Xpert MTB/RIF Ultra Is Highly Sensitive for the Diagnosis of Tuberculosis Lymphadenitis in a High-HIV Setting.
Xpert MTB/RIF Ultra Is Highly Sensitive for the Diagnosis of Tuberculosis Lymphadenitis in a High-HIV Setting.
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DOI：
10.1128/jcm.01316-21
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发表时间：
2021-11-18
影响因子：
9.4
通讯作者：
Theron G
中科院分区：
文献类型：
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作者：
Minnies S;Reeve BWP;Rockman L;Nyawo G;Naidoo CC;Kitchin N;Rautenbach C;Wright CA;Whitelaw A;Schubert P;Warren RM;Theron G
结核性淋巴结炎（TBL）是肺外结核（EPTB）最常见的表现。Xpert MTB/RIF Ultra（Ultra）是世界卫生组织认可的诊断检测试剂，但TBL的性能数据（包括非侵入性标本）有限。来自门诊患者（≥18岁）的推定TBL患者（n = 135）的细针抽吸活检标本（FNAB）接受了（i）常规Xpert MTB/RIF检测（随后使用Ultra，一旦程序可用），（ii）MGIT 960培养（如果Xpert或Ultra阴性或利福平耐药），和（iii）研究Ultra检测。浓缩的成对尿液标本接受Ultra检测。主要分析使用微生物参比标准品（MRS）。在FNAB研究Ultra和Xpert的头对头比较（n = 92）中，Ultra的灵敏度增加（91% [95%置信区间：79，98] vs 72% [57，84]; P = 0.016）和特异性降低（76% [61，87] vs 93% [82，99]; P = 0.020）和未接受治疗的确诊患者。HIV或替代参考标准均不影响灵敏度和特异性。在常规和研究Ultra检测的患者中，后者检测到更多病例（+20% [0，42]; P = 0.034），假阴性研究Ultra结果比真阳性结果受到更多抑制。研究Ultra假阳性的分枝杆菌DNA比真阳性少（痕量阳性比例，59% [13/22] vs 12% [5/51]; P < 0.001）。“Trace”排除或重新分类删除了Xpert提供的潜在优势。尿液Ultra检测的灵敏度较低（18% [7，35]）。FNAB的Ultra检测具有高度灵敏度，比Xpert检测到更多的TBL（Ultra仍然遗漏了一些病例，部分原因是抑制）。FNAB超阳性“微量”结果的患者，其中大多数将是培养阴性，可能需要额外的临床研究。尿液超检测可以减少需要侵入性采样的患者数量。
Tuberculosis lymphadenitis (TBL) is the most common extrapulmonary tuberculosis (EPTB) manifestation. Xpert MTB/RIF Ultra (Ultra) is a World Health Organization-endorsed diagnostic test, but performance data for TBL, including on noninvasive specimens, are limited. Fine-needle aspiration biopsy specimens (FNABs) from outpatients (≥18 years) with presumptive TBL (n = 135) underwent (i) routine Xpert MTB/RIF testing (later with Ultra once programmatically available), (ii) MGIT 960 culture (if Xpert or Ultra negative or rifampicin resistant), and (iii) study Ultra testing. Concentrated paired urine specimens underwent Ultra testing. Primary analyses used a microbiological reference standard (MRS). In a head-to-head comparison (n = 92) of an FNAB study Ultra and Xpert, Ultra had increased sensitivity (91% [95% confidence interval: 79, 98] versus 72% [57, 84]; P = 0.016) and decreased specificity (76% [61, 87] versus 93% [82, 99]; P = 0.020) and diagnosed patients not on treatment. Neither HIV nor alternative reference standards affected sensitivity and specificity. In patients with both routine and study Ultra tests, the latter detected more cases (+20% [0, 42]; P = 0.034), and false-negative study Ultra results were more inhibited than true-positive results. Study Ultra false positives had less mycobacterial DNA than true positives (trace-positive proportions, 59% [13/22] versus 12% [5/51]; P < 0.001). “Trace” exclusion or recategorization removed potential benefits offered over Xpert. Urine Ultra tests had low sensitivity (18% [7, 35]). Ultra testing on FNABs is highly sensitive and detects more TBL than Xpert (Ultra still missed some cases due in part to inhibition). Patients with FNAB Ultra-positive “trace” results, most of whom will be culture negative, may require additional clinical investigation. Urine Ultra testing could reduce the number of patients needing invasive sampling.
DOI：
10.1016/j.ijid.2021.03.022
发表时间：
2021-04
期刊：
International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases
影响因子：
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作者：
Spener-Gomes R;Costa AG;Melo HF;Souza AB;Beraldi-Magalhães F;Jesus JS;Arriaga MB;Kritski A;Safe I;Andrade BB;Trajman A;Cordeiro-Santos M
通讯作者：
Cordeiro-Santos M