Challenges in the development of an immunochromatographic interferon-gamma test for diagnosis of pleural tuberculosis
Existing diagnostic tests for pleural tuberculosis (TB) have inadequate accuracy and/or turnaround time. Interferon-gamma (IFNg) has been identified in many studies as a biomarker for pleural TB. Our objective was to develop a lateral flow, immunochromatographic test (ICT) based on this biomarker an...
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| creator | Denkinger, Claudia M Kalantri, Yatiraj Schumacher, Samuel G Michael, Joy S Shankar, Deepa Saxena, Arvind Sriram, Natarajan Balamugesh, Thangakunam Luo, Robert Pollock, Nira R Pai, Madhukar Christopher, Devasahayam J |
| description | Existing diagnostic tests for pleural tuberculosis (TB) have inadequate accuracy and/or turnaround time. Interferon-gamma (IFNg) has been identified in many studies as a biomarker for pleural TB. Our objective was to develop a lateral flow, immunochromatographic test (ICT) based on this biomarker and to evaluate the test in a clinical cohort. Because IFNg is commonly present in non-TB pleural effusions in low amounts, a diagnostic IFNg-threshold was first defined with an enzyme-linked immunosorbent assay (ELISA) for IFNg in samples from 38 patients with a confirmed clinical diagnosis (cut-off of 300 pg/ml; 94% sensitivity and 93% specificity). The ICT was then designed; however, its achievable limit of detection (5000 pg/ml) was over 10-fold higher than that of the ELISA. After several iterations in development, the prototype ICT assay for IFNg had a sensitivity of 69% (95% confidence interval (CI): 50-83) and a specificity of 94% (95% CI: 81-99%) compared to ELISA on frozen samples. Evaluation of the prototype in a prospective clinical cohort (72 patients) on fresh pleural fluid samples, in comparison to a composite reference standard (including histopathological and microbiologic test results), showed that the prototype had 65% sensitivity (95% CI: 44-83) and 89% specificity (95% CI: 74-97). Discordant results were observed in 15% of samples if testing was repeated after one freezing and thawing step. Inter-rater variability was limited (3%; 1 out of 32). In conclusion, despite an iterative development and optimization process, the performance of the IFNg ICT remained lower than what could be expected from the published literature on IFNg as a biomarker in pleural fluid. Further improvements in the limit of detection of an ICT for IFNg, and possibly combination of IFNg with other biomarkers such as adenosine deaminase, are necessary for such a test to be of value in the evaluation of pleural tuberculosis. |
| doi_str_mv | 10.1371/journal.pone.0085447 |
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Interferon-gamma (IFNg) has been identified in many studies as a biomarker for pleural TB. Our objective was to develop a lateral flow, immunochromatographic test (ICT) based on this biomarker and to evaluate the test in a clinical cohort. Because IFNg is commonly present in non-TB pleural effusions in low amounts, a diagnostic IFNg-threshold was first defined with an enzyme-linked immunosorbent assay (ELISA) for IFNg in samples from 38 patients with a confirmed clinical diagnosis (cut-off of 300 pg/ml; 94% sensitivity and 93% specificity). The ICT was then designed; however, its achievable limit of detection (5000 pg/ml) was over 10-fold higher than that of the ELISA. After several iterations in development, the prototype ICT assay for IFNg had a sensitivity of 69% (95% confidence interval (CI): 50-83) and a specificity of 94% (95% CI: 81-99%) compared to ELISA on frozen samples. Evaluation of the prototype in a prospective clinical cohort (72 patients) on fresh pleural fluid samples, in comparison to a composite reference standard (including histopathological and microbiologic test results), showed that the prototype had 65% sensitivity (95% CI: 44-83) and 89% specificity (95% CI: 74-97). Discordant results were observed in 15% of samples if testing was repeated after one freezing and thawing step. Inter-rater variability was limited (3%; 1 out of 32). In conclusion, despite an iterative development and optimization process, the performance of the IFNg ICT remained lower than what could be expected from the published literature on IFNg as a biomarker in pleural fluid. Further improvements in the limit of detection of an ICT for IFNg, and possibly combination of IFNg with other biomarkers such as adenosine deaminase, are necessary for such a test to be of value in the evaluation of pleural tuberculosis.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0085447</identifier><identifier>PMID: 24376880</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Accuracy ; Adenosine ; Adenosine deaminase ; Adolescent ; Adult ; Analysis ; Bioindicators ; Biological response modifiers ; Biomarkers ; Biomarkers - metabolism ; Biopsy ; Chromatography, Affinity - methods ; Cohort Studies ; Confidence intervals ; Consent ; Diagnosis ; Diagnostic systems ; Enzyme-Linked Immunosorbent Assay ; Enzymes ; Epidemiology ; Evaluation ; Female ; Freeze-thaw ; Freezing ; Freezing and thawing ; Humans ; Infectious diseases ; Interferon ; Interferon-gamma - metabolism ; Laboratories ; Male ; Medical diagnosis ; Medical tests ; Medicine ; Meta-analysis ; Middle Aged ; Occupational health ; Optimization ; Patients ; Pleural fluid ; Sensitivity ; Sensitivity and Specificity ; Studies ; Systematic review ; Thawing ; Tuberculosis ; Tuberculosis, Pleural - diagnosis ; Tuberculosis, Pleural - immunology</subject><ispartof>PloS one, 2013-12, Vol.8 (12), p.e85447</ispartof><rights>COPYRIGHT 2013 Public Library of Science</rights><rights>2013 Denkinger et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2013 Denkinger et al 2013 Denkinger et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-7c5b6273debfb3c62b7de1d9403ffa25aab1e9f34c0e558a491457df447be763</citedby><cites>FETCH-LOGICAL-c692t-7c5b6273debfb3c62b7de1d9403ffa25aab1e9f34c0e558a491457df447be763</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3871622/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3871622/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2095,2914,23846,27903,27904,53770,53772,79347,79348</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24376880$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Goletti, Delia</contributor><creatorcontrib>Denkinger, Claudia M</creatorcontrib><creatorcontrib>Kalantri, Yatiraj</creatorcontrib><creatorcontrib>Schumacher, Samuel G</creatorcontrib><creatorcontrib>Michael, Joy S</creatorcontrib><creatorcontrib>Shankar, Deepa</creatorcontrib><creatorcontrib>Saxena, Arvind</creatorcontrib><creatorcontrib>Sriram, Natarajan</creatorcontrib><creatorcontrib>Balamugesh, Thangakunam</creatorcontrib><creatorcontrib>Luo, Robert</creatorcontrib><creatorcontrib>Pollock, Nira R</creatorcontrib><creatorcontrib>Pai, Madhukar</creatorcontrib><creatorcontrib>Christopher, Devasahayam J</creatorcontrib><title>Challenges in the development of an immunochromatographic interferon-gamma test for diagnosis of pleural tuberculosis</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Existing diagnostic tests for pleural tuberculosis (TB) have inadequate accuracy and/or turnaround time. Interferon-gamma (IFNg) has been identified in many studies as a biomarker for pleural TB. Our objective was to develop a lateral flow, immunochromatographic test (ICT) based on this biomarker and to evaluate the test in a clinical cohort. Because IFNg is commonly present in non-TB pleural effusions in low amounts, a diagnostic IFNg-threshold was first defined with an enzyme-linked immunosorbent assay (ELISA) for IFNg in samples from 38 patients with a confirmed clinical diagnosis (cut-off of 300 pg/ml; 94% sensitivity and 93% specificity). The ICT was then designed; however, its achievable limit of detection (5000 pg/ml) was over 10-fold higher than that of the ELISA. After several iterations in development, the prototype ICT assay for IFNg had a sensitivity of 69% (95% confidence interval (CI): 50-83) and a specificity of 94% (95% CI: 81-99%) compared to ELISA on frozen samples. Evaluation of the prototype in a prospective clinical cohort (72 patients) on fresh pleural fluid samples, in comparison to a composite reference standard (including histopathological and microbiologic test results), showed that the prototype had 65% sensitivity (95% CI: 44-83) and 89% specificity (95% CI: 74-97). Discordant results were observed in 15% of samples if testing was repeated after one freezing and thawing step. Inter-rater variability was limited (3%; 1 out of 32). In conclusion, despite an iterative development and optimization process, the performance of the IFNg ICT remained lower than what could be expected from the published literature on IFNg as a biomarker in pleural fluid. Further improvements in the limit of detection of an ICT for IFNg, and possibly combination of IFNg with other biomarkers such as adenosine deaminase, are necessary for such a test to be of value in the evaluation of pleural tuberculosis.</description><subject>Accuracy</subject><subject>Adenosine</subject><subject>Adenosine deaminase</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Analysis</subject><subject>Bioindicators</subject><subject>Biological response modifiers</subject><subject>Biomarkers</subject><subject>Biomarkers - metabolism</subject><subject>Biopsy</subject><subject>Chromatography, Affinity - methods</subject><subject>Cohort Studies</subject><subject>Confidence intervals</subject><subject>Consent</subject><subject>Diagnosis</subject><subject>Diagnostic systems</subject><subject>Enzyme-Linked Immunosorbent Assay</subject><subject>Enzymes</subject><subject>Epidemiology</subject><subject>Evaluation</subject><subject>Female</subject><subject>Freeze-thaw</subject><subject>Freezing</subject><subject>Freezing and thawing</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Interferon</subject><subject>Interferon-gamma - 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Interferon-gamma (IFNg) has been identified in many studies as a biomarker for pleural TB. Our objective was to develop a lateral flow, immunochromatographic test (ICT) based on this biomarker and to evaluate the test in a clinical cohort. Because IFNg is commonly present in non-TB pleural effusions in low amounts, a diagnostic IFNg-threshold was first defined with an enzyme-linked immunosorbent assay (ELISA) for IFNg in samples from 38 patients with a confirmed clinical diagnosis (cut-off of 300 pg/ml; 94% sensitivity and 93% specificity). The ICT was then designed; however, its achievable limit of detection (5000 pg/ml) was over 10-fold higher than that of the ELISA. After several iterations in development, the prototype ICT assay for IFNg had a sensitivity of 69% (95% confidence interval (CI): 50-83) and a specificity of 94% (95% CI: 81-99%) compared to ELISA on frozen samples. Evaluation of the prototype in a prospective clinical cohort (72 patients) on fresh pleural fluid samples, in comparison to a composite reference standard (including histopathological and microbiologic test results), showed that the prototype had 65% sensitivity (95% CI: 44-83) and 89% specificity (95% CI: 74-97). Discordant results were observed in 15% of samples if testing was repeated after one freezing and thawing step. Inter-rater variability was limited (3%; 1 out of 32). In conclusion, despite an iterative development and optimization process, the performance of the IFNg ICT remained lower than what could be expected from the published literature on IFNg as a biomarker in pleural fluid. Further improvements in the limit of detection of an ICT for IFNg, and possibly combination of IFNg with other biomarkers such as adenosine deaminase, are necessary for such a test to be of value in the evaluation of pleural tuberculosis.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>24376880</pmid><doi>10.1371/journal.pone.0085447</doi><tpages>e85447</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2013-12, Vol.8 (12), p.e85447 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_1470558623 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Public Library of Science (PLoS); PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Accuracy Adenosine Adenosine deaminase Adolescent Adult Analysis Bioindicators Biological response modifiers Biomarkers Biomarkers - metabolism Biopsy Chromatography, Affinity - methods Cohort Studies Confidence intervals Consent Diagnosis Diagnostic systems Enzyme-Linked Immunosorbent Assay Enzymes Epidemiology Evaluation Female Freeze-thaw Freezing Freezing and thawing Humans Infectious diseases Interferon Interferon-gamma - metabolism Laboratories Male Medical diagnosis Medical tests Medicine Meta-analysis Middle Aged Occupational health Optimization Patients Pleural fluid Sensitivity Sensitivity and Specificity Studies Systematic review Thawing Tuberculosis Tuberculosis, Pleural - diagnosis Tuberculosis, Pleural - immunology |
| title | Challenges in the development of an immunochromatographic interferon-gamma test for diagnosis of pleural tuberculosis |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-23T02%3A16%3A53IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Challenges%20in%20the%20development%20of%20an%20immunochromatographic%20interferon-gamma%20test%20for%20diagnosis%20of%20pleural%20tuberculosis&rft.jtitle=PloS%20one&rft.au=Denkinger,%20Claudia%20M&rft.date=2013-12-23&rft.volume=8&rft.issue=12&rft.spage=e85447&rft.pages=e85447-&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0085447&rft_dat=%3Cgale_plos_%3EA478148932%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1470558623&rft_id=info:pmid/24376880&rft_galeid=A478148932&rft_doaj_id=oai_doaj_org_article_76e79e1cb9794335aafea9c687182e4f&rfr_iscdi=true |