Commercial Serological Tests for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis: An Updated Systematic Review and Meta-Analysis
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{"title"=>"Commercial Serological tests for the diagnosis of active pulmonary and extrapulmonary tuberculosis: An updated systematic review and Meta-Analysis", "type"=>"generic", "authors"=>[{"first_name"=>"Karen R.", "last_name"=>"Steingart", "scopus_author_id"=>"8438524800"}, {"first_name"=>"Laura L.", "last_name"=>"Flores", "scopus_author_id"=>"7101922951"}, {"first_name"=>"Nandini", "last_name"=>"Dendukuri", "scopus_author_id"=>"6604062316"}, {"first_name"=>"Ian", "last_name"=>"Schiller", "scopus_author_id"=>"26027271000"}, {"first_name"=>"Suman", "last_name"=>"Laal", "scopus_author_id"=>"16190298700"}, {"first_name"=>"Andrew", "last_name"=>"Ramsay", "scopus_author_id"=>"14120309700"}, {"first_name"=>"Philip C.", "last_name"=>"Hopewell", "scopus_author_id"=>"24372908500"}, {"first_name"=>"Madhukar", "last_name"=>"Pai", "scopus_author_id"=>"14054425400"}], "year"=>2011, "source"=>"PLoS Medicine", "identifiers"=>{"pmid"=>"21857806", "doi"=>"10.1371/journal.pmed.1001062", "sgr"=>"80052339714", "isbn"=>"1549-1277", "scopus"=>"2-s2.0-80052339714", "issn"=>"15491277", "pui"=>"362471708"}, "id"=>"39891805-99ca-331e-87c5-438d279d2cf0", "abstract"=>"BACKGROUND: Serological (antibody detection) tests for tuberculosis (TB) are widely used in developing countries. As part of a World Health Organization policy process, we performed an updated systematic review to assess the diagnostic accuracy of commercial serological tests for pulmonary and extrapulmonary TB with a focus on the relevance of these tests in low- and middle-income countries. METHODS AND FINDINGS: We used methods recommended by the Cochrane Collaboration and GRADE approach for rating quality of evidence. In a previous review, we searched multiple databases for papers published from 1 January 1990 to 30 May 2006, and in this update, we add additional papers published from that period until 29 June 2010. We prespecified subgroups to address heterogeneity and summarized test performance using bivariate random effects meta-analysis. For pulmonary TB, we included 67 studies (48% from low- and middle-income countries) with 5,147 participants. For all tests, estimates were variable for sensitivity (0% to 100%) and specificity (31% to 100%). For anda-TB IgG, the only test with enough studies for meta-analysis, pooled sensitivity was 76% (95% CI 63%-87%) in smear-positive (seven studies) and 59% (95% CI 10%-96%) in smear-negative (four studies) patients; pooled specificities were 92% (95% CI 74%-98%) and 91% (95% CI 79%-96%), respectively. Compared with ELISA (pooled sensitivity 60% [95% CI 6%-65%]; pooled specificity 98% [95% CI 96%-99%]), immunochromatographic tests yielded lower pooled sensitivity (53%, 95% CI 42%-64%) and comparable pooled specificity (98%, 95% CI 94%-99%). For extrapulmonary TB, we included 25 studies (40% from low- and middle-income countries) with 1,809 participants. For all tests, estimates were variable for sensitivity (0% to 100%) and specificity (59% to 100%). Overall, quality of evidence was graded very low for studies of pulmonary and extrapulmonary TB. CONCLUSIONS: Despite expansion of the literature since 2006, commercial serological tests continue to produce inconsistent and imprecise estimates of sensitivity and specificity. Quality of evidence remains very low. These data informed a recently published World Health Organization policy statement against serological tests. Please see later in the article for the Editors' Summary.", "link"=>"http://www.mendeley.com/research/commercial-serological-tests-diagnosis-active-pulmonary-extrapulmonary-tuberculosis-updated-systemat-4", "reader_count"=>150, "reader_count_by_academic_status"=>{"Unspecified"=>5, "Professor > Associate Professor"=>4, "Researcher"=>36, "Student > Doctoral Student"=>8, "Student > Ph. D. Student"=>23, "Student > Postgraduate"=>14, "Student > Master"=>32, "Other"=>8, "Student > Bachelor"=>10, "Lecturer"=>3, "Lecturer > Senior Lecturer"=>3, "Professor"=>4}, "reader_count_by_user_role"=>{"Unspecified"=>5, "Professor > Associate Professor"=>4, "Researcher"=>36, "Student > Doctoral Student"=>8, "Student > Ph. D. Student"=>23, "Student > Postgraduate"=>14, "Student > Master"=>32, "Other"=>8, "Student > Bachelor"=>10, "Lecturer"=>3, "Lecturer > Senior Lecturer"=>3, "Professor"=>4}, "reader_count_by_subject_area"=>{"Unspecified"=>15, "Agricultural and Biological Sciences"=>29, "Veterinary Science and Veterinary Medicine"=>2, "Business, Management and Accounting"=>2, "Chemistry"=>2, "Economics, Econometrics and Finance"=>2, "Engineering"=>3, "Biochemistry, Genetics and Molecular Biology"=>13, "Nursing and Health Professions"=>1, "Mathematics"=>1, "Medicine and Dentistry"=>72, "Social Sciences"=>2, "Immunology and Microbiology"=>6}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>72}, "Social Sciences"=>{"Social Sciences"=>2}, "Mathematics"=>{"Mathematics"=>1}, "Unspecified"=>{"Unspecified"=>15}, "Engineering"=>{"Engineering"=>3}, "Chemistry"=>{"Chemistry"=>2}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>2}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>6}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>29}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>2}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>13}, "Veterinary Science and Veterinary Medicine"=>{"Veterinary Science and Veterinary Medicine"=>2}}, "reader_count_by_country"=>{"Canada"=>1, "Colombia"=>2, "Argentina"=>1, "United States"=>3, "Philippines"=>1, "Brazil"=>4, "United Kingdom"=>1, "Chile"=>1, "Switzerland"=>1, "India"=>1}, "group_count"=>7}

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  • {"files"=>["https://ndownloader.figshare.com/files/376711", "https://ndownloader.figshare.com/files/376744", "https://ndownloader.figshare.com/files/376786", "https://ndownloader.figshare.com/files/376816", "https://ndownloader.figshare.com/files/376861", "https://ndownloader.figshare.com/files/376909", "https://ndownloader.figshare.com/files/377026", "https://ndownloader.figshare.com/files/377110", "https://ndownloader.figshare.com/files/377137"], "description"=>"<div><h3>Background</h3><p>Serological (antibody detection) tests for tuberculosis (TB) are widely used in developing countries. As part of a World Health Organization policy process, we performed an updated systematic review to assess the diagnostic accuracy of commercial serological tests for pulmonary and extrapulmonary TB with a focus on the relevance of these tests in low- and middle-income countries.</p> <h3>Methods and Findings</h3><p>We used methods recommended by the Cochrane Collaboration and GRADE approach for rating quality of evidence. In a previous review, we searched multiple databases for papers published from 1 January 1990 to 30 May 2006, and in this update, we add additional papers published from that period until 29 June 2010. We prespecified subgroups to address heterogeneity and summarized test performance using bivariate random effects meta-analysis. For pulmonary TB, we included 67 studies (48% from low- and middle-income countries) with 5,147 participants. For all tests, estimates were variable for sensitivity (0% to 100%) and specificity (31% to 100%). For anda-TB IgG, the only test with enough studies for meta-analysis, pooled sensitivity was 76% (95% CI 63%–87%) in smear-positive (seven studies) and 59% (95% CI 10%–96%) in smear-negative (four studies) patients; pooled specificities were 92% (95% CI 74%–98%) and 91% (95% CI 79%–96%), respectively. Compared with ELISA (pooled sensitivity 60% [95% CI 6%–65%]; pooled specificity 98% [95% CI 96%–99%]), immunochromatographic tests yielded lower pooled sensitivity (53%, 95% CI 42%–64%) and comparable pooled specificity (98%, 95% CI 94%–99%). For extrapulmonary TB, we included 25 studies (40% from low- and middle-income countries) with 1,809 participants. For all tests, estimates were variable for sensitivity (0% to 100%) and specificity (59% to 100%). Overall, quality of evidence was graded very low for studies of pulmonary and extrapulmonary TB.</p> <h3>Conclusions</h3><p>Despite expansion of the literature since 2006, commercial serological tests continue to produce inconsistent and imprecise estimates of sensitivity and specificity. Quality of evidence remains very low. These data informed a recently published World Health Organization policy statement against serological tests.</p> <h3></h3><p> <em>Please see later in the article for the Editors' Summary</em></p> </div>", "links"=>[], "tags"=>["serological", "tests", "pulmonary", "extrapulmonary", "updated", "systematic", "meta-analysis"], "article_id"=>134427, "categories"=>["Cancer", "Biotechnology"], "users"=>["Karen R. Steingart", "Laura L. Flores", "Nandini Dendukuri", "Ian Schiller", "Suman Laal", "Andrew Ramsay", "Philip C. Hopewell", "Madhukar Pai"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001062.s001", "https://dx.doi.org/10.1371/journal.pmed.1001062.s002", "https://dx.doi.org/10.1371/journal.pmed.1001062.s003", "https://dx.doi.org/10.1371/journal.pmed.1001062.s004", "https://dx.doi.org/10.1371/journal.pmed.1001062.s005", "https://dx.doi.org/10.1371/journal.pmed.1001062.s006", "https://dx.doi.org/10.1371/journal.pmed.1001062.s007", "https://dx.doi.org/10.1371/journal.pmed.1001062.s008", "https://dx.doi.org/10.1371/journal.pmed.1001062.s009"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Commercial_Serological_Tests_for_the_Diagnosis_of_Active_Pulmonary_and_Extrapulmonary_Tuberculosis_An_Updated_Systematic_Review_and_Meta_Analysis/134427", "title"=>"Commercial Serological Tests for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis: An Updated Systematic Review and Meta-Analysis", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2011-08-09 01:13:47"}
  • {"files"=>["https://ndownloader.figshare.com/files/747483"], "description"=>"<p>Flow of studies in the review of commercial serological tests for the diagnosis of active tuberculosis.</p>", "links"=>[], "tags"=>["studies", "serological"], "article_id"=>417845, "categories"=>["Biotechnology", "Infectious Diseases"], "users"=>["Karen R. Steingart", "Laura L. Flores", "Nandini Dendukuri", "Ian Schiller", "Suman Laal", "Andrew Ramsay", "Philip C. Hopewell", "Madhukar Pai"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001062.g001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flow_of_studies_in_the_review_of_commercial_serological_tests_for_the_diagnosis_of_active_tuberculosis_/417845", "title"=>"Flow of studies in the review of commercial serological tests for the diagnosis of active tuberculosis.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-08-09 02:10:45"}
  • {"files"=>["https://ndownloader.figshare.com/files/747692"], "description"=>"<p>Review authors' judgments about each methodological quality item.</p>", "links"=>[], "tags"=>["pulmonary"], "article_id"=>418063, "categories"=>["Biotechnology", "Infectious Diseases"], "users"=>["Karen R. Steingart", "Laura L. Flores", "Nandini Dendukuri", "Ian Schiller", "Suman Laal", "Andrew Ramsay", "Philip C. Hopewell", "Madhukar Pai"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001062.g002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Methodological_quality_graph_all_studies_pulmonary_TB_/418063", "title"=>"Methodological quality graph, all studies, pulmonary TB.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-08-09 02:14:23"}
  • {"files"=>["https://ndownloader.figshare.com/files/747845"], "description"=>"<p>Specificity data for Mizusawa et al. [49] were not reported. FN, false negative; FP, false positive; TN, true negative; TP, true positive. 95% CIs are included in brackets. On the right, the sensitivity and specificity estimates for individual studies are indicated by blue squares and the 95% CIs are indicated by black horizontal lines.</p>", "links"=>[], "tags"=>["plots", "pulmonary"], "article_id"=>418212, "categories"=>["Biotechnology", "Infectious Diseases"], "users"=>["Karen R. Steingart", "Laura L. Flores", "Nandini Dendukuri", "Ian Schiller", "Suman Laal", "Andrew Ramsay", "Philip C. Hopewell", "Madhukar Pai"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001062.g003"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Forest_plots_of_sensitivity_and_specificity_all_studies_pulmonary_TB_/418212", "title"=>"Forest plots of sensitivity and specificity, all studies, pulmonary TB.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-08-09 02:16:52"}
  • {"files"=>["https://ndownloader.figshare.com/files/747953"], "description"=>"<p>Review authors' judgments about each methodological quality item.</p>", "links"=>[], "tags"=>["pulmonary", "studies", "smear-negative"], "article_id"=>418318, "categories"=>["Biotechnology", "Infectious Diseases"], "users"=>["Karen R. Steingart", "Laura L. Flores", "Nandini Dendukuri", "Ian Schiller", "Suman Laal", "Andrew Ramsay", "Philip C. Hopewell", "Madhukar Pai"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001062.g004"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Methodological_quality_summary_pulmonary_TB_studies_of_smear_negative_patients_/418318", "title"=>"Methodological quality summary, pulmonary TB, studies of smear-negative patients.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-08-09 02:18:38"}
  • {"files"=>["https://ndownloader.figshare.com/files/748054"], "description"=>"<p>FN, false negative; FP, false positive; TN, true negative; TP, true positive. 95% CIs are included in the brackets. On the right, the sensitivity and specificity estimates for individual studies are indicated by blue squares, and the 95% CIs are indicated by black horizontal lines.</p>", "links"=>[], "tags"=>["plots", "pulmonary", "studies", "smear-negative"], "article_id"=>418421, "categories"=>["Biotechnology", "Infectious Diseases"], "users"=>["Karen R. Steingart", "Laura L. Flores", "Nandini Dendukuri", "Ian Schiller", "Suman Laal", "Andrew Ramsay", "Philip C. Hopewell", "Madhukar Pai"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001062.g005"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Forest_plots_of_sensitivity_and_specificity_pulmonary_TB_studies_of_smear_negative_patients_/418421", "title"=>"Forest plots of sensitivity and specificity, pulmonary TB, studies of smear-negative patients.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-08-09 02:20:21"}
  • {"files"=>["https://ndownloader.figshare.com/files/748206"], "description"=>"<p>Smear-positive (line A; open circles) and smear-negative (line B; gray circles) pulmonary TB patients. The width of the circles is proportional to the number of patients in each study. The red squares are the summary values for sensitivity and specificity.</p>", "links"=>[], "tags"=>["hsroc", "plots", "specificity", "anda-tb", "igg", "smear-positive", "smear-negative", "pulmonary", "tb"], "article_id"=>418557, "categories"=>["Biotechnology", "Infectious Diseases"], "users"=>["Karen R. Steingart", "Laura L. Flores", "Nandini Dendukuri", "Ian Schiller", "Suman Laal", "Andrew Ramsay", "Philip C. Hopewell", "Madhukar Pai"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001062.g006"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Summary_HSROC_plots_of_sensitivity_and_specificity_for_anda_TB_IgG_in_smear_positive_and_smear_negative_pulmonary_TB_patients_/418557", "title"=>"Summary HSROC plots of sensitivity and specificity for anda-TB IgG in smear-positive and smear-negative pulmonary TB patients.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-08-09 02:22:37"}
  • {"files"=>["https://ndownloader.figshare.com/files/748347"], "description"=>"<p>ELISA (line A; open circles) and immunochromatographic test (line B; gray circles). The width of the circles is proportional to the number of patients in each study. The red squares are the summary values for sensitivity and specificity.</p>", "links"=>[], "tags"=>["hsroc", "plots", "specificity", "assay"], "article_id"=>418711, "categories"=>["Biotechnology", "Infectious Diseases"], "users"=>["Karen R. Steingart", "Laura L. Flores", "Nandini Dendukuri", "Ian Schiller", "Suman Laal", "Andrew Ramsay", "Philip C. Hopewell", "Madhukar Pai"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001062.g007"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Summary_HSROC_plots_of_sensitivity_and_specificity_by_assay_technique_/418711", "title"=>"Summary HSROC plots of sensitivity and specificity by assay technique.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-08-09 02:25:11"}
  • {"files"=>["https://ndownloader.figshare.com/files/748497"], "description"=>"<p>Review authors' judgments about each methodological quality item.</p>", "links"=>[], "tags"=>["extrapulmonary"], "article_id"=>418867, "categories"=>["Biotechnology", "Infectious Diseases"], "users"=>["Karen R. Steingart", "Laura L. Flores", "Nandini Dendukuri", "Ian Schiller", "Suman Laal", "Andrew Ramsay", "Philip C. Hopewell", "Madhukar Pai"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001062.g008"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Methodological_quality_summary_all_studies_extrapulmonary_TB_/418867", "title"=>"Methodological quality summary, all studies, extrapulmonary TB.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-08-09 02:27:47"}
  • {"files"=>["https://ndownloader.figshare.com/files/748622"], "description"=>"<p>FN, false negative; FP, false positive; TN, true negative; TP, true positive. 95% CIs are included in the brackets. On the right, the sensitivity and specificity estimates for individual studies are indicated by blue squares, and the 95% CIs are indicated by black horizontal lines.</p>", "links"=>[], "tags"=>["plots", "extrapulmonary"], "article_id"=>418990, "categories"=>["Biotechnology", "Infectious Diseases"], "users"=>["Karen R. Steingart", "Laura L. Flores", "Nandini Dendukuri", "Ian Schiller", "Suman Laal", "Andrew Ramsay", "Philip C. Hopewell", "Madhukar Pai"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001062.g009"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Forest_plots_of_sensitivity_and_specificity_all_studies_extrapulmonary_TB_/418990", "title"=>"Forest plots of sensitivity and specificity, all studies, extrapulmonary TB.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-08-09 02:29:50"}
  • {"files"=>["https://ndownloader.figshare.com/files/748689"], "description"=>"<p>ICT, immunochromatographic test; LAM, lipoarabinomannan.</p>a<p>Some manufacturers may no longer provide the serological tests listed above. It is also possible that the same test may be marketed under various names by different companies.</p>b<p>anda-TB: IgG (13 studies), IgM (one study), IgA (two studies).</p>c<p>Pathozyme Myco: IgG (three studies), IgM (two studies), IgA (two studies), IgG plus IgM (one study), IgG plus IgA (one study), IgM plus IgA (one study), IgG plus IgM plus IgA (one study).</p>d<p>Pathozyme TB Complex Plus as a single test (three studies) or in combination with Pathozyme Myco G (one study), Pathozyme Myco M (one study), Pathozyme Myco A (one study), Pathozyme Myco G and A (one study), Pathozyme Myco M and A (one study), Pathozyme Myco G, M, and A (one study).</p>", "links"=>[], "tags"=>["serological", "included", "systematic", "pulmonary"], "article_id"=>419052, "categories"=>["Biotechnology", "Infectious Diseases"], "users"=>["Karen R. Steingart", "Laura L. Flores", "Nandini Dendukuri", "Ian Schiller", "Suman Laal", "Andrew Ramsay", "Philip C. Hopewell", "Madhukar Pai"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001062.t001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Commercial_serological_tests_included_in_this_systematic_review_for_pulmonary_TB_/419052", "title"=>"Commercial serological tests included in this systematic review for pulmonary TB.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-08-09 02:30:52"}
  • {"files"=>["https://ndownloader.figshare.com/files/748734"], "description"=>"<p>Sensitivity and specificity estimates given as posterior means (percent) with 95% credible intervals in parentheses.</p>a<p>Serological tests included: ICT TB (three studies), Assure TB (two studies), MycoDot (three studies), SDHO (two studies), Hexagon (one study), Serocheck-MTB (one study).</p>", "links"=>[], "tags"=>["pooled", "specificity", "estimates"], "article_id"=>419097, "categories"=>["Biotechnology", "Infectious Diseases"], "users"=>["Karen R. Steingart", "Laura L. Flores", "Nandini Dendukuri", "Ian Schiller", "Suman Laal", "Andrew Ramsay", "Philip C. Hopewell", "Madhukar Pai"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001062.t002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Bivariate_meta_analyses_pooled_sensitivity_and_specificity_estimates_by_subgroup_/419097", "title"=>"Bivariate meta-analyses: pooled sensitivity and specificity estimates by subgroup.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-08-09 02:31:37"}
  • {"files"=>["https://ndownloader.figshare.com/files/748782"], "description"=>"<p>Based on sample size = 8,318, sensitivity median = 64%, specificity median = 91%. The quality of evidence was rated as high (no points subtracted), moderate (one point subtracted), low (two points subtracted), or very low (>2 points subtracted) based on five factors: study limitations, indirectness of evidence, inconsistency in results across studies, imprecision in summary estimates, and likelihood of publication bias. For each outcome, the quality of evidence started at high when there were randomized controlled trials or high-quality observational studies (cross-sectional or cohort studies enrolling patients with diagnostic uncertainty) and at moderate when these types of studies were absent. No points were subtracted when there were negligible issues identified; one point was subtracted when there was a serious issue identified; two points were subtracted when there was a very serious issue identified in any of the criteria used to judge the quality of evidence. Points subtracted are in parentheses. Publication bias was rated as “not likely,” “likely,” or “very likely” <a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001062#pmed.1001062-Schunemann1\" target=\"_blank\">[23]</a>.</p>a<p>What do these results mean given 10% or 30% disease prevalence among individuals being screened for TB?</p>b<p>Outcomes were ranked by their relative importance as critical, important, or of limited importance. Ranking helped to focus attention on those outcomes that were considered most important.</p>c<p>The majority of studies lacked a representative patient population and were not blinded.</p>d<p>Although diagnostic accuracy is considered a surrogate for patient-important outcomes, we did not downgrade.</p>e<p>There was considerable heterogeneity in study results.</p>f<p>We did not pool accuracy estimates. The 95% CIs were wide for many individual studies. We did not downgrade as there were a large number of studies and we had already taken off two points for inconsistency.</p>g<p>Data included in the review did not allow for formal assessment of publication bias using methods such as funnel plots or regression tests. Therefore, publication bias cannot be ruled out. It is prudent to assume some degree of publication bias as studies showing poor performance of serological tests were probably less likely to be published. No points were deducted.</p>", "links"=>[], "tags"=>["serological", "smear", "microscopy", "patients", "suspected", "having", "pulmonary"], "article_id"=>419139, "categories"=>["Biotechnology", "Infectious Diseases"], "users"=>["Karen R. Steingart", "Laura L. Flores", "Nandini Dendukuri", "Ian Schiller", "Suman Laal", "Andrew Ramsay", "Philip C. Hopewell", "Madhukar Pai"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001062.t003"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_GRADE_evidence_profile_should_commercial_serological_tests_be_used_as_a_replacement_test_for_conventional_tests_such_as_smear_microscopy_in_patients_of_any_age_suspected_of_having_pulmonary_tuberculosis_/419139", "title"=>"GRADE evidence profile: should commercial serological tests be used as a replacement test for conventional tests such as smear microscopy in patients of any age suspected of having pulmonary tuberculosis?", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-08-09 02:32:19"}
  • {"files"=>["https://ndownloader.figshare.com/files/748824"], "description"=>"<p>This table includes studies conducted in smear-negative patients as a proxy for a diagnostic strategy using serological tests in addition to smear microscopy. Based on sample size = 3,433, sensitivity median = 61% and specificity median = 92%. The quality of evidence was rated as high (no points subtracted), moderate (one point subtracted), low (two points subtracted), or very low (>2 points subtracted) based on five factors: study limitations, indirectness of evidence, inconsistency in results across studies, imprecision in summary estimates, and likelihood of publication bias. For each outcome, the quality of evidence started at high when there were randomized controlled trials or high-quality observational studies (cross-sectional or cohort studies enrolling patients with diagnostic uncertainty) and at moderate when these types of studies were absent. No points were subtracted when there were negligible issues identified; one point was subtracted when there was a serious issue identified; two points were subtracted when there was a very serious issue identified in any of the criteria used to judge the quality of evidence. Points subtracted are in parentheses. Publication bias was rated as “not likely,” “likely,” or “very likely” <a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1001062#pmed.1001062-Schunemann1\" target=\"_blank\">[23]</a>.</p>a<p>What do these results mean given 10% disease prevalence among individuals being screened for TB?</p>b<p>Outcomes were ranked by their relative importance as critical, important, or of limited importance. Ranking helped to focus attention on those outcomes that were considered most important.</p>c<p>Only 14/28 (50%) studies were considered to include a representative patient population; 75% of studies reported blinding of the serological test result.</p>d<p>We downgraded for indirectness because these studies were used as a proxy for a diagnostic strategy using serological tests in addition to smear microscopy.</p>e<p>There was considerable heterogeneity in study results.</p>f<p>We did not pool accuracy estimates. The 95% CIs were wide for many individual studies. We did not downgrade as there were a large number of studies and we had already taken off two points for inconsistency.</p>g<p>Data included in the review did not allow for formal assessment of publication bias using methods such as funnel plots or regression tests. Therefore, publication bias cannot be ruled out. It is prudent to assume some degree of publication bias as studies showing poor performance of serological tests were probably less likely to be published. No points were deducted.</p>", "links"=>[], "tags"=>["serological", "smear", "microscopy", "patients", "suspected", "having", "pulmonary"], "article_id"=>419179, "categories"=>["Biotechnology", "Infectious Diseases"], "users"=>["Karen R. Steingart", "Laura L. Flores", "Nandini Dendukuri", "Ian Schiller", "Suman Laal", "Andrew Ramsay", "Philip C. Hopewell", "Madhukar Pai"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1001062.t004"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_GRADE_evidence_profile_should_commercial_serological_tests_be_used_as_an_8220_add_on_8221_test_to_smear_microscopy_in_patients_of_any_age_suspected_of_having_pulmonary_TB_/419179", "title"=>"GRADE evidence profile: should commercial serological tests be used as an “add on” test to smear microscopy in patients of any age suspected of having pulmonary TB?", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-08-09 02:32:59"}

PMC Usage Stats | Further Information

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  • {"unique-ip"=>"69", "full-text"=>"80", "pdf"=>"4", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"2", "cited-by"=>"0", "year"=>"2019", "month"=>"5"}
  • {"unique-ip"=>"92", "full-text"=>"109", "pdf"=>"4", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"1", "supp-data"=>"9", "cited-by"=>"0", "year"=>"2019", "month"=>"8"}
  • {"unique-ip"=>"132", "full-text"=>"151", "pdf"=>"6", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2019", "month"=>"9"}
  • {"unique-ip"=>"157", "full-text"=>"181", "pdf"=>"5", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"1", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2019", "month"=>"10"}

Relative Metric

{"start_date"=>"2011-01-01T00:00:00Z", "end_date"=>"2011-12-31T00:00:00Z", "subject_areas"=>[{"subject_area"=>"/Biology and life sciences", "average_usage"=>[304, 568, 702, 818, 927, 1027, 1118, 1206, 1285, 1357, 1427, 1500, 1564, 1636, 1705, 1773, 1840, 1909, 1974, 2039, 2106, 2170, 2234, 2296, 2358, 2423, 2484, 2546, 2606, 2673, 2734, 2795, 2857, 2921, 2984, 3046, 3100]}, {"subject_area"=>"/Biology and life sciences/Organisms", "average_usage"=>[316, 571, 699, 812, 915, 1008, 1095, 1180, 1255, 1319, 1393, 1461, 1528, 1595, 1662, 1729, 1802, 1868, 1937, 1997, 2062, 2130, 2192, 2254, 2324, 2386, 2450, 2510, 2579, 2642, 2716, 2778, 2842, 2908, 2979, 3042, 3095]}, {"subject_area"=>"/Physical sciences", "average_usage"=>[303, 547, 667, 770, 875, 974, 1062, 1140, 1210, 1276, 1344, 1408, 1473, 1534, 1602, 1665, 1732, 1800, 1863, 1920, 1984, 2048, 2099, 2161, 2222, 2285, 2341, 2404, 2473, 2528, 2595, 2650, 2713, 2772, 2835, 2886, 2938]}, {"subject_area"=>"/Physical sciences/Mathematics", "average_usage"=>[347, 582, 700, 805, 909, 997, 1061, 1147, 1220, 1282, 1350, 1411, 1471, 1532, 1600, 1665, 1726, 1790, 1868, 1927, 1986, 2048, 2105, 2166, 2229, 2288, 2347, 2407, 2463, 2525, 2589, 2650, 2704, 2755, 2806, 2854, 2896]}]}
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