Accuracy of the tuberculosis point-of-care Alere determine lipoarabinomannan antigen diagnostic test using α-mannosidase treated and untreated urine in a cohort of people living with HIV in Guatemala.
Accuracy of the tuberculosis point-of-care Alere determine lipoarabinomannan antigen diagnostic test using α-mannosidase treated and untreated urine in a cohort of people living with HIV in Guatemala.
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DOI：
10.1186/s12981-020-00318-8
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发表时间：
2020-10-19
影响因子：
2.2
通讯作者：
Ikeda J
中科院分区：
文献类型：
--
作者：
García JI;Meléndez J;Álvarez R;Mejía-Chew C;Kelley HV;Sidiki S;Castillo A;Mazariegos C;López-Téllez C;Forno D;Ayala N;Balada-Llasat JM;Mejía-Villatoro CR;Wang SH;Torrelles JB;Ikeda J
需要改善严重免疫抑制的艾滋病毒感染者（PLWH）的结核病（TB）护理点诊断测试，以降低发病率和死亡率。本研究的目的是在危地马拉初级保健诊所的PLWH队列中评价脂阿拉伯甘露聚糖抗原检测（LAM检测）在有和没有α-甘露糖苷酶预处理尿液的情况下的性能。我们进一步确定了结核病的发病率，死亡率及其危险因素的PLWH与结核病的症状。有结核病症状的艾滋病病毒感染者前瞻性纵向研究。在2个HIV研究中心采集尿液样本，以检测尿液中LAM检测的灵敏度（有和无α-甘露糖苷酶预处理）。在LAM检测诊断准确性研究中使用阳性结核分枝杆菌复合群培养物和/或GeneXpert® MTB/RIF（Xpert，Cepheid，桑尼维尔，CA，USA）结果的复合参考标准。考克斯比例风险回归用于研究死亡率预测因子。LAM检验的总体灵敏度为56.1%，95% CI为（43.3-68.3）。LAM检测灵敏度与医院和CD 4 T细胞值均无差异。在CD 4 T细胞< 200/µl的PLWH中，LAM试验灵敏度为62.2%（95% CI 46.5-76.2）。当比较未处理与α-甘露糖苷酶处理尿液中获得的LAM检测结果时，灵敏度无显著差异[分别为55.2%（95% CI 42.6-67.4）vs. 56.9%（95% CI 44-69.2）]。我们队列中的结核病发病率为21.4/100人年（PY）（95% CI 16.6-27.6），死亡率为11.1/100 PY（95% CI 8.2-15.0）。重要的是，与LAM检测结果阴性的PLWH相比，LAM检测结果阳性的PLWH的死亡校正风险比（aHR）为1.98（1.0-3.8），显著p值为0.044。在本研究中，α-甘露糖苷酶处理尿液并未显著提高LAM检测性能;然而，由于我们的研究局限性，这需要在大规模研究中进一步评价。重要的是，发现结核病的发病率和死亡率很高，阳性LAM试验结果预测了有结核病临床症状的PLWH的死亡率。
Improved point-of-care diagnostic tests for tuberculosis (TB) in severe immune suppressed people living with HIV (PLWH) are needed to decrease morbidity and mortality outcomes. The aim of the study is to evaluate the performance of the lipoarabinomannan antigen test (LAM-test) with and without α-mannosidase pre-treated urine in a cohort of PLWH in primary care clinics in Guatemala. We further determined TB incidence, and mortality rates and its risk factors in PLWH with TB symptoms. Prospective longitudinal study of PLWH with TB symptoms. Urine samples were collected at 2 HIV sites to test the sensitivity of the LAM-test in urine with and without α-mannosidase pre-treatment. A composite reference standard of either a positive Mycobacterium tuberculosis complex culture and/or GeneXpert® MTB/RIF (Xpert, Cepheid, Sunnyvale, CA, USA) results was used in the LAM-test diagnostic accuracy studies. Cox proportional hazards regression was used to study mortality predictors. The overall sensitivity of the LAM-test was of 56.1% with 95% CI of (43.3–68.3). There were no differences in the LAM-test sensitivity neither by hospital nor by CD4 T cell values. LAM-test sensitivity in PLWH with < 200 CD4 T cells/µl was of 62.2% (95% CI 46.5–76.2). There were no significant differences in sensitivity when comparing LAM-test results obtained from untreated vs. α-mannosidase treated urine [55.2% (95% CI 42.6–67.4) vs. 56.9% (95% CI 44–69.2), respectively]. TB incidence in our cohort was of 21.4/100 person years (PYs) (95% CI 16.6–27.6), and mortality rate was of 11.1/100 PYs (95% CI 8.2–15.0). Importantly, PLWH with a positive LAM-test result had an adjusted hazard ratio (aHR) of death of 1.98 (1.0–3.8) with a significant p value of 0.044 when compared to PLWH with a negative LAM-test result. In this study, α-mannosidase treatment of urine did not significantly increase the LAM-test performance, however; this needs to be further evaluated in a large-scale study due to our study limitations. Importantly, high rates of TB incidence and mortality were found, and a positive LAM-test result predicted mortality in PLWH with TB clinical symptoms.
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DOI：
10.4049/jimmunol.1601199
发表时间：
2017-03-01
期刊：
Journal of immunology (Baltimore, Md. : 1950)
影响因子：
--
作者：
Athman JJ;Sande OJ;Groft SG;Reba SM;Nagy N;Wearsch PA;Richardson ET;Rojas R;Boom WH;Shukla S;Harding CV
通讯作者：
Harding CV
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
发表时间：
2012-11
期刊：
The European respiratory journal
影响因子：
--
作者：
Peter JG;Theron G;van Zyl-Smit R;Haripersad A;Mottay L;Kraus S;Binder A;Meldau R;Hardy A;Dheda K
通讯作者：
Dheda K
影响因子：
4.6
作者：
Kerkhoff, Andrew D.;Barr, David A.;Meintjes, Graeme
通讯作者：
Meintjes, Graeme
影响因子：
4.4
作者：
Ikeda, Janet Midori;Tellez, Cesar A. Lopez;Hearst, Norman
通讯作者：
Hearst, Norman
影响因子：
4.4
作者：
Ikeda JM;Racancoj O;Welty S;Page K;Hearst N;McFarland W
通讯作者：
McFarland W