Commercial Serological Antibody Detection Tests for the Diagnosis of Pulmonary Tuberculosis: A Systematic Review
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{"title"=>"Commercial serological antibody detection tests for the diagnosis of pulmonary tuberculosis: A systematic review", "type"=>"journal", "authors"=>[{"first_name"=>"Karen R.", "last_name"=>"Steingart", "scopus_author_id"=>"8438524800"}, {"first_name"=>"Megan", "last_name"=>"Henry", "scopus_author_id"=>"14119683700"}, {"first_name"=>"Suman", "last_name"=>"Laal", "scopus_author_id"=>"16190298700"}, {"first_name"=>"Philip C.", "last_name"=>"Hopewell", "scopus_author_id"=>"24372908500"}, {"first_name"=>"Andrew", "last_name"=>"Ramsay", "scopus_author_id"=>"14120309700"}, {"first_name"=>"Dick", "last_name"=>"Menzies", "scopus_author_id"=>"7006221407"}, {"first_name"=>"Jane", "last_name"=>"Cunningham", "scopus_author_id"=>"14119491900"}, {"first_name"=>"Karin", "last_name"=>"Weldingh", "scopus_author_id"=>"6603246145"}, {"first_name"=>"Madhukar", "last_name"=>"Pai", "scopus_author_id"=>"14054425400"}], "year"=>2007, "source"=>"PLoS Medicine", "identifiers"=>{"scopus"=>"2-s2.0-34347242491", "sgr"=>"34347242491", "issn"=>"15491277", "doi"=>"10.1371/journal.pmed.0040202", "pmid"=>"17564490", "isbn"=>"1549-1676 (Electronic)", "pui"=>"46998622"}, "id"=>"11b57ded-cc44-3680-8499-6e26f7d8fa21", "abstract"=>"BACKGROUND: The global tuberculosis epidemic results in nearly 2 million deaths and 9 million new cases of the disease a year. The vast majority of tuberculosis patients live in developing countries, where the diagnosis of tuberculosis relies on the identification of acid-fast bacilli on unprocessed sputum smears using conventional light microscopy. Microscopy has high specificity in tuberculosis-endemic countries, but modest sensitivity which varies among laboratories (range 20% to 80%). Moreover, the sensitivity is poor for paucibacillary disease (e.g., pediatric and HIV-associated tuberculosis). Thus, the development of rapid and accurate new diagnostic tools is imperative. Immune-based tests are potentially suitable for use in low-income countries as some test formats can be performed at the point of care without laboratory equipment. Currently, dozens of distinct commercial antibody detection tests are sold in developing countries. The question is \"do they work?\" METHODS AND FINDINGS: We conducted a systematic review to assess the accuracy of commercial antibody detection tests for the diagnosis of pulmonary tuberculosis. Studies from all countries using culture and/or microscopy smear for confirmation of pulmonary tuberculosis were eligible. Studies with fewer than 50 participants (25 patients and 25 control participants) were excluded. In a comprehensive search, we identified 68 studies. The results demonstrate that (1) overall, commercial tests vary widely in performance; (2) sensitivity is higher in smear-positive than smear-negative samples; (3) in studies of smear-positive patients, Anda-TB IgG by enzyme-linked immunosorbent assay shows limited sensitivity (range 63% to 85%) and inconsistent specificity (range 73% to 100%); (4) specificity is higher in healthy volunteers than in patients in whom tuberculosis disease is initially suspected and subsequently ruled out; and (5) there are insufficient data to determine the accuracy of most commercial tests in smear microscopy-negative patients, as well as their performance in children or persons with HIV infection. CONCLUSIONS: None of the commercial tests evaluated perform well enough to replace sputum smear microscopy. Thus, these tests have little or no role in the diagnosis of pulmonary tuberculosis. Lack of methodological rigor in these studies was identified as a concern. It will be important to review the basic science literature evaluating serological tests for the diagnosis of pulmonary tuberculosis to determine whether useful antigens have been described but their potential has not been fully exploited. Activities leading to the discovery of new antigens with immunodiagnostic potential need to be intensified.", "link"=>"http://www.mendeley.com/research/commercial-serological-antibody-detection-tests-diagnosis-pulmonary-tuberculosis-systematic-review-5", "reader_count"=>161, "reader_count_by_academic_status"=>{"Unspecified"=>4, "Professor > Associate Professor"=>8, "Researcher"=>44, "Student > Doctoral Student"=>10, "Student > Ph. D. Student"=>35, "Student > Postgraduate"=>9, "Student > Master"=>28, "Other"=>4, "Student > Bachelor"=>11, "Lecturer"=>3, "Professor"=>5}, "reader_count_by_user_role"=>{"Unspecified"=>4, "Professor > Associate Professor"=>8, "Researcher"=>44, "Student > Doctoral Student"=>10, "Student > Ph. D. Student"=>35, "Student > Postgraduate"=>9, "Student > Master"=>28, "Other"=>4, "Student > Bachelor"=>11, "Lecturer"=>3, "Professor"=>5}, "reader_count_by_subject_area"=>{"Unspecified"=>8, "Agricultural and Biological Sciences"=>42, "Arts and Humanities"=>1, "Chemistry"=>7, "Economics, Econometrics and Finance"=>2, "Engineering"=>7, "Environmental Science"=>1, "Biochemistry, Genetics and Molecular Biology"=>13, "Nursing and Health Professions"=>1, "Medicine and Dentistry"=>68, "Sports and Recreations"=>1, "Psychology"=>1, "Social Sciences"=>4, "Immunology and Microbiology"=>5}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>68}, "Social Sciences"=>{"Social Sciences"=>4}, "Sports and Recreations"=>{"Sports and Recreations"=>1}, "Psychology"=>{"Psychology"=>1}, "Unspecified"=>{"Unspecified"=>8}, "Environmental Science"=>{"Environmental Science"=>1}, "Arts and Humanities"=>{"Arts and Humanities"=>1}, "Engineering"=>{"Engineering"=>7}, "Chemistry"=>{"Chemistry"=>7}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>2}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>5}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>42}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>13}}, "reader_count_by_country"=>{"Colombia"=>1, "Argentina"=>1, "United States"=>2, "Philippines"=>1, "Ukraine"=>1, "Sudan"=>1, "Egypt"=>1, "United Kingdom"=>1, "Switzerland"=>2, "India"=>2, "Spain"=>2, "Russia"=>1, "Canada"=>2, "Belgium"=>1, "Brazil"=>3, "South Africa"=>1, "Tunisia"=>1, "Germany"=>1}, "group_count"=>8}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/950745"], "description"=>"<p>(A) Smear microscopy–positive patients; (B) smear microscopy–negative patients. Each solid circle represents an individual study in the meta-analysis. The curve is the regression line that summarizes the overall diagnostic accuracy. SE (AUC), standard error of AUC; Q*, an index defined by the point on the SROC curve where the sensitivity and specificity are equal; SE (Q*), standard error of Q* index.</p>", "links"=>[], "tags"=>["pulmonary"], "article_id"=>621064, "categories"=>["Biotechnology", "Medicine", "Infectious Diseases", "Immunology"], "users"=>["Karen R Steingart", "Megan Henry", "Suman Laal", "Philip C Hopewell", "Andrew Ramsay", "Dick Menzies", "Jane Cunningham", "Karin Weldingh", "Madhukar Pai"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.0040202.g005", "stats"=>{"downloads"=>0, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_SROC_Curve_of_Commercial_Tests_for_the_Diagnosis_of_Pulmonary_TB_/621064", "title"=>"SROC Curve of Commercial Tests for the Diagnosis of Pulmonary TB", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2007-06-12 00:17:44"}
  • {"files"=>["https://ndownloader.figshare.com/files/950651"], "description"=>"<p>Each solid circle represents an individual study in the meta-analysis. The curve is the regression line that summarizes the overall diagnostic accuracy. SE (AUC), standard error of AUC; Q*, an index defined by the point on the SROC curve where the sensitivity and specificity are equal; SE (Q*), standard error of Q* index.</p>", "links"=>[], "tags"=>["pulmonary"], "article_id"=>620970, "categories"=>["Biotechnology", "Medicine", "Infectious Diseases", "Immunology"], "users"=>["Karen R Steingart", "Megan Henry", "Suman Laal", "Philip C Hopewell", "Andrew Ramsay", "Dick Menzies", "Jane Cunningham", "Karin Weldingh", "Madhukar Pai"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.0040202.g004", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_SROC_Curve_of_Commercial_Tests_for_the_Diagnosis_of_Pulmonary_TB_/620970", "title"=>"SROC Curve of Commercial Tests for the Diagnosis of Pulmonary TB", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2007-06-12 00:16:10"}
  • {"files"=>["https://ndownloader.figshare.com/files/950444"], "description"=>"<p>The circles and lines represent the point estimates and 95% CIs, respectively. The size of the circle indicates the study size.</p>", "links"=>[], "tags"=>["estimates", "pulmonary"], "article_id"=>620758, "categories"=>["Biotechnology", "Medicine", "Infectious Diseases", "Immunology"], "users"=>["Karen R Steingart", "Megan Henry", "Suman Laal", "Philip C Hopewell", "Andrew Ramsay", "Dick Menzies", "Jane Cunningham", "Karin Weldingh", "Madhukar Pai"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.0040202.g002", "stats"=>{"downloads"=>1, "page_views"=>2, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Sensitivity_Estimates_of_Commercial_Tests_for_the_Diagnosis_of_Pulmonary_TB_/620758", "title"=>"Sensitivity Estimates of Commercial Tests for the Diagnosis of Pulmonary TB", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2007-06-12 00:12:38"}
  • {"files"=>["https://ndownloader.figshare.com/files/468654", "https://ndownloader.figshare.com/files/468739", "https://ndownloader.figshare.com/files/468819", "https://ndownloader.figshare.com/files/468865", "https://ndownloader.figshare.com/files/468919", "https://ndownloader.figshare.com/files/468959"], "description"=>"<div><h3>Background</h3><p>The global tuberculosis epidemic results in nearly 2 million deaths and 9 million new cases of the disease a year. The vast majority of tuberculosis patients live in developing countries, where the diagnosis of tuberculosis relies on the identification of acid-fast bacilli on unprocessed sputum smears using conventional light microscopy. Microscopy has high specificity in tuberculosis-endemic countries, but modest sensitivity which varies among laboratories (range 20% to 80%). Moreover, the sensitivity is poor for paucibacillary disease (e.g., pediatric and HIV-associated tuberculosis). Thus, the development of rapid and accurate new diagnostic tools is imperative. Immune-based tests are potentially suitable for use in low-income countries as some test formats can be performed at the point of care without laboratory equipment. Currently, dozens of distinct commercial antibody detection tests are sold in developing countries. The question is “do they work?”</p> <h3>Methods and Findings</h3><p>We conducted a systematic review to assess the accuracy of commercial antibody detection tests for the diagnosis of pulmonary tuberculosis. Studies from all countries using culture and/or microscopy smear for confirmation of pulmonary tuberculosis were eligible. Studies with fewer than 50 participants (25 patients and 25 control participants) were excluded. In a comprehensive search, we identified 68 studies. The results demonstrate that (1) overall, commercial tests vary widely in performance; (2) sensitivity is higher in smear-positive than smear-negative samples; (3) in studies of smear-positive patients, Anda-TB IgG by enzyme-linked immunosorbent assay shows limited sensitivity (range 63% to 85%) and inconsistent specificity (range 73% to 100%); (4) specificity is higher in healthy volunteers than in patients in whom tuberculosis disease is initially suspected and subsequently ruled out; and (5) there are insufficient data to determine the accuracy of most commercial tests in smear microscopy–negative patients, as well as their performance in children or persons with HIV infection.</p> <h3>Conclusions</h3><p>None of the commercial tests evaluated perform well enough to replace sputum smear microscopy. Thus, these tests have little or no role in the diagnosis of pulmonary tuberculosis. Lack of methodological rigor in these studies was identified as a concern. It will be important to review the basic science literature evaluating serological tests for the diagnosis of pulmonary tuberculosis to determine whether useful antigens have been described but their potential has not been fully exploited. Activities leading to the discovery of new antigens with immunodiagnostic potential need to be intensified.</p> </div>", "links"=>[], "tags"=>["serological", "antibody", "detection", "tests", "pulmonary", "systematic"], "article_id"=>152407, "categories"=>["Medicine", "Cancer", "Biotechnology", "Immunology"], "users"=>["Karen R Steingart", "Megan Henry", "Suman Laal", "Philip C Hopewell", "Andrew Ramsay", "Dick Menzies", "Jane Cunningham", "Karin Weldingh", "Madhukar Pai"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.0040202.sg001", "https://dx.doi.org/10.1371/journal.pmed.0040202.sg002", "https://dx.doi.org/10.1371/journal.pmed.0040202.sg003", "https://dx.doi.org/10.1371/journal.pmed.0040202.sg004", "https://dx.doi.org/10.1371/journal.pmed.0040202.sg005", "https://dx.doi.org/10.1371/journal.pmed.0040202.sg006"], "stats"=>{"downloads"=>71, "page_views"=>15, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Commercial_Serological_Antibody_Detection_Tests_for_the_Diagnosis_of_Pulmonary_Tuberculosis_A_Systematic_Review/152407", "title"=>"Commercial Serological Antibody Detection Tests for the Diagnosis of Pulmonary Tuberculosis: A Systematic Review", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2007-06-12 00:40:07"}
  • {"files"=>["https://ndownloader.figshare.com/files/950571"], "description"=>"<p>The circles and lines represent the point estimates and 95% CIs, respectively. The size of the circle indicates the study size.</p>", "links"=>[], "tags"=>["estimates", "pulmonary"], "article_id"=>620888, "categories"=>["Biotechnology", "Medicine", "Infectious Diseases", "Immunology"], "users"=>["Karen R Steingart", "Megan Henry", "Suman Laal", "Philip C Hopewell", "Andrew Ramsay", "Dick Menzies", "Jane Cunningham", "Karin Weldingh", "Madhukar Pai"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.0040202.g003", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Specificity_Estimates_of_Commercial_Tests_for_the_Diagnosis_of_Pulmonary_TB_/620888", "title"=>"Specificity Estimates of Commercial Tests for the Diagnosis of Pulmonary TB", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2007-06-12 00:14:48"}
  • {"files"=>["https://ndownloader.figshare.com/files/950351"], "description"=>"<p>Flow Diagram for Study Selection</p>", "links"=>[], "tags"=>["diagram"], "article_id"=>620666, "categories"=>["Biotechnology", "Medicine", "Infectious Diseases", "Immunology"], "users"=>["Karen R Steingart", "Megan Henry", "Suman Laal", "Philip C Hopewell", "Andrew Ramsay", "Dick Menzies", "Jane Cunningham", "Karin Weldingh", "Madhukar Pai"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.0040202.g001", "stats"=>{"downloads"=>1, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flow_Diagram_for_Study_Selection_/620666", "title"=>"Flow Diagram for Study Selection", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2007-06-12 00:11:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/951021"], "description"=>"<div><p>(A) Healthy control participants; (B) patients with nontuberculous respiratory disease. Studies using identical comparison groups appear only once. The circles and lines represent the point estimates and 95% CIs, respectively. The size of the circle indicates the study size.</p>\n <p>doi:10.1371/journal.pmed.0040202.g007</p></div>", "links"=>[], "tags"=>["estimates"], "article_id"=>621339, "categories"=>["Biotechnology", "Medicine", "Infectious Diseases", "Immunology"], "users"=>["Karen R Steingart", "Megan Henry", "Suman Laal", "Philip C Hopewell", "Andrew Ramsay", "Dick Menzies", "Jane Cunningham", "Karin Weldingh", "Madhukar Pai"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.0040202.g007", "stats"=>{"downloads"=>0, "page_views"=>2, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Specificity_Estimates_of_Commercial_Tests_/621339", "title"=>"Specificity Estimates of Commercial Tests", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2007-06-12 00:22:19"}
  • {"files"=>["https://ndownloader.figshare.com/files/950843"], "description"=>"<p>(A) Sensitivity; (B) specificity. The circles and lines represent the point estimates and 95% CIs, respectively. The size of the circle indicates the study size.</p>", "links"=>[], "tags"=>["specificity", "estimates", "anda-tb", "igg", "pulmonary", "smear"], "article_id"=>621151, "categories"=>["Biotechnology", "Medicine", "Infectious Diseases", "Immunology"], "users"=>["Karen R Steingart", "Megan Henry", "Suman Laal", "Philip C Hopewell", "Andrew Ramsay", "Dick Menzies", "Jane Cunningham", "Karin Weldingh", "Madhukar Pai"], "doi"=>"https://dx.doi.org/10.1371/journal.pmed.0040202.g006", "stats"=>{"downloads"=>1, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Sensitivity_and_Specificity_Estimates_of_Anda_TB_IgG_for_the_Diagnosis_of_Pulmonary_TB_Smear_Microscopy_8211_Positive_Patients_/621151", "title"=>"Sensitivity and Specificity Estimates of Anda-TB IgG for the Diagnosis of Pulmonary TB, Smear Microscopy–Positive Patients", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2007-06-12 00:19:11"}

PMC Usage Stats | Further Information

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Relative Metric

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