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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="para0002" class="elsevierStylePara elsevierViewall">Syphilis is a sexually transmitted&#44; bacterial infection that persists as a significant public health problem despite the availability of an effective and affordable treatment for more than&#160;70-years&#46;<a class="elsevierStyleCrossRef" href="#bib0001"><span class="elsevierStyleSup">1</span></a> The incidence of syphilis has been increasing in several settings&#44; particularly in low and middle-income countries and among vulnerable populations&#44; including people living with HIV&#46;<a class="elsevierStyleCrossRef" href="#bib0002"><span class="elsevierStyleSup">2</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0003"><span class="elsevierStyleSup">3</span></a> In addition to the morbidity associated with clinical manifestations in both sexually-acquired and congenital infections&#44; untreated syphilis can significantly increase the risk of HIV acquisition&#59; furthermore&#44; syphilis-HIV coinfection has been associated with more aggressive manifestations than either infection alone&#46;<a class="elsevierStyleCrossRef" href="#bib0004"><span class="elsevierStyleSup">4</span></a></p><p id="para0003" class="elsevierStylePara elsevierViewall">Clinical manifestations of syphilis are often uncharacteristic or may be completely absent&#44; highlighting the crucial importance of diagnostic tests to identify and treat individuals who inadvertently participate in transmission chains&#46; In clinical settings&#44; particularly when dealing with hard-to-reach populations and scarce laboratory services&#44; point-of-care tests are invaluable tools allowing immediate diagnosis and treatment&#46; The adoption of point-of-care&#44; Rapid Diagnostic Tests &#40;RDT&#41; for several health conditions is in rapid progress&#44; underscoring the need for reliability and accuracy assessments of different tests using real-life samples&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">5</span></a></p><p id="para0004" class="elsevierStylePara elsevierViewall">In a recently published systematic review&#44; Zhang et al&#46; evaluated&#160;19&#160;studies addressing the performance of RDT for syphilis&#44; including a meta-analysis of&#160;13&#160;studies&#46; Although the pooled sensitivity and specificity of the treponemal component were high &#40;93&#37;&#160;and 98&#37;&#160;respectively&#41;&#44; there was a high variability across studies&#44; from&#160;48&#37; to&#160;100&#37; in sensitivity&#44; and 62&#37;&#160;to&#160;100&#37; in specificity&#46; In addition&#44; results were not stratified by syphilis stages&#44; which likely influence the overall performance of RDT&#46;<a class="elsevierStyleCrossRef" href="#bib0006"><span class="elsevierStyleSup">6</span></a> Few studies have addressed the accuracy of syphilis RDT among people living with HIV&#59;<a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a> this is a relevant issue since previous studies suggest higher risk of false-positive syphilis reactivity in this population using different diagnostic tools&#46;<a class="elsevierStyleCrossRef" href="#bib0008"><span class="elsevierStyleSup">8</span></a></p><p id="para0005" class="elsevierStylePara elsevierViewall">In this study&#44; we aimed to assess the sensitivity and specificity of a treponemal RDT routinely used in primary care settings in Brazil for syphilis diagnosis using samples from blood donors previously tested with traditional laboratory-based treponemal and non-treponemal serologic assays&#46; We also explored the performance of the RDT in samples with positive test results for HIV&#44; to address potential variations in RDT specificity in this subgroup&#46;</p><p id="para0006" class="elsevierStylePara elsevierViewall">The blood bank at &#40;anonymized information&#41; in S&#227;o Paulo&#44; Brazil&#44; routinely selects potential blood donors with an interview addressing exposure to transfusion-transmissible infections followed by a comprehensive laboratory screening&#46; We identified stored blood samples from volunteer&#44; healthy blood donors aged&#160;18-years old and older who underwent the screening interview between&#160;2017&#8210;2021 and had available information on demographics and laboratory test results for syphilis and HIV&#46; Serologic tests for HIV and syphilis Chemiluminescence &#40;QML&#41; were performed using the ARCHITECT i2000SR immunoassay analyzer &#40;ABBOTT Diagnostics&#44; Chicago&#44; USA&#41;&#46; HIV was also tested using Real-Time Polymerase Chain Reaction &#40;RT-PCR&#41; tests from COBAS&#174; S201 System&#44; Roche NAT instruments &#40;Roche&#44; Basel&#44; Switzerland&#41; according to the manufacturer&#39;s instructions&#46; Samples with reactive results in the initial treponemal syphilis screening with QML underwent confirmatory testing for treponemal reactivity using FTA-Abs indirect immunofluorescence &#40;Wama diagnostica&#44; S&#227;o Carlos&#44; Brazil&#41;&#59; samples were subsequently tested with the venereal disease research laboratory &#40;VDRL&#41; flocculation assay to assess non-treponemal reactivity &#40;Wama diagnostica&#44; Sao Carlos&#44; Brazil&#41;&#46; We categorized the samples included in this study into&#160;5&#160;groups&#58; 1&#160;-&#160;Donors with reactive results in QML&#44; FTA-Abs&#44; and VDRL&#59; 2&#160;-&#160;Donors with reactive QML and FTA-Abs&#44; with negative VDRL&#59; 3&#160;-&#160;Donors with reactive QML&#44; and negative results for other markers &#40;false positives&#41;&#59; 4&#160;-&#160;Controls with nonreactive QML&#59; and 5&#160;-&#160;Donors with positive test results for HIV and nonreactive QML&#46; FTA-Abs were considered the reference &#40;gold-standard&#41; treponemal test&#46; All samples were thawed&#44; centrifuged&#44; and submitted to the syphilis RDT &#40;RT Syphilis Bio&#44; Bioclin&#44; Belo Horizonte&#44; Brazil&#41;&#44; an immunochromatographic treponemal assay for qualitative detection of IgG and IgM&#44; according to the manufacturer&#39;s instructions&#46;</p><p id="para0007" class="elsevierStylePara elsevierViewall">Descriptive analysis was performed&#44; including frequencies and percentages for categorical variables&#44; as well as medians and interquartile ranges for numeric variables&#46; Specificity was calculated separately for samples from groups&#160;4&#160;and&#160;5&#44; while sensitivity was calculated separately for groups&#160;1&#160;and&#160;2&#46; We also estimated RDT positivity and specificity in group&#160;3&#44; and sensitivity estimates in group&#160;1 based on VDRL titers when available&#46; For each indicator&#44; we present precision estimates using 95&#37;&#160;Confidence Intervals &#40;95&#37;&#160;CI&#41;&#46; We identified and included in the study all available samples for groups&#160;1&#44; 2&#44; 3&#44; and&#160;5 to obtain the highest possible precision in estimates&#59; additionally&#44; we planned to include at least&#160;300&#160;samples in group&#160;4 to obtain specificity estimates with a total width of&#160;95&#37;&#160;CI of&#160;1&#46;2&#37;&#46;</p><p id="para0008" class="elsevierStylePara elsevierViewall">The institutional Ethics Committee revised and approved this study with exemption of informed consent &#40;approval number&#160;4&#46;528&#46;454&#41;&#46; All participants&#8217; identifiable information was kept confidential throughout the study&#46;</p><p id="para0009" class="elsevierStylePara elsevierViewall">A total of&#160;811&#160;samples were included in the study&#59; groups&#160;1&#8210;5 included&#44; respectively&#44; 136&#44; 150&#44; 163&#44; 301&#44; and 61&#160;participants&#46; Most donors&#160;&#40;58&#37;&#41; were males&#44; with a median age of&#160;36-years old &#40;interquartile range&#160;28&#8210;46&#41;&#44; and 64&#37;&#160;declared Caucasian race&#47;ethnicity&#46; <a class="elsevierStyleCrossRef" href="#tbl0001">Table 1</a> presents estimates of sensitivity and specificity for each group&#44; as well as estimates according to VDRL titers in group&#160;1&#46; The overall sensitivity of the RDT was&#160;91&#46;9&#37; in group&#160;1&#44; but only&#160;81&#46;3&#37; in group&#160;2&#46; In group&#160;3&#44; 4 of&#160;163 samples&#160;&#40;2&#46;4&#37;&#41; were reactive in the RDT&#44; representing a&#160;97&#46;5&#37;&#160;specificity in this group&#46; Both groups&#160;4 and&#160;5 had&#160;100&#37;&#160;specificity&#46; In the analysis according to the VDRL titer in group&#160;1&#44; we found that sensitivity varied between&#160;75&#46;0&#37; among donors with a&#160;1&#58;1&#160;titer&#44; and 100&#37;&#160;among donors with titers&#160;&#8805;1&#58;16&#46;</p><elsevierMultimedia ident="tbl0001"></elsevierMultimedia><p id="para0010" class="elsevierStylePara elsevierViewall">In this study&#44; we found that the RDT had a very high specificity&#44; with only&#160;2&#46;4&#37; false-positive results in samples with a positive QML and negative FTA-Abs&#47;VDRL&#44; and no false positive results in samples with a negative QML&#46; The overall sensitivity of the RDT was high&#160;&#40;91&#46;9&#37;&#41; in blood donor samples with reactive VDRL but varied between&#160;75&#46;0&#37; and&#160;100&#37; according to VDRL titers&#46; The overall sensitivity was lower&#160;&#40;81&#46;3&#37;&#41; in samples with a positive FTA-Abs and negative VDRL&#46; These findings suggest that the RDT is a useful tool to detect active cases of syphilis but may have a more limited applicability for cases with very early or remote incident infection&#44; or those with prior treatment&#46; Finally&#44; we found that the specificity of the RDT was very high in samples with positive test results for HIV&#46;</p><p id="para0011" class="elsevierStylePara elsevierViewall">Our findings support results from studies addressing other syphilis RDT that showed increased sensitivity when including a reactive non-treponemal test as part of the reference diagnostic workup&#46;<a class="elsevierStyleCrossRef" href="#bib0009"><span class="elsevierStyleSup">9</span></a> They are also reassuring for the specificity of this RDT in people living with HIV&#46;</p><p id="para0012" class="elsevierStylePara elsevierViewall">Our study had a few limitations regarding the specimens and the population included for analysis&#46; We used thawed serum samples&#44; which differ from fresh whole blood samples that are usually employed in point-of-care RDT&#46; Since comparative studies suggest that RDT sensitivity in whole blood specimens may be lower when compared to serum samples&#44;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">10</span></a> the test sensitivity observed in our study may be an overestimation of true values&#46; As for the population included in the study&#44; blood donors are often considered healthier than the general population&#59; it is plausible to assume that populations with higher prevalence of comorbidities and coinfections could have a higher prevalence of false positive results due to the presence of cross-reactive antibodies&#46; Finally&#44; we were unable to include samples from donors with reactive results for both HIV and syphilis in our sensitivity analysis&#46;</p><p id="para0013" class="elsevierStylePara elsevierViewall">Despite these limitations&#44; our study included a large number of well-characterized samples and demonstrated a consistent trend of lower sensitivity of the RDT in samples with lower or negative VDRL titers&#46; Although our findings suggest that the RDT is a robust tool to detect active syphilis cases&#44; certain conditions that require higher test sensitivity&#44; such as antenatal care&#44; may benefit from strategies such as recurrent testing and concurrent use of conventional laboratory-based tests&#46; Our results also provide useful information for the development of testing policies in Brazil as well as other countries&#46; The implementation of robust point-of-care tests is a key strategy to control the dissemination and detrimental outcomes associated with syphilis&#46;</p><span id="sec0001" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0004">Data sharing</span><p id="para0014" class="elsevierStylePara elsevierViewall">Currently&#44; the datasets used and&#47;or analysed during the study are available from the corresponding author on reasonable request&#46;</p></span><span id="sec0002" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0005">Ethics approval</span><p id="para0015" class="elsevierStylePara elsevierViewall">The institutional Ethics Committee revised and approved this study with exemption of informed consent &#40;approval number&#160;4&#46;528&#46;454&#41;&#46; All participants&#8217; identifiable information was kept confidential throughout the study&#46;</p></span><span id="sec0003" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0006">Authors&#8217; contributions</span><p id="para0016" class="elsevierStylePara elsevierViewall">CSA&#44; JALM&#44; MVA and VAS conceived the study&#46; CBB and LDS identified samples to be included in the analysis&#46; CSA and JALM performed the syphilis rapid tests&#46; VAS performed data analysis&#46; MVA&#44; AEM&#44; LDS&#44; CBB and VAS contributed with interpretation of results&#46; CSA&#44; JALM&#44; MVA and VAS wrote the first draft of the manuscript&#46; All authors revised and approved the final version of the manuscript&#46;</p></span><span id="sec0004" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0007">Funding</span><p id="para0017" class="elsevierStylePara elsevierViewall">This research received no specific grant from any funding agency in the public&#44; commercial or not-for-profit sectors&#46;</p></span></span>"
    "textoCompletoSecciones" => array:1 [
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        1 => array:2 [
          "identificador" => "xpalclavsec1751548"
          "titulo" => "Keywords"
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        2 => array:2 [
          "identificador" => "sec0001"
          "titulo" => "Data sharing"
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        3 => array:2 [
          "identificador" => "sec0002"
          "titulo" => "Ethics approval"
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        4 => array:2 [
          "identificador" => "sec0003"
          "titulo" => "Authors&#8217; contributions"
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        5 => array:2 [
          "identificador" => "sec0004"
          "titulo" => "Funding"
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        6 => array:2 [
          "identificador" => "xack714676"
          "titulo" => "Acknowledgement"
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        7 => array:1 [
          "titulo" => "References"
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    ]
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    "fechaRecibido" => "2023-06-29"
    "fechaAceptado" => "2023-10-31"
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        0 => array:4 [
          "clase" => "keyword"
          "titulo" => "Keywords"
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          "palabras" => array:4 [
            0 => "Syphilis"
            1 => "Syphilis serodiagnosis"
            2 => "Sensitivity and specificity"
            3 => "Point-of-care testing"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abss0001" class="elsevierStyleSection elsevierViewall"><p id="spara004" class="elsevierStyleSimplePara elsevierViewall">Rapid Diagnostic Tests &#40;RDT&#41; are useful to identify syphilis cases&#44; particularly for hard-to-reach populations and if laboratory services are scarce&#46; However&#44; RDT performance may be suboptimal&#46; We aimed to assess the sensitivity and specificity of a syphilis RDT using well-characterized blood donors&#8217; samples&#46; We categorized samples from&#160;811&#160;blood donors into five groups&#58; 1&#160;-&#160;Samples with reactive Chemiluminescence &#40;QML&#41;&#44; FTA-Abs&#44; and VDRL&#59; 2&#160;-&#160;Samples with reactive QML and FTA-Abs&#44; and nonreactive VDRL&#59; 3&#160;-&#160;Samples with reactive QML&#44; and nonreactive for other markers &#40;false-positives&#41;&#59; 4&#160;-&#160;Controls with nonreactive QML&#59; and 5&#160;-&#160;Samples reactive for HIV&#44; with nonreactive QML&#46; Sensitivity was tested in groups&#160;1 &#40;overall and according to VDRL titers&#41; and&#160;2&#59; specificity was tested in groups&#160;3&#8210;5&#46; The RDT had high specificity&#44; even in samples reactive for HIV&#46; The sensitivity was high&#160;&#40;91&#46;9&#37;&#41; in samples with reactive VDRL but varied between&#160;75&#46;0&#37;&#8210;100&#37; according to VDRL titers&#46; The overall sensitivity was lower&#160;&#40;81&#46;3&#37;&#41; in samples with reactive FTA-Abs and nonreactive VDRL&#46; The RDT is a useful tool to detect active syphilis but may be more limited for cases with very early or remote infection&#44; or those with prior treatment&#46; When higher sensitivity is needed&#44; additional strategies including recurrent testing or laboratory-based tests may be required&#46;</p></span>"
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    "bibliografia" => array:2 [
      "titulo" => "References"
      "seccion" => array:1 [
        0 => array:2 [
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            0 => array:3 [
              "identificador" => "bib0001"
              "etiqueta" => "1"
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                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Syphilis"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:6 [
                            0 => "R&#46; Peeling"
                            1 => "D&#46; Mabey"
                            2 => "M&#46; Kamb"
                            3 => "X&#46;S&#46; Chen"
                            4 => "J&#46;D&#46; Radolf"
                            5 => "A&#46; Benzaken"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
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Brief Communication
Sensitivity and specificity of a syphilis rapid diagnostic test in blood donors’ samples
Carolina Araia,1, Juliano Alves Lemos-Machadoa,1, Marcelo Vivolo Auna, Carolina Bonet-Bubb, Leandro Dinalli Santosb, Angelica Espinosa Mirandac,d, Vivian I. Avelino-Silvaa,e,
Corresponding author
vavelino-silva@vitalant.org

Corresponding author.
a Faculdade Israelita de Ciências da Saúde Albert Einstein, Hospital Israelita Albert Einstein, São Paulo, SP, Brazil
b Hospital Israelita Albert Einstein, Departamento Hemoterapia e Terapia Celular, São Paulo, SP, Brazil
c Universidade Federal do Espírito Santo, Departamento de Medicina Social, Vitória, ES, Brazil
d Ministério da Saúde, Departamento de Doenças de Condições Crônicas e Infecções Sexualmente Transmissíveis, Brazil
e Faculdade de Medicina da Universidade de São Paulo, Departamento de Doenças Infecciosas e Parasitárias, São Paulo, SP, Brazil
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="para0002" class="elsevierStylePara elsevierViewall">Syphilis is a sexually transmitted&#44; bacterial infection that persists as a significant public health problem despite the availability of an effective and affordable treatment for more than&#160;70-years&#46;<a class="elsevierStyleCrossRef" href="#bib0001"><span class="elsevierStyleSup">1</span></a> The incidence of syphilis has been increasing in several settings&#44; particularly in low and middle-income countries and among vulnerable populations&#44; including people living with HIV&#46;<a class="elsevierStyleCrossRef" href="#bib0002"><span class="elsevierStyleSup">2</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0003"><span class="elsevierStyleSup">3</span></a> In addition to the morbidity associated with clinical manifestations in both sexually-acquired and congenital infections&#44; untreated syphilis can significantly increase the risk of HIV acquisition&#59; furthermore&#44; syphilis-HIV coinfection has been associated with more aggressive manifestations than either infection alone&#46;<a class="elsevierStyleCrossRef" href="#bib0004"><span class="elsevierStyleSup">4</span></a></p><p id="para0003" class="elsevierStylePara elsevierViewall">Clinical manifestations of syphilis are often uncharacteristic or may be completely absent&#44; highlighting the crucial importance of diagnostic tests to identify and treat individuals who inadvertently participate in transmission chains&#46; In clinical settings&#44; particularly when dealing with hard-to-reach populations and scarce laboratory services&#44; point-of-care tests are invaluable tools allowing immediate diagnosis and treatment&#46; The adoption of point-of-care&#44; Rapid Diagnostic Tests &#40;RDT&#41; for several health conditions is in rapid progress&#44; underscoring the need for reliability and accuracy assessments of different tests using real-life samples&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">5</span></a></p><p id="para0004" class="elsevierStylePara elsevierViewall">In a recently published systematic review&#44; Zhang et al&#46; evaluated&#160;19&#160;studies addressing the performance of RDT for syphilis&#44; including a meta-analysis of&#160;13&#160;studies&#46; Although the pooled sensitivity and specificity of the treponemal component were high &#40;93&#37;&#160;and 98&#37;&#160;respectively&#41;&#44; there was a high variability across studies&#44; from&#160;48&#37; to&#160;100&#37; in sensitivity&#44; and 62&#37;&#160;to&#160;100&#37; in specificity&#46; In addition&#44; results were not stratified by syphilis stages&#44; which likely influence the overall performance of RDT&#46;<a class="elsevierStyleCrossRef" href="#bib0006"><span class="elsevierStyleSup">6</span></a> Few studies have addressed the accuracy of syphilis RDT among people living with HIV&#59;<a class="elsevierStyleCrossRef" href="#bib0007"><span class="elsevierStyleSup">7</span></a> this is a relevant issue since previous studies suggest higher risk of false-positive syphilis reactivity in this population using different diagnostic tools&#46;<a class="elsevierStyleCrossRef" href="#bib0008"><span class="elsevierStyleSup">8</span></a></p><p id="para0005" class="elsevierStylePara elsevierViewall">In this study&#44; we aimed to assess the sensitivity and specificity of a treponemal RDT routinely used in primary care settings in Brazil for syphilis diagnosis using samples from blood donors previously tested with traditional laboratory-based treponemal and non-treponemal serologic assays&#46; We also explored the performance of the RDT in samples with positive test results for HIV&#44; to address potential variations in RDT specificity in this subgroup&#46;</p><p id="para0006" class="elsevierStylePara elsevierViewall">The blood bank at &#40;anonymized information&#41; in S&#227;o Paulo&#44; Brazil&#44; routinely selects potential blood donors with an interview addressing exposure to transfusion-transmissible infections followed by a comprehensive laboratory screening&#46; We identified stored blood samples from volunteer&#44; healthy blood donors aged&#160;18-years old and older who underwent the screening interview between&#160;2017&#8210;2021 and had available information on demographics and laboratory test results for syphilis and HIV&#46; Serologic tests for HIV and syphilis Chemiluminescence &#40;QML&#41; were performed using the ARCHITECT i2000SR immunoassay analyzer &#40;ABBOTT Diagnostics&#44; Chicago&#44; USA&#41;&#46; HIV was also tested using Real-Time Polymerase Chain Reaction &#40;RT-PCR&#41; tests from COBAS&#174; S201 System&#44; Roche NAT instruments &#40;Roche&#44; Basel&#44; Switzerland&#41; according to the manufacturer&#39;s instructions&#46; Samples with reactive results in the initial treponemal syphilis screening with QML underwent confirmatory testing for treponemal reactivity using FTA-Abs indirect immunofluorescence &#40;Wama diagnostica&#44; S&#227;o Carlos&#44; Brazil&#41;&#59; samples were subsequently tested with the venereal disease research laboratory &#40;VDRL&#41; flocculation assay to assess non-treponemal reactivity &#40;Wama diagnostica&#44; Sao Carlos&#44; Brazil&#41;&#46; We categorized the samples included in this study into&#160;5&#160;groups&#58; 1&#160;-&#160;Donors with reactive results in QML&#44; FTA-Abs&#44; and VDRL&#59; 2&#160;-&#160;Donors with reactive QML and FTA-Abs&#44; with negative VDRL&#59; 3&#160;-&#160;Donors with reactive QML&#44; and negative results for other markers &#40;false positives&#41;&#59; 4&#160;-&#160;Controls with nonreactive QML&#59; and 5&#160;-&#160;Donors with positive test results for HIV and nonreactive QML&#46; FTA-Abs were considered the reference &#40;gold-standard&#41; treponemal test&#46; All samples were thawed&#44; centrifuged&#44; and submitted to the syphilis RDT &#40;RT Syphilis Bio&#44; Bioclin&#44; Belo Horizonte&#44; Brazil&#41;&#44; an immunochromatographic treponemal assay for qualitative detection of IgG and IgM&#44; according to the manufacturer&#39;s instructions&#46;</p><p id="para0007" class="elsevierStylePara elsevierViewall">Descriptive analysis was performed&#44; including frequencies and percentages for categorical variables&#44; as well as medians and interquartile ranges for numeric variables&#46; Specificity was calculated separately for samples from groups&#160;4&#160;and&#160;5&#44; while sensitivity was calculated separately for groups&#160;1&#160;and&#160;2&#46; We also estimated RDT positivity and specificity in group&#160;3&#44; and sensitivity estimates in group&#160;1 based on VDRL titers when available&#46; For each indicator&#44; we present precision estimates using 95&#37;&#160;Confidence Intervals &#40;95&#37;&#160;CI&#41;&#46; We identified and included in the study all available samples for groups&#160;1&#44; 2&#44; 3&#44; and&#160;5 to obtain the highest possible precision in estimates&#59; additionally&#44; we planned to include at least&#160;300&#160;samples in group&#160;4 to obtain specificity estimates with a total width of&#160;95&#37;&#160;CI of&#160;1&#46;2&#37;&#46;</p><p id="para0008" class="elsevierStylePara elsevierViewall">The institutional Ethics Committee revised and approved this study with exemption of informed consent &#40;approval number&#160;4&#46;528&#46;454&#41;&#46; All participants&#8217; identifiable information was kept confidential throughout the study&#46;</p><p id="para0009" class="elsevierStylePara elsevierViewall">A total of&#160;811&#160;samples were included in the study&#59; groups&#160;1&#8210;5 included&#44; respectively&#44; 136&#44; 150&#44; 163&#44; 301&#44; and 61&#160;participants&#46; Most donors&#160;&#40;58&#37;&#41; were males&#44; with a median age of&#160;36-years old &#40;interquartile range&#160;28&#8210;46&#41;&#44; and 64&#37;&#160;declared Caucasian race&#47;ethnicity&#46; <a class="elsevierStyleCrossRef" href="#tbl0001">Table 1</a> presents estimates of sensitivity and specificity for each group&#44; as well as estimates according to VDRL titers in group&#160;1&#46; The overall sensitivity of the RDT was&#160;91&#46;9&#37; in group&#160;1&#44; but only&#160;81&#46;3&#37; in group&#160;2&#46; In group&#160;3&#44; 4 of&#160;163 samples&#160;&#40;2&#46;4&#37;&#41; were reactive in the RDT&#44; representing a&#160;97&#46;5&#37;&#160;specificity in this group&#46; Both groups&#160;4 and&#160;5 had&#160;100&#37;&#160;specificity&#46; In the analysis according to the VDRL titer in group&#160;1&#44; we found that sensitivity varied between&#160;75&#46;0&#37; among donors with a&#160;1&#58;1&#160;titer&#44; and 100&#37;&#160;among donors with titers&#160;&#8805;1&#58;16&#46;</p><elsevierMultimedia ident="tbl0001"></elsevierMultimedia><p id="para0010" class="elsevierStylePara elsevierViewall">In this study&#44; we found that the RDT had a very high specificity&#44; with only&#160;2&#46;4&#37; false-positive results in samples with a positive QML and negative FTA-Abs&#47;VDRL&#44; and no false positive results in samples with a negative QML&#46; The overall sensitivity of the RDT was high&#160;&#40;91&#46;9&#37;&#41; in blood donor samples with reactive VDRL but varied between&#160;75&#46;0&#37; and&#160;100&#37; according to VDRL titers&#46; The overall sensitivity was lower&#160;&#40;81&#46;3&#37;&#41; in samples with a positive FTA-Abs and negative VDRL&#46; These findings suggest that the RDT is a useful tool to detect active cases of syphilis but may have a more limited applicability for cases with very early or remote incident infection&#44; or those with prior treatment&#46; Finally&#44; we found that the specificity of the RDT was very high in samples with positive test results for HIV&#46;</p><p id="para0011" class="elsevierStylePara elsevierViewall">Our findings support results from studies addressing other syphilis RDT that showed increased sensitivity when including a reactive non-treponemal test as part of the reference diagnostic workup&#46;<a class="elsevierStyleCrossRef" href="#bib0009"><span class="elsevierStyleSup">9</span></a> They are also reassuring for the specificity of this RDT in people living with HIV&#46;</p><p id="para0012" class="elsevierStylePara elsevierViewall">Our study had a few limitations regarding the specimens and the population included for analysis&#46; We used thawed serum samples&#44; which differ from fresh whole blood samples that are usually employed in point-of-care RDT&#46; Since comparative studies suggest that RDT sensitivity in whole blood specimens may be lower when compared to serum samples&#44;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">10</span></a> the test sensitivity observed in our study may be an overestimation of true values&#46; As for the population included in the study&#44; blood donors are often considered healthier than the general population&#59; it is plausible to assume that populations with higher prevalence of comorbidities and coinfections could have a higher prevalence of false positive results due to the presence of cross-reactive antibodies&#46; Finally&#44; we were unable to include samples from donors with reactive results for both HIV and syphilis in our sensitivity analysis&#46;</p><p id="para0013" class="elsevierStylePara elsevierViewall">Despite these limitations&#44; our study included a large number of well-characterized samples and demonstrated a consistent trend of lower sensitivity of the RDT in samples with lower or negative VDRL titers&#46; Although our findings suggest that the RDT is a robust tool to detect active syphilis cases&#44; certain conditions that require higher test sensitivity&#44; such as antenatal care&#44; may benefit from strategies such as recurrent testing and concurrent use of conventional laboratory-based tests&#46; Our results also provide useful information for the development of testing policies in Brazil as well as other countries&#46; The implementation of robust point-of-care tests is a key strategy to control the dissemination and detrimental outcomes associated with syphilis&#46;</p><span id="sec0001" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0004">Data sharing</span><p id="para0014" class="elsevierStylePara elsevierViewall">Currently&#44; the datasets used and&#47;or analysed during the study are available from the corresponding author on reasonable request&#46;</p></span><span id="sec0002" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0005">Ethics approval</span><p id="para0015" class="elsevierStylePara elsevierViewall">The institutional Ethics Committee revised and approved this study with exemption of informed consent &#40;approval number&#160;4&#46;528&#46;454&#41;&#46; All participants&#8217; identifiable information was kept confidential throughout the study&#46;</p></span><span id="sec0003" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0006">Authors&#8217; contributions</span><p id="para0016" class="elsevierStylePara elsevierViewall">CSA&#44; JALM&#44; MVA and VAS conceived the study&#46; CBB and LDS identified samples to be included in the analysis&#46; CSA and JALM performed the syphilis rapid tests&#46; VAS performed data analysis&#46; MVA&#44; AEM&#44; LDS&#44; CBB and VAS contributed with interpretation of results&#46; CSA&#44; JALM&#44; MVA and VAS wrote the first draft of the manuscript&#46; All authors revised and approved the final version of the manuscript&#46;</p></span><span id="sec0004" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cesectitle0007">Funding</span><p id="para0017" class="elsevierStylePara elsevierViewall">This research received no specific grant from any funding agency in the public&#44; commercial or not-for-profit sectors&#46;</p></span></span>"
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        "resumen" => "<span id="abss0001" class="elsevierStyleSection elsevierViewall"><p id="spara004" class="elsevierStyleSimplePara elsevierViewall">Rapid Diagnostic Tests &#40;RDT&#41; are useful to identify syphilis cases&#44; particularly for hard-to-reach populations and if laboratory services are scarce&#46; However&#44; RDT performance may be suboptimal&#46; We aimed to assess the sensitivity and specificity of a syphilis RDT using well-characterized blood donors&#8217; samples&#46; We categorized samples from&#160;811&#160;blood donors into five groups&#58; 1&#160;-&#160;Samples with reactive Chemiluminescence &#40;QML&#41;&#44; FTA-Abs&#44; and VDRL&#59; 2&#160;-&#160;Samples with reactive QML and FTA-Abs&#44; and nonreactive VDRL&#59; 3&#160;-&#160;Samples with reactive QML&#44; and nonreactive for other markers &#40;false-positives&#41;&#59; 4&#160;-&#160;Controls with nonreactive QML&#59; and 5&#160;-&#160;Samples reactive for HIV&#44; with nonreactive QML&#46; Sensitivity was tested in groups&#160;1 &#40;overall and according to VDRL titers&#41; and&#160;2&#59; specificity was tested in groups&#160;3&#8210;5&#46; The RDT had high specificity&#44; even in samples reactive for HIV&#46; The sensitivity was high&#160;&#40;91&#46;9&#37;&#41; in samples with reactive VDRL but varied between&#160;75&#46;0&#37;&#8210;100&#37; according to VDRL titers&#46; The overall sensitivity was lower&#160;&#40;81&#46;3&#37;&#41; in samples with reactive FTA-Abs and nonreactive VDRL&#46; The RDT is a useful tool to detect active syphilis but may be more limited for cases with very early or remote infection&#44; or those with prior treatment&#46; When higher sensitivity is needed&#44; additional strategies including recurrent testing or laboratory-based tests may be required&#46;</p></span>"
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Article information
ISSN: 14138670
Original language: English
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The Brazilian Journal of Infectious Diseases