Diagnostic accuracy of a point-of-care urine test for tuberculosis screening among newly-diagnosed HIV-infected adults: a prospective, clinic-based study.

Diagnostic accuracy of a point-of-care urine test for tuberculosis screening among newly-diagnosed HIV-infected adults: a prospective, clinic-based study.
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DOI:
10.1186/1471-2334-14-110
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发表时间:
2014-02-26
影响因子:
3.7
通讯作者:
Bassett IV
Bassett IV
中科院分区:
医学3区
文献类型:
--
作者:
Drain PK;Losina E;Coleman SM;Giddy J;Ross D;Katz JN;Walensky RP;Freedberg KA;Bassett IV

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在临床护理点对活动性结核病(TB)进行快速诊断测试可以加快病例检测并加速TB治疗的启动。我们评估了快速尿阿拉伯甘露聚糖脂(LAM)检测在结核病流行的HIV感染成人中进行结核病筛查的诊断准确性。我们前瞻性招募了2011年10月至2012年5月在德班的4家门诊诊所新诊断的HIV感染成人(≥18岁),不包括接受TB治疗的患者。医生评估了所有参与者并提供了CD 4细胞计数检测。经过培训的研究护士采集痰液样本进行抗酸杆菌涂片显微镜检查(AFB)和分枝杆菌培养,并在诊所使用Determine™ TB LAM进行尿液LAM检测。无论尿LAM试验强度如何,均认为存在条带为阳性。我们将痰结核分枝杆菌培养阳性作为活动性肺结核的金标准。单独和结合涂片镜检评估尿LAM的诊断准确性,并按CD 4细胞计数分层。在342名新诊断的HIV感染者中,190名(56%)为男性,平均年龄为35.6岁,中位CD 4为182/mm 3。60名受试者培养阳性肺结核,估计患病率为17.5%(95%CI 13.7-22.0%)。45例(13.2%)受试者尿液LAM阳性。从尿液样本采集到LAM检测结果的平均时间为40分钟(95% CI 34-46分钟)。尿LAM试验敏感性为28.3%(95% CI 17.5-41.4)总体,37.5% CD 4 <100/mm 3者的95%CI为21.1-56.3,特异性为90.1%(95% CI 86.0-93.3),CD 4 < 100/mm 3的患者为86.9%(95% CI 75.8-94.2)。当与痰AFB(任一检测阳性)结合时,敏感性增加至38.3%(95%CI 26.0-51.8),但特异性降低至85.8%(95%CI 81.1-89.7)。在这项前瞻性的,以临床为基础的研究与训练有素的护士,快速尿LAM测试结核病筛查新诊断的艾滋病毒感染的成年人中的敏感性较低,但提高敏感性时,结合痰涂片镜检。
A rapid diagnostic test for active tuberculosis (TB) at the clinical point-of-care could expedite case detection and accelerate TB treatment initiation. We assessed the diagnostic accuracy of a rapid urine lipoarabinomannan (LAM) test for TB screening among HIV-infected adults in a TB-endemic setting. We prospectively enrolled newly-diagnosed HIV-infected adults (≥18 years) at 4 outpatient clinics in Durban from Oct 2011-May 2012, excluding those on TB therapy. A physician evaluated all participants and offered CD4 cell count testing. Trained study nurses collected a sputum sample for acid-fast bacilli smear microscopy (AFB) and mycobacterial culture, and performed urine LAM testing using Determine™ TB LAM in the clinic. The presence of a band regardless of intensity on the urine LAM test was considered positive. We defined as the gold standard for active pulmonary TB a positive sputum culture for Mycobacterium tuberculosis. Diagnostic accuracy of urine LAM was assessed, alone and in combination with smear microscopy, and stratified by CD4 cell count. Among 342 newly-diagnosed HIV-infected participants, 190 (56%) were male, mean age was 35.6 years, and median CD4 was 182/mm3. Sixty participants had culture-positive pulmonary TB, resulting in an estimated prevalence of 17.5% (95% CI 13.7-22.0%). Forty-five (13.2%) participants were urine LAM positive. Mean time from urine specimen collection to LAM test result was 40 minutes (95% CI 34–46 minutes). Urine LAM test sensitivity was 28.3% (95% CI 17.5-41.4) overall, and 37.5% (95% CI 21.1-56.3) for those with CD4 count <100/mm3, while specificity was 90.1% (95% CI 86.0-93.3) overall, and 86.9% (95% CI 75.8-94.2) for those with CD4 < 100/mm3. When combined with sputum AFB (either test positive), sensitivity increased to 38.3% (95% CI 26.0-51.8), but specificity decreased to 85.8% (95% CI 81.1-89.7). In this prospective, clinic-based study with trained nurses, a rapid urine LAM test had low sensitivity for TB screening among newly-diagnosed HIV-infected adults, but improved sensitivity when combined with sputum smear microscopy.
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