFT-IT)在结核病和HIV流行人群中培养确认的肺结核(PTB)患者中的敏感性,以及HIV感染和CD4细胞计数对测试性能的影响。对161例痰培养确诊的肺结核患者进行了HIV-和QFT-IT检测,并测定了CD4细胞计数。QFT-IT的阳性率为74%(119/161;95%CI:67~81%)。艾滋病毒阴性患者的敏感性(75/93)高于艾滋病毒阳性患者(44/68)(81%比65%,p = 0.02),并且随着艾滋病毒阳性患者CD_4细胞计数的增加而增加(趋势p = 0.03)。23名患者(14%)有不确定的结果,这一比例随着艾滋病毒阳性患者中CD_4细胞计数的增加而下降(趋势p = 为0.03)。低CD_4细胞计数(<300个/µL)并不能解释QFT-IT的所有不确定结果或所有阴性结果。排除不确定结果的敏感性为86%(95%CI:81-92%),在艾滋病毒阴性和艾滋病毒阳性患者之间没有差异(88%比83%,p = 0.39)。在排除不确定结果和HIV阴性患者的情况下,QFT-IT诊断活动性肺结核感染的敏感性是合理的。然而,由于这项检测漏掉了10%以上的患者,它作为活动性结核病排除测试的潜力是有限的。此外,HIV阳性患者的CD4细胞计数低,以及艾滋病毒阳性和HIV阴性患者的其他因素也可能影响检测性能。这可能会限制该测试在艾滋病毒感染盛行的人群中的潜力。
The performance of the tuberculosis specific Interferon Gamma Release Assays (IGRAs) has not been sufficiently documented in tuberculosis- and HIV-endemic settings. This study evaluated the sensitivity of the QuantiFERON TB-Gold In-Tube (QFT-IT) in patients with culture confirmed pulmonary tuberculosis (PTB) in a TB- and HIV-endemic population and the effect of HIV-infection and CD4 cell count on test performance. 161 patients with sputum culture confirmed PTB were subjected to HIV- and QFT-IT testing and measurement of CD4 cell count. The QFT-IT was positive in 74% (119/161; 95% CI: 67–81%). Sensitivity was higher in HIV-negative (75/93) than in HIV-positive (44/68) patients (81% vs. 65%, p = 0.02) and increased with CD4 cell count in HIV-positive patients (test for trend p = 0.03). 23 patients (14%) had an indeterminate result and this proportion decreased with increasing CD4 cell count in HIV-positive patients (test for trend p = 0.03). Low CD4 cell count (<300 cells/µl) did not account for all QFT-IT indeterminate nor all negative results. Sensitivity when excluding indeterminate results was 86% (95% CI: 81–92%) and did not differ between HIV-negative and HIV–positive patients (88 vs. 83%, p = 0.39). Sensitivity of the QFT-IT for diagnosing active PTB infection was reasonable when excluding indeterminate results and in HIV-negative patients. However, since the test missed more than 10% of patients, its potential as a rule-out test for active TB disease is limited. Furthermore, test performance is impaired by low CD4 cell count in HIV-positive patients and possibly by other factors as well in both HIV-positive and HIV-negative patients. This might limit the potential of the test in populations where HIV-infection is prevalent.
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