Performance of QuantiFERON-TB Gold Plus for detection of latent tuberculosis infection in pregnant women living in a tuberculosis- and HIV-endemic setting

We evaluated the performance of QuantiFERON-TB Gold Plus (QFT-Plus), which includes two Mycobacterium tuberculosis antigen formulations (TB1 and TB2), for detection of latent tuberculosis infection during pregnancy. Eight-hundred-twenty-nine Ethiopian pregnant women (5.9% HIV-positive) were tested with QFT-Plus, with bacteriological sputum analysis performed for women with clinically suspected tuberculosis and HIV-positive women irrespective of clinical presentation. QFT-Plus read-out was categorized according to the conventional cut-off (0.35 IU/ml) for both antigen formulations. In addition, we analysed the distribution of QFT-Plus results within a borderline zone (0.20–0.70 IU/ml), and interferon-γ response in relation to HIV infection and gestational age. Two-hundred-seventy-seven women (33%) were QFT-Plus-positive (HIV-positive 16/49 [33%]; HIV-negative 261/780 [33%]). There was a strong agreement between the two antigen formulations (κ = 0.92), with discordant results in 29 cases (3.5%). Whereas discordant QFT-Plus results were rare in pregnancy, several results with both TB1 and TB2 within the borderline range were observed (11/49 [22%] vs. 43/780 [5.5%] in HIV-positive and HIV-negative women, respectively; p我们评估了QuantiFERON-TB Gold Plus（QFT-Plus）的检测性能，该试剂包含两种结核分枝杆菌（Mycobacterium tuberculosis）抗原制剂TB1与TB2，用于妊娠期潜伏结核感染的诊断。本研究共纳入829名埃塞俄比亚孕妇，其中5.9%为人类免疫缺陷病毒（HIV）阳性者，所有受试者均接受QFT-Plus检测；对于临床疑似结核患者，以及无论临床表现如何的HIV阳性孕妇，均额外开展了细菌学痰涂片分析。QFT-Plus的结果判读针对两种抗原制剂统一采用常规临界值（0.35 IU/ml）。此外，本研究还分析了QFT-Plus结果处于临界区间（0.20~0.70 IU/ml）的分布特征，以及γ干扰素（interferon-γ）应答水平与HIV感染状态及胎龄的相关性。最终共有277名孕妇（占比33%）的QFT-Plus检测结果为阳性，其中HIV阳性者16/49[33%]，HIV阴性者261/780[33%]。两种抗原制剂的检测结果具有高度一致性（κ=0.92），仅29例（3.5%）出现结果不一致的情况。尽管妊娠期QFT-Plus检测结果不一致的案例较为罕见，但仍观察到部分孕妇的TB1与TB2检测结果均处于临界区间：HIV阳性者中为11/49[22%]，HIV阴性者中为43/780[5.5%]；p