Huerga Helena, Ferlazzo Gabriella, Bevilacqua Paolo, Kirubi Beatrice, Ardizzoni Elisa, Wanjala Stephen, Sitienei Joseph, Bonnet Maryline
Epicentre, Paris, France.
Médecins Sans Frontières, Paris, France.
PLoS One. 2017 Jan 26;12(1):e0170976. doi: 10.1371/journal.pone.0170976. eCollection 2017.
Determine-TB LAM assay is a urine point-of-care test useful for TB diagnosis in HIV-positive patients. We assessed the incremental diagnostic yield of adding LAM to algorithms based on clinical signs, sputum smear-microscopy, chest X-ray and Xpert MTB/RIF in HIV-positive patients with symptoms of pulmonary TB (PTB).
Prospective observational cohort of ambulatory (either severely ill or CD4<200cells/μl or with Body Mass Index<17Kg/m2) and hospitalized symptomatic HIV-positive adults in Kenya. Incremental diagnostic yield of adding LAM was the difference in the proportion of confirmed TB patients (positive Xpert or MTB culture) diagnosed by the algorithm with LAM compared to the algorithm without LAM. The multivariable mortality model was adjusted for age, sex, clinical severity, BMI, CD4, ART initiation, LAM result and TB confirmation.
Among 474 patients included, 44.1% were severely ill, 69.6% had CD4<200cells/μl, 59.9% had initiated ART, 23.2% could not produce sputum. LAM, smear-microscopy, Xpert and culture in sputum were positive in 39.0% (185/474), 21.6% (76/352), 29.1% (102/350) and 39.7% (92/232) of the patients tested, respectively. Of 156 patients with confirmed TB, 65.4% were LAM positive. Of those classified as non-TB, 84.0% were LAM negative. Adding LAM increased the diagnostic yield of the algorithms by 36.6%, from 47.4% (95%CI:39.4-55.6) to 84.0% (95%CI:77.3-89.4%), when using clinical signs and X-ray; by 19.9%, from 62.2% (95%CI:54.1-69.8) to 82.1% (95%CI:75.1-87.7), when using clinical signs and microscopy; and by 13.4%, from 74.4% (95%CI:66.8-81.0) to 87.8% (95%CI:81.6-92.5), when using clinical signs and Xpert. LAM positive patients had an increased risk of 2-months mortality (aOR:2.7; 95%CI:1.5-4.9).
LAM should be included in TB diagnostic algorithms in parallel to microscopy or Xpert request for HIV-positive patients either ambulatory (severely ill or CD4<200cells/μl) or hospitalized. LAM allows same day treatment initiation in patients at higher risk of death and in those not able to produce sputum.
Determine-TB LAM检测是一种用于HIV阳性患者结核病诊断的即时尿液检测。我们评估了在基于临床症状、痰涂片显微镜检查、胸部X线和Xpert MTB/RIF的算法中加入LAM对有肺结核（PTB）症状的HIV阳性患者的额外诊断收益。
对肯尼亚门诊（病情严重或CD4<200细胞/μl或体重指数<17Kg/m2）及住院的有症状HIV阳性成人进行前瞻性观察队列研究。加入LAM后的额外诊断收益是指与未加入LAM的算法相比，加入LAM的算法诊断出的确诊结核病患者（Xpert阳性或MTB培养阳性）比例的差异。多变量死亡率模型根据年龄、性别、临床严重程度、BMI、CD4、开始抗逆转录病毒治疗情况、LAM结果和结核病确诊情况进行了调整。
在纳入的474例患者中，44.1%病情严重，69.6%的CD4<200细胞/μl，59.9%已开始抗逆转录病毒治疗，23.2%无法咳痰。检测的患者中，LAM、痰涂片显微镜检查、Xpert和痰培养阳性率分别为39.0%（185/474）、21.6%（76/352）、29.1%（102/350）和39.7%（92/232）。在156例确诊结核病的患者中，65.4%的LAM呈阳性。在那些被分类为非结核病的患者中，84.0%的LAM呈阴性。当使用临床症状和X线时，加入LAM使算法的诊断收益提高了36.6%，从47.4%（95%CI：39.4 - 55.6）提高到84.0%（95%CI：77.3 - 89.4%）；当使用临床症状和显微镜检查时，提高了19.9%，从62.2%（95%CI：54.1 - 69.8）提高到82.1%（95%CI：75.1 - ..... 87.7）；当使用临床症状和Xpert时，提高了13.4%，从74.4%（95%CI：66.8 -..... 81.0）提高到87.8%（95%CI：81.6 - 92.5）。LAM阳性患者2个月死亡率风险增加（调整后比值比：2.7；95%CI：1.5 - 4.9）。
对于门诊（病情严重或CD4<2..... 00细胞/μl）或住院的HIV阳性患者，LAM应与显微镜检查或Xpert检测同时纳入结核病诊断算法中。LAM可使死亡风险较高和无法咳痰的患者在同一天开始治疗。
