{"title":"未经刺激的 IFN-γ (IRISA-TB) 对胸膜结核的诊断性能：南非和印度的前瞻性研究。","authors":"Devasahayam J Christopher, Aliasgar Esmail, Alex J Scott, Lindsay Wilson, Philippa Randall, Balamugesh Thangakunam, Deepa Shankar, Sekar Rajasekar, Christhunesa S Christudass, Louié Kühn, Jeremi Swanepoel, Tahlia Perumal, Anil Pooran, Suzette Oelofse, Keertan Dheda","doi":"10.1093/ofid/ofae533","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Tuberculous pleural effusion (TPE) is the most common form of extrapulmonary tuberculosis in many settings. The diagnostic performance of the frontline polymerase chain reaction-based GeneXpert MTB/RIF Ultra (Xpert Ultra) remains suboptimal (sensitivity of ∼30%), but data are limited. Improved diagnostic approaches are urgently needed to detect extrapulmonary tuberculosis (EPTB) in tuberculosis (TB)-endemic settings.</p><p><strong>Methods: </strong>This multicenter, prospective cohort study evaluated the diagnostic performance of a rapid (same-day) interferon gamma rapid immunosuspension assay (IRISA-TB) in patients with presumed TPE from South Africa and India. Participants underwent pleural biopsy, and testing with other available same-day diagnostic assays (adenosine deaminase [ADA], Xpert Ultra, and IRISA-TB) was concurrently undertaken. The reference standard for TB was microbiological and/or histopathological confirmation using pleural fluid and/or pleural biopsy samples.</p><p><strong>Results: </strong>A total of 217 participants with presumed TPE were recruited (106 from South Africa, 111 from India). The sensitivity of IRISA-TB (cut-point 20.5 pg/mL) was significantly better than that of Xpert Ultra (81.8% [70.4-90.2] vs 32.9% [22.1-45.1]; <i>P</i> < .001) and ADA at the 40 IU/mL cut-point used in India (81.8% [70.4-90.2] vs 53.8% [41.0-66.3]; <i>P</i> <i>=</i> .002). Compared with ADA at the 30 IU/mL cut-point used in South Africa, IRISA-TB had a higher specificity (96.6% [90.3-99.3] vs 87.1% [78.6-93.2]) and a higher positive predictive value (94.7% [85.5-97.3] vs 81.8% [72.4-88.5]). The negative predictive value (NPV; rule-out value) of IRISA-TB was significantly better than that of Xpert Ultra (87.5% [83.2-93.0] vs 64.9% [61.1-68.6]; <i>P</i> < .001) and ADA at the 40 IU/mL cut-point (87.5% [83.2-93.0] vs 74.1% [68.7-79.0]; <i>P</i> < .001).</p><p><strong>Conclusions: </strong>IRISA-TB demonstrated markedly better sensitivity and NPV than Xpert Ultra and excellent specificity for the diagnosis of TPE. These data have implications for clinical practice in TB-endemic settings.</p>","PeriodicalId":19517,"journal":{"name":"Open Forum Infectious Diseases","volume":"11 10","pages":"ofae533"},"PeriodicalIF":3.8000,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11489880/pdf/","citationCount":"0","resultStr":"{\"title\":\"Diagnostic Performance of Unstimulated IFN-γ (IRISA-TB) for Pleural Tuberculosis: A Prospective Study in South Africa and India.\",\"authors\":\"Devasahayam J Christopher, Aliasgar Esmail, Alex J Scott, Lindsay Wilson, Philippa Randall, Balamugesh Thangakunam, Deepa Shankar, Sekar Rajasekar, Christhunesa S Christudass, Louié Kühn, Jeremi Swanepoel, Tahlia Perumal, Anil Pooran, Suzette Oelofse, Keertan Dheda\",\"doi\":\"10.1093/ofid/ofae533\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Tuberculous pleural effusion (TPE) is the most common form of extrapulmonary tuberculosis in many settings. The diagnostic performance of the frontline polymerase chain reaction-based GeneXpert MTB/RIF Ultra (Xpert Ultra) remains suboptimal (sensitivity of ∼30%), but data are limited. Improved diagnostic approaches are urgently needed to detect extrapulmonary tuberculosis (EPTB) in tuberculosis (TB)-endemic settings.</p><p><strong>Methods: </strong>This multicenter, prospective cohort study evaluated the diagnostic performance of a rapid (same-day) interferon gamma rapid immunosuspension assay (IRISA-TB) in patients with presumed TPE from South Africa and India. Participants underwent pleural biopsy, and testing with other available same-day diagnostic assays (adenosine deaminase [ADA], Xpert Ultra, and IRISA-TB) was concurrently undertaken. The reference standard for TB was microbiological and/or histopathological confirmation using pleural fluid and/or pleural biopsy samples.</p><p><strong>Results: </strong>A total of 217 participants with presumed TPE were recruited (106 from South Africa, 111 from India). The sensitivity of IRISA-TB (cut-point 20.5 pg/mL) was significantly better than that of Xpert Ultra (81.8% [70.4-90.2] vs 32.9% [22.1-45.1]; <i>P</i> < .001) and ADA at the 40 IU/mL cut-point used in India (81.8% [70.4-90.2] vs 53.8% [41.0-66.3]; <i>P</i> <i>=</i> .002). Compared with ADA at the 30 IU/mL cut-point used in South Africa, IRISA-TB had a higher specificity (96.6% [90.3-99.3] vs 87.1% [78.6-93.2]) and a higher positive predictive value (94.7% [85.5-97.3] vs 81.8% [72.4-88.5]). The negative predictive value (NPV; rule-out value) of IRISA-TB was significantly better than that of Xpert Ultra (87.5% [83.2-93.0] vs 64.9% [61.1-68.6]; <i>P</i> < .001) and ADA at the 40 IU/mL cut-point (87.5% [83.2-93.0] vs 74.1% [68.7-79.0]; <i>P</i> < .001).</p><p><strong>Conclusions: </strong>IRISA-TB demonstrated markedly better sensitivity and NPV than Xpert Ultra and excellent specificity for the diagnosis of TPE. These data have implications for clinical practice in TB-endemic settings.</p>\",\"PeriodicalId\":19517,\"journal\":{\"name\":\"Open Forum Infectious Diseases\",\"volume\":\"11 10\",\"pages\":\"ofae533\"},\"PeriodicalIF\":3.8000,\"publicationDate\":\"2024-09-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11489880/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Open Forum Infectious Diseases\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/ofid/ofae533\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/10/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"IMMUNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Open Forum Infectious Diseases","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/ofid/ofae533","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
Diagnostic Performance of Unstimulated IFN-γ (IRISA-TB) for Pleural Tuberculosis: A Prospective Study in South Africa and India.
Background: Tuberculous pleural effusion (TPE) is the most common form of extrapulmonary tuberculosis in many settings. The diagnostic performance of the frontline polymerase chain reaction-based GeneXpert MTB/RIF Ultra (Xpert Ultra) remains suboptimal (sensitivity of ∼30%), but data are limited. Improved diagnostic approaches are urgently needed to detect extrapulmonary tuberculosis (EPTB) in tuberculosis (TB)-endemic settings.
Methods: This multicenter, prospective cohort study evaluated the diagnostic performance of a rapid (same-day) interferon gamma rapid immunosuspension assay (IRISA-TB) in patients with presumed TPE from South Africa and India. Participants underwent pleural biopsy, and testing with other available same-day diagnostic assays (adenosine deaminase [ADA], Xpert Ultra, and IRISA-TB) was concurrently undertaken. The reference standard for TB was microbiological and/or histopathological confirmation using pleural fluid and/or pleural biopsy samples.
Results: A total of 217 participants with presumed TPE were recruited (106 from South Africa, 111 from India). The sensitivity of IRISA-TB (cut-point 20.5 pg/mL) was significantly better than that of Xpert Ultra (81.8% [70.4-90.2] vs 32.9% [22.1-45.1]; P < .001) and ADA at the 40 IU/mL cut-point used in India (81.8% [70.4-90.2] vs 53.8% [41.0-66.3]; P= .002). Compared with ADA at the 30 IU/mL cut-point used in South Africa, IRISA-TB had a higher specificity (96.6% [90.3-99.3] vs 87.1% [78.6-93.2]) and a higher positive predictive value (94.7% [85.5-97.3] vs 81.8% [72.4-88.5]). The negative predictive value (NPV; rule-out value) of IRISA-TB was significantly better than that of Xpert Ultra (87.5% [83.2-93.0] vs 64.9% [61.1-68.6]; P < .001) and ADA at the 40 IU/mL cut-point (87.5% [83.2-93.0] vs 74.1% [68.7-79.0]; P < .001).
Conclusions: IRISA-TB demonstrated markedly better sensitivity and NPV than Xpert Ultra and excellent specificity for the diagnosis of TPE. These data have implications for clinical practice in TB-endemic settings.
期刊介绍：
Open Forum Infectious Diseases provides a global forum for the publication of clinical, translational, and basic research findings in a fully open access, online journal environment. The journal reflects the broad diversity of the field of infectious diseases, and focuses on the intersection of biomedical science and clinical practice, with a particular emphasis on knowledge that holds the potential to improve patient care in populations around the world. Fully peer-reviewed, OFID supports the international community of infectious diseases experts by providing a venue for articles that further the understanding of all aspects of infectious diseases.
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