Field evaluation of a dual rapid Human Immunodeficiency Virus and treponemal syphilis rapid test in community-based clinics in Los Angeles and New York

Stafylis, Chrysovalantis; Bristow, Claire; Natoli, Lauren; Salow, Katheryn R; Davidson, Emma; Granados, Yancy; McGrath, Mark R.; Klausner, Jeffrey D.

doi:10.1016/j.diagmicrobio.2018.10.002

Cited by 6 publications

(7 citation statements)

References 7 publications

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“…Therefore, it would be of interest, to focus future research on the effect of the implementation of dual treponemal and non-treponemal POCTs on syphilis-related pregnancy outcomes, as well as testing and treatment rates [62]. Furthermore, studies implementing syphilis POCTs in established HIV screening programs did show promising results, suggesting a possible way to efficiently introduce syphilis POCT screening in low-resource settings [52,[54][55][56].…”

Section: Resultsmentioning

confidence: 99%

The impact of antenatal syphilis point of care testing on pregnancy outcomes: A systematic review

Brandenburger

Ambrosino

2021

PLoS ONE

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Background Mother-to-child transmission of syphilis remains a leading cause of neonatal death and stillbirth, disproportionally affecting women in low-resource settings where syphilis prevalence rates are high and testing rates low. Recently developed syphilis point-of-care tests (POCTs) are promising alternatives to conventional laboratory screening in low-resource settings as they do not require a laboratory setting, intensive technical training and yield results in 10–15 minutes thereby enabling both diagnosis and treatment in a single visit. Aim of this review was to provide clarity on the benefits of different POCTs and assess whether the implementation of syphilis POCTs is associated with decreased numbers of syphilis-related adverse pregnancy outcomes. Methods Following the PRISMA guidelines, three electronic databases (PubMed, Medline (Ovid), Cochrane) were systematically searched for intervention studies and cost-effectiveness analyses investigating the association between antenatal syphilis POCT and pregnancy outcomes such as congenital syphilis, low birth weight, prematurity, miscarriage, stillbirth as well as perinatal, fetal or infant death. Results Nine out of 278 initially identified articles were included, consisting of two clinical studies and seven modelling studies. Studies compared the effect on pregnancy outcomes of treponemal POCT, non-treponemal POCT and dual POCT to laboratory screening and no screening program. Based on the clinical studies, significantly higher testing and treatment rates, as well as a significant reduction (93%) in adverse pregnancy outcomes was reported for treponemal POCT compared to laboratory screening. Compared to no screening and laboratory screening, modelling studies assumed higher treatment rates for POCT and predicted the most prevented adverse pregnancy outcomes for treponemal POCT, followed by a dual treponemal and non-treponemal POCT strategy. Conclusion Implementation of treponemal POCT in low-resource settings increases syphilis testing and treatment rates and prevents the most syphilis-related adverse pregnancy outcomes compared to no screening, laboratory screening, non-treponemal POCT and dual POCT. Regarding the benefits of dual POCT, more research is needed. Overall, this review provides evidence on the contribution of treponemal POCT to healthier pregnancies and contributes greater clarity on the impact of diverse diagnostic methods available for the detection of syphilis.

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Section: Resultsmentioning

confidence: 99%

The impact of antenatal syphilis point of care testing on pregnancy outcomes: A systematic review

Brandenburger

Ambrosino

2021

PLoS ONE

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“…15,18,34 Across numerous studies, study participants seeking regular screening for sexually transmitted infections, medical consultation, or a biological check-up, suspected of having a sexually transmitted infection, women seeking syndromic care, or sexually active women aged 14-49 years presenting with lower urinary tract infection symptoms were included. 20,22,24,25,[27][28][29][30][31]38 Many studies focused on key at-risk populations such as men who have sex with men, transgender populations, Aboriginal populations, people who inject drugs, women with at least two recent partners, female sex workers, and labourers who have paid for sex. 17,19,21,23,26,32,33,[35][36][37] Additional populations of interest included pregnant women, women who are infertile, and patients with genital ulcer disease (table 1).…”

Section: Resultsmentioning

confidence: 99%

“…Rapid multiplexed immunochromatographic tests complement the usage of RNAAT platform testing and Review might prove useful to fill timely access and screening gaps for simulatenous testing as shown in many studies [32][33][34][35][36][37][38]41 done in diverse outpatient clinics or mobile units at or near the point of care. These tests are generally best suited for application in remote or low-resource areas at or near the point of care, although screening can also be done by rapid sample collection in the field followed by sample testing with an RNAAT platform at a centralised facility.…”

Section: Discussionmentioning

confidence: 99%

“…32,37 The INSTI Multiplex HIV-1/HIV-2/ syphilis antibody test kit (BioLytical, Richmond, BC, Canada) yielded suboptimal sensitivity (56•8% [44•7-68•2]) and high specificity (98•5% [95•7-99•7]; table 3). 38 For the detection of hepatitis B virus (table 3), the sole immunochromatographic test that could detect the virus was HIV/HCV/HBsAg Triplex (Biosynex, Strasbourg, France; blood), which yielded optimal diagnostic accuracy. 34 Similar to hepatitis B virus values, the HIV/HCV/ HBsAg Triplex (blood) yielded ideal sensitivity and specificity.…”

Section: Reviewmentioning

confidence: 99%

“…34 The SD Bioline HIV/Syphilis Duo Test (venous blood [plasma] or fingerstick blood) and the INSTI Multiplex HIV-1/HIV-2/ syphilis antibody test (fingerstick blood) were shown to yield optimal or near-optimal sensitivity and specificity. 32,36,38 The quality assessment as evaluated by the QUADAS-2 checklist is described in the appendix (pp 1-2). An important subset of questions showed positive answers for the majority of studies, including appropriate study design and use of a quality index and reference standard tests, among others.…”

Section: Reviewmentioning

confidence: 99%

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Multiplexed rapid technologies for sexually transmitted infections: a systematic review

et al. 2022

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Multiplexed technologies for sexually transmitted infections offer a convenient diagnostics option to screen, confirm, and treat multiple pathogens simultaneously. Due to scarce published real-world diagnostic performance data, we did a systematic review. Two reviewers searched major databases for data published between Jan 1, 2009, and April 20, 2020, and abstracted and analysed sensitivity and specificity data from 24 studies, which assessed 17 multiplex rapid nucleic acid amplification test platforms and seven multiplex immunochromatographic devices. Overall, these studies evaluated 19 sexually transmitted infections in 26 126 individuals. High sensitivity and specificity were shown for rapid nucleic acid amplification platform tests and immunochromatographic devices, with performance varying by pathogen, device, seropositivity, and subpopulation screened. As most devices yielded more than 95% sensitivity and specificity, immunochromatographic tests and rapid nucleic acid amplification test platforms can be advised for screening and confirmatory use. These highly accurate devices are appropriate for integrated, rapid screening initiatives for sexually transmitted infections to screen and treat many of these infections simultaneously, for antimicrobial stewardship, and for disease elimination programmes.

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Multiplexed technologies for sexually transmitted infections: global evidence on patient-centered and clinical health outcomes

et al. 2021

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IntroductionConventional care packages around screening for sexually transmitted infections (STIs) entail multiple clinic visits and precipitate losses to follow-up. To prevent these losses, multiplexed technologies for STIs (immunochromatographic tests/devices/assays and molecular assays that can screen multiple pathogens or multiple strains of one STI) can yield same-day results in a single visit. Research evidence of patient-centred (preference, satisfaction) and clinical health outcomes (feasibility, case positivity, uptake, impact) has not been synthesised. We conducted a systematic review to fill this gap.MethodsFor the period 2009–2020, two independent reviewers searched PubMed and Embase, retrieved 4440 citations and abstracted data from 42 relevant studies.ResultsOf 42 studies, 10 (23.8%) evaluated multiplexed immunochromatographic and 32 (76.2%) molecular assays. Outcomes were reported as follows: preference (n=3), satisfaction (n=2), uptake (n=1), feasibility (n=2), case positivity (n=42) and impact (n=11). Screened populations included various at-risk groups. A majority (86.1%–92.4%) of participants preferred (60.2%–97.2%) multiplexed technologies (over conventional testing). Compared with conventional lab-based testing, test uptake improved by 99.4% (hepatitis C), 99.6% (Trichomonas vaginalis), 78.6% (hepatitis B) and 42.0% (HIV). Varying case positivities were documented depending on populations screened: HIV (1.8%–29.3%), hepatitis B (1.1%–23.9%), hepatitis C (0.5%–42.2%), Chlamydia trachomatis (2.8%–30.2%), Neisseria gonorrhoeae (0.0%–30.3%) and T. vaginalis (0.0%–32.7%). Regarding impact, 70.0%–100.0% of screened participants were linked to care, with result turnaround times ranging from 14 min (immunochromatographic assays) to 300 min (molecular assays).ConclusionsCompared with conventional lab-based testing, rapid multiplexed technologies were preferred by testees and led to quicker turnaround times for many STIs yielding same-day results thereby allowing to initiate rapid linkages to care. They were further shown to be highly feasible and impactful for detection and treatment facilitation. Based on these promising results, multiplexed technologies offer potential to screen at-risk populations to reduce onward STI transmission worldwide.

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Field evaluation of a dual rapid Human Immunodeficiency Virus and treponemal syphilis rapid test in community-based clinics in Los Angeles and New York

Cited by 6 publications

References 7 publications

The impact of antenatal syphilis point of care testing on pregnancy outcomes: A systematic review

The impact of antenatal syphilis point of care testing on pregnancy outcomes: A systematic review

Multiplexed rapid technologies for sexually transmitted infections: a systematic review

Multiplexed technologies for sexually transmitted infections: global evidence on patient-centered and clinical health outcomes

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