Single-test syphilis serology: A case of not seeing the forest for the trees.

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.

[Recent Advances in Laboratory Diagnosis of Syphilis]. / Sifilisin Laboratuvar Tanisinda Güncel Gelismeler.

Syphilis is a sexually transmitted disease caused by Treponema pallidum subsp. pallidum. This historical disease has diverse clinical manifestations making laboratory testing crucial for optimal patient management. Direct detection of T.pallidum by dark-field microscopy is possible when lesions are present. Culture of the bacteria is complex and not performed routinely. There is no well-validated commercially available polymerase chain reaction (PCR) test. Serological tests are currently the most common diagnostic methods adapted in clinical laboratories. They provide a presumptive diagnosis and used for screening, diagnosis, and follow-up of the treatment. They are divided into two groups, named as nontreponemal and treponemal tests and performed by the application of the traditional algorithm, the reverse sequence algorithm or European Centre for Disease Prevention and Control (ECDC) algorithm. The traditional algorithm starts with a nontreponemal test and a reactive result is confirmed with a treponemal test. In the reverse sequence algorithm, a treponemal test is used for screening and a reactive result is confirmed by a quantitative nontreponemal test. When the nontreponemal test is negative, a second different treponemal test preferably T.pallidum particle agglutination test (TPPA) is used. The ECDC algorithm recommends screening by a treponemal test such as T.pallidum enzym immunoassay (TP-EIA), T.pallidum chemiluminescence immunoassay (CIA) and if reactive, a reflex confirmatory treponemal test is performed. The treponemal tests become reactive a few weeks after infection and remain reactive even after successful treatment. The nontreponemal tests are used to assess disease activity and response to therapy. Serological tests have many limitations such as false-positivity, falsenegativity in various stages of the disease and also challenging difficulties when evaluating response to therapy. In recent years, rapid syphilis tests which are mostly treponemal-specific tests have been developed for high-prevalence populations in resource limited settings. There has been requirement for the utility of standart PCR and IgM testing in the diagnosis of congenital syphilis and neurosyphilis cases. In this review article, it was aimed to present the diagnostic tests, the algorithms, the correct indications for testing and interpretation of the test results to the likely corresponding clinical stage of the disease with in the perspective of recent advances.

Performance evaluation of eight treponemal antibody tests in China.

In this study, the performance of 8 commercially available treponemal antibody tests was evaluated. Higher specificity was achieved in the automated chemiluminescence immunoassays(CIA assays) than enzyme-linked immunosorbent (ELISA) assays, but no significant differences were found in terms of the sensitivity levels. The levels of test sensitivity did not differ by HIV status and TRUST titer but did differ by clinical stage. The results of WB-IgG revealed that the level of antibodies against the 4 antigens showed an upward trend with the development of the clinical stages of syphilis, reaching a peak in tertiary syphilis and then decreasing. The present results supported the good performance of CIA tests used in the blood source screening of syphilis, which reduced the waste of plasma. The reaction intensities of anti-TP17 and TP47 antibodies in past treated syphilis samples were considerably weak and were expected to be used for monitoring the therapeutic effect of syphilis.

Diffuse lymphadenopathy and fever without a rash: an atypical presentation of secondary syphilis.

A woman in her 30s presented to the emergency department with 4 days of fever, headache and back pain. The patient was admitted for pain control, inability to tolerate oral intake and intravenous antibiotics for presumed diagnosis of pyelonephritis. Following admission, CT of the abdomen/pelvis showed multiple prominent pelvic and inguinal lymph nodes, and the patient was noted to have anterior and posterior cervical and submandibular lymphadenopathy on examination. The differential diagnosis was broadened to infectious, haematological, malignant and autoimmune aetiologies of diffuse lymphadenopathy. Workup included serum studies, imaging, lumbar puncture and lymph node biopsy. Rapid plasma reagin (RPR) returned positive with titre 1:16 and confirmatory reactive Treponema pallidum particle agglutination. With an otherwise unrevealing workup, the diagnosis of secondary syphilis was confirmed. This case highlights the differential and diagnostic approach for diffuse lymphadenopathy and an unusual presentation of secondary syphilis. Additionally, it indicates that secondary syphilis can be present even with a relatively low RPR titre.

COVID-19 mRNA Vaccines May Cause False Reactivity in Some Serologic Laboratory Tests, Including Rapid Plasma Reagin Tests.

OBJECTIVES: Acute viral infections and some vaccines have been shown to increase false positivity in serologic assays. We assessed if the messenger RNA coronavirus disease 2019 (COVID-19) vaccines could cause false reactivity in common serologic assays in a pilot longitudinal cohort. METHODS: Thirty-eight participants with sera available prevaccination, 2 weeks after each vaccine dose, and monthly thereafter for up to 5 months were tested for common infectious disease serologies and antiphospholipid syndrome (APS) serology markers on the BioPlex 2200, Sure-Vue rapid plasma reagin (RPR), and Macro-Vue RPR. Twenty-two participants received the Moderna vaccine and 16 received the Pfizer vaccine. RESULTS: Most assays had no change in reactivity over the course of the sample draws, including APS markers. Epstein-Barr virus immunoglobulin G (IgG), measles IgG, and rubella immunoglobulin M all had possible false reactivity in one to two participants. RPR tests demonstrated false reactivity, with baseline nonreactive participant samples becoming reactive following vaccination. There were more false reactive participants (7/38) in the BioPlex RPR than in the Sure-Vue (2/38) and Macro-Vue (1/38) tests. All falsely reactive RPR tests were in participants who received the Moderna vaccine. CONCLUSIONS: Serologic assays with results that do not fit the clinical picture following COVID-19 vaccination should be repeated. Effects of false reactivity can last more than 5 months in some assays. In particular, RPR is susceptible to false reactivity, and there is variability among assays. Larger longitudinal studies are needed to determine the incidence and window of false reactivity.

Correlation of Treponemal Chemiluminescent Microparticle Immunoassay Screening Test Signal Strength Values With Reactivity of Confirmatory Testing.

BACKGROUND: Automated chemiluminescent microparticle immunoassays (CMIAs) are the most common first step at high-volume laboratories for syphilis screening. If the initial screening test is reactive, 1 more treponemal test is required, resulting in increased cost. In this multicenter study, we aimed to determine the correlation between the CMIA signal-to-cutoff ratio (S/Co) and the confirmatory tests to reduce unnecessary confirmatory testing. METHODS: Eight hospitals from 5 provinces participated in this study. All laboratories used Architect Syphilis TP CMIA (Abbott Diagnostics, Abbott Park, IL) for initial screening. Treponema pallidum hemagglutination (TPHA), rapid plasma reagin (RPR), and fluorescent treponemal antibody absorption (FTA-ABS) were used as confirmatory tests according to the reverse or European Centre for Disease Prevention and Control algorithms. A receiver operating characteristic analysis was used to determine the optimal S/Co ratio to predict the confirmation results. RESULTS: We evaluated 129,346 serum samples screened by CMIA between January 2018 and December 2020. A total of 2468 samples were reactive; 2247 (91%) of them were confirmed to be positive and 221 (9%) were negative. Of the 2468 reactive specimens, 1747 (70.8%) had an S/Co ratio ≥10.4. When the S/Co ratios were ≥7.2 and ≥10.4, the specificity values were determined to be 95% and 100%, respectively. In a subgroup of 75 CMIA-positive patients, FTA-ABS was performed and 62 were positive. Among these FTA-ABS-positive patients, 24 had an S/Co ratio <10.4, and negative TPHA and RPR. CONCLUSIONS: We propose a potentially cost-effective reverse screening algorithm with a treponemal CMIA S/Co ratio ≥10.4, obviating the need for secondary treponemal testing in about 71% of the screening-reactive samples. This would substantially reduce the confirmatory testing volume and laboratory expenses. However, in high-risk group patients with CMIA positive results, S/Co ratio <10.4, and negative TPHA and RPR, FTA-ABS may be used for confirmation.

Diagnosis and Treatment of Sexually Transmitted Infections: A Review.

Importance: Approximately 1 in 5 adults in the US had a sexually transmitted infection (STI) in 2018. This review provides an update on the epidemiology, diagnosis, and treatment of gonorrhea, chlamydia, syphilis, Mycoplasma genitalium, trichomoniasis, and genital herpes. Observations: From 2015 to 2019, the rates of gonorrhea, chlamydia, and syphilis increased in the US; from 1999 to 2016, while the rates of herpes simplex virus type 1 (HSV-1) and HSV-2 declined. Populations with higher rates of STIs include people younger than 25 years, sexual and gender minorities such as men and transgender women who have sex with men, and racial and ethnic minorities such as Black and Latinx people. Approximately 70% of infections with HSV and trichomoniasis and 53% to 100% of extragenital gonorrhea and chlamydia infections are asymptomatic or associated with few symptoms. STIs are associated with HIV acquisition and transmission and are the leading cause of tubal factor infertility in women. Nucleic acid amplification tests have high sensitivities (86.1%-100%) and specificities (97.1%-100%) for the diagnosis of gonorrhea, chlamydia, M genitalium, trichomoniasis, and symptomatic HSV-1 and HSV-2. Serology remains the recommended method to diagnose syphilis, typically using sequential testing to detect treponemal and nontreponemal (antiphospholipid) antibodies. Ceftriaxone, doxycycline, penicillin, moxifloxacin, and the nitroimidazoles, such as metronidazole, are effective treatments for gonorrhea, chlamydia, syphilis, M genitalium, and trichomoniasis, respectively, but antimicrobial resistance limits oral treatment options for gonorrhea and M genitalium. No cure is available for genital herpes. Effective STI prevention interventions include screening, contact tracing of sexual partners, and promoting effective barrier contraception. Conclusions and Relevance: Approximately 1 in 5 adults in the US had an STI in 2018. Rates of gonorrhea, chlamydia, and syphilis in the US have increased, while rates of HSV-1 and HSV-2 have declined. Ceftriaxone, doxycycline, penicillin, moxifloxacin, and the nitroimidazoles are effective treatments for gonorrhea, chlamydia, syphilis, Mycoplasma genitalium, and trichomoniasis, respectively, but antimicrobial resistance limits oral therapies for gonorrhea and Mycoplasma genitalium, and no cure is available for genital herpes.

Risk Factors for Syphilis at a Large Urban Emergency Department.

BACKGROUND: The prevalence of syphilis is increasing in the United States. The emergency department (ED) is an important setting to screen and treat underserved populations. To tailor testing protocols to the local population, we aimed to identify risk factors for syphilis positivity in ED patients. METHODS: We performed a retrospective analysis of ED patients who were screened for syphilis between November 2018 and August 2020. Patients were screened for Treponema pallidum antibody using a multiplex flow immunoassay, and positive results were confirmed by rapid plasma reagin or T. pallidum particle agglutination. Risk factors for new syphilis diagnoses were identified using multiple logistic regression. RESULTS: We screened 1974 patients for syphilis (mean age, 37 ± 16 years; 56% female). We identified 201 patients with new infections without previous treatment. Independent risk factors for a new diagnosis of syphilis included housing status (undomiciled, 23% [60 of 256]; domiciled, 9% [133 of 1559]; adjusted odds ratio [aOR], 1.9 [95% confidence interval {CI}, 1.2-3.0]), history of HIV (positive, 44% [28 of 63]; negative, 9% [173 of 1893]; aOR, 5.8 [95% CI, 3.0-11.2]), tobacco use (positive, 15% [117 of 797]; negative, 4% [29 of 665]; aOR, 2.4 [95% CI, 1.5-3.9]), and illicit drug use (positive, 14% [112 of 812]; negative, 8% [52 of 678]; aOR, 2.2 [95% CI, 1.0-2.5]). CONCLUSIONS: Undomiciled housing status, history of HIV, history of tobacco use, and history of illicit drug use were independently associated with a new diagnosis of syphilis in the ED. Broadening targeted syphilis screening algorithms beyond sexually transmitted disease-related complaints could help identify new syphilis cases for treatment.

New screening approach to detecting congenital syphilis in China: a retrospective cohort study.

BACKGROUND: Diagnosis of congenital syphilis (CS) is not straightforward and can be challenging. This study aimed to evaluate the validity of an algorithm using timing of maternal antisyphilis treatment and titres of non-treponemal antibody as predictors of CS. METHODS: Confirmed CS cases and those where CS was excluded were obtained from the Guangzhou Prevention of Mother-to-Child Transmission of syphilis programme between 2011 and 2019. We calculated sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) using receiver operating characteristics (ROC) in two situations: (1) receiving antisyphilis treatment or no-treatment during pregnancy and (2) initiating treatment before 28 gestational weeks (GWs), initiating after 28 GWs or receiving no treatment for syphilis seropositive women. RESULTS: Among 1558 syphilis-exposed children, 39 had confirmed CS. Area under the curve, sensitivity and specificity of maternal non-treponemal titres before treatment and treatment during pregnancy were 0.80, 76.9%, 78.7% and 0.79, 69.2%, 88.7%, respectively, for children with CS. For the algorithm, ROC results showed that PPV and NPV for predicting CS were 37.3% and 96.4% (non-treponemal titres cut-off value 1:8 and no antisyphilis treatment), 9.4% and 100% (non-treponemal titres cut-off value 1:16 and treatment after 28 GWs), 4.2% and 99.5% (non-treponemal titres cut-off value 1:32 and treatment before 28 GWs), respectively. CONCLUSIONS: An algorithm using maternal non-treponemal titres and timing of treatment during pregnancy could be an effective strategy to diagnose or rule out CS, especially when the rate of loss to follow-up is high or there are no straightforward diagnostic tools.

Serologic false-positive reactions for syphilis in children of adenoidal hypertrophy:2 case reports and review of the literature.

Adenoid hypertrophy (AH) is a common disease in children. We describe two cases of AH in children with syphilis enzyme-linked immunosorbent assay (EIA) for false-positive. To our knowledge, there are few reports of false-positive in syphilis EIA in children with AH. Two cases of AH children with syphilis EIA positive samples were confirmed by TPPA and LIA, both showed negative reaction. Therefore, the occurrence of syphilis EIA positive reactions in such diseases should dramatically arouse the attention of docimasters and doctors so as to avoid misdiagnosis caused by false-positive in children with AH.

Pseudoretinitis pigmentosa due to syphilis: a case report and literature review / Pseudorretinose pigmentária por sífilis: relato de caso e revisão de literatura

ABSTRACT Syphilis is a sexually transmitted infection caused by the spirochete Treponema pallidum. Ocular involvement can occur at any time, and it may affect 10% of patients in the secondary stage, and from 2% to 5% in the tertiary stage. Uveitis is the most common presentation of ocular syphilis, affecting 0.4% to 8% of patients with systemic disease. Chorioretinitis is the most common posterior alteration. We present the case of a 53-year-old male patient, presenting with bilateral low visual acuity and nyctalopia for 3 years. His physical examination revealed decreased pupillary reflex, anterior vitreous cells, physiologic papillae, arteriolar attenuation, reduced foveal reflex, diffuse retinal pigment epithelium atrophy, peripapillary and perivascular punctate pigment accumulation and peripheral chorioretinitis. Full-field electroretinogram was extinct in both eyes. Treponemal syphilis test was positive. Previously diagnosed as retinitis pigmentosa, evolved to blindness, despite proper treatment. Our case shows syphilis as a significant cause of blindness. Atypical presentations of retinitis pigmentosa must warn ophthalmologists to etiologies of pseudoretinitis pigmentosa, such as syphilis.

RESUMO A sífilis é uma infecção sexualmente transmissível causada pela espiroqueta Treponema pallidum. A sífilis ocular pode ocorrer em qualquer estágio da doença, chegando a 10% na forma secundária e a 2% a 5% em sua forma terciária. A uveíte é a manifestação ocular mais comum, ocorrendo em 0,4% a 8% dos pacientes com a doença sistêmica. A coriorretinite é a manifestação mais comum do segmento posterior. Apresentamos o caso de um paciente do sexo masculino, 53 anos, com queixa de baixa acuidade visual e nictalopia há ٣ anos. Seu exame físico revelou lentificação dos reflexos pupilares, celularidade no vítreo anterior, papilas fisiológicas, atenuação arteriolar, redução do reflexo foveal, atrofia difusa do epitélio pigmentar da retina, acúmulo punctato de pigmento em regiões peripapilar e perivascular e coriorretinite periférica. Eletrorretinograma de campo total extinto em ambos os olhos. O teste treponêmico foi positivo. Foi previamente diagnosticado como portador de retinose pigmentar, evoluindo com cegueira, a despeito do tratamento correto instituído. Esse caso mostra a sífilis como importante causadora de cegueira. Casos atípicos de retinose pigmentar devem alertar o oftalmologista para causas de pseudorretinose pigmentar, como a sífilis.

Recognizing and limiting syphilis to prevent congenital syphilis.

Syphilis is on the rise in every age and ethnicity group across the United States. The rate of congenital syphilis has started to rise as well, increasing the need for syphilis screening before pregnancy occurs. Raising awareness for syphilis screening, especially among sexually active women, is important, as the implications of this disease have lifelong effects for mother and child.

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.

BACKGROUND: Men who have sex with men (MSM) bear a high burden of syphilis infection. Expanding syphilis testing to improve timely diagnosis and treatment is critical to improve syphilis control. However, syphilis testing rates remain low among MSM, particularly in low- and middle-income countries. We describe the protocol for a randomised controlled trial (RCT) to assess whether provision of syphilis self-testing services can increase the uptake of syphilis testing among MSM in China. METHODS: Four hundred forty-four high-risk MSM will be recruited online and randomized in a 1:1:1 ratio to (1) standard syphilis self-testing arm; (2) a self-testing arm program enhanced with crowdsourcing and a lottery-based incentive, and (3) a standard of care (control). Self-testing services include a free syphilis self-test kit through the mail at monthly intervals. Participants in the lottery incentive arm will additionally receive health promotion materials generated from an open crowdsourcing contest and be given a lottery draw with a 10% chance to win 100 RMB (approximately 15 US Dollars) upon confirmed completion of syphilis testing. Syphilis self-test kits have step-by-step instructions and an instructional video. This is a non-blinded, open-label, parallel RCT. Participants in each arm will be followed-up at three and 6 months through WeChat (a social media app like Facebook messenger). Confirmation of syphilis self-test use will be determined by requiring participants to submit a photo of the used test kit to study staff via secure data messaging. Both self-testing and facility-based testing will be ascertained by sending a secure photographic image of the completed kit through an existing digital platform. The primary outcome is the proportion of participants who tested for syphilis in the past 3 months. DISCUSSION: Findings from this study will provide much needed insight on the impact of syphilis self-testing on promoting routine syphilis screening among MSM. The findings will also contribute to our understanding of the safety, effectiveness and acceptability of syphilis self-testing. These findings will have important implications for self-testing policy, both in China and internationally. TRIAL REGISTRATION: ChiCTR1900022409 (10 April, 2019).

Comparison and evaluation of Abbott chemiluminescent microparticle immunoassay and ChIVD light-initiated chemiluminescent assay in the detection of Treponema pallidum antibody.

BACKGROUND: Laboratory tests play an important role in the diagnosis of syphilis. This study aimed to compare and assess the performance of the Abbott chemiluminescent microparticle immunoassay (CMIA) and the ChIVD light-initiated chemiluminescent assay (LICA) in the detection of Treponema pallidum (TP) antibody. METHODS: A total of 10 498 serum samples were detected with two assays, and the Treponema pallidum particle agglutination assay (TPPA) and recombinant immunoblot assay (RIBA) methods were used for confirmation. The sensitivity, specificity, positive predictive value, and negative predictive value of the Abbott CMIA and ChIVD LICA were calculated. The coincidence rate between two assays was also evaluated. The causes of false positive and false negative of two assays were studied. RESULTS: For the Abbott CMIA and ChIVD LICA, the sensitivity was 94.44% and 98.15%, the specificity was 99.89% and 99.81%, the positive predictive value was 93.29% and 88.83%, and the negative predictive value was 99.91% and 99.97%, respectively. The coincidence rate between Abbott CMIA and ChIVD LICA was 99.26%, and κ value was .790. The disease of infertility, hypertensive disease, liver disease, and cancer were the common causes of false positive in both assays, while infertility was also the main reason lead to false negative. CONCLUSION: Our results demonstrated that the Abbott CMIA and ChIVD LICA generally had high sensitivity and specificity and therefore may be suitable for the detection of TP antibody and screening for syphilis.

Prevalencia de marcadores serológicos en donantes de sangre de Boyacá, Colombia, 2014-2015 / Prevalence of serological markers in blood donors in Boyaca, Colombia, 2014-2015

Introducción: La infección que se ocasiona por la transfusión sanguínea se produce por una transmisión directa de un agente infeccioso desde una unidad de sangre al receptor susceptible. Esto constituyen una complicación de gran importancia en relación con la morbilidad y mortalidad de los receptores de sangre y un problema de salud pública. Objetivo: Determinar la prevalencia de marcadores serológicos en donantes de sangre del departamento Boyacá y su relación con variables sociodemográficas. Métodos: Estudio descriptivo transversal, realizado en 32 957 donantes del departamento de Boyacá. La fuente de información fue secundaria. Se determinó la seroprevalencia de marcadores de infección y se compararon según sexo, grupo etario y tipo de donante a través de análisis de frecuencias: Chi cuadrado y Fisher. Resultados: La prevalencia de marcadores serológicos fue 1,15 por ciento en la tamización y 0,24 por ciento con las pruebas confirmatorias. El marcador más prevalente fue sífilis con 0,20 por ciento, seguido el virus de la inmunodeficiencia humana 0,02 por ciento, virus de la hepatitis B 0,01 por ciento y virus de la hepatitis C 0,003 por ciento. La prevalencia del VIH y la prevalencia global de infección presentaron asociación estadísticamente significativa con el sexo y con el grupo etario respectivamente. Conclusiones: La identificación de la prevalencia de marcadores serológicos y las variables sociodemográficas permiten establecer un perfil epidemiológico en donantes de sangre del departamento de Boyacá(AU)

Introduction: The infection that is caused by blood transfusion is produced by a direct transmission of an infectious agent from a unit of blood to the sensitive recipient. This represents a complication of great importance in relation to morbidity and mortality of blood recipients and also a public health problem. Objective: To determine the prevalence of serological markers in blood donors of Boyacá department and its relationship to socio-demographic variables. Methods: A cross-sectional descriptive study was conducted in 32 957 donors of Boyacá department. The source of information was secondary. It was determined the seroprevalence of infection´s markers and those were compared according to sex, age group and type of donor through analysis of frequencies: Chi-square and Fisher. Results: The prevalence of serological markers was 1.15 percent in screening and 0.24 percent with the confirmatory tests. The most prevalent marker was syphilis with 0.20 percent, followed by HIV with 0.02 percent, hepatitis B with 0.01 percent and Hepatitis C virus with 0.003 percent. The prevalence of HIV and the infection´s overall prevalence presented statistically significant association with sex and with the age group respectively. Conclusions: The identification of the serological markers prevalence and socio-demographic variables allow setting an epidemiological profile in blood donors of Boyacá department(AU)

Enhancing the Routine Screening Infrastructure to Address a Syphilis Epidemic in Miami-Dade County.

BACKGROUND: In a recent sexually transmitted disease surveillance report from the Centers for Disease Control and Prevention, Miami-Dade County had the nation's fourth highest rate of infectious syphilis, with rates of congenital syphilis on the rise. As a public health response, Homestead Hospital, in collaboration with the Florida Department of Health, enhanced their emergency department's routine HIV/HCV "opt-out" screening infrastructure to include a syphilis smart screening algorithm. The purpose of this article is to describe the development, implementation, and evaluation of the algorithm. METHODS: A retrospective evaluation of patient records prompted the development of the algorithm. Homestead Hospital's electronic health record system automatically triggers a syphilis test based on the reason for medical visit (e.g., rash, penile discharge, a positive pregnancy test, historical or present sexually transmitted disease result). If a patient tests positive, he/she is counseled and linked to care. RESULTS: Since implementation (April 2018 to August 2019), the smart screening algorithm triggered 4806 syphilis tests: 122 patients tested positive (2.5% seropositivity). After confirmatory testing, 59 patients were positive for syphilis, of which 27 were pregnant. CONCLUSIONS: The Homestead Hospital and Department of Health-Miami-Dade's response to Miami-Dade County's syphilis problem is innovative and replicable. The program embraces technology, enhances the routine opt-out screening model, and does not affect preexisting workflows. Ultimately, implementation of this algorithm allows patients to get treatment, receive comprehensive prevention services, and, in some cases, avert congenital syphilis.

Evaluate performance of the Abbott chemiluminescent microparticle immunoassay assay for detection of syphilis infection in Chinese blood donors.

BACKGROUND AND OBJECTIVES: To prevent Treponema Pallidum (TP) transmission from blood transfusion, enzyme-linked immunosorbent assay (EIA) for anti-TP has been widely used in routine blood donation screening in China for many years. The aim of this study was to evaluate the performance of the Abbott CMIA assay for detection of anti-TP in Chinese blood donors. MATERIALS AND METHODS: A total of 2420 plasma samples, already routinely screened for anti-TP by two different EIAs, from four blood Centers were tested for anti-TP by Abbott CMIA. Subsequently, all samples with positive results by one or both EIAs and/or by Abbott CMIA were subjected to confirmatory testing (CT) using recombinant immunoblot assay (RIBA) or Treponema Pallidum particle agglutination assay (TPPA). TP infection was defined by a RIBA or TPPA positive. RESULTS: Compared with two EIAs strategy, Abbott CMIA showed a relatively best sensitivity as 98.80% (95% CI: 97.44%-100.16%) and a relatively best specificity as 99.58% (95% CI: 99.30%-99.85%), yielding the best consistency (99.49%) between anti-TP CT results with the highest κ value of .98. CONCLUSION: This is the first study to evaluate the performance of the Abbott CMIA assays for detection of syphilis in Chinese blood donors. Our results suggested that CMIA performed better than both EIAs, and implementation of CMIA replacing two different EIA reagents might help to further reduce the risk of transfusion-transmitted TP infection, decrease unnecessary blood waste and loss of blood donors.

[Implementation of the reverse screening syphilis algorithm in a clinical laboratory]. / Implementación del algoritmo reverso para el cribado de sífilis en un laboratorio clínico.

BACKGROUND: Syphilis remains a public health concern worldwide, the accuracy of diagnostic tests is critical for its successful control. Currently, there are two approaches to the diagnosis of syphilis using serological tests: the traditional algorithm and the reverse algorithm. AIM: The goal of this study was to analyse the advantages and disadvantages in the implementation of the syphilis reverse-screening algorithm in an outpatient clinical laboratory. METHODS: An observational cross-sectional study was carried out analyzing 246 reactive sera from a total of 14700 requests for syphilis serology. Chemiluminescent assay ARCHITECT Syphilis TP, V.D.R.L. and FTA-Abs were performed. RESULTS: Among 246 reactive sera by ARCHITECT Syphilis TP, 129 were reactive and 117 were non-reactive by V.D.R.L. the last mentioned resulted in 97 reactive and 20 non-reactive by FTA-Abs, suggesting false positives (0.13%). Two patients with primary infection were detected, that were not detected by V.D.R.L. and one pregnant woman with primary infection with a high value S/CO and V.D.R.L.:1 dils. CONCLUSIONS: Among the advantages of using a reverse algorithm were greater sensitivity in the detection of patients with primary syphilis; automation, complete traceability of the samples; objective interpretation and conclusive results.