Sputum quality and diagnostic performance of GeneXpert MTB/RIF among smear-negative adults with presumed tuberculosis in Uganda.

Sputum quality and diagnostic performance of GeneXpert MTB/RIF among smear-negative adults with presumed tuberculosis in Uganda.
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DOI:
10.1371/journal.pone.0180572
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发表时间:
2017
期刊:
影响因子:
3.7
通讯作者:
Davis JL
Davis JL
中科院分区:
综合性期刊3区
文献类型:
--
作者:
Meyer AJ;Atuheire C;Worodria W;Kizito S;Katamba A;Sanyu I;Andama A;Ayakaka I;Cattamanchi A;Bwanga F;Huang L;Davis JL

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GeneXpert MTB/RIF (Xpert) 检测的推出为结核病 (TB) 诊断带来了重大突破。一些患者因素可能会影响 Xpert 的诊断性能,包括痰质量。我们进行了一项前瞻性、观察性、横断面研究,以确定痰质量对乌干达疑似结核病患者中 Xpert 诊断性能的影响。我们收集了参与者的临床和人口统计信息以及两份痰样本。工作人员记录痰液质量并对每个样本进行 LED 荧光显微镜检查和分枝杆菌培养。如果两次涂片检查均为阴性,则进行 Xpert 检测。我们参考分枝杆菌培养标准,计算了Xpert对痰质量各层的诊断率、敏感性、特异性等指标。与所有其他痰样本类型的患者 (221/1496, 15%, 95% CI 13–17) 相比,唾液痰患者的 Xpert 阳性样本比例 (54/286, 19%, 95% CI 15–24) 呈明显更高的趋势。血染痰的敏感性最低(28%;95% CI 12-49),唾液痰的敏感性最高(66%;95% CI 53-77)。样本类型的特异性没有显着差异。唾液痰的敏感性明显高于粘液痰(+13%,95% CI +1 至 +26),而血痰的敏感性明显较低(-24%,95% CI -42 至 -5)。我们的研究结果表明,在为 Xpert 收集痰液和解释结果时需要谨慎行事,因为痰液质量可能会影响测试的产量和灵敏度。特别是,如果血染痰测试呈阴性,则进行额外的测试可能是明智的,而唾液痰应该很容易接受 Xpert 测试,因为它比其他样本类型具有更高的灵敏度和潜在的更高的产量。这些发现挑战了反对收集唾液痰进行结核病诊断的传统建议,并可能为痰质量的新标准提供信息。
Introduction of GeneXpert MTB/RIF (Xpert) assay has constituted a major breakthrough for tuberculosis (TB) diagnostics. Several patient factors may influence diagnostic performance of Xpert including sputum quality. We carried out a prospective, observational, cross-sectional study to determine the effect of sputum quality on diagnostic performance of Xpert among presumed TB patients in Uganda. We collected clinical and demographic information and two sputum samples from participants. Staff recorded sputum quality and performed LED fluorescence microscopy and mycobacterial culture on each sample. If both smear examinations were negative, Xpert testing was performed. We calculated diagnostic yield, sensitivity, specificity, and other indicators for Xpert for each stratum of sputum quality in reference to a standard of mycobacterial culture. Patients with salivary sputum showed a trend towards a substantially higher proportion of samples that were Xpert-positive (54/286, 19%, 95% CI 15–24) compared with those with all other sputum sample types (221/1496, 15%, 95% CI 13–17). Blood-stained sputum produced the lowest sensitivity (28%; 95% CI 12–49) and salivary sputum the highest (66%; 95% CI 53–77). Specificity didn’t vary meaningfully by sample types. Salivary sputum was significantly more sensitive than mucoid sputum (+13%, 95% CI +1 to +26), while blood-stained sputum was significantly less sensitive (-24%, 95% CI -42 to -5). Our findings demonstrate the need to exercise caution in collecting sputum for Xpert and in interpreting results because sputum quality may impact test yield and sensitivity. In particular, it may be wise to pursue additional testing should blood-stained sputum test negative while salivary sputum should be readily accepted for Xpert testing given its higher sensitivity and potentially higher yield than other sample types. These findings challenge conventional recommendations against collecting salivary sputum for TB diagnosis and could inform new standards for sputum quality.
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