Clinic-based evaluation of point-of-care dual HIV/syphilis rapid diagnostic tests at primary healthcare antenatal facilities in South Africa and Zambia.
Humans
Zambia
/ epidemiology
Female
Syphilis
/ diagnosis
HIV Infections
/ diagnosis
Pregnancy
South Africa
/ epidemiology
Adult
Sensitivity and Specificity
Young Adult
Pregnancy Complications, Infectious
/ diagnosis
Adolescent
Point-of-Care Systems
Primary Health Care
Point-of-Care Testing
Prevalence
Mass Screening
/ methods
Prenatal Care
Diagnostic Tests, Routine
/ methods
Rapid Diagnostic Tests
ANC
Antenatal care
Clinic-based evaluation
Diagnostic evaluation
Dual EMTCT HIV/syphilis
HIV
Point-of-care tests
Public health
Syphilis
Journal
BMC infectious diseases
ISSN: 1471-2334
Titre abrégé: BMC Infect Dis
Pays: England
ID NLM: 100968551
Informations de publication
Date de publication:
19 Jun 2024
19 Jun 2024
Historique:
received:
18
08
2022
accepted:
31
05
2024
medline:
20
6
2024
pubmed:
20
6
2024
entrez:
19
6
2024
Statut:
epublish
Résumé
Southern African countries have the largest global burden of HIV and syphilis, with a high prevalence among women of reproductive age. Although antenatal screening is standard of care, syphilis screening has generally lagged behind HIV screening. We aimed to evaluate the performance and operational characteristics of two commercial dual HIV/syphilis point-of-care tests (POCTs) for simultaneous maternal HIV/syphilis screening. A clinic-based evaluation of dual HIV/syphilis POCTs (SD Bioline and Chembio) was conducted at five primary healthcare centres (PHCs) in South Africa and Zambia. POCT results using capillary fingerprick blood were compared to reference laboratory syphilis and HIV serological assays. Three thousand four hundred twelve consenting pregnant women aged ≥ 18 years were enrolled. The prevalence of treponemal antibody seropositivity and HIV infection ranged from 3.7 to 9.9% (n = 253) and 17.8 to 21.3% (n = 643), respectively. Pooled sensitivity for syphilis compared to the reference assay was 66.0% (95%CI 57.7-73.4) with SD Bioline and 67.9% (95%CI 58.2-76.3) with Chembio. Pooled specificity for syphilis was above 98% with both POCTs. The sensitivities of SD Bioline and Chembio assays were 78.0% (95%CI 68.6-85.7) and 81.0% (95%CI 71.9-88.2), respectively compared to an active syphilis case definition of treponemal test positive with a rapid plasma reagin titre of ≥ 8. The negative predictive values (NPVs) based on various prevalence estimates for syphilis with both assays ranged from 97 to 99%. The pooled sensitivity for HIV was 92.1% (95%CI 89.4-94.2) with SD Bioline; and 91.5% (95%CI 88.2-93.9) with Chembio. The pooled specificities for HIV were 97.2% (95%CI 94.8-98.5) with SD Bioline and 96.7% (95%CI 95.1-97.8) with Chembio. The NPV based on various prevalence estimates for HIV with both assays was approximately 98%. Most participating women (91%) preferred dual POCTs over two single POCTs for HIV and syphilis, and healthcare providers gave favourable feedback on the utility of both assays at PHC level. Based on the need to improve antenatal screening coverage for syphilis, dual HIV/syphilis POCTs could be effectively incorporated into antenatal testing algorithms to enhance efforts towards elimination of mother-to-child transmission of these infections.
Sections du résumé
BACKGROUND
BACKGROUND
Southern African countries have the largest global burden of HIV and syphilis, with a high prevalence among women of reproductive age. Although antenatal screening is standard of care, syphilis screening has generally lagged behind HIV screening. We aimed to evaluate the performance and operational characteristics of two commercial dual HIV/syphilis point-of-care tests (POCTs) for simultaneous maternal HIV/syphilis screening.
METHODS
METHODS
A clinic-based evaluation of dual HIV/syphilis POCTs (SD Bioline and Chembio) was conducted at five primary healthcare centres (PHCs) in South Africa and Zambia. POCT results using capillary fingerprick blood were compared to reference laboratory syphilis and HIV serological assays.
RESULTS
RESULTS
Three thousand four hundred twelve consenting pregnant women aged ≥ 18 years were enrolled. The prevalence of treponemal antibody seropositivity and HIV infection ranged from 3.7 to 9.9% (n = 253) and 17.8 to 21.3% (n = 643), respectively. Pooled sensitivity for syphilis compared to the reference assay was 66.0% (95%CI 57.7-73.4) with SD Bioline and 67.9% (95%CI 58.2-76.3) with Chembio. Pooled specificity for syphilis was above 98% with both POCTs. The sensitivities of SD Bioline and Chembio assays were 78.0% (95%CI 68.6-85.7) and 81.0% (95%CI 71.9-88.2), respectively compared to an active syphilis case definition of treponemal test positive with a rapid plasma reagin titre of ≥ 8. The negative predictive values (NPVs) based on various prevalence estimates for syphilis with both assays ranged from 97 to 99%. The pooled sensitivity for HIV was 92.1% (95%CI 89.4-94.2) with SD Bioline; and 91.5% (95%CI 88.2-93.9) with Chembio. The pooled specificities for HIV were 97.2% (95%CI 94.8-98.5) with SD Bioline and 96.7% (95%CI 95.1-97.8) with Chembio. The NPV based on various prevalence estimates for HIV with both assays was approximately 98%. Most participating women (91%) preferred dual POCTs over two single POCTs for HIV and syphilis, and healthcare providers gave favourable feedback on the utility of both assays at PHC level.
CONCLUSIONS
CONCLUSIONS
Based on the need to improve antenatal screening coverage for syphilis, dual HIV/syphilis POCTs could be effectively incorporated into antenatal testing algorithms to enhance efforts towards elimination of mother-to-child transmission of these infections.
Identifiants
pubmed: 38898466
doi: 10.1186/s12879-024-09463-1
pii: 10.1186/s12879-024-09463-1
doi:
Types de publication
Journal Article
Evaluation Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
600Subventions
Organisme : UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a cosponsored programme executed by the World Health Organization (WHO) and Government of Canada
ID : UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a cosponsored programme executed by the World Health Organization (WHO) and Government of Canada
Informations de copyright
© 2024. The Author(s).
Références
UNAIDS epidemiological estimates, 2021. Available at https://www.unaids.org/en/resources/documents/2021/2021_unaids_data . Accessed 15 Jul 2022.
Mid-year population estimates 2021. Republic of South Africa: statistics South Africa; 2021. Statistical release P0302. Available at https://www.statssa.gov.za/ . Accessed 15 Jul 2022.
Woldesenbet SA, Lombard, C., Manda, S. et al. The 2019 National Antenatal Sentinel HIV Survey, South Africa. National Department of Health, Republic of South Africa, 2021. Available at https://www.knowledgehub.org.za/elibrary/2019-national-antenatal-hiv-sentinel-survey-anchss-key-findings . Accessed 15 Jul 2022.
Zambia Statistics Agency - ZSA, Ministry of Health - MOH, University Teaching Hospital Virology Laboratory - UTH-VL, and ICF. 2020. Zambia Demographic and Health Survey 2018. Lusaka, Zambia: ZSA, MOH, UTH-VL and ICF. Available at https://www.dhsprogram.com/pubs/pdf/FR361/FR361.pdf . Accessed 15 Jul 2022.
The Global Health Observatory. Antenatal care attendees who were positive for syphilis. World Health Organization. Available at https://www.who.int/data/gho/data/themes/topics/indicator-groups/indicator-group-details/GHO/antenatal-care-attendees-who-were-positive-for-syphilis . Accessed 15 Jul 2022.
National HIV Testing Services: Policy 2016. National Department of Health, Republic of South Africa. Available at https://sahivsoc.org/Files/HTS%20Policy%2028%20July%20final%20copy.pdf . Accessed 15 Jul 2022.
Storey A, Seghers F, Pyne-Mercier L, Peeling RW, Owiredu MN, Taylor MM, et al. Syphilis diagnosis and treatment during antenatal care: the potential catalytic impact of the dual HIV and Syphilis rapid diagnostic test. Lancet Glob Health. 2019;7(8):e1006–8.
doi: 10.1016/S2214-109X(19)30248-7
pubmed: 31303285
pmcid: 6759458
World Health Organisation, Consolidated guidelines on HIV testing services, 2019. Available at https://www.who.int/publications/i/item/978-92-4-155058-1 . Accessed 15 July 2022.
Guideline for the prevention of mother-to-child transmission of communicable infections: 2019. National Department of Health, Republic of South Africa. Available at https://www.knowledgehub.org.za/elibrary/guideline-prevention-mother-child-transmission-communicable-infections . Accessed 15 July 2022.
Gomez GB, Kamb ML, Newman LM, Mark J, Broutet N, Hawkes SJ. Untreated maternal syphilis and adverse outcomes of pregnancy: a systematic review and meta-analysis. Bull World Health Organ. 2013;91(3):217–26.
doi: 10.2471/BLT.12.107623
pubmed: 23476094
pmcid: 3590617
Korenromp EL, Rowley J, Alonso M, Mello MB, Wijesooriya NS, Mahiane SG, et al. Global burden of maternal and congenital syphilis and associated adverse birth outcomes-estimates for 2016 and progress since 2012. PLoS ONE. 2019;14(2):e0211720.
doi: 10.1371/journal.pone.0211720
pubmed: 30811406
pmcid: 6392238
Investment case for eliminating mother-to-child transmission of syphilis: promoting better maternal and child health and stronger health systems. Geneva: World Health Organization; 2012. Available at https://apps.who.int/iris/bitstream/handle/10665/75480/9789241504348_eng.pdf?sequence=1 . Accessed 15 July 2022.
Global guidance on criteria and processes for validation. : elimination of mother-to-child transmission of HIV, syphilis and hepatitis B virus. Geneva, Switzerland: World Health Organization; 2021. Licence: CC BY-NC-SA 3.0 IGO.
Rodriguez PJ, Roberts DA, Meisner J, Sharma M, Owiredu MN, Gomez B, et al. Cost-effectiveness of dual maternal HIV and syphilis testing strategies in high and low HIV prevalence countries: a modelling study. Lancet Glob Health. 2021;9(1):e61–71.
doi: 10.1016/S2214-109X(20)30395-8
pubmed: 33227254
Policy brief: HIV Testing Services. Dual HIV/ Syphilis rapid diagnostic tests can be used as the first test in antenatal care. Geneva, Switzerland: World Health Organizatiom; 2019. Available at: https://www.who.int/publications/i/item/WHO-CDS-HIV-19.38 . Accessed 15 Jul 2022.
The ProSPeRO network. Standardised protocol for a prospective cross-sectional multicentre clinic-based evaluation of two dual point-of-care tests for the screening of HIV and Syphilis in men who have sex with men, sex workers and pregnant women. BMJ Open. 2020;10(11):e044479.
doi: 10.1136/bmjopen-2020-044479
Mabey D, Peeling RW, Ballard R, Benzaken AS, Galbán E, Changalucha J, Everett D, Balira R, Fitzgerald D, Joseph P, Nerette S, Li J, Zheng H. Prospective, multi-centre clinic-based evaluation of four rapid diagnostic tests for syphilis. Sex Transm Infect. 2006;82 Suppl 5(Suppl 5):v13–16. https://doi.org/10.1136/sti.2006.022467 . PMID: 17215274; PMCID: PMC2563907.
doi: 10.1136/sti.2006.022467
pubmed: 17215274
Kasaro MP, Bosomprah S, Taylor MM, Sindano N, Phiri C, Tambatamba B, et al. Field performance evaluation of dual rapid HIV and syphilis tests in three antenatal care clinics in Zambia. Int J STD AIDS. 2019;30(4):323–8.
doi: 10.1177/0956462418800872
pubmed: 30472926
National Department of Health. Republic of South Africa. The 2015 National Antenatal Sentinel HIV & Syphilis Survey. Pretoria: 2017.
Banoo SBD, Bossuyt P, et al. Evaluation of diagnostic tests for infectious diseases: general principles. Nat Rev Microbiol. 2006;4:S21–31.
doi: 10.1038/nrmicro1523
pubmed: 17034069
Samoff E, Koumans EH, Gibson JJ, Ross M, Markowitz LE. Pre-treatment syphilis titers: distribution and evaluation of their use to distinguish early from late latent syphilis and to prioritize contact investigations. Sex Transm Dis. 2009;36(12):789–93.
doi: 10.1097/OLQ.0b013e3181b3566b
pubmed: 19773682
Pandey K, Fairley CK, Chen MY, Williamson DA, Bradshaw CS, Ong JJ, et al. Changes in the syphilis rapid plasma reagin titer between diagnosis and treatment. Clin Infect Dis. 2023;76(5):795–9.
doi: 10.1093/cid/ciac843
pubmed: 36285535
Watson-Jones D, Gumodoka B, Weiss H, Changalucha J, Todd J, Mugeye K, et al. Syphilis in pregnancy in Tanzania. II. The effectiveness of antenatal syphilis screening and single-dose benzathine penicillin treatment for the prevention of adverse pregnancy outcomes. J Infect Dis. 2002;186(7):948–57.
doi: 10.1086/342951
pubmed: 12232835
Sexually Transmitted Infections Treatment Guidelines, 2021. USA: US Department of Health and Human Services/ Centers for Disease Control and Prevention. Available at https://www.cdc.gov/std/treatment-guidelines/toc.htm . Accessed 15 Jul 2022.
Mwapasa V, Rogerson SJ, Kwiek JJ, Wilson PE, Milner D, Molyneux ME, et al. Maternal syphilis infection is associated with increased risk of mother-to-child transmission of HIV in Malawi. AIDS. 2006;20(14):1869–77.
doi: 10.1097/01.aids.0000244206.41500.27
pubmed: 16954728
Shava E, Moyo S, Zash R, Diseko M, Dintwa EN, Mupfumi L, et al. Brief report: high rates of adverse birth outcomes in HIV and syphilis coinfected women in Botswana. J Acquir Immune Defic Syndr. 2019;81(5):e135–140.
doi: 10.1097/QAI.0000000000002082
pubmed: 31295173
pmcid: 6636337
Gliddon HD, Peeling RW, Kamb ML, Toskin I, Wi TE, Taylor MM. A systematic review and meta-analysis of studies evaluating the performance and operational characteristics of dual point-of-care tests for HIV and Syphilis. Sex Transm Infect. 2017;93(S4):S3–15.
pubmed: 28747410
Holden J, Goheen J, Jett-Goheen M, Barnes M, Hsieh YH, Gaydos CA. An evaluation of the SD Bioline HIV/syphilis duo test. Int J STD AIDS. 2018;29(1):57–62.
doi: 10.1177/0956462417717649
pubmed: 28661234
Olugbenga I, Taiwo O, Laverty M, Ngige E, Anyaike C, Bakare R, et al. Clinic-based evaluation study of the diagnostic accuracy of a dual rapid test for the screening of HIV and Syphilis in pregnant women in Nigeria. PLoS ONE. 2018;13(7):e0198698.
doi: 10.1371/journal.pone.0198698
pubmed: 29990336
pmcid: 6038984
Consolidated guidelines on HIV testing services, 2019. Geneva: World Health Organization; 2020. Available at: https://apps.who.int/iris/handle/10665/336323 . Licence: CC BY-NC-SA 3.0 IGO. Accessed 15 Jul 2022.
Liu LL, Lin LR, Tong ML, Zhang HL, Huang SJ, Chen YY, et al. Incidence and risk factors for the prozone phenomenon in serologic testing for syphilis in a large cohort. Clin Infect Dis. 2014;59(3):384–9.
doi: 10.1093/cid/ciu325
pubmed: 24803377
Smith A, Sabido M, Camey E, Batres A, Casabona J. Lessons learned from integrating simultaneous triple point-of-care screening for syphilis, hepatitis B, and HIV in prenatal services through rural outreach teams in Guatemala. Int J Gynaecol Obstet. 2015;130 Suppl 1:S70–72.
pubmed: 25968489
Smit PW, Mabey D, Changalucha J, Mngara J, Clark B, Andreasen A, et al. The trade-off between accuracy and accessibility of syphilis screening assays. PLoS ONE. 2013;8(9):e75327.
doi: 10.1371/journal.pone.0075327
pubmed: 24066175
pmcid: 3774815
Mishra S, Naik B, Venugopal B, Kudur P, Washington R, Becker M, et al. Syphilis screening among female sex workers in Bangalore, India: comparison of point-of-care testing and traditional serological approaches. Sex Transm Infect. 2010;86(3):193–8.
doi: 10.1136/sti.2009.038778
pubmed: 19965800
Morifi M, Kufa-Chakezha, T. Congenital syphilis quarterly surveillance report, December 2020. South Africa: National Institute for Communicable Diseases; 2021. Available at: https://www.nicd.ac.za/wp-content/uploads/2021/02/Congenital-Syphilis-Quarterly-Surveillance-Report.pdf . Accessed 15 Jul 2022.
Lawi JD, Mirambo MM, Magoma M, Mushi MF, Jaka HM, Gumodoka B, et al. Sero-conversion rate of Syphilis and HIV among pregnant women attending antenatal clinic in Tanzania: a need for re-screening at delivery. BMC Pregnancy Childbirth. 2015;15:3.
doi: 10.1186/s12884-015-0434-2
pubmed: 25613487
pmcid: 4307991
O’Connor NP, Gonzalez BE, Esper FP, Tamburro J, Kadkhoda K, Foster CB. Congenital syphilis: missed opportunities and the case for rescreening during pregnancy and at delivery. IDCases. 2020;22:e00964.
doi: 10.1016/j.idcr.2020.e00964
pubmed: 33024697
pmcid: 7528198
World Health Organization. WHO Public Reports for In Vitro Diagnostics. Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control). 2022. Available at: https://extranet.who.int/pqweb/vitro-diagnostics/prequalification-reports/whopr . Accessed 15 Jul 2022.
Chembio Diagnostics I. Chembio diagnostics receives FDA approval for DPP HIV-syphilis system. 2020.
World Health Organization. WHO HIV policy adoption and implementation status in countries. Geneva; 2019. Available at: https://apps.who.int/iris/bitstream/handle/10665/326035/WHO-CDS-HIV-19.20-eng.pdf?ua=1 . Report No.: CC BY_NC-SA 3.0 IGO licence. Accessed 15 Jul 2022.
World Health Organization. WHO guideline on syphilis screening and treatment for pregnant women. Geneva; 2017. https://www.who.int/publications/i/item/9789241550093 . Accessed 15 Jul 2022.
Swartzendruber A, Steiner RJ, Adler MR, Kamb ML, Newman LM. Introduction of rapid syphilis testing in antenatal care: a systematic review of the impact on HIV and syphilis testing uptake and coverage. Int J Gynaecol Obstet. 2015;130 Suppl 1:S15–21.
pubmed: 26001704
Strasser S, Bitarakwate E, Gill M, Hoffman HJ, Musana O, Phiri A, et al. Introduction of rapid syphilis testing within prevention of mother-to-child transmission of HIV programs in Uganda and Zambia: a field acceptability and feasibility study. J Acquir Immune Defic Syndr. 2012;61(3):e40–46.
doi: 10.1097/QAI.0b013e318267bc94
pubmed: 22820810
Bristow CC, Larson E, Anderson LJ, Klausner JD. Cost-effectiveness of HIV and Syphilis antenatal screening: a modelling study. Sex Transm Infect. 2016;92(5):340–6.
doi: 10.1136/sextrans-2015-052367
pubmed: 26920867
Wang Q, Chan PL, Newman LM, Dou LX, Wang XY, Qiao YP, et al. Acceptability and feasibility of dual HIV and syphilis point-of-care testing for early detection of infection among pregnant women in China: a prospective study. BMJ Open. 2018;8(10):e020717.
doi: 10.1136/bmjopen-2017-020717
pubmed: 30366912
pmcid: 6224742
Dassah ET, Adu-Sarkodie Y, Mayaud P. Rollout of rapid point of care tests for antenatal syphilis screening in Ghana: healthcare provider perspectives and experiences. BMC Health Serv Res. 2018;18(1):130.
doi: 10.1186/s12913-018-2935-y
pubmed: 29458363
pmcid: 5819248
Maseko DV, Valashiya D, Kularatne RS. Development and trial of a dried tube specimen (DTS) proficiency testing panel for dual HIV/syphilis rapid diagnostic tests. Diagn Microbiol Infect Dis. 2022;102(3):115607.
doi: 10.1016/j.diagmicrobio.2021.115607
pubmed: 34953370
World Health Organization. Global Sexually Transmitted Infections Programme. WHO/CDC Syphilis Serology Proficiency Programme. Available at https://www.who.int/teams/global-hiv-hepatitis-and-stis-programmes/stis/testing-diagnostics/who-cdc-syphilis-serology-proficiency-programme . Accessed 15 Jul 2022.
Bonawitz RE, Duncan J, Hammond E, Hamomba L, Nambule J, Sambambi K, et al. Assessment of the impact of rapid syphilis tests on syphilis screening and treatment of pregnant women in Zambia. Int J Gynaecol Obstet. 2015;130(Suppl 1):S58–62.
pubmed: 25968492
pmcid: 8991823
Nurse-Findlay S, Taylor MM, Savage M, Mello MB, Saliyou S, Lavayen M, et al. Shortages of benzathine penicillin for prevention of mother-to-child transmission of syphilis: an evaluation from multi-country surveys and stakeholder interviews. PLoS Med. 2017;14(12): e1002473.
doi: 10.1371/journal.pmed.1002473
pubmed: 29281619
pmcid: 5744908
Shah S, Garg S, Heath K, Ofili O, Bansal Y, Seghers F, et al. Estimation of benzathine penicillin G demand for congenital syphilis elimination with adoption of dual HIV/syphilis rapid diagnostic tests in eleven high burden countries. PLoS ONE. 2021;16(8):e0256400.
doi: 10.1371/journal.pone.0256400
pubmed: 34411167
pmcid: 8376004
World Health Organization. Global sexually transmitted infections programme. WHO Congenital Syphilis Estimation Tool. Available at https://www.who.int/teams/global-hiv-hepatitis-and-stis-programmes/stis/strategic-information/congenital-syphilis-estimation-tool#:~:text=The%20WHO%20Congenital%20Syphilis%20Estimation,rates%20and%20adverse%20birth%20outcomes . Accessed 15 Jul 2022.
Heath K, Alonso M, Aguilar G, Samudio T, Korenromp E, Rowley J, et al. WHO method for estimating congenital syphilis to inform surveillance and service provision, Paraguay. Bull World Health Organ. 2022;100(3):231–6.
doi: 10.2471/BLT.20.271569
pubmed: 35261411
pmcid: 8886258