Department of Epidemiology, Biostatistics and Occupational Health, Faculty of Medicine and Health Sciences, McGill University, Montreal, QC, Canada; McGill International TB Centre, Research Institute of the McGill University Health Centre, Montreal, QC, Canada.
Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia Lima, Peru.
Lancet Microbe. 2023 Jun;4(6):e452-e460. doi: 10.1016/S2666-5247(23)00042-3. Epub 2023 Apr 15.
Integrated molecular testing could be an opportunity to detect and provide care for both tuberculosis and COVID-19. Many high tuberculosis burden countries, such as Peru, have existing GeneXpert systems for tuberculosis testing with GeneXpert Xpert MTB/RIF Ultra (Xpert Ultra), and a GeneXpert SARS-CoV-2 assay, GeneXpert Xpert Xpress SARS-CoV-2 (Xpert Xpress), is also available. We aimed to assess the feasibility of integrating tuberculosis and COVID-19 testing using one sputum specimen with Xpert Ultra and Xpert Xpress in Lima, Peru.
In this cross-sectional, diagnostic accuracy study, we recruited adults presenting with clinical symptoms or suggestive history of tuberculosis or COVID-19, or both. Participants were recruited from a total of 35 primary health facilities in Lima, Peru. Participants provided one nasopharyngeal swab and one sputum sample. For COVID-19, we tested nasopharyngeal swabs and sputum using Xpert Xpress; for tuberculosis, we tested sputum using culture and Xpert Ultra. We compared diagnostic accuracy of sputum testing using Xpert Xpress with nasopharyngeal swab testing using Xpert Xpress. Individuals with positive Xpert Xpress nasopharyngeal swab results were considered COVID-19 positive, and a positive culture indicated tuberculosis. To assess testing integration, the proportion of cases identified in sputum by Xpert Xpress was compared with Xpert Xpress on nasopharyngeal swabs, and sputum by Xpert Ultra was compared with culture.
Between Jan 11, 2021, and April 26, 2022, we recruited 600 participants (312 [52%] women and 288 [48%] men). In-study prevalence of tuberculosis was 13% (80 participants, 95% CI 11-16) and of SARS-CoV-2 was 35% (212 participants, 32-39). Among tuberculosis cases, 13 (2·2%, 1·2-3·7) participants were concurrently positive for SARS-CoV-2. Regarding the diagnostic yield of integrated testing, Xpert Ultra detected 96% (89-99) of culture-confirmed tuberculosis cases (n=77), and Xpert Xpress-sputum detected 67% (60-73) of COVID-19 cases (n=134). All five study staff reported that integrated molecular testing was easy and acceptable.
The diagnostic yield of Xpert Xpress on sputum was moderate, but integrated testing for tuberculosis and COVID-19 with GeneXpert was feasible. However, systematic testing for both diseases might not be the ideal approach for everyone presenting with presumptive tuberculosis or COVID-19, as concurrent positive cases were rare during the study period. Further research might help to identify when integrated testing is most worthwhile and its optimal implementation.
Canadian Institutes of Health Research and International Development Research Centre.
For the Spanish translation of the abstract see Supplementary Materials section.
整合分子检测可能是发现和为结核病及 COVID-19 患者提供护理的机会。许多结核病负担较高的国家，如秘鲁，已经拥有用于结核病检测的 GeneXpert 系统，包括 GeneXpert Xpert MTB/RIF Ultra（Xpert Ultra），并且也有 GeneXpert SARS-CoV-2 检测试剂盒，即 GeneXpert Xpert Xpress SARS-CoV-2（Xpert Xpress）。我们旨在评估在秘鲁利马使用 Xpert Ultra 和 Xpert Xpress 对一份痰标本进行结核和 COVID-19 检测的可行性。
这是一项横断面、诊断准确性研究，我们招募了出现结核病临床症状或疑似 COVID-19 病史或同时出现这两种症状的成年人。参与者是从秘鲁利马的 35 个初级保健机构招募的。参与者提供了一份鼻咽拭子和一份痰标本。对于 COVID-19，我们使用 Xpert Xpress 对鼻咽拭子和痰进行检测；对于结核病，我们使用培养和 Xpert Ultra 对痰进行检测。我们比较了 Xpert Xpress 对痰的检测与 Xpert Xpress 对鼻咽拭子的检测的诊断准确性。使用 Xpert Xpress 对鼻咽拭子检测结果阳性的个体被认为 COVID-19 阳性，而培养阳性则表明结核病。为了评估检测整合，我们比较了 Xpert Xpress 在痰中的阳性病例比例与 Xpert Xpress 在鼻咽拭子中的阳性病例比例，以及 Xpert Ultra 在痰中的阳性病例比例与培养的阳性病例比例。
2021 年 1 月 11 日至 2022 年 4 月 26 日期间，我们招募了 600 名参与者（312 名女性[52%]和 288 名男性[48%]）。研究期间结核病的患病率为 13%（80 名参与者，95%CI 11-16），SARS-CoV-2 的患病率为 35%（212 名参与者，32-39）。在结核病病例中，有 13 名（2·2%，1·2-3·7）患者同时对 SARS-CoV-2 呈阳性。在整合检测的诊断效果方面，Xpert Ultra 检测到 96%（89-99）的培养确诊结核病病例（n=77），Xpert Xpress 检测到 67%（60-73）的 COVID-19 病例（n=134）。所有五名研究人员均表示，整合分子检测很容易且易于接受。
Xpert Xpress 在痰中的检测效果中等，但 GeneXpert 用于结核和 COVID-19 的整合检测是可行的。然而，在研究期间，同时出现阳性病例的情况很少，因此针对所有疑似结核病或 COVID-19 的患者进行系统性检测可能并非理想方法。进一步的研究可能有助于确定何时最值得进行整合检测及其最佳实施方式。
加拿大卫生研究院和国际发展研究中心。
Zotero 插件
