-, Sena AC, White BL, Sparling PF. The tests under investigation could further improve in accuracy, especially in the detection of treponemal antibodies, but are promising enough to be introduced into screening programmes. HIV screening programmes have been widely used for many years. This website is governed by applicable U.S. laws and governmental regulations. Today, a new partnership between the Clinton Health Access Initiative, MedAccess and SD Biosensor will make dual HIV/syphilis rapid diagnostic tests (RDTs) available for under US$ 1. Abbott - A Leader in Rapid Point-of-Care Diagnostics. 2016;92:4958. Studies that used archived specimens reported syphilis sensitivities and specificities ranging from 93% to 100% and 97% to 100%, respectively. Visual intensity of the color of the bands indicating positive results Bristow CC, Leon SR, Huang E, Brown BJ, Ramos LB, Vargas SK, Flores JA, Caceres CF, Klausner JD. (2017) TP: Mixed methods: Bolivia: ANC (urban) HCWs The diagnostic performance evaluation of the SD BIOLINE HIV/syphilis Novel Treponema pallidum serologic tests: a paradigm shift in syphilis screening for the 21st century. Dual HIV/syphilis rapid diagnostic tests (RDTs) can be used as the first test for pregnant women as part of antenatal care (ANC). The accuracy of syphilis testing was good (similar to single tests for syphilis), although not as high as HIV, in both laboratory and field settings and regardless of manufacturer. enVpTFIkz>tK;1K%Y},&t The sensitivity of the syphilis component was similarly unaffected, but the specificity was slightly lower when the electronic reader was used (99.7%, 95% CI 98.2% to 100%) compared with visual interpretation (100%, 95% CI 98.8% to 100%), although this was not statistically significant. 8600 Rockville Pike Three authors of this article are WHO members. However, as other studies of treponemal rapid tests have suggested, the positive detections missed by SD DUO in our study might be a result of lower levels of antibody titer remaining below the test's limit of detection due to testing at either the onset of syphilis antibody production or when encountering a PTI. Laboratory evaluations executed in an ideal situation give a good reflection of the test with optimal performance characteristics. The https:// ensures that you are connecting to the The searches were rerun immediately before the final analyses to check for recent relevant literature. 2014 Oct 22;7:746. doi: 10.1186/1756-0500-7-746. https://doi.org/10.1136/sextrans-2016-053069. 228 0 obj <>/Filter/FlateDecode/ID[]/Index[201 45]/Info 200 0 R/Length 120/Prev 241341/Root 202 0 R/Size 246/Type/XRef/W[1 2 1]>>stream After initial testing, 83.8% (335/400) of the results were in concordance with the Treponema pallidum antibodies reference results in all assays. Separate aliquots (approximate 200l) of each specimen were kept stored at 20C. P5.090 Evaluation of a Double Rapid Test For Syphilis and HIV: SD Bioline HIV/Syphilis Duo, Sensitivity and specificity of point-of-care rapid combination syphilis-HIV-HCV tests, Laboratory evaluation of three rapid diagnostic tests for dual detection of HIV and Treponema pallidum antibodies, Evaluation of the SD BIOLINE HIV/syphilis Duo assay at a rural health center in Southwestern Uganda. Several studies have reported varied performance of currently available combined HIV/syphilis RDTs [5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24]. Here are the instructions how to enable JavaScript in your web browser, Declaration for California Compliance Law, instructions how to enable JavaScript in your web browser. Titles and abstracts were checked for relevance. Understanding and Improving Syphilis Screening | AACC.org The study by Hess et al32 also assessed the performance of an integrated test for HIV, hepatitis C virus (HCV) and syphilis on a single diagnostic platform (Chembio DPP HIV-HCV-Syphilis Assay); but these results were not included in the meta-analysis because no other studies were identified that evaluated this particular RDT. -, Schmid G. Economic and programmatic aspects of congenital syphilis prevention. 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%. FOIA The 18 diagnostic accuracy studies that were included in the meta-analysis for diagnostic accuracy are detailed in table 1. Rapid point-of-care diagnostic test for syphilis in high-risk populations, Manaus, Brazil, Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations, Prevention and treatment of HIV and other sexually transmitted infections among men who have sex with men and transgender people. SD DUO HIV sensitivity and specificity, when compared to BCHD results, were 91.7 and 99.5%, respectively. eCollection 2022 Jun. It should be noted that single RDTs for syphilis have also shown sensitivities between 64% and 100% and reduced sensitivities for clinic-based evaluations compared with laboratory evaluations.54 A target product profile (TPP) for an ideal dual HIV/syphilis RDT was developed at the 1st Technical Consultation on Point-Of-Care Diagnostic Tests for Sexually Transmitted Infections convened by the WHO Reproductive Health Research Department in May 2004.59 This TPP set out the desired operational characteristics for a dual HIV/syphilis RDT and included minimal and optimal specifications for parameters such as sensitivity and specificity of HIV and syphilis diagnosis. Another limitation of the current study is the low number of HIV or syphilis non-reactive specimens (200 for each) included in the evaluation. Public Report for CheckNOW HIV SELF TEST (PQDx 0481-032-00) Syphilis rapid diagnostic tests. [25] found that 10cycles appear to have a minimal effect on the sensitivity of IgG and IgM for serological testing. Sensitivities and specificities improved slightly after repeat testing of specimens with discrepant results (results in Table2). The SD Bioline HIV/Syphilis Test has received WHO prequalification21 and is ready for use according to country-established quality performance measures. Summary ROC curves are shown for (C) HIV and (D) syphilis diagnosis. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 002.5 Evaluation of five rapid point-of-care tests for syphilis: two treponemal only, and three dual treponemal/hiv assays, O15.5 Performance Characteristics of SD Bio Line Rapid HIV-Syphilis Duo Test Kit For Simultaneous Detection of HIV and Syphilis Infections. Contributors HDG, MMT and TW planned the systematic review. For syphilis diagnosis, reported sensitivities ranged from 93% to 100% in laboratory settings, whereas for field settings, they ranged from 47% to 96%. Chiappe MA, Lopez-Torres L, Carcamo C, et al. J Assoc Med Microbiol Infect Dis Can. Multisite Laboratory evaluation of a dual human immunodeficiency virus (HIV)/Syphilis Point-of-Care Rapid Test for simultaneous detection of HIV and Syphilis infection, Evaluation of 9 rapid diagnostic tests for screening HIV infection, in Lom, Togo, Laboratory evaluation of a dual rapid immunodiagnostic test for HIV and syphilis infection, Laboratory evaluation of three dual rapid diagnostic tests for HIV and syphilis in China and Nigeria, The diagnostic performance evaluation of the SD BIOLINE HIV/syphilis duo rapid test in southern Ethiopia: a cross-sectional study, Laboratory evaluation of a Dual-Path Platform assay for rapid Point-of-Care HIV and Syphilis testing, Field evaluation of a dual rapid diagnostic test for HIV infection and syphilis in Lima, Peru, Dual rapid lateral flow immunoassay fingerstick wholeblood testing for syphilis and HIV infections is acceptable and accurate, Port-au-Prince, Haiti, Field evaluation of a dual rapid immunodiagnostic test for HIV and Syphilis infection in Peru, Evaluation of SD Bioline HIV/syphilis duo rapid test kits in Nepal, Field evaluation of Standard Diagnostics Bioline HIV/Syphilis Duo test among female sex workers in Johannesburg, South Africa, A bundle of health- syphilis test performance in the field evaluation of a novel dual HIV/syphilis rapid test - Malawi, 20142015, Laboratory evaluation of the Chembio dual path platform HIV-Syphilis assay. The result that occurred the most (at least two out of three) was recorded as the final result. CAS For SD Bioline and the Multiplo assay the IFU state that they detect IgG as well as IgM antibodies. Tests were first stratified by manufacturer (figure 2), by evaluation setting (laboratory or field) (figure 3) and by specimen type used for evaluation (including serum versus whole blood, and archived versus fresh specimens) (figures 4 and and55). The most important factors included cost, the requirement for a single finger prick sample and time to result.51 Published literature on simultaneous testing for HIV and syphilis using separate RDTs also provided evidence on the feasibility of implementation of incorporating syphilis testing into pre-existing HIV screening programmes, acceptability and cost-effectiveness.53,5658 Unfortunately, less data were available in the literature concerning ease of dual RDT interpretation. Using 200 archived serum specimens from high-risk individuals in Peru, the results of this study suggested a high sensitivity (100%, 95% CI 95.9% to 100%) and specificity (95.5%, 95% CI 89.9% to 98.5%) for HIV diagnosis and a slightly lower sensitivity (87.4%, 95% CI 81.4% to 92.0%) but a higher specificity (97%, 95% CI 84.2% to 99.9%) for syphilis diagnosis. We searched seven electronic bibliographic databases from 2012 to December 2016 with no language restrictions. Global burden of maternal and congenital syphilis in 2008 and 2012: a health systems modelling study, Syphilis, still a major cause of infant mortality, HIV: prevention of mother-to-child transmission, Global guidance on Criteria and Processes for Validation: elimination of Mother-to-Child Transmission of HIV and Syphilis. The protocol has been designed (collection, analysis and interpretation of data) and written in close collaboration with the WHO. No language restrictions were used. Privacy Syphilis in pregnancy in Tanzania. Our meta-analysis has some limitations. Forest plots are shown for the diagnostic accuracy of (A) HIV and (B) syphilis diagnosis. official website and that any information you provide is encrypted 2004;82:402409. Notably, 7% of the 200 anti-TP positive specimens were false non-reactive for TP antibodies in all four assays, all were TPA and TPPA positive and RPR negative, and another 28 were misclassified by two or three assays. Bristow et al. Most remained false non-reactive after repeat testing (see Table4). The authors wish to acknowledge the helpful guidance of the WHO HIV diagnostics team. CID. Sex Transm Dis. Study investigators were contacted if further information was required. Most studies either scored as low or unclear risk of bias where patient selection, index tests and study flow and timing were concerned. Both for the HIV and the TP seroconversion panels, the SD Bioline assay was more sensitive in early detection of antibodies compared with the other three assays and compared to the reference assays. BMC Infect Dis. Dual HIV/Syphilis RDTs have the additional advantage of using the same specimen (serum/plasma or whole blood) and test device for testing the two infections simultaneously. 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. Alternatively, click YES to acknowledge and proceed. Epub 2018 Oct 23. Diagnostic tests are available but often not accessible for populations living in the areas where they are needed the most, highlighting the importance of accessibility to simple and affordable tests, such as rapid diagnostic tests (RDTs). -, Mishra S, Boily MC, Ng V, et al. Expanding syphilis testing: a scoping review of syphilis testing interventions among key populations. The types of studies that were eligible for inclusion were evaluation studies, cost-effectiveness analyses and usability and acceptability studies. There were 12 studies that evaluated the SD BIOLINE HIV/Syphilis Duo Test, four studies that assessed the MedMira Multiplo Rapid TP/HIV Antibody Test and six that appraised the Chembio DPP HIV/Syphilis Assay, although one of these, reported by Bowen et al46 only reported the accuracy of syphilis diagnosis. 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. All kits were donated by Standard Diagnostics, Chembio Diagnostics Systems, Medmira Inc. and bioLytical Laboratories through the facilitation of WHO. In the interim, WHO has developed interim guidance for use and interpretation of these tests.65 Future work will be required to build a toolkit for programme and clinic managers, similar to the one that was established for rapid syphilis testing,66 which would provide guidance on planning, management and implementation of dual RDTs for HIV and syphilis. As a library, NLM provides access to scientific literature. Simple-to-use dual HIV/syphilis RDTs, which are recommended by WHO, can integrate and streamline services, and enable more countries to eliminate mother-to-child transmission of HIV and syphilis. All assays were performed by one operator (blinded to the reference results) according to the manufacturers instructions for use (IFU). RDTs, rapid diagnostic tests; ROC, receiver operating characteristic. This systematic review will inform the WHO process for developing diagnostic algorithms for the use of dual RDTs for HIV and syphilis diagnosis. Two studies identified improvements in sensitivity when RPR titre values were included to identify active syphilis.4143,45,46 This suggests that despite lower overall reported sensitivities, these tests may preferentially detect active syphilis over old or treated syphilis, which is clinically advantageous. 2014;7:746. https://doi.org/10.1186/1756-0500-7-746. Gaitn-Duarte HG, Newman L, Laverty M, et al. eCollection 2022 Mar. Evaluation of the SD Bioline HIV/Syphilis Duo assay at a rural health center in Southwestern Uganda. Fakile Y, Hoover K, Delaney K, Wesolowski L, Asef C, Sun Y, Park I, Chow J, Schapiro J, Novak S, Philip S, Karem K. Evaluation of five rapid point-of-care tests for syphilis: two treponemal only, and three dual treponemal/HIV assays. Multisite laboratory evaluation of a dual human immunodeficiency virus (HIV)/syphilis point-of-care rapid test for simultaneous detection of HIV and syphilis infection. In this respect the WHO published a note in early 2017 in order to provide advice for countries planning to introduce the HIV/syphilis dual test in antenatal care settings. Our results demonstrate excellent performance for the HIV component of the dual RDTs for HIV and syphilis and good performance for the syphilis component, similar to the performance of single syphilis RDTs.54,62 When considering performance, cost-effectiveness and feasibility, these tests should be prioritised for use in settings and among populations where HIV and syphilis screening are recommended, namely, antenatal care settings. eCollection 2019. A field evaluation of a rapid dual immunoassay for human The specificity values reported for syphilis diagnosis using SD BIOLINE HIV/Syphilis Duo Test ranged from 91% to 100% (figure 2B). [8, 11] and Black et al. Minimum standards for HIV RDTs have been suggested to be >99% for sensitivity and >98% specificity.60. Sex Transm Dis. The introduction of rapid point-of-care tests (RDTs) that can detect both HIV and syphilis, using one single blood specimen, would be a promising tool to integrate the . [Computer program] Version 5.3.5. Accessibility Rogoziska E, Kara-Newton L, Zamora JR, Khan KS. Laboratory assessment of SD Bioline HIV/Syphilis Duo Kit among pregnant Diagnostic accuracy for syphilis appears to be higher in studies that used serum rather than whole blood, with improved sensitivity ranges being reported (between 93% and 100% for studies that used serum, compared with 47% and 96% for studies that used whole blood) and specificities (93% to 100% for studies using serum compared with 91% to 100% for studies that used whole blood) (figure 4B). . This site needs JavaScript to work properly. Meta-analysis of the diagnostic accuracy of dual HIV/syphilis RDTs, stratified according to the setting in which the evaluation was conducted. 2013;89(Suppl 1):A363. Herald Souza dos Reis Yan Corra Rodrigues Maria Luiza Bazzo We field-assessed the accuracy, acceptability, and feasibility of the SD BIOLINE HIV/Syphilis Duo rapid diagnostic test in three. Terms and Conditions, 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%). In laboratory settings, the sensitivity of HIV diagnosis ranged from 94% to 99%, and specificity from 92% to 100%. 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. Sixty men and transgender . All people with suspected syphilis should be referred to a genito-urinary medicine (GUM) clinic or other local specialist sexual health service. The ranges for sensitivity and specificity reported for the syphilis component of MedMira Multiplo Rapid TP/HIV Antibody Test were 81% to 95% and 93% to 100%, respectively. The SD BIOLINE HIV/Syphilis Duo test is a solid phase immunochromatographic assay for the qualitative detection of antibodies to all isotypes(IgG, IgM, and IgA) specific to HIV-1/2 and/or Treponema pallidum (TP) simultaneously in human serum, plasma, or whole blood. Performance characteristics of SD Bioline Rapid HIV-Syphilis Duo test for simultaneous detection of HIV and Syphilis infection. Dual HIV/syphilis rapid diagnostic tests - HIV : Sensitivity 99.91% / Specificity 99.67% This makes the sensitivity and specificity calculations very comparable between the four assays. In particular, studies were reported as having an unclear risk of bias for the reference standard if they did not state that results of the reference standard were interpreted without knowledge of the results of the index tests. 2014;52(12):43947. 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. For in vitro diagnostic use only. Dual HIV/syphilis RDT may be selected and validated as Assay 1 of these testing strategies. endstream endobj startxref Bristow CC, Adu-Sarkodie Y, Ondondo RO, et al. Sex Transm Dis. On the other hand, non-treponemal antibodies decrease and may disappear over time, especially after successful treatment. In comparison, the SD BIOLINE HIV/Syphilis Duo Test and Chembio DPP HIV/Syphilis Assay gave higher levels of sensitivities, with a range of 98% to 100% for each. Int J STD AIDS. Performance of a Dual Human Immunodeficiency Virus/Syphilis Rapid Test Compared With Conventional Serological Testing for Syphilis and Human Immunodeficiency Virus in a Laboratory Setting: Results From the Zimbabwe STI Etiology Study. Fhn qzNn4 Sexually transmitted infections, such as HIV and syphilis, are one of the major health care problems worldwide, especially in low- and middle income countries. For the syphilis component, among pregnant women or in areas with a low prevalence of syphilis, treatment should be considered for anyone with a reactive anti-treponemal test result (i.e. However, we believe that this evaluation reflects the performance of the four assays. A study published by Owusu-Edusei et al58 simulated the cost-effectiveness of using separate laboratory-based diagnosis for HIV and syphilis in China. Field evaluation of a dual rapid diagnostic test for HIV infection and syphilis in Lima, Peru. The ability of the assays to detect various levels of HIV antibodies was tested by using eight HIV seroconversion panels (PRB914, PRB925, PRB926, PRB930, PRB955, PRB965, PRB968 and PRB 969; SeraCare Life Science Inc., USA), one anti-HIV mixed titre performance panel (PRB205; SeraCare Life Science Inc., USA) and the WHO international biological reference preparation panel (catalogue number 02/210; NIBSC). Specimens were not thawed more than twice. BMC Research Notes. Sexually transmitted infections (STIs) are one of the major health care problems worldwide, especially in resource-poor settings. FN, false negative; FP, false positive; RDTs, rapid diagnostic tests; ROC, receiver operating characteristic; TN, true negative; TP, true positive. The proportion of clients tested who received timely results increased by 30.8% for HIV and 35.7% for syphilis in pregnant women. The IFU of the DPP assay does not specify the type of antibody but states that individuals with syphilis who are receiving antibacterial therapy may produce false negative results.
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