A Laboratory-Based Evaluation of Four Rapid Point-of-Care Tests for Syphilis
Publication Date
March 11, 2014
Journal
PLOS ONE
Authors
Louise M. Causer, John M. Kaldor, Christopher K. Fairley, Basil Donovan, et al
Volume
9
Issue
3
Pages
e91504
DOI
https://dx.plos.org/10.1371/journal.pone.0091504
Publisher URL
http://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0091504
PubMed
http://www.ncbi.nlm.nih.gov/pubmed/24618681
PubMed Central
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3950184
Europe PMC
http://europepmc.org/abstract/MED/24618681
Web of Science
000332842400097
Scopus
84897484571
Mendeley
http://www.mendeley.com/research/laboratorybased-evaluation-four-rapid-pointofcare-tests-syphilis
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Mendeley | Further Information

{"title"=>"A laboratory-based evaluation of four rapid point-of-care tests for syphilis", "type"=>"journal", "authors"=>[{"first_name"=>"Louise M.", "last_name"=>"Causer", "scopus_author_id"=>"6507645853"}, {"first_name"=>"John M.", "last_name"=>"Kaldor", "scopus_author_id"=>"56962717500"}, {"first_name"=>"Christopher K.", "last_name"=>"Fairley", "scopus_author_id"=>"55382768300"}, {"first_name"=>"Basil", "last_name"=>"Donovan", "scopus_author_id"=>"7103301343"}, {"first_name"=>"Theo", "last_name"=>"Karapanagiotidis", "scopus_author_id"=>"15764908700"}, {"first_name"=>"David E.", "last_name"=>"Leslie", "scopus_author_id"=>"36872947000"}, {"first_name"=>"Peter W.", "last_name"=>"Robertson", "scopus_author_id"=>"7201477085"}, {"first_name"=>"Anna M.", "last_name"=>"McNulty", "scopus_author_id"=>"7003604259"}, {"first_name"=>"David", "last_name"=>"Anderson", "scopus_author_id"=>"7410021720"}, {"first_name"=>"Handan", "last_name"=>"Wand", "scopus_author_id"=>"7004268283"}, {"first_name"=>"Damian P.", "last_name"=>"Conway", "scopus_author_id"=>"26021821900"}, {"first_name"=>"Ian", "last_name"=>"Denham", "scopus_author_id"=>"6603641388"}, {"first_name"=>"Claire", "last_name"=>"Ryan", "scopus_author_id"=>"12645005400"}, {"first_name"=>"Rebecca J.", "last_name"=>"Guy", "scopus_author_id"=>"8696464300"}], "year"=>2014, "source"=>"PLoS ONE", "identifiers"=>{"issn"=>"19326203", "pui"=>"372764688", "doi"=>"10.1371/journal.pone.0091504", "sgr"=>"84897484571", "scopus"=>"2-s2.0-84897484571", "isbn"=>"1932-6203 (Electronic)\\r1932-6203 (Linking)", "pmid"=>"24618681"}, "id"=>"93dfb822-fc2b-3f85-a421-8043bdaeccc4", "abstract"=>"BACKGROUND: Syphilis point-of-care tests may reduce morbidity and ongoing transmission by increasing the proportion of people rapidly treated. Syphilis stage and co-infection with HIV may influence test performance. We evaluated four commercially available syphilis point-of-care devices in a head-to-head comparison using sera from laboratories in Australia.\\n\\nMETHODS: Point-of-care tests were evaluated using sera stored at Sydney and Melbourne laboratories. Sensitivity and specificity were calculated by standard methods, comparing point-of-care results to treponemal immunoassay (IA) reference test results. Additional analyses by clinical syphilis stage, HIV status, and non-treponemal antibody titre were performed. Non-overlapping 95% confidence intervals (CI) were considered statistically significant differences in estimates.\\n\\nRESULTS: In total 1203 specimens were tested (736 IA-reactive, 467 IA-nonreactive). Point-of-care test sensitivities were: Determine 97.3%(95%CI:95.8-98.3), Onsite 92.5%(90.3-94.3), DPP 89.8%(87.3-91.9) and Bioline 87.8%(85.1-90.0). Specificities were: Determine 96.4%(94.1-97.8), Onsite 92.5%(90.3-94.3), DPP 98.3%(96.5-99.2), and Bioline 98.5%(96.8-99.3). Sensitivity of the Determine test was 100% for primary and 100% for secondary syphilis. The three other tests had reduced sensitivity among primary (80.4-90.2%) compared to secondary syphilis (94.3-98.6%). No significant differences in sensitivity were observed by HIV status. Test sensitivities were significantly higher among high-RPR titre (RPR ≥ 8) (range: 94.6-99.5%) than RPR non-reactive infections (range: 76.3-92.9%).\\n\\nCONCLUSIONS: The Determine test had the highest sensitivity overall. All tests were most sensitive among high-RPR titre infections. Point-of-care tests have a role in syphilis control programs however in developed countries with established laboratory infrastructures, the lower sensitivities of some tests observed in primary syphilis suggest these would need to be supplemented with additional tests among populations where syphilis incidence is high to avoid missing early syphilis cases.", "link"=>"http://www.mendeley.com/research/laboratorybased-evaluation-four-rapid-pointofcare-tests-syphilis", "reader_count"=>36, "reader_count_by_academic_status"=>{"Unspecified"=>2, "Professor > Associate Professor"=>1, "Librarian"=>1, "Researcher"=>8, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>4, "Other"=>2, "Student > Master"=>9, "Student > Bachelor"=>2, "Lecturer"=>1, "Lecturer > Senior Lecturer"=>1, "Professor"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>2, "Professor > Associate Professor"=>1, "Librarian"=>1, "Researcher"=>8, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>4, "Other"=>2, "Student > Master"=>9, "Student > Bachelor"=>2, "Lecturer"=>1, "Lecturer > Senior Lecturer"=>1, "Professor"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>3, "Engineering"=>3, "Mathematics"=>1, "Medicine and Dentistry"=>19, "Agricultural and Biological Sciences"=>4, "Psychology"=>1, "Chemistry"=>1, "Social Sciences"=>2, "Immunology and Microbiology"=>2}, "reader_count_by_subdiscipline"=>{"Engineering"=>{"Engineering"=>3}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>19}, "Chemistry"=>{"Chemistry"=>1}, "Social Sciences"=>{"Social Sciences"=>2}, "Psychology"=>{"Psychology"=>1}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>4}, "Mathematics"=>{"Mathematics"=>1}, "Unspecified"=>{"Unspecified"=>3}}, "reader_count_by_country"=>{"United States"=>1, "Brazil"=>1, "France"=>1, "Spain"=>2}, "group_count"=>3}

Scopus | Further Information

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/1414973"], "description"=>"<p>*IA+/IA-  =  Treponemal immunoassay reactive/Treponemal immunoassay nonreactive.</p><p>Sens  =  sensitivity; Spec  =  specificity; SYD = Sydney (Architect Syphilis Chemiluminescence IA); MEL = Melbourne (Trepanostika TP recombinant Enzyme IA)</p><p>Differences between estimates were considered to be statistically significant where 95% CI were not overlapping.</p>", "links"=>[], "tags"=>["microbiology", "Virology", "co-infections", "Clinical immunology", "Immunologic techniques", "immunoassays", "Clinical research design", "Retrospective studies", "Diagnostic medicine", "Clinical laboratory sciences", "Test evaluation", "epidemiology", "Clinical epidemiology", "Infectious disease epidemiology", "Infectious diseases", "Sexually transmitted diseases", "syphilis", "Viral diseases", "hiv", "Infectious disease control", "poc", "specificity", "treponemal", "cd4"], "article_id"=>957853, "categories"=>["Biological Sciences", "Medicine"], "users"=>["Louise M. Causer", "John M. Kaldor", "Christopher K. Fairley", "Basil Donovan", "Theo Karapanagiotidis", "David E. Leslie", "Peter W. Robertson", "Anna M. McNulty", "David Anderson", "Handan Wand", "Damian P. Conway", "Ian Denham", "Claire Ryan", "Rebecca J. Guy"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0091504.t003", "stats"=>{"downloads"=>2, "page_views"=>33, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Syphilis_POC_test_sensitivity_and_specificity_compared_to_reference_Treponemal_immunoassay_overall_and_by_HIV_status_and_CD4_cell_count_/957853", "title"=>"Syphilis POC test sensitivity and specificity (compared to reference Treponemal immunoassay), overall and by HIV status and CD4 cell count.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-03-11 02:58:17"}
  • {"files"=>["https://ndownloader.figshare.com/files/1414974"], "description"=>"<p>* Syphilis testing in Australia involves screening with a treponemal antibody test, followed by RPR, if positive, to stage disease. 198 specimens with non-reactive IA did not have routinely performed RPR results available.</p>", "links"=>[], "tags"=>["microbiology", "Virology", "co-infections", "Clinical immunology", "Immunologic techniques", "immunoassays", "Clinical research design", "Retrospective studies", "Diagnostic medicine", "Clinical laboratory sciences", "Test evaluation", "epidemiology", "Clinical epidemiology", "Infectious disease epidemiology", "Infectious diseases", "Sexually transmitted diseases", "syphilis", "Viral diseases", "hiv", "Infectious disease control", "specimens", "tested"], "article_id"=>957854, "categories"=>["Biological Sciences", "Medicine"], "users"=>["Louise M. Causer", "John M. Kaldor", "Christopher K. Fairley", "Basil Donovan", "Theo Karapanagiotidis", "David E. Leslie", "Peter W. Robertson", "Anna M. McNulty", "David Anderson", "Handan Wand", "Damian P. Conway", "Ian Denham", "Claire Ryan", "Rebecca J. Guy"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0091504.t002", "stats"=>{"downloads"=>0, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Selected_demographic_and_clinical_characteristics_of_specimens_tested_n_8202_8202_1203_/957854", "title"=>"Selected demographic and clinical characteristics of specimens tested (n = 1203).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-03-11 02:58:17"}
  • {"files"=>["https://ndownloader.figshare.com/files/1414972"], "description"=>"<p>Positive syphilis serology – either reactive immunoassay ± reactive RPR (need two sets of positive results to confirm if asymptomatic if no prior history of syphilis or reactive RPR with a fourfold titre increase if past treated syphilis).</p>", "links"=>[], "tags"=>["microbiology", "Virology", "co-infections", "Clinical immunology", "Immunologic techniques", "immunoassays", "Clinical research design", "Retrospective studies", "Diagnostic medicine", "Clinical laboratory sciences", "Test evaluation", "epidemiology", "Clinical epidemiology", "Infectious disease epidemiology", "Infectious diseases", "Sexually transmitted diseases", "syphilis", "Viral diseases", "hiv", "Infectious disease control"], "article_id"=>957852, "categories"=>["Biological Sciences", "Medicine"], "users"=>["Louise M. Causer", "John M. Kaldor", "Christopher K. Fairley", "Basil Donovan", "Theo Karapanagiotidis", "David E. Leslie", "Peter W. Robertson", "Anna M. McNulty", "David Anderson", "Handan Wand", "Damian P. Conway", "Ian Denham", "Claire Ryan", "Rebecca J. Guy"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0091504.t001", "stats"=>{"downloads"=>1, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Clinical_Syphilis_Case_Definitions_/957852", "title"=>"Clinical Syphilis Case Definitions.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-03-11 02:58:17"}
  • {"files"=>["https://ndownloader.figshare.com/files/1414969"], "description"=>"<p>Sensitivity of POC test result compared to reference treponemal immunoassays (IA); RPR = reactive plasma reagin; R = reactive; NR = non-reactive</p><p>Differences between estimates were considered to be statistically significant where 95% CI were not overlapping.</p>", "links"=>[], "tags"=>["microbiology", "Virology", "co-infections", "Clinical immunology", "Immunologic techniques", "immunoassays", "Clinical research design", "Retrospective studies", "Diagnostic medicine", "Clinical laboratory sciences", "Test evaluation", "epidemiology", "Clinical epidemiology", "Infectious disease epidemiology", "Infectious diseases", "Sexually transmitted diseases", "syphilis", "Viral diseases", "hiv", "Infectious disease control", "treponemal", "immunoassay", "reactive", "rpr", "reactivity"], "article_id"=>957849, "categories"=>["Biological Sciences", "Medicine"], "users"=>["Louise M. Causer", "John M. Kaldor", "Christopher K. Fairley", "Basil Donovan", "Theo Karapanagiotidis", "David E. Leslie", "Peter W. Robertson", "Anna M. McNulty", "David Anderson", "Handan Wand", "Damian P. Conway", "Ian Denham", "Claire Ryan", "Rebecca J. Guy"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0091504.t005", "stats"=>{"downloads"=>1, "page_views"=>11, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_POC_test_sensitivity_among_reference_Treponemal_immunoassay_reactive_specimens_by_RPR_reactivity_and_titre_/957849", "title"=>"POC test sensitivity among reference Treponemal immunoassay reactive specimens, by RPR reactivity and titre.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-03-11 02:58:17"}
  • {"files"=>["https://ndownloader.figshare.com/files/1414970"], "description"=>"<p>Clinical stage  =  documented in medical records for patient specimens; Sens = sensitivity; *Among Primary syphilis, 2 specimens were IA non-reactive but PCR positive. ** Among past/treated syphilis, 5 specimens were IA non-reactive.</p><p>Differences between estimates were considered to be statistically significant where 95% CI were not overlapping.</p>", "links"=>[], "tags"=>["microbiology", "Virology", "co-infections", "Clinical immunology", "Immunologic techniques", "immunoassays", "Clinical research design", "Retrospective studies", "Diagnostic medicine", "Clinical laboratory sciences", "Test evaluation", "epidemiology", "Clinical epidemiology", "Infectious disease epidemiology", "Infectious diseases", "Sexually transmitted diseases", "syphilis", "Viral diseases", "hiv", "Infectious disease control", "poc", "compared"], "article_id"=>957850, "categories"=>["Biological Sciences", "Medicine"], "users"=>["Louise M. Causer", "John M. Kaldor", "Christopher K. Fairley", "Basil Donovan", "Theo Karapanagiotidis", "David E. Leslie", "Peter W. Robertson", "Anna M. McNulty", "David Anderson", "Handan Wand", "Damian P. Conway", "Ian Denham", "Claire Ryan", "Rebecca J. Guy"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0091504.t004", "stats"=>{"downloads"=>1, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Sensitivity_of_syphilis_POC_tests_compared_to_clinical_syphilis_stage_/957850", "title"=>"Sensitivity of syphilis POC tests compared to clinical syphilis stage.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-03-11 02:58:17"}

PMC Usage Stats | Further Information

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Relative Metric

{"start_date"=>"2014-01-01T00:00:00Z", "end_date"=>"2014-12-31T00:00:00Z", "subject_areas"=>[{"subject_area"=>"/Biology and life sciences", "average_usage"=>[291]}, {"subject_area"=>"/Biology and life sciences/Microbiology", "average_usage"=>[317]}, {"subject_area"=>"/Medicine and health sciences", "average_usage"=>[285]}, {"subject_area"=>"/Medicine and health sciences/Tropical diseases", "average_usage"=>[381, 651]}, {"subject_area"=>"/Medicine and health sciences/Urology", "average_usage"=>[287, 446]}, {"subject_area"=>"/People and places", "average_usage"=>[302]}, {"subject_area"=>"/People and places/Population groupings", "average_usage"=>[300]}]}
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