Single-test syphilis serology: A case of not seeing the forest for the trees
There have been few empirical studies for diagnostic test accuracy of syphilis using a sequence of rapid tests in populations with low prevalence of syphilis such as pregnant women. This analysis describes syphilis test positivity frequency among pregnant women at an antenatal clinic in Zambia using...
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| Published in: | PloS one Vol. 19; no. 5; p. e0303253 |
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| ISSN: | 1932-6203, 1932-6203 |
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| Abstract | There have been few empirical studies for diagnostic test accuracy of syphilis using a sequence of rapid tests in populations with low prevalence of syphilis such as pregnant women. This analysis describes syphilis test positivity frequency among pregnant women at an antenatal clinic in Zambia using a reverse-sequence testing algorithm for antenatal syphilis screening.
Between August 2019 and May 2023, we recruited 1510 pregnant women from a peri-urban hospital in Lusaka, Zambia. HIV positive and HIV negative women were enrolled in a 1:1 ratio. Blood collected at recruitment from the pregnant mothers was tested on-site for syphilis using a rapid treponemal test. Samples that tested positive were further tested at a different laboratory, with rapid plasma reagin using archived plasma.
Of the total 1,421 sera samples which were screened with a rapid treponemal test, 127 (8.9%) were positive and 1,294 (91.1%) were negative. Sufficient additional samples were available to perform RPR testing on 114 of the 127 (89.8%) RDT positive specimens. Thirty-one (27.2%) of these 114 were reactive by RPR and 83 (72.8%) were negative, resulting in a syphilis overtreatment rate of 3 fold (i.e, 84/114). Insufficient sample or test kit availability prevented any testing for the remaining 89 (5.9%) participants.
Use of only treponemal tests in low prevalence populations, like pregnant women, subjects individuals with non-active syphilis to the costs and possible risks of overtreatment. The use of the dual treponemal and non-treponemal tests would minimize this risk at some additional cost. |
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| AbstractList | There have been few empirical studies for diagnostic test accuracy of syphilis using a sequence of rapid tests in populations with low prevalence of syphilis such as pregnant women. This analysis describes syphilis test positivity frequency among pregnant women at an antenatal clinic in Zambia using a reverse-sequence testing algorithm for antenatal syphilis screening. Between August 2019 and May 2023, we recruited 1510 pregnant women from a peri-urban hospital in Lusaka, Zambia. HIV positive and HIV negative women were enrolled in a 1:1 ratio. Blood collected at recruitment from the pregnant mothers was tested on-site for syphilis using a rapid treponemal test. Samples that tested positive were further tested at a different laboratory, with rapid plasma reagin using archived plasma. Of the total 1,421 sera samples which were screened with a rapid treponemal test, 127 (8.9%) were positive and 1,294 (91.1%) were negative. Sufficient additional samples were available to perform RPR testing on 114 of the 127 (89.8%) RDT positive specimens. Thirty-one (27.2%) of these 114 were reactive by RPR and 83 (72.8%) were negative, resulting in a syphilis overtreatment rate of 3 fold (i.e, 84/114). Insufficient sample or test kit availability prevented any testing for the remaining 89 (5.9%) participants. Use of only treponemal tests in low prevalence populations, like pregnant women, subjects individuals with non-active syphilis to the costs and possible risks of overtreatment. The use of the dual treponemal and non-treponemal tests would minimize this risk at some additional cost. Introduction There have been few empirical studies for diagnostic test accuracy of syphilis using a sequence of rapid tests in populations with low prevalence of syphilis such as pregnant women. This analysis describes syphilis test positivity frequency among pregnant women at an antenatal clinic in Zambia using a reverse-sequence testing algorithm for antenatal syphilis screening. Methods Between August 2019 and May 2023, we recruited 1510 pregnant women from a peri-urban hospital in Lusaka, Zambia. HIV positive and HIV negative women were enrolled in a 1:1 ratio. Blood collected at recruitment from the pregnant mothers was tested on-site for syphilis using a rapid treponemal test. Samples that tested positive were further tested at a different laboratory, with rapid plasma reagin using archived plasma. Results Of the total 1,421 sera samples which were screened with a rapid treponemal test, 127 (8.9%) were positive and 1,294 (91.1%) were negative. Sufficient additional samples were available to perform RPR testing on 114 of the 127 (89.8%) RDT positive specimens. Thirty-one (27.2%) of these 114 were reactive by RPR and 83 (72.8%) were negative, resulting in a syphilis overtreatment rate of 3 fold (i.e, 84/114). Insufficient sample or test kit availability prevented any testing for the remaining 89 (5.9%) participants. Conclusion Use of only treponemal tests in low prevalence populations, like pregnant women, subjects individuals with non-active syphilis to the costs and possible risks of overtreatment. The use of the dual treponemal and non-treponemal tests would minimize this risk at some additional cost. There have been few empirical studies for diagnostic test accuracy of syphilis using a sequence of rapid tests in populations with low prevalence of syphilis such as pregnant women. This analysis describes syphilis test positivity frequency among pregnant women at an antenatal clinic in Zambia using a reverse-sequence testing algorithm for antenatal syphilis screening.INTRODUCTIONThere have been few empirical studies for diagnostic test accuracy of syphilis using a sequence of rapid tests in populations with low prevalence of syphilis such as pregnant women. This analysis describes syphilis test positivity frequency among pregnant women at an antenatal clinic in Zambia using a reverse-sequence testing algorithm for antenatal syphilis screening.Between August 2019 and May 2023, we recruited 1510 pregnant women from a peri-urban hospital in Lusaka, Zambia. HIV positive and HIV negative women were enrolled in a 1:1 ratio. Blood collected at recruitment from the pregnant mothers was tested on-site for syphilis using a rapid treponemal test. Samples that tested positive were further tested at a different laboratory, with rapid plasma reagin using archived plasma.METHODSBetween August 2019 and May 2023, we recruited 1510 pregnant women from a peri-urban hospital in Lusaka, Zambia. HIV positive and HIV negative women were enrolled in a 1:1 ratio. Blood collected at recruitment from the pregnant mothers was tested on-site for syphilis using a rapid treponemal test. Samples that tested positive were further tested at a different laboratory, with rapid plasma reagin using archived plasma.Of the total 1,421 sera samples which were screened with a rapid treponemal test, 127 (8.9%) were positive and 1,294 (91.1%) were negative. Sufficient additional samples were available to perform RPR testing on 114 of the 127 (89.8%) RDT positive specimens. Thirty-one (27.2%) of these 114 were reactive by RPR and 83 (72.8%) were negative, resulting in a syphilis overtreatment rate of 3 fold (i.e, 84/114). Insufficient sample or test kit availability prevented any testing for the remaining 89 (5.9%) participants.RESULTSOf the total 1,421 sera samples which were screened with a rapid treponemal test, 127 (8.9%) were positive and 1,294 (91.1%) were negative. Sufficient additional samples were available to perform RPR testing on 114 of the 127 (89.8%) RDT positive specimens. Thirty-one (27.2%) of these 114 were reactive by RPR and 83 (72.8%) were negative, resulting in a syphilis overtreatment rate of 3 fold (i.e, 84/114). Insufficient sample or test kit availability prevented any testing for the remaining 89 (5.9%) participants.Use of only treponemal tests in low prevalence populations, like pregnant women, subjects individuals with non-active syphilis to the costs and possible risks of overtreatment. The use of the dual treponemal and non-treponemal tests would minimize this risk at some additional cost.CONCLUSIONUse of only treponemal tests in low prevalence populations, like pregnant women, subjects individuals with non-active syphilis to the costs and possible risks of overtreatment. The use of the dual treponemal and non-treponemal tests would minimize this risk at some additional cost. IntroductionThere have been few empirical studies for diagnostic test accuracy of syphilis using a sequence of rapid tests in populations with low prevalence of syphilis such as pregnant women. This analysis describes syphilis test positivity frequency among pregnant women at an antenatal clinic in Zambia using a reverse-sequence testing algorithm for antenatal syphilis screening.MethodsBetween August 2019 and May 2023, we recruited 1510 pregnant women from a peri-urban hospital in Lusaka, Zambia. HIV positive and HIV negative women were enrolled in a 1:1 ratio. Blood collected at recruitment from the pregnant mothers was tested on-site for syphilis using a rapid treponemal test. Samples that tested positive were further tested at a different laboratory, with rapid plasma reagin using archived plasma.ResultsOf the total 1,421 sera samples which were screened with a rapid treponemal test, 127 (8.9%) were positive and 1,294 (91.1%) were negative. Sufficient additional samples were available to perform RPR testing on 114 of the 127 (89.8%) RDT positive specimens. Thirty-one (27.2%) of these 114 were reactive by RPR and 83 (72.8%) were negative, resulting in a syphilis overtreatment rate of 3 fold (i.e, 84/114). Insufficient sample or test kit availability prevented any testing for the remaining 89 (5.9%) participants.ConclusionUse of only treponemal tests in low prevalence populations, like pregnant women, subjects individuals with non-active syphilis to the costs and possible risks of overtreatment. The use of the dual treponemal and non-treponemal tests would minimize this risk at some additional cost. Introduction There have been few empirical studies for diagnostic test accuracy of syphilis using a sequence of rapid tests in populations with low prevalence of syphilis such as pregnant women. This analysis describes syphilis test positivity frequency among pregnant women at an antenatal clinic in Zambia using a reverse-sequence testing algorithm for antenatal syphilis screening. Methods Between August 2019 and May 2023, we recruited 1510 pregnant women from a peri-urban hospital in Lusaka, Zambia. HIV positive and HIV negative women were enrolled in a 1:1 ratio. Blood collected at recruitment from the pregnant mothers was tested on-site for syphilis using a rapid treponemal test. Samples that tested positive were further tested at a different laboratory, with rapid plasma reagin using archived plasma. Results Of the total 1,421 sera samples which were screened with a rapid treponemal test, 127 (8.9%) were positive and 1,294 (91.1%) were negative. Sufficient additional samples were available to perform RPR testing on 114 of the 127 (89.8%) RDT positive specimens. Thirty-one (27.2%) of these 114 were reactive by RPR and 83 (72.8%) were negative, resulting in a syphilis overtreatment rate of 3 fold (i.e, 84/114). Insufficient sample or test kit availability prevented any testing for the remaining 89 (5.9%) participants. Conclusion Use of only treponemal tests in low prevalence populations, like pregnant women, subjects individuals with non-active syphilis to the costs and possible risks of overtreatment. The use of the dual treponemal and non-treponemal tests would minimize this risk at some additional cost. There have been few empirical studies for diagnostic test accuracy of syphilis using a sequence of rapid tests in populations with low prevalence of syphilis such as pregnant women. This analysis describes syphilis test positivity frequency among pregnant women at an antenatal clinic in Zambia using a reverse-sequence testing algorithm for antenatal syphilis screening. Between August 2019 and May 2023, we recruited 1510 pregnant women from a peri-urban hospital in Lusaka, Zambia. HIV positive and HIV negative women were enrolled in a 1:1 ratio. Blood collected at recruitment from the pregnant mothers was tested on-site for syphilis using a rapid treponemal test. Samples that tested positive were further tested at a different laboratory, with rapid plasma reagin using archived plasma. Of the total 1,421 sera samples which were screened with a rapid treponemal test, 127 (8.9%) were positive and 1,294 (91.1%) were negative. Sufficient additional samples were available to perform RPR testing on 114 of the 127 (89.8%) RDT positive specimens. Thirty-one (27.2%) of these 114 were reactive by RPR and 83 (72.8%) were negative, resulting in a syphilis overtreatment rate of 3 fold (i.e, 84/114). Insufficient sample or test kit availability prevented any testing for the remaining 89 (5.9%) participants. Use of only treponemal tests in low prevalence populations, like pregnant women, subjects individuals with non-active syphilis to the costs and possible risks of overtreatment. The use of the dual treponemal and non-treponemal tests would minimize this risk at some additional cost. |
| Audience | Academic |
| Author | Chavuma, Roy Herlihy, Julie M. Gill, Christopher J. Zulu, Ethan Mabvuto Forman, Leah Payne-Lohman, Barbara Duffy, Cassandra R. Mwananyanda, Lawrence Heeren, Tim Thea, Donald M. Chilengi, Roma |
| AuthorAffiliation | 3 Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, United States of America 4 Department of Obstetrics & Gynecology, Division of Maternal-Fetal Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America 5 Centre for Infectious Disease Research in Zambia, Lusaka, Zambia 2 Department of Pediatrics, Boston Medical Center, Boston University, Chobanian & Avedisian School of Medicine, Boston, Massachusetts, United States of America Universita degli Studi di Bologna Scuola di Medicina e Chirurgia, ITALY 1 Right to Care Zambia, Lusaka, Zambia 8 Institute for Immunology and Informatics, University of Rhode Island, Kingston, Rhode Island, United States of America 6 Biostatistics and Epidemiology Data Analytics Center, Boston University School of Public Health, Boston, Massachusetts, United States of America 7 Department of Biostatistics, Boston University School of Public Health, Boston, Massachuse |
| AuthorAffiliation_xml | – name: 8 Institute for Immunology and Informatics, University of Rhode Island, Kingston, Rhode Island, United States of America – name: Universita degli Studi di Bologna Scuola di Medicina e Chirurgia, ITALY – name: 1 Right to Care Zambia, Lusaka, Zambia – name: 3 Department of Global Health, Boston University School of Public Health, Boston, Massachusetts, United States of America – name: 6 Biostatistics and Epidemiology Data Analytics Center, Boston University School of Public Health, Boston, Massachusetts, United States of America – name: 2 Department of Pediatrics, Boston Medical Center, Boston University, Chobanian & Avedisian School of Medicine, Boston, Massachusetts, United States of America – name: 7 Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts, United States of America – name: 4 Department of Obstetrics & Gynecology, Division of Maternal-Fetal Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America – name: 5 Centre for Infectious Disease Research in Zambia, Lusaka, Zambia |
| Author_xml | – sequence: 1 givenname: Ethan Mabvuto orcidid: 0009-0005-8491-7346 surname: Zulu fullname: Zulu, Ethan Mabvuto – sequence: 2 givenname: Julie M. surname: Herlihy fullname: Herlihy, Julie M. – sequence: 3 givenname: Cassandra R. surname: Duffy fullname: Duffy, Cassandra R. – sequence: 4 givenname: Lawrence surname: Mwananyanda fullname: Mwananyanda, Lawrence – sequence: 5 givenname: Roma surname: Chilengi fullname: Chilengi, Roma – sequence: 6 givenname: Leah surname: Forman fullname: Forman, Leah – sequence: 7 givenname: Tim surname: Heeren fullname: Heeren, Tim – sequence: 8 givenname: Christopher J. surname: Gill fullname: Gill, Christopher J. – sequence: 9 givenname: Roy surname: Chavuma fullname: Chavuma, Roy – sequence: 10 givenname: Barbara surname: Payne-Lohman fullname: Payne-Lohman, Barbara – sequence: 11 givenname: Donald M. surname: Thea fullname: Thea, Donald M. |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/38723103$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1038/nrdp.2017.73 10.1177/0956462413518194 10.1212/01.CPJ.0000435752.17621.48 10.1186/s40168-017-0248-8 10.1128/JCM.00100-21 10.1097/OLQ.0b013e3182036a0f 10.1086/655832 |
| ContentType | Journal Article |
| Copyright | Copyright: © 2024 Zulu et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. COPYRIGHT 2024 Public Library of Science 2024 Zulu et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2024 Zulu et al 2024 Zulu et al 2024 Zulu et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
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| DOI | 10.1371/journal.pone.0303253 |
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| References | MM Taylor (pone.0303253.ref013) 2014; 25 M Pammi (pone.0303253.ref014) 2017; 5 K Jr Owusu-Edusei (pone.0303253.ref018) 2011; 38 S Hussen (pone.0303253.ref012) 2019; 2019 pone.0303253.ref005 AC Seña (pone.0303253.ref004) 2010; 51 pone.0303253.ref006 S Frederic (pone.0303253.ref016) 2023 pone.0303253.ref003 A Nogacka (pone.0303253.ref019) 2017; 5 pone.0303253.ref015 pone.0303253.ref001 F Satyaputra (pone.0303253.ref011) 2021; 59 RW Peeling (pone.0303253.ref010) 2017; 3 pone.0303253.ref009 pone.0303253.ref007 F Terris-Prestholt (pone.0303253.ref017) 2015; 1301 AF Henao-Martínez (pone.0303253.ref008) 2014; 4 J Anna (pone.0303253.ref002) 2022; 9 |
| References_xml | – ident: pone.0303253.ref015 – volume: 9 issue: 2 year: 2022 ident: pone.0303253.ref002 publication-title: Low Treatment Rates and Associated Factors Among Pregnant Women with Syphilis in Zambia, Open Forum Infectious Diseases – volume: 3 start-page: 17073 year: 2017 ident: pone.0303253.ref010 article-title: Syphilis publication-title: Nat Rev Dis Primers doi: 10.1038/nrdp.2017.73 – volume: 25 start-page: 716 issue: 10 year: 2014 ident: pone.0303253.ref013 article-title: Correlates of syphilis seropositivity and risk for syphilis-associated adverse pregnancy outcomes among women attending antenatal care clinics in the Democratic Republic of Congo publication-title: Int J STD AIDS doi: 10.1177/0956462413518194 – year: 2023 ident: pone.0303253.ref016 article-title: Securing the supply of benzathine penicillin: a global perspective on risks and mitigation strategies to prevent future shortages publication-title: International Health – volume: 5 issue: 93 year: 2017 ident: pone.0303253.ref019 article-title: Impact of intrapartum antimicrobial prophylaxis upon the intestinal microbiota and the prevalence of antibiotic resistance genes in vaginally delivered full term neonates publication-title: Microbiome – volume: 4 start-page: 114 issue: 2 year: 2014 ident: pone.0303253.ref008 article-title: Diagnostic tests for syphilis: New tests and new algorithms publication-title: Neurol Clin Pract doi: 10.1212/01.CPJ.0000435752.17621.48 – ident: pone.0303253.ref001 – ident: pone.0303253.ref003 – volume: 5 start-page: 31 issue: 1 year: 2017 ident: pone.0303253.ref014 article-title: Intestinal dysbiosis in preterm infants preceding necrotizing enterocolitis: a systematic review and meta-analysis publication-title: Microbiome doi: 10.1186/s40168-017-0248-8 – volume: 59 start-page: e0010021 issue: 10 year: 2021 ident: pone.0303253.ref011 article-title: The Laboratory Diagnosis of Syphilis publication-title: J Clin Microbiol doi: 10.1128/JCM.00100-21 – volume: 2019 start-page: 1 issue: 4 year: 2019 ident: pone.0303253.ref012 article-title: Prevalence of Syphilis among Pregnant Women in Sub-Saharan Africa: A Systematic Review and Meta-Analysis publication-title: BioMed Res.I – ident: pone.0303253.ref007 – volume: 38 start-page: 448 issue: 5 year: 2011 ident: pone.0303253.ref018 article-title: The tale of two serologic tests to screen for syphilis—treponemal and nontreponemal: does the order matter? publication-title: Sex Transm Dis doi: 10.1097/OLQ.0b013e3182036a0f – ident: pone.0303253.ref006 – volume: 1301 start-page: S73 issue: Suppl 1 year: 2015 ident: pone.0303253.ref017 article-title: The cost-effectiveness of 10 antenatal syphilis screening and treatment approaches in Peru, Tanzania, and Zambia publication-title: Int J Gynaecol Obstet – volume: 51 start-page: 700 issue: 6 year: 2010 ident: pone.0303253.ref004 article-title: Novel Treponema pallidum serologic tests: a paradigm shift in syphilis screening for the 21st century publication-title: Clin Infect Dis doi: 10.1086/655832 – ident: pone.0303253.ref005 – ident: pone.0303253.ref009 |
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| Snippet | There have been few empirical studies for diagnostic test accuracy of syphilis using a sequence of rapid tests in populations with low prevalence of syphilis... Introduction There have been few empirical studies for diagnostic test accuracy of syphilis using a sequence of rapid tests in populations with low prevalence... IntroductionThere have been few empirical studies for diagnostic test accuracy of syphilis using a sequence of rapid tests in populations with low prevalence... Introduction There have been few empirical studies for diagnostic test accuracy of syphilis using a sequence of rapid tests in populations with low prevalence... |
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| SubjectTerms | Adult Algorithms Analysis Antibiotics Antibodies Antimicrobial agents Availability Biology and Life Sciences Cohort analysis Congenital diseases Consent Diagnosis Diagnostic tests Enzymes Female Health aspects HIV Human immunodeficiency virus Humans Immunoassay Infections Laboratories Mass Screening - methods Medical research Medicine and Health Sciences Medicine, Experimental Methods Penicillin Penicillin G People and Places Plasma Populations Pregnancy Pregnancy Complications, Infectious - diagnosis Pregnancy Complications, Infectious - epidemiology Pregnant women Reagin Serodiagnosis Serology Sexually transmitted diseases Socioeconomic factors STD Syphilis Syphilis - blood Syphilis - diagnosis Syphilis - epidemiology Syphilis Serodiagnosis - methods Treponema pallidum - immunology Womens health Young Adult Zambia - epidemiology |
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| Title | Single-test syphilis serology: A case of not seeing the forest for the trees |
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