Performance Assessment of Treponemal and Nontreponemal Tests for the Diagnosis of Acquired Syphilis.

There are a variety of nontreponemal test (NTT) and treponemal test (TT) kits for the serologic diagnosis of syphilis. Because of the complexity of the infection (multiple clinical stages) and the different antigens used in these kits, a systematic evaluation of the accuracy of the currently available commercial tests is warranted. Our objective was to evaluate the performance of commercially available tests for the diagnosis of syphilis infection. In this study, we analyzed one NTT (Venereal Disease Research Laboratory [VDRL] test, Wiener Laboratories, Rosario, Argentina) and two TTs (fluorescent treponemal antibody absorption [FTA-ABS] test, Euroimmun, Lübeck, Germany, and syphilis recombinant ELISA v. 4.0 test [ELISA], Wiener Laboratories, Rosario, Argentina) using a panel of 187 samples, including serum samples from 31 individuals with primary syphilis, 77 with secondary syphilis, and 79 with latent syphilis. An additional 192 samples from uninfected individuals and 323 serum samples from individuals with other diseases were included. The sensitivities of the VDRL, ELISA, and FTA-ABS tests were 97.9%, 100%, and 96.3%, respectively. The VDRL and ELISA tests showed a specificity of 100%, and the FTA-ABS test showed a specificity of 99.5%. Accuracy was 98.9% for the VDRL test, 100% for the ELISA, and 97.9% for the FTA-ABS test. For primary, secondary, and latent syphilis, the ELISA achieved a diagnostic performance of 100%, whereas the sensitivity for the VDRL and FTA-ABS tests ranged from 96.8% to 98.7% and 93.7% to 98.7%, respectively. No difference was observed when the tests were used as traditional or reverse algorithms. In general, all three tests are able to discriminate positive and negative samples for syphilis, regardless of the diagnostic algorithm.

External quality assessment to support the WHO ProSPeRo study for the evaluation of two dual HIV/syphilis point-of-care tests in seven countries.

BACKGROUND: Sexually transmitted infections (STIs) such as syphilis and HIV remain to be a significant public health issue worldwide. Dual rapid point-of-care tests (POCTs) have shown promise for detecting antibodies to HIV and syphilis but have not been fully evaluated in the field. Our study supported the WHO ProSPeRo study on Sexually Transmitted Infection Point-of-Care Testing (STI POCT) by providing external quality assessment (EQA) for HIV and syphilis testing in reference laboratories and their associated clinical sites in seven countries. METHODS: HIV/syphilis serum liquid and dried tube specimen (DTS) panels were prepared by CDC. Liquid panels were distributed to the reference laboratories for three rounds of testing using commercially and locally available laboratory-based serological tests. DTS panels were sent to the clinical testing sites for 8 rounds of POC testing using the Abbott SD BIOLINE HIV/Syphilis Duo test (hereafter referred to as SD BIOLINE) and the Chembio Dual Path Platform (DPP) HIV-Syphilis assay. EQA panels were tested at CDC using the Rapid Plasma Reagin (RPR) test and the Treponema pallidum Particle Agglutination assay (TP-PA) for syphilis antibodies. Genetic Systems HIV-1/HIV-2 Plus O EIA, Geenius HIV Supplemental Assay and the Oraquick Advance HIV test were used to detect HIV antibodies in the EQA panels. Results from the reference laboratories and POCT sites were compared to those obtained at the CDC and a percentage agreement was calculated. RESULTS: Qualitative RPR and TP-PA performed at the reference laboratories demonstrated 95.4-100% agreement with CDC results while quantitative RPR and TP-PA tests demonstrated 87.7% and 89.2% agreement, respectively. A 93.8% concordance rate was observed for qualitative HIV testing in laboratories. EQA testing at clinical sites using dual tests showed 98.7% and 99.1% agreement for detection of HIV antibodies and eight out of 10 sites had > 95.8% agreement for syphilis testing. However, two clinical sites showed only 65.0-66.7% agreement for SD BIOLINE and 84.0-86.7% for DPP, respectively, for syphilis testing. CONCLUSIONS: Overall, laboratories demonstrated high EQA performance in this study. Both HIV/syphilis POCTs gave expected results in the clinic-based evaluations using DTS. However, testing errors were identified in a few testing sites suggesting the necessity for continuous training and monitoring the quality of POC testing.

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

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.

Laboratory assessment of SD Bioline HIV/Syphilis Duo Kit among pregnant women attending antenatal clinic Mayuge Health Center III, East central Uganda.

OBJECTIVE: Efforts to dual eradication of mother-to-child transmission of human immune deficiency virus (HIV) and syphilis have improved in the previous decades. This has however been hindered by limited validation studies. A cross-sectional study was conducted among adult pregnant women attending antenatal care clinic at Mayuge Health Center III. Two milliliters of venous blood were collected into Ethylene di-amine tetra acetic acid vacutainers, and tested for HIV and syphilis using the SD Bioline HIV/Syphilis Duo assay, and the national HIV and syphilis testing algorithm. Sensitivity and specificity were calculated for the Duo Kit against the gold standards within 95% confidence intervals. RESULTS: Three hundred and eighty-two (382) participants were enrolled. Their mean age was 25.8 years. The prevalence of HIV was 1.8% (95% confidence interval 1.23-2.41); while that of syphilis was 2.1% (95% confidence interval 1.81-2.54), and the dual infection was 0.52% (95% confidence interval 0.37-0.92). The sensitivity and specificity of the SD Bioline HIV/Syphilis Duo assay were all 100.0% (95% confidence interval 99.5 to 100.0 and 98.6 to 100.0, respectively). The performance of the SD Bioline HIV/Syphilis Duo Kit was optimal, reassuring its aptness for use, and favorable qualities to a limited resource setting.

Economic Assessment of Reverse Algorithm Syphilis Screening in a High Prevalence Population.

BACKGROUND: More laboratories are screening for syphilis with automated treponemal immunoassays. We compared direct costs and downstream consequences when a local public health laboratory switches from a traditional algorithm (nontreponemal screening) to a reverse algorithm (treponemal screening). METHODS: We created a decision analysis model based on laboratory and surveillance data to estimate the cost-effectiveness of a reverse syphilis-screening algorithm from the perspectives of the Los Angeles County Public Health Laboratory and the Los Angeles County Department of Public Health (laboratory + STD Program costs) in 2015 US dollars. RESULTS: The estimated total costs for the Department (Public Health Laboratories) were $2,153,225 ($367,119) for the traditional algorithm and $2,197,478 ($239,855) for the reverse algorithm. Reverse algorithm screening was estimated to detect an additional 626 cases of syphilis, 9.7% more than the traditional algorithm. The incremental cost-effectiveness ratio for the reverse algorithm from the Public Health Department's perspective was $39 per additional syphilis case detected. Cost of follow-up, screening test costs, positivity rates, and frequency of repeat infections most affected the cost-effectiveness of reverse algorithm. Costs were significantly higher for the reverse algorithm when the enzyme Immunoassay/chemiluminescence immunoassay screening test cost was the same as the published Centers for Medicaid Services treponemal test cost. CONCLUSIONS: Using the reverse algorithm would have been slightly more expensive for the Los Angeles County Department of Public Health, but would have identified more syphilis cases and would have resulted in lower laboratory costs.

Suboptimal Prenatal Syphilis Testing Among Commercially Insured Women in the United States, 2013.

United States surveillance data demonstrate that congenital syphilis cases are increasing. We performed an analysis of commercially insured pregnant females using MarketSan to determine syphilis screening rates at different prenatal stages; 85% of pregnant women in this population had a syphilis test performed at least once during the prenatal period.

Prevalence of Traditional and Reverse-Algorithm Syphilis Screening in Laboratory Practice: A Survey of Participants in the College of American Pathologists Syphilis Serology Proficiency Testing Program.

CONTEXT: -Syphilis serology screening in laboratory practice is evolving. Traditionally, the syphilis screening algorithm begins with a nontreponemal immunoassay, which is manually performed by a laboratory technologist. In contrast, the reverse algorithm begins with a treponemal immunoassay, which can be automated. The Centers for Disease Control and Prevention has recognized both approaches, but little is known about the current state of laboratory practice, which could impact test utilization and interpretation. OBJECTIVE: -To assess the current state of laboratory practice for syphilis serologic screening. DESIGN: -In August 2015, a voluntary questionnaire was sent to the 2360 laboratories that subscribe to the College of American Pathologists syphilis serology proficiency survey. RESULTS: -Of the laboratories surveyed, 98% (2316 of 2360) returned the questionnaire, and about 83% (1911 of 2316) responded to at least some questions. Twenty-eight percent (378 of 1364) reported revision of their syphilis screening algorithm within the past 2 years, and 9% (170 of 1905) of laboratories anticipated changing their screening algorithm in the coming year. Sixty-three percent (1205 of 1911) reported using the traditional algorithm, 16% (304 of 1911) reported using the reverse algorithm, and 2.5% (47 of 1911) reported using both algorithms, whereas 9% (169 of 1911) reported not performing a reflex confirmation test. Of those performing the reverse algorithm, 74% (282 of 380) implemented a new testing platform when introducing the new algorithm. CONCLUSION: -The majority of laboratories still perform the traditional algorithm, but a significant minority have implemented the reverse-screening algorithm. Although the nontreponemal immunologic response typically wanes after cure and becomes undetectable, treponemal immunoassays typically remain positive for life, and it is important for laboratorians and clinicians to consider these assay differences when implementing, using, and interpreting serologic syphilis screening algorithms.

Determinación de sífilis por método serológico en gestantes de la ciudad de Guayaquil / Detection of syphilis by a serological method in pregnant women from Guayaquil City

INTRODUCCIÓN: en Ecuador la sífilis es un problema de salud pública. La sífilis congénita conlleva a la aplicación de medidas para lograr la disminución de la transmisión y la erradicación de la enfermedad. El uso de las técnicas de diagnóstico permite detectarla durante la gestación, garantiza un seguimiento durante el control prenatal de las gestantes, para brindar un tratamiento adecuado en caso necesario. OBJETIVO: determinar la sífilis por método serológico en las gestantes que acuden al Centro de Salud # 3, de la ciudad de Guayaquil. MÉTODOS: se aplicó un estudio de carácter correlacionar y retrospectivo a las 445 gestantes que acudieron al centro, para su control prenatal o por libre demanda, de abril a agosto del 2012. Se identificaron las que resultaron positivas a sífilis, mediante la prueba serológica Venereal Disease Research Labotarory. Se diseñó un cuestionario para evaluar el nivel de conocimiento existente sobre la enfermedad, que se aplicó a 71 mujeres seleccionadas al azar. Además se propuso un programa educativo. RESULTADOS: los resultados se estratificaron según el grupo etario y etapa de gestación. De las 18 gestantes con sífilis (4 %), solo 3 recibieron tratamiento. El mayor porcentaje de casos positivos correspondió al rango entre los 21 y 28 años de edad (61 %) y el 50 % correspondió a mujeres en etapa de gestación entre 21 y 28 semanas. La aplicación del cuestionario demostró un gran desconocimiento sobre el tema, por lo que el programa educativo incluyó 9 tareas vinculadas, directo a la capacitación y divulgación del tema.

INTRODUCTION: syphilis is a public health problem in Ecuador. Congenital syphilis leads to the implementation of actions to achieve the reduction of transmission and finally eradication of disease. The use of diagnostic techniques allows detecting the disease during gestation, thus guaranteeing a follow-up in prenatal management stage and an adequate treatment if necessary. OBJECTIVE: to determine syphilis by a serological method in pregnant women who went to the Health Center #3 in the city of Guayaquil. METHODS: aretrospective correlational study of 445 pregnant women who went to the center for prenatal management or at will in the period of April to August 2012. The syphilis positivity was determined by the serological test Venereal Disease Research Laboratory. A questionnaire was designed to evaluate the level of knowledge on the disease and given to 71 randomly selected women. Additionally, an educational program was suggested. RESULTS: the results were stratified by aged group and pregnancy stage. Of 18 pregnant women with syphilis (4%), just 3 were treated. The highest percentage of positive cases was found in 21-28 age group (61%) and 50% of women were in gestational stage between 21 and 28 weeks. the application of the questionnaire showed a lack of knowledge on the topic, so the educational program included 9 tasks directly related to training in and dissemination of information on this topic.

The cost-effectiveness of 10 antenatal syphilis screening and treatment approaches in Peru, Tanzania, and Zambia.

OBJECTIVE: Rapid plasma reagin (RPR) is frequently used to test women for maternal syphilis. Rapid syphilis immunochromatographic strip tests detecting only Treponema pallidum antibodies (single RSTs) or both treponemal and non-treponemal antibodies (dual RSTs) are now available. This study assessed the cost-effectiveness of algorithms using these tests to screen pregnant women. METHODS: Observed costs of maternal syphilis screening and treatment using clinic-based RPR and single RSTs in 20 clinics across Peru, Tanzania, and Zambia were used to model the cost-effectiveness of algorithms using combinations of RPR, single, and dual RSTs, and no and mass treatment. Sensitivity analyses determined drivers of key results. RESULTS: Although this analysis found screening using RPR to be relatively cheap, most (>70%) true cases went untreated. Algorithms using single RSTs were the most cost-effective in all observed settings, followed by dual RSTs, which became the most cost-effective if dual RST costs were halved. Single test algorithms dominated most sequential testing algorithms, although sequential algorithms reduced overtreatment. Mass treatment was relatively cheap and effective in the absence of screening supplies, though treated many uninfected women. CONCLUSION: This analysis highlights the advantages of introducing RSTs in three diverse settings. The results should be applicable to other similar settings.

[Assessment of the congenital syphilis prevention programs]. / Evaluari asupra programelor de preventie a sifilisului congenital.

UNLABELLED: The Romanian program for the management and screening of syphilis includes the recording, follow-up, and antenatal care of pregnant women. It aims at testing all pregnant women for syphilis with the help of VDLR (Venereal Disease Research Laboratory) or RPR (Rapid Plasma Reagin) tests, and in the women with positive tests to confirm the results by treponemal tests (treponemal antibodies): THPA (Treponema Pallidum Hemagglutination), FTA-Abs (Fluorescent Treponemal Antibody with Absorption), ELISA-Captia-IgM, and Western Blotting-IgM. In the pregnant women with positive tests two doses of 2.4 million units of penicillin G benzathine were administered at 5 days interval. These pregnant women are in the evidence of a specialist (obstetrician, dermatologist), and District Department of Public Health, and required to come for another serology test in 3 months. In case they still test positive, the same treatment is applied at the beginning of the third trimester of pregnancy. AIM: To assess the outcome of congenital syphilis prevention programs in lasi, Romania. MATERIAL AND METHODS: In the interval 2005-2011, in the Iasi town, 84 RPR positive pregnant women were recorded. There was no significant difference in the number of pregnant women residing in urban as compared to rural areas. Most of these women were from poor social environments and had a low level of education. The diagnosis of acquired syphilis was made by serological tests as most pregnant women presented in the period of syphilis latency, being asymptomatic. All pregnant women followed the treatment, and were tested periodically. Ultrasound examination was normal in all women (no changes suggestive of fetal malformations). RESULTS: Free clinical, laboratory, and ultrasound investigations, history taking, psychological assessment, sex education, rapid identification of contacts of known patients, follow-up of the interaction between health care providers and syphilitic pregnant women, booklets, and leaflets altogether made that in the last 3 years (2008-2010) no new case of congenital syphilis to be reported in the study area. CONCLUSIONS: Encouraging women to attend antenatal care early in their pregnancy is essential, this way all pregnancy-related problems (syphilis included) could be managed.

Cost-effectiveness of a dual non-treponemal/treponemal syphilis point-of-care test to prevent adverse pregnancy outcomes in sub-Saharan Africa.

BACKGROUND: A dual nontreponemal/treponemal point-of-care test (Dual-POC) that simultaneously detects both nontreponemal and treponemal antibodies has been developed and evaluated. In this study, we compare the health and economic outcomes of the new test with existing syphilis tests/testing algorithms in a high prevalence setting. METHODS: We used a cohort decision analysis model to examine 4 testing/screening algorithms; the Dual-POC test, the laboratory-based rapid plasma reagin and Treponema pallidum haemagglutination assay (RPR+TPHA) algorithm, an onsite RPR testing, and point-of-care treponemal immunochromatographic strip (ICS) testing. Outcomes included miscarriage, stillbirth, congenital syphilis, low birth weight, and neonatal death. Disability-adjusted life-years were estimated for all health outcomes. The analytic horizon was the life expectancy for the mother and child. RESULTS: For a cohort of 1000 pregnant women in a historically high syphilis prevalence population (10% infected and 15% previously infected), the model predicted a total of 39 adverse pregnancy outcomes if no serologic screening were performed; 13 for the laboratory-based RPR+TPHA; 11 for the on-site RPR strategy; 5 for the Dual-POC strategy; and 2 for the ICS strategy. On the basis of assumption that the cost of ICS and the Dual-POC tests were the same, the ICS strategy was the most cost saving (saved $30,000) followed by the Dual-POC strategy (saved $27,000). CONCLUSIONS: The dual-POC test may help save cost in resource-poor settings where disease prevalence (and loss to follow-up) is high, while substantially reducing overtreatment.

Serologic testing for syphilis in the United States: a cost-effectiveness analysis of two screening algorithms.

BACKGROUND: The introduction of automated treponemal enzyme immunoassays and chemiluminescence assays (EIA/CA) tests has led some laboratories in the United States to use new syphilis screening algorithms that start with a treponemal test. We compared the economic and health outcomes of this new algorithm with the standard algorithm from the perspective of the United States health system. METHODS: We used a cohort decision analysis to estimate the expected costs and effects (including follow-ups and overtreatment) of the 2 algorithms from a health-care system perspective. In the standard algorithm, rapid plasma reagin (RPR) is followed (if reactive) by EIA/CA (Nontreponemal-First). In the new algorithm, EIA/CA is followed (if reactive) by RPR. If the RPR is negative, Treponema pallidum passive particle agglutination assay (TP-PA) test is used (Treponemal-First). RESULTS: For a cohort of 200,000 individuals (1000 current infections and 10,000 previous infections), the net costs were $1.6 m (Treponemal-First) and $1.4 m (Nontreponemal-First). The Treponemal-First option treated 118 more cases (986 vs. 868) but resulted in a substantially higher number of follow-ups (11,450 vs. 3756) and overtreatment (964 vs. 38). Treating the additional 118 cases might prevent 1 case of tertiary syphilis. The estimated cost-effectiveness ratios were $1671 (Treponemal-First) and $1621 (Nontreponemal-First) per case treated. The overtreatment was a function of the specificity of the EIA/CA and the lack of independence of EIA/CA and TP-PA. CONCLUSION: The Treponemal-First option costs slightly more and results in more unnecessary treatment.

The tale of two serologic tests to screen for syphilis--treponemal and nontreponemal: does the order matter?

BACKGROUND: Standard syphilis screening involves an initial screening with a nontreponemal test and confirmation of positives with a treponemal test. However, some laboratories have reversed the order. There is no detailed quantitative and qualitative evaluation for the order of testing. In this study, we analyzed the health and economic outcomes of the order of testing for the 2 serologic tests used in syphilis screening under pure screening settings. METHODS: We used a cohort decision analysis to examine the health and economic outcomes of the screening algorithms for low and high prevalence settings. The 2-step algorithms were nontreponemal followed by treponemal (Nontrep-First) and treponemal followed by nontreponemal (Trep-First). We included the 1-step algorithms (treponemal only [Trep-Only] and an on-site nontreponemal only [Nontrep-Only]) for comparison. We estimated overtreatment rates and the number of confirmatory tests required for each algorithm. RESULTS: For a cohort of 10,000 individuals, our results indicated that the overtreatment rates were substantially higher (more than 3 times) for the 1-step algorithms, although they treated a higher number of cases (over 15%). The 2-step algorithms detected and treated the same number of individuals. Among the 2-step algorithms, the Nontrep-First was more cost-effective in the low prevalence setting ($1400 vs. $1500 per adverse outcome prevented) and more cost-saving ($102,000 vs. $84,000) in the high prevalence setting. CONCLUSIONS: The difference in cost was largely due to the substantially higher number of confirmatory tests required for the Trep-First algorithm, although the number of cases detected and treated was the same.

Cost effectiveness of enzyme immunoassay and immunoblot testing for the diagnosis of syphilis.

The burden of disease and associated health-care costs of syphilis are significant despite widespread screening and treatment. Our objective was to conduct an economic evaluation using a simulation model when comparing enzyme immunoassay (EIA) initial testing and Inno-Lia (IL) confirmatory testing (EIA + IL) with rapid plasma reagin (RPR) initial testing and Treponema pallidum particle agglutination assay (TPPA) and fluorescent treponemal antibody absorption assay (FTA-ABS) confirmatory testing (RPR + TPPA/FTA). Estimates of prevalence, test costs and utilization of services for 2006 were derived from Alberta databases. Estimates of test characteristics were derived from the available literature. The incremental cost-effectiveness ratio was Canadian $461 per additional correct diagnosis (less costly and more effective). EIA + IL is cost-effective when compared with RPR + TPPA/FTA for screening and diagnosis of syphilis.

[Current status of external quality assessment of syphilis test in Korea].

BACKGROUND: Current status of external quality assessment (EQA) of laboratory tests for syphilis in Korea was analyzed to find out the problems that should be improved in the future. METHODS: Based on the data from the external quality assessment program performed twice a year by the Immunoserology Subcommittee of the Korean Association of Quality Assurance for Clinical Laboratory from the year 2004 to 2006, discordance rates were analyzed according to the test method and commercial kit used. RESULTS: Among the laboratories participating in the EQA program for syphilis test, about 90% of them used non-treponemal tests and about 55% treponemal tests. The non-treponemal tests included RPR (rapid plasma reagin) and VDRL tests used in 88% (363/412) and 11% (45/412), respectively, of the laboratories. The discordance rates were 2.2% for RPR test and 3.6% for VDRL. For the treponemal tests, Treponema pallidum hemagglutination assay (TPHA) was used in 60-76% and Immunochromatography assay (ICA) in about 30% of the laboratories in 2006. A high discordance rate of over 10% was reported in both TPHA and in ICA methods, possibly due to a low titer (1:1 in VDRL) of EQA samples in 2005. Analysis of the accumulated data from year 2004 to 2006 showed that the discordance rates of TPHA, ICA, and FTA-ABS were 4.6%, 3.7%, and 2.7%, respectively. CONCLUSIONS: For syphilis tests, RPR test, TPHA, and ICA are mainly used in Korea. A high discordance rate is still reported in TPHA and ICA, especially when testing samples with a low titer. Further analysis of data and education of laboratory personnel are needed for the improvement of the EQA program.

Comparative evaluation of 15 serological assays for the detection of syphilis infection.

Fifteen commercial syphilis kits were assessed against the same moderately sized specimen panel that included 114 serum and plasma specimens from syphilis cases and 249 specimens from unselected blood donors. The 114 specimens from syphilis cases comprised 40 from cases of primary syphilis, 43 from cases of secondary syphilis, 19 from cases of early latent syphilis, and 12 from cases of late latent syphilis. Of the 15 kits, ten were enzyme immunoassays, four were Treponema pallidum haemagglutination assays, and one was a T. pallidum particle agglutination assay. Thirteen of the 15 kits gave final specificities of 100%; the other two kits were repeatedly reactive with one to two specimens. Initial sensitivities ranged from 93.9 to 99.1%. Most variation between kits was observed in results for the groups with untreated primary and treated late latent disease, although the differences were not statistically significant. The comparative data on kit performance derived from this study is useful for examining syphilis testing guidelines and for making informed purchasing decisions.

Screening for syphilis in pregnancy: which is the proper method?

BACKGROUND: Consequences of syphilis in mother, pregnancy, fetus and child are considerable, but preventable. Serological screening must be offered at the first prenatal visit. Presently, the diagnosis of syphilis is dependent mainly on serological tests. The most widely used screening tests for syphilis are the VDRL and the rapid plasma reagin (RPR) and for confirmation the fluorescent treponemal antibody (FTA) and the treponema pallidum hemagglutination (TPHA) tests. METHOD: The four alternative nodes for diagnosis of can be a) VDRL + FTA, b) VDRL + TPHA, c) RPR + FTA and d) RPR + TPHA. Here the author reports an evaluation of cost utility of those tests in obstetrical practice. According to this study, it can be shown that the cost per accurate diagnosis for VDRL + TPHA is the least expensive choice and for RPR + FTA is the most expensive choice. CONCLUSION: Therefore, this alternative is the best method for serological diagnosis of syphilis, based on medical laboratory economics principles.

[The value of prophylactic serological tests for syphilis in the region of Bialystok in years 1994-2004 (before and after the introducing the health care system reform in Poland)]. / Profilaktyczne badania serologiczne w kierunku kily na bialostocczyznie w latach 1994-2004.

The prophylactic serological tests for syphilis (psts), belong to the principal methods of controling the spread of the disease. The aim of the study was to to analyze the epidemiological efficacy of psts performed in Bialystok region before and after the health care system reform. The results of psts performed in 1994-1998 (N = 752.787) and in 1999-2004 (N = 407.366) were analyzed. The average annual number of psts declined from 150.557 to 68.687 in two periods analyzed, respectively. The lowest number of tests performed (51.654) was noticed in 2004. Sixty-one of 117 (52.14%) and 30 of 52 (57.97%) syphilis cases have been detected owing to psts in two periods analyzed, respectively. The efficacy index of psts was highest in convicts or prisoners and in pregnant women in both periods (172,1 and 134,6 and 67,9 and 50,7, respectively). The significant decline in efficacy index was noticed for tests performed as periodic prophylactic examinations of employees and prior to employment. The results indicate that psts remain one of the most efficient methods of diagnosis and prevention of syphilis despite the decline in the number of the tests and the formal renouncement of the screening among convicts and prisoners since 2003. Low syphilis incidence rate in Poland can be, in part, own to diminished number of performed tests. There is a need for the parallel studies in other regions of Poland.

Syphilis serology testing: a comparative study of Abbot Determine, Rapid Plasma Reagin (RPR) card test and Venereal Disease Research Laboratory (VDRL) methods.

Blood from 2100 women attending the antenatal clinic of the Port Moresby General Hospital (PMGH) and the 9 Mile urban clinic of Port Moresby was tested for syphili using the laboratory-based Venereal Disease Research Laboratory (VDRL) syphilis serology test and two clinic-based syphilis tests, Abbot Determine and Abbot Syfacard-RR (Rapid Plasma Reagin (RPR) card test). The Abbot Determine and the Syfacard-R tests were compared with the VDRL test, the gold standard in this study. The validation test results of Determine versus VDRL were as follows: sensitivity 92.0%; specificity 94.6%; the predictive value of a positive test 42.6%; and the predictive value of a negative test 99.6%. The validation tests for RPR versus VDRL were as follows: sensitivity 56.3% specificity 96.5%; predictive value of a positive test 41.2%; and the predictive value of a negative test 98.1%. The RPR test costs 3.5 kina (about one US dollar) a test, the VDRL less than 1 kina a test whilst the Determine test kit costs about 5 kina a test. When laboratory time, salaries and other supplies are costed the Determine test is expected to cost relatively much less. Our recommendation is that the Determine test be made available in areas of the country where VDRL is unavailable or where logistics do not allow for test results to be available early enough to make a difference to the care of th pregnant woman and her fetus.

Internet-based site-specific interventions for syphilis prevention among gay and bisexual men.

Recent increases in syphilis in gay men in urban areas in the US and Europe have been associated with men meeting new sex partners on the Internet in chat-rooms and at websites that facilitate partner meeting. In response to the syphilis epidemic in San Francisco, the San Francisco Department of Public Health partnered with a community-based organization, Internet Sexuality Information Services, Inc., to develop, implement and evaluate a broad range of innovative Internet-based prevention interventions including the creation of a website, individual online outreach, banner advertisements, chats, an educational site, message boards, warnings and an online syphilis testing program. This paper documents the varied success of these interventions with process measures and calls for greater emphasis on impact measures in the evaluation of these types of intervention.