用于诊断 HIV/AIDS 患者进行性播散性组织胞浆菌病的尿液抗原检测和不同临床样本的分子检测的诊断准确性：一项在墨西哥进行的前瞻性多中心研究。
Diagnostic accuracy of antigen detection in urine and molecular assays testing in different clinical samples for the diagnosis of progressive disseminated histoplasmosis in patients living with HIV/AIDS: A prospective multicenter study in Mexico.
机构信息
Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán; Tlalpan, Mexico City, Mexico.
Department of Pathology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Mexico City, Mexico.
出版信息
PLoS Negl Trop Dis. 2021 Mar 8;15(3):e0009215. doi: 10.1371/journal.pntd.0009215. eCollection 2021 Mar.
BACKGROUND
The progressive disseminated histoplasmosis (PDH) has been associated with severe disease and high risk of death among people living with HIV (PLWHIV). Therefore, the purpose of this multicenter, prospective, double-blinded study done in ten Mexican hospitals was to determine the diagnostic accuracy of detecting Histoplasma capsulatum antigen in urine using the IMMY ALPHA Histoplasma EIA kit (IAHE), clarus Histoplasma GM Enzyme Immunoassay (cHGEI IMMY) and MiraVista Histoplasma Urine Antigen LFA (MVHUALFA); as well as the Hcp100 and 1281-1283220SCAR nested PCRs in blood, bone-marrow, tissue biopsies and urine.
METHODOLOGY/PRINCIPAL FINDINGS: We included 415 PLWHIV older than 18 years of age with suspicion of PDH. Using as diagnostic standard recovery of H. capsulatum in blood, bone marrow or tissue cultures, or histopathological exam compatible, detected 108 patients (26%, [95%CI, 21.78-30.22]) with proven-PDH. We analyzed 391 urine samples by the IAHE, cHGEI IMMY and MVHUALFA; the sensitivity/specificity values obtained were 67.3% (95% CI, 57.4-76.2) / 96.2% (95% CI, 93.2-98.0) for IAHE, 91.3% (95% CI, 84.2-96.0) / 90.9% (95% CI, 87.0-94.0) for cHGEI IMMY and 90.4% (95% CI, 83.0-95.3) / 92.3% (95% CI, 88.6-95.1) for MVHUALFA. The Hcp100 nested PCR was performed on 393, 343, 75 and 297, blood, bone marrow, tissue and urine samples respectively; the sensitivity/specificity values obtained were 62.9% (95%CI, 53.3-72.5)/ 89.5% (95%CI, 86.0-93.0), 65.9% (95%CI, 56.0-75.8)/ 89.0% (95%CI, 85.2-92.9), 62.1% (95%CI, 44.4-79.7)/ 82.6% (95%CI, 71.7-93.6) and 34.9% (95%CI, 24.8-46.2)/ 67.3% (95%CI, 60.6-73.5) respectively; and 1281-1283220SCAR nested PCR was performed on 392, 344, 75 and 291, respectively; the sensitivity/specificity values obtained were 65.3% (95% CI, 55.9-74.7)/ 58.8% (95%CI, 53.2-64.5), 70.8% (95%CI, 61.3-80.2)/ 52.9% (95%CI, 46.8-59.1), 71.4% (95%CI, 54.7-88.2)/ 40.4% (95%CI, 26.4-54.5) and 18.1% (95%CI, 10.5-28.1)/ 90.4% (95%CI, 85.5-94.0), respectively.
CONCLUSIONS/SIGNIFICANCE: The cHGEI IMMY and MVHUALFA tests showed excellent performance for the diagnosis of PDH in PLWHIV. The integration of these tests in clinical laboratories will certainly impact on early diagnosis and treatment.
背景
进行性播散性组织胞浆菌病（PDH）与 HIV 感染者（PLWHIV）的严重疾病和高死亡风险相关。因此，这项在墨西哥十家医院进行的多中心、前瞻性、双盲研究的目的是确定使用 IMMY ALPHA 组织胞浆菌 EIA 试剂盒（IAHE）、clarus 组织胞浆菌 GM 酶免疫测定法（cHGEI IMMY）和 MiraVista 组织胞浆菌尿液抗原 LFA（MVHUALFA）检测尿中荚膜组织胞浆菌抗原的诊断准确性；以及血液、骨髓、组织活检和尿液中的 Hcp100 和 1281-1283220SCAR 巢式 PCR。
方法/主要发现：我们纳入了 415 名年龄大于 18 岁且疑似 PDH 的 PLWHIV。使用血、骨髓或组织培养物中荚膜组织胞浆菌的恢复或组织病理学检查为诊断标准，检测出 108 例（26%[95%CI，21.78-30.22]）有明确 PDH 的患者。我们对 391 份尿样进行了 IAHE、cHGEI IMMY 和 MVHUALFA 分析；获得的灵敏度/特异性值分别为 67.3%（95%CI，57.4-76.2）/96.2%（95%CI，93.2-98.0）、91.3%（95%CI，84.2-96.0）/90.9%（95%CI，87.0-94.0）和 90.4%（95%CI，83.0-95.3）/92.3%（95%CI，88.6-95.1）。对 393、343、75 和 297 份血、骨髓、组织和尿液样本分别进行了 Hcp100 巢式 PCR；获得的灵敏度/特异性值分别为 62.9%（95%CI，53.3-72.5）/89.5%（95%CI，86.0-93.0）、65.9%（95%CI，56.0-75.8）/89.0%（95%CI，85.2-92.9）、62.1%（95%CI，44.4-79.7）/82.6%（95%CI，71.7-93.6）和 34.9%（95%CI，24.8-46.2）/67.3%（95%CI，60.6-73.5）。对 392、344、75 和 291 份样本分别进行了 1281-1283220SCAR 巢式 PCR；获得的灵敏度/特异性值分别为 65.3%（95%CI，55.9-74.7）/58.8%（95%CI，53.2-64.5）、70.8%（95%CI，61.3-80.2）/52.9%（95%CI，46.8-59.1）、71.4%（95%CI，54.7-88.2）/40.4%（95%CI，26.4-54.5）和 18.1%（95%CI，10.5-28.1）/90.4%（95%CI，85.5-94.0）。
结论/意义：cHGEI IMMY 和 MVHUALFA 检测对 PLWHIV 的 PDH 诊断具有出色的性能。这些检测方法在临床实验室中的整合肯定会影响早期诊断和治疗。
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