尿液脂阿拉伯甘露聚糖检测与 Xpert MTB/RIF 在 HIV 感染者中的比较性能。
Comparative performance of urinary lipoarabinomannan assays and Xpert MTB/RIF in HIV-infected individuals.
机构信息
aJohns Hopkins University School of Medicine, Baltimore, Maryland, USA bDepartment of Microbiology cInfectious Diseases Institute, Makerere University College of Health Sciences, Kampala, Uganda dBoston Medical Center, Boston University School of Medicine, Boston, Massachusetts, USA.
出版信息
AIDS. 2014 Jun 1;28(9):1307-14. doi: 10.1097/QAD.0000000000000264.
BACKGROUND
Xpert MTB/RIF ('Xpert') and urinary lipoarabinomannan (LAM) assays offer rapid tuberculosis (TB) diagnosis, but have suboptimal sensitivity when used individually in HIV-positive patients. The yield of these tests used in combination for the diagnosis of active TB among HIV-infected TB suspects is unknown.
DESIGN
Study of comparative diagnostic accuracy nested into a prospective study of HIV-infected individuals with signs and/or symptoms of TB in Uganda.
METHODS
Xpert testing of archived sputum was conducted for culture-confirmed TB cases and TB suspects in whom a diagnosis of TB was excluded. Additional testing included sputum smear microscopy, sputum culture (solid and liquid media), mycobacterial blood culture, and urinary testing for LAM using a lateral flow test ('LF-LAM') and an enzyme-linked immunosorbance assay ('ELISA-LAM').
RESULTS
Among 103 participants with culture-confirmed TB, sensitivity of Xpert was 76% (95% confidence interval, CI 0.66-0.84), and was superior to that of LF-LAM (49%, 95% CI 0.39-0.59, P < 0.001). Specificity was greater than 97% for both tests among 105 individuals without TB. The combination of smear microscopy and LF-LAM identified 67% (95% CI 0.57-0.76) of culture-confirmed TB cases and approached sensitivity of Xpert testing alone (P = 0.15). The sensitivity of the combination of Xpert and LF-LAM was 85% (88/103 95% CI 0.77-0.92), which was superior to either test alone (P < 0.05) and approached sensitivity of sputum liquid culture testing (94%, 95% CI 0.88-0.98, P = 0.17).
CONCLUSION
Sputum Xpert and urinary LAM assays were complementary for the diagnosis of active TB in HIV-infected patients, and sensitivity of the combination of these tests was superior to that of either test alone.
背景
Xpert MTB/RIF（“Xpert”）和尿液脂阿拉伯甘露聚糖（LAM）检测可快速诊断结核病（TB），但在 HIV 阳性患者中单独使用时敏感性欠佳。在 HIV 感染的 TB 疑似患者中，这些检测联合用于诊断活动性 TB 的效果尚不清楚。
设计
在乌干达进行的一项 HIV 感染者出现 TB 症状或体征的前瞻性研究中，嵌套一项比较诊断准确性的研究。
方法
对培养确诊的 TB 病例和 TB 疑似患者进行存档痰液的 Xpert 检测，这些患者的 TB 诊断已排除。其他检测包括痰涂片显微镜检查、痰培养（固体和液体培养基）、分枝杆菌血培养和尿液 LAM 检测，使用侧向流检测（“LF-LAM”）和酶联免疫吸附测定（“ELISA-LAM”）。
结果
在 103 例培养确诊的 TB 患者中，Xpert 的敏感性为 76%（95%置信区间，0.66-0.84），优于 LF-LAM（49%，95%置信区间，0.39-0.59，P<0.001）。在 105 例无 TB 的患者中，两种检测的特异性均大于 97%。涂片显微镜检查和 LF-LAM 联合检测可发现 67%（95%置信区间，0.57-0.76）的培养确诊 TB 病例，与单独 Xpert 检测的敏感性相近（P=0.15）。Xpert 和 LF-LAM 联合检测的敏感性为 85%（88/103，95%置信区间，0.77-0.92），优于单独任何一种检测（P<0.05），且接近痰液培养检测的敏感性（94%，95%置信区间，0.88-0.98，P=0.17）。
结论
痰液 Xpert 和尿液 LAM 检测可互补用于诊断 HIV 感染患者的活动性 TB，且这些检测联合的敏感性优于单独任何一种检测。
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