Derendinger Brigitta, Mochizuki Tessa K, Marcelo Danaida, Shankar Deepa, Mangeni Wilson, Nguyen Hanh, Yerikaya Seda, Worodria William, Yu Charles, Nguyen Nhung Viet, Christopher Devasahayam Jesudas, Theron Grant, Phillips Patrick P J, Nahid Payam, Denkinger Claudia M, Cattamanchi Adithya, Yoon Christina
Department of Science and Technology-National Research Foundation Centre of Excellence for Biomedical Tuberculosis Research, South African Medical Research Council Centre for Tuberculosis Research, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Division of Pulmonary and Critical Care Medicine, San Francisco General Hospital, and.
Am J Respir Crit Care Med. 2025 Mar;211(3):499-506. doi: 10.1164/rccm.202405-1000OC.
C-reactive protein (CRP)-based tuberculosis (TB) screening is recommended for people with HIV. However, its performance among people without HIV and in diverse settings is unknown. In a multicountry study, we aimed to determine whether CRP meets the minimum accuracy targets (sensitivity ⩾ 90%, specificity ⩾ 70%) for an effective TB screening test. Consecutive outpatient adults with cough ⩾2 weeks from five TB endemic countries in Africa and Asia had baseline blood collected for point-of-care CRP testing and HIV and diabetes screening. Sputum samples were collected for Xpert MTB/RIF Ultra (Xpert) testing and culture. CRP sensitivity and specificity (5 mg/L cut-point) was determined in reference to sputum test results and compared by country, sex, and HIV and diabetes status. Variables affecting CRP performance were identified using a multivariate receiver operating curve regression model. Among 2,904 participants, of whom 613 (21%) had microbiologically confirmed TB, CRP sensitivity was 84% (95% confidence interval [CI], 81-87%) and specificity was 61% (95% CI, 59-63%). CRP accuracy varied geographically, with higher sensitivity in African countries (⩾91%) than Asian countries (64-82%). Sensitivity was higher among men than women (86% vs. 78%; difference, +8%; 95% CI, 1-15%) and specificity was lower among people with HIV than people without HIV (64% vs. 45%; difference, +19%; 95% CI, 13-25%). Receiver operating curve regression identified country and measures of TB disease severity as predictors of CRP performance. Overall, CRP did not achieve the minimum accuracy targets, and its performance varied by setting and in some subgroups, likely reflecting population differences in mycobacterial load.
建议对艾滋病毒感染者进行基于C反应蛋白（CRP）的结核病（TB）筛查。然而，其在无艾滋病毒人群及不同环境中的表现尚不清楚。在一项多国研究中，我们旨在确定CRP是否符合有效结核病筛查试验的最低准确性目标（敏感性⩾90%，特异性⩾70%）。来自非洲和亚洲五个结核病流行国家的连续咳嗽⩾2周的门诊成年患者采集了基线血液，用于即时CRP检测、艾滋病毒和糖尿病筛查。采集痰液样本进行Xpert MTB/RIF Ultra（Xpert）检测和培养。根据痰液检测结果确定CRP的敏感性和特异性（切点为5 mg/L），并按国家、性别、艾滋病毒和糖尿病状况进行比较。使用多变量受试者工作特征曲线回归模型确定影响CRP表现的变量。在2904名参与者中，613人（21%）经微生物学确诊患有结核病，CRP的敏感性为84%（95%置信区间[CI]，81 - 87%），特异性为61%（95%CI，59 - 63%）。CRP的准确性因地理位置而异，非洲国家（⩾91%）的敏感性高于亚洲国家（64 - 82%）。男性的敏感性高于女性（86%对78%；差异为+8%；95%CI，1 - 15%），艾滋病毒感染者的特异性低于无艾滋病毒感染者（64%对45%；差异为+19%；95%CI，13 - 25%）。受试者工作特征曲线回归确定国家和结核病严重程度指标为CRP表现的预测因素。总体而言，CRP未达到最低准确性目标，其表现在不同环境和一些亚组中有所不同，这可能反映了分枝杆菌载量的人群差异。
