Diagnostic accuracy of a urine lipoarabinomannan strip-test for TB detection in HIV-infected hospitalised patients.

Diagnostic accuracy of a urine lipoarabinomannan strip-test for TB detection in HIV-infected hospitalised patients.
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HIV感染的住院患者的TB检测的尿液脂肪氨基氨基少量测试的诊断准确性。

DOI:
10.1183/09031936.00201711
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发表时间:
2012-11
期刊:
The European respiratory journal
影响因子:
--
通讯作者:
Dheda K
Dheda K
中科院分区:
其他
文献类型:
--
作者:
Peter JG;Theron G;van Zyl-Smit R;Haripersad A;Mottay L;Kraus S;Binder A;Meldau R;Hardy A;Dheda K

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缺乏结核病的护理点检测导致诊断延误,并增加死亡率和医疗保健相关费用。在335例前瞻性招募的疑似TB-HIV合并感染住院患者(第1组)和88例非TB诊断的HIV感染住院患者(第2组)中评价了尿液Determine ™ TB-LAM床旁试纸条检测。使用以下方法进行截止点特异性分析:1)微生物参考标准(培养阳性与阴性); 2)复合参考标准(从培养阴性组中排除临床TB患者)。使用微生物参考品和制造商推荐的1级临界点,LAM的灵敏度和特异性为66%(95%CI 57 - 74%)。相比之下,使用复合参考灵敏度为60%(95% CI 53 - 67%),特异性提高至96%(95% CI 89 - 100%)(p = 0.001)。当使用2级临界点时,观察到相同的模式(特异性75% vs 96%; p = 0.01)。在第二组患者中,使用1级临界点时特异性较差,但使用2级临界点时显著改善(90% vs 99%; p = 0.009)。2级临界点还提供了更好的阅片者间可靠性(p = 0.002)。在CD4 <200个细胞/mL的患者中灵敏度最高。LAM联合涂片镜检能够在71%的结核分枝杆菌培养阳性患者中排除结核病。这项初步研究表明,LAM试纸测试可能是一个潜在的有用的快速规则在结核病的晚期免疫抑制住院患者的测试。2级,而不是牧师推荐的1级分界点,提供了优越的规则在效用和读者间的可靠性。迫切需要更大规模的研究来评估临界点和诊断准确性。
Lack of point-of-care tests for tuberculosis (TB) result in diagnostic delay, and increased mortality and healthcare-related costs. The urine Determine™ TB-LAM point-of-care strip-test was evaluated in 335 prospectively-recruited hospitalised patients with suspected TB-HIV co-infection (group 1) and from 88 HIV-infected hospitalised patients with non-TB diagnoses (group 2). Cut-off point-specific analyses were performed using: 1) a microbiological reference standard (culture positive versus.negative); and 2) a composite reference standard (exclusion of patients with clinical-TB from the culture-negative group). Using the microbiological reference and the manufacturer-recommended grade-1 cut-off point, LAM sensitivity and specificity was 66% (95% CI 57–74%). By contrast, using the composite reference sensitivity was 60% (95% CI 53–67%) and specificity improved to 96% (95% CI 89–100%) (p=0.001). The same pattern was seen when the grade-2 cut-off point was used (specificity 75% versus 96%; p=0.01). In group two patients specificity was poor using the grade-1 cut-off point, but improved significantly when the grade-2 cut-off point was used (90% versus 99%; p=0.009). The grade-2 cut-off point also offered superior inter-reader reliability (p=0.002). Sensitivity was highest in those with a CD4 <200 cells per mL. LAM combined with smear-microscopy was able to rule-in TB in 71% of Mycobacterium tuberculosis culture-positive patients. This preliminary study indicates that the LAM strip-test may be a potentially useful rapid rule-in test for TB in hospitalised patients with advanced immunosuppression. The grade 2, but not the manufacturer-recommended grade 1 cut-off point, offered superior rule-in utility and inter-reader reliability. Larger studies to evaluate cut-off points and diagnostic accuracy are urgently required.
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