All four assays were evaluated using the same characterized evaluation panel of 400 serum/plasma specimens from European, African, Asian, South American and Australian origin collected from patients/study participants attending the Institute of Tropical Medicine (ITM) clinic, collaborating sexually transmitted infection (STI) clinics and blood donation centres. Yassa P, Hira R, Sibinda CKim R, Seeda S, Mulenga V, Mukalay A, Gnynis D, Chisela S, Tamba T, Tembo G. Evaluation of the rapid dual HIV and syphilis tests in women attending antenatal clinic at the University Teaching Hospital, Lusaka, Zambia. Swartzendruber A, Steiner RJ, Adler MR, et al. During this study, the operational aspects, such as ease of use, number of steps and ease of interpretation, were assessed by the lab technician who performed the tests (Table1). Diagnostic Considerations Interpretation of treponemal and nontreponemal serologic tests for persons with HIV infection is the same as for persons without HIV. Take a history and ask about: Symptoms of syphilis. Diagnostic accuracy studies evaluated the performance of the SD BIOLINE HIV/Syphilis Duo Test, the MedMira Multiplo Rapid TP/HIV Antibody Test (MedMira, Canada) and the Chembio Dual Path Platform (DPP) HIV/Syphilis Assay (Chembio Diagnostic Systems, USA) (table s1). HIV screening programmes have been widely used for many years. The operational characteristics, such as ease of use, number of steps and ease of interpretation, were assessed by the lab technician who performed the tests. All studies were assessed against quality criteria and assessed for risk of bias. Dual rapid lateral flow immunoassay fingerstick wholeblood testing for Bristow CC, Leon SR, Huang E, Brown BJ, Ramos LB, Vargas SK, Flores JA, Caceres CF, Klausner JD. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). APW no. These weakly reactive bands may be a result of non-specific serological cross-reactivity as described in a review by Klarkowski et al., where possible causes of false reactivity on RDTs are discussed [23]. However, results for the SD DUO syphilis component, when compared to TPPA, support the need for further testing and assessment. https://doi.org/10.1093/ofid/ofu015. Patchy lesions on the oral mucosa. A systemic review and meta-analysis of studies evaluating the performance and operational characteristics of dual point-of-care tests for HIV and Syphilis. [Computer program] Version 5.3.5. [25] found that 10cycles appear to have a minimal effect on the sensitivity of IgG and IgM for serological testing. For all four assays the Treponema pallidum specificities were superior to the optimal desired clinical specificity of 95%. In field settings, reported HIV sensitivity values were between 96% and 99% for all but one of the field evaluations. Rogoziska E, Kara-Newton L, Zamora JR, Khan KS. 1995;8:121. Finally, only three commercially available dual HIV/syphilis, RDTs were evaluated in this meta-analysis. negative result in recent syphilis infection and a false-positive result in the absence of disease activity hinder the interpretation of treponemal test results. BJOG. Before hbbd``b`S qHY 0 R$qwY @B|pIh$x& ,QD3&F3Dg` r Dual HIV/syphilis rapid diagnostic tests can be used as the first test HIV screening programmes have been widely used for many years. J Assoc Med Microbiol Infect Dis Can. Yin Y, Ngige E, Anyaike C, Ijaodola G, Oyelade TA, Vaz RG, Newman LM, Chen X. Performance characteristics of SD Bioline Rapid HIV-Syphilis Duo test for simultaneous detection of HIV and Syphilis infection. We included studies that evaluated the operational characteristics of dual HIV/syphilis RDTs. In this study, only 11% of positive TPPA cases were RPR reactive, suggesting that the majority of cases represented previously treated rather than active syphilis infection. -. 2013;40(11):8701. The diagnostic accuracy for HIV was found to be slightly lower for the MedMira Multiplo Rapid TP/HIV Antibody Test, which gave sensitivities of between 94% and 100% and specificities between 98% and 100%. Causes of false positive HIV rapid diagnostic test results. Promoting routine syphilis screening among men who have sex with men in China: study protocol for a randomised controlled trial of syphilis self-testing and lottery incentive. The range for specificity of HIV diagnosis reported in field settings was 97% to 100%. Results for test interpretation using the electronic reader were not included in the meta-analysis. Where archived specimens were used, studies did not mention when reference testing was carried out (ie, at the time of collection or at the same time as the index test), and this timing could affect the agreement between the results of reference and index test. These are tests that can be used for testing at point of care, with no requirement for sophisticated laboratory equipment, or specific storage conditions; making them useful in all kinds of healthcare facilities. This study, by Bristow et al43 reported a sensitivity of 94% for the MedMira Multiplo Rapid TP/HIV Antibody Test. The summary ROC curves for the three test manufacturers are presented in figure 2C, and andD.D. Advantages of RDTs over traditional laboratory-based in vitro diagnostics are their ability to be used in rural settings with limited laboratory access, their simplicity of execution and the shorter time to result. Google Scholar. For the Treponema pallidum positive but HIV negative specimens, 31% were false reactive for HIV antibodies in at least one of the four evaluated assays. Cheng W, Wang C, Tang W, Ong JJ, Fu H, Marks M, Smith MK, Li C, Nie J, Zhao P, Zheng H, Yang B, Tucker JD. Mother-to-child transmission (MTCT) of syphilis and HIV continue to be important yet preventable causes of perinatal and infant morbidity and mortality. 2023 Feb 20;13(4):810. doi: 10.3390/diagnostics13040810. PRISMA, preferred reporting items for systematic reviews and meta-analysis. While the best diagnostic performance was observed for the SD BIOLINE HIV/Syphilis Duo Test, more evaluation studies were available for this test compared with the two others included in the meta-analysis. For our study we made sure that the panel was composed of specimens from different geographic origins but no selection was made based on the syphilis stage. The Hess et al32 study reported two sets of sensitivities and specificities for the original order of the test and the reverse order. Additionally, the invalid rate and inter-reader variability were calculated for each assay (for the WHO specimen reference panel). A novel point-of-care immunochromatographic test for dual diagnosis of both HIV and syphilis by detecting IgG, IgM and IgA antibodies to HIV, and specific and recombinant Treponema pallidum antigens has recently been developed, but has not been evaluated in rural field settings. The STARD checklist was used to appraise the quality of reporting of studies included in the meta-analysis (see online supplementary file 1). Not all products are available in all regions. Having seen the test results in the prototype app that accompanied use of the INSTI and Syphilis Health Check, which displayed HIV and syphilis tests results as "positive" or "negative," all participants preferred textual test results to those of existing rapid tests that required interpretation (e.g. Assessment of the Accuracy, Usability and Acceptability of a Rapid Test for the Simultaneous Diagnosis of Syphilis and HIV Infection in a Real-Life Scenario in the Amazon Region, Brazil. Summary HIV ROC curve for the MedMira Multiplo Rapid TP/HIV Antibody test falls slightly below that of the curve for the SD BIOLINE HIV/Syphilis Duo Test and Chembio DPP HIV/Syphilis Assay, indicating that this test might have a lower diagnostic performance for HIV (figure 2C). Holden J, Goheen J, Jett-Goheen M, Barnes M, Hasieh YH, Gaydos CA. Rapid diagnostic tests are mainly developed to be used in the field, by healthcare workers. https://doi.org/10.1136/sextrans-2013-051184.1134. 2016;92:4958. Although rare, unusual serologic responses have been observed among persons with HIV infection who have syphilis. Search keywords included HIV, syphilis and diagnosis. Part of Elimination of mother-to-child transmission of HIV and syphilis: A dual approach in the African Region to improve quality of antenatal care and integrated disease control, WHO Information note on the use of dual hiv/syphilis rapid diagnostic tests, Rapid Syphilis Test Toolkit: a Guide to Planning, Management and Implementation. - Abstract - Europe PMC Europe PMC is an archive of life sciences journal literature. Rietmeijer CA, Mungati M, Kilmarx PH, Barr BT, Gonese E, Kularatne RS, Lewis DA, Klausner JD, Rodgers L, Handsfield HH. However, for the Multiplo Rapid TP/HIV Antibody Test, invalid results were initially obtained for eight specimens, mainly due to non or incomplete absorption of the sample, and of these, two remained invalid after repeat testing (final invalid rate 2/400=0.5%). Federal government websites often end in .gov or .mil. 2014;7:746. https://doi.org/10.1186/1756-0500-7-746. However, other items were poorly reported, such as the rationale for choosing the reference standard where alternatives exist and whether clinical information and reference standard results were available to the performers of the index tests or if clinical information and index test results were available to assessors of the reference standard. No extra individual approval should be submitted for each of the WHO evaluations on existing panels as all ethical regulations are followed. Terms and Conditions, Sex Transm Dis. Another limitation is that for the studies that used archived specimens, it was unclear what population these specimens were taken from and in what setting. More recently, in Kampala, Uganda, the introduction of syphilis testing within integrated HIV-antenatal care settings was shown to be effective, feasible and successfully capitalised on programmes that have already been established and optimised for HIV care.56. A table (Table7) shows positive and negative predictive values at three different prevalences for both markers HIV and Treponema. 2014;52(12):43947. Bookshelf Potential for false positives, preference for one blood draw over two, and shorter wait time for testing results were the highest ranked attributes by participants according to their willingness to test. Secondly, the number of freeze/thaw cycles that a specimen had already passed through before being used in this evaluation could differ between the RDTs evaluated, and also between initial testing and eventual repeat testing. Please click NO to return to the homepage. GDPR Statement|Declaration for California Compliance Law. Sign up to receive valuable updates from Abbott. https://creativecommons.org/licenses/by/3.0/igo, NIHMS1050480-supplement-Supplemental.docx, www.unaids.org/en/resources/documents/2016/Global-AIDS-update-2016, http://apps.who.int/iris/bitstream/10665/112858/1/9789241505888_eng.pdf, http://apps.who.int/iris/bitstream/10665/43782/1/9789241595858_eng.pdf, http://apps.who.int/iris/bitstream/10665/246296/1/WHO-RHR-16.09-eng.pdf?ua=1, www.iris.paho.org/xmlui/bitstream/handle/123456789/18372/9789275118702_eng.pdf?sequence=3&isAllowed=y, http://apps.who.int/iris/bitstream/10665/128048/1/9789241507431_eng.pdf?ua=1&ua=1, http://apps.who.int/iris/bitstream/10665/44619/1/9789241501750_eng.pdf?ua=1, www.who.int/diagnostics_laboratory/evaluations/151028_final_report_0179-012-00_sd_bioline_hiv_syphilis2.pdf?ua=1, www.who.int/diagnostics_laboratory/evaluations/hiv/150819_hiv_assay_report18_final_version.pdf?ua=1, http://apps.who.int/iris/bitstream/10665/252849/1/WHO-RHR-17.01-eng.pdf, www.lshtm.ac.uk/itd/crd/research/rapidsyphilistoolkit/, Ghana, Mexico, Lao Peoples Democratic Republic, Togo, Kenya and Myanmar, Archived specimens from STI clinic attendees, MedMira Multiplo Rapid TP/HIV Antibody Test, Nanjing, China, Zaria, Nigeria and Ibadan, Nigeria. Article https://doi.org/10.1136/sextrans-2015-052270.89. Laboratory assessment of SD Bioline HIV/Syphilis Duo Kit among pregnant Katrien Fransen. Published literature on the cost-effectiveness and feasibility of dual RDTs for HIV and syphilis was limited but demonstrated encouraging results that, along with performance results, could be used to support the use of these tests for screening of populations at risk for HIV and syphilis. and transmitted securely. CAS In addition, few studies included a flow diagram of participants. Only the results of the reverse order (which has since become the standard order for the test) were included in the meta-analysis. 2022 Jun 3;7(2):85-96. doi: 10.3138/jammi-2021-0021. To systematically review, critically appraise and perform a meta-analysis to evaluate the operational characteristics of dual rapid diagnostic tests (RDTs) for HIV/syphilis and evaluate whether they are cost effective, acceptable and easy to use. J Clin Micrbiol. All kits were donated by Standard Diagnostics, Chembio Diagnostics Systems, Medmira Inc. and bioLytical Laboratories through the facilitation of WHO. For syphilis diagnosis, the reported sensitivities for the SD BIOLINE HIV/Syphilis Duo Test were all between 89% and 100%, except for one study published by Black et al45 which reported a sensitivity of 67%. Newman Owiredu M, Newman L, Nzomo T, et al. Careers. Impact of maternal syphilis on outcome of pregnancy, Untreated maternal syphilis and adverse outcomes of pregnancy: a systematic review and meta-analysis, The global elimination of congenital Syphilis: rationale and strategy for Action, Maternal syphilis infection is associated with increased risk of mother-to-child transmission of HIV in Malawi, Global Health Sector Strategy on sexually transmitted infections 20162021: towards ending STIs, Elimination of mother-to-child transmission of HIV and syphilis in Cuba and Thailand, Elimination of mother-to-child transmission of HIV and syphilis, Elimination of Mother-to-Child Transmission of HIV and Syphilis in the Americas, Global estimates of syphilis in pregnancy and associated adverse outcomes: analysis of multinational antenatal surveillance data. . For many years, HIV screening programmes that use a validated testing algorithm of anti-HIV RDTs, have been widely used in low- and middle-income countries. Sex Transm Infect. %PDF-1.4 % Contributors HDG, MMT and TW planned the systematic review. A qualitative study conducted among patients seeking STI, HIV testing or antenatal care in Haiti evaluated the importance of various factors for HIV and syphilis dual testing to patients.51 The majority of study participants cited cost as the most important factor, but also selected single finger prick sampling and time to result as important attributes for dual testing. These two stages are the most contagious. Flow through (or vertical flow) immunoassays rely on the same basic principles as the more common lateral flow immunoassays (such as DPP and SD Bioline), with the flow of the fluid, vertically versus laterally, as the most obvious difference. 2015;5:e007371. Int J STD AIDS. The SD BIOLINE HIV/syphilis Duo is simple to test and can be performed by a variety of healthcare workers . Methods and findings Participants were recruited at 12 antenatal clinic sites in three states of . With the increased availability of highly sensitive, low cost rapid point-of-care tests, the ability to meet those recommendations has increased, granting wider access to quick and accurate diagnoses. Specificities ranged from 99.0 to 100%. Field evaluation of a dual rapid immunodiagnostic test for HIV and syphilis infection in Peru. Centrifugation was not described in the other IFU and was therefore not performed for INSTI, SD Bioline and DPP. Unable to load your collection due to an error, Unable to load your delegates due to an error. 2016;54(7):19224. Characterization of patient infection status, Characterization of patient infection status by simulated traditional (a) and reverse (b) algorithms, MeSH This systematic review will inform the WHO process for developing diagnostic algorithms for the use of dual RDTs for HIV and syphilis diagnosis. Specimens with discrepant results to the reference result were further characterized using the BD Macro-Vue RPR Card Tests (Becton Dickinson, USA) for the determination of non-treponemal antibodies and/or recomLine Treponema IgM (MIKROGEN, Diagnostik, Germany) for the detection of treponemal IgM antibodies. Studies published between January 2012 and the December 2016 were sought. eCollection 2022 Jun. A larger sample size would have given the study results more power. Any reactive test should always be confirmed by additional testing, as recommended by WHO [24]. The median sample sizes were 415 and 450 for HIV and syphilis, respectively, with the range for each falling between 150 and 10 000.3047, Characteristics and results of studies evaluating the diagnostic test accuracy of dual HIV/syphilis RDTs that were included in the meta-analysis according to order of date published. An evaluation of the SD Bioline HIV/syphilis duo test Based on your current location, the content on this page may not be relevant for your country. Public Report for Bioline HIV/Syphilis Duo, (PQDx 0179-012-00) HIV Self-Test. 2017 Apr;124(5):734-741. doi: 10.1111/1471-0528.14455. syphilis test line reactive). Syphilis and HIV infection: an update. Costs of prevention and care were calculated, showing that a dual HIV/syphilis rapid testing strategy was both the least costly (US$226.92 per pregnancy) and resulted in the fewest adverse pregnancy outcomes (15 370 per 100 000 pregnancies for dual HIV/syphilis testing compared with 15 820 for HIV rapid testing only, 15 779 for HIV rapid testing and syphilis laboratory testing and 15 778 for single, separate RDTs for HIV and syphilis). HIV/STI Reference Laboratory, Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium, Annelies Van Den Heuvel,Hilde Smet,Katrien Fransen&Tania Crucitti, World Health Organisation (WHO), Geneva, Switzerland, You can also search for this author in The SD BIOLINE HIV/syphilis Duo test detected syphilis with sensitivity and specificity of 97.6 and 96%, respectively. Laboratory evaluation of three rapid diagnostic test for dual detection of HIV and Treponema pallidum antibodies. This meta-analysis reviewed the results of 18 recently published studies on the performance characteristics of rapid dual HIV/syphilis tests when evaluated by manufacturer and performance in field versus laboratory settings. Article Limited data were available on the cost effectiveness, usability, ease of test interpretation and acceptability of single device dual tests for dual HIV/syphilis diagnosis. For each test band the inter-reader variability was expressed as the percentage of specimens for which initial results were differently interpreted (i.e., reactive or non-reactive or indeterminate) by the independent readers. Data entry into the standardized excel files was checked by a second person by visually comparing a print-out of the entered data with the raw data. Bristow CC, Adu-Sarkodie Y, Ondondo RO, et al. 1London Centre for Nanotechnology, University College London, London, UK, 2Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK, 3Division of STD Prevention, Center for Disease Control and Prevention, Atlanta, Georgia, USA, 4Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland. Syphilis | Health topics A to Z | CKS | NICE Dual HIV/syphilis rapid diagnostic tests The summary ROC curve in figure 2D shows that SD BIOLINE HIV/syphilis Duo Test gives the highest syphilis diagnostic accuracy, followed by the Chembio DPP HIV/Syphilis Assay and then the MedMira Multiplo Rapid TP/HIV Antibody Test. Performance Standard for band intensity for SD BIOLINE HIV/Syphilis Duo test. The The products and information contained herewith may not be accessible in all countries, and Abbott takes no responsibility for such information which may not comply with local country legal process, regulation, registration and usage. Independent of the HIV status, 30.5% (61/200) of the TP antibody positive samples were not detected by at least one of the assays after first testing, of which 42 were discrepant from the reference result (false non-reactive or indeterminate) in two or more assays (21%).
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