New screening approach to detecting congenital syphilis in China: a retrospective cohort study (original) (raw)
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Congenital syphilis: refining newborn evaluation and management in Shenzhen, southern China
Sexually Transmitted Infections, 2010
Consistent definitions of congenital syphilis are critical for determining true incidences and setting up targets of elimination. This study aimed to assess the evaluation and management of infants at high risk of congenital syphilis with an antenatal syphilis-screening programme in the Shenzhen SEZ and to develop feasible definitions for the detection of congenital syphilis in China. A retrospective study was conducted of all standardised records of pregnant women with positive syphilis between 2003 and 2007. Infants at high risk of congenital syphilis were evaluated by laboratory tests at birth and longitudinal follow-up. A screening test-positive congenital syphilis case was defined based on a positive 19S-IgM-FTA-ABS result at birth. Assuming that 19S-IgM-FTA-ABS was the gold standard, the sensitivity and specificity of the ascertainment methods were calculated. During the study period, 1010 live infants were born to women with active syphilis during pregnancy. 19S-IgM-FTA-ABS detected 42 screening-positive congenital syphilis cases and another nine cases were identified by longitudinal follow-up only. Using 19S-IgM-FTA-ABS as the gold standard, 'fourfold rapid plasma reagin (RPR) titres' had the highest sensitivity and specificity compared with the other two follow-up methods. 19S-IgM-FTA-ABS makes congenital syphilis case classification simpler and faster for newborns. In areas where 19S-IgM-FTA-ABS is not available, comparing newborn RPR titres with maternal titres can be an alternative method. Meanwhile, positive follow-up results act as treatment indicators for older infants. As congenital syphilis definitions vary over the country, the Shenzhen programme suggested a practical model for surveillance and treatment in areas with or without available 19S-IgM-FTA-ABS testing.
The Journal of Infection in Developing Countries, 2015
Introduction: This study aimed to document the prevalence of syphilis among pregnant women in Turkey. Methodology: In this retrospective cohort study, a total of 63,276 sera obtained between January 2007 and June 2014 from women who were routinely screened for syphilis as a part of antenatal care at a tertiary referral hospital in Turkey were analyzed. Serological screening was done with the rapid plasma reagin (RPR) test on venous blood samples. Treponema pallidum hemagglutination assay (TPHA) was the confirmation test for the diagnosis of syphilis in patients who had positive results in the screening test. Results: Between 2007 and the first six months of 2014, 41 RPR+ and only five confirmed syphilis-positive patients were determined. The syphilis seroprevalence rate was 0.0648%. Within these years, there was no case of congenital syphilis detected in the hospital. Conclusion: As there is evidence of effective screening of syphilis contributing to the effective treatment and prev...
Diagnostic accuracy of a point-of-care syphilis test when used among pregnant women in Bolivia
Sexually Transmitted Infections, 2006
Objective: To evaluate the performance of a point-of-care (POC) syphilis test when used in urban Bolivian maternity hospitals. Methods: We tested 8892 pregnant women for syphilis using the Abbott Determine Syphilis TP rapid POC test and rapid plasma reagin (RPR) in the laboratory of four large urban maternity hospitals where national statistics reported a syphilis prevalence of at least 3%. Sera were stored and transferred to the national reference laboratory (INLASA) where RPR testing was repeated. When the reference laboratory staff observed a positive RPR result, a Treponema pallidum particle agglutination assay (TPPA) was performed to confirm these findings. We calculated test performance characteristics for the POC test and hospital RPR using RPR performed at the reference laboratory confirmed by TPPA as the reference standard. Participants received treatment during their initial visit based on the POC test results.
Diagnostic tools for preventing and managing maternal and congenital syphilis: an overview
Bulletin of The World Health Organization, 2004
Syphilis is a major cause of adverse outcomes in pregnancy in developing countries. Fetal death and morbidity due to congenital syphilis are preventable if infected mothers are identified and treated appropriately by the middle of the second trimester. Most pregnant women with syphilis are asymptomatic and can only be identified through serological screening. Non-treponemal tests, such as the rapid plasma reagin (RPR) test, are sensitive, simple to perform, and inexpensive. However, they have often not been available at primary health-care settings because they required cold storage for reagents and electricity to operate a rotator. Additionally, as many as 28% of positive RPR results in pregnant women are biological false positives. Confirmatory assays are usually available only in reference laboratories. Technological advances have resulted in improved serodiagnostic tools for syphilis. New enzyme immunoassays are available for surveillance and for large-scale screening programmes. Decentralized antenatal screening with on-site confirmation is now possible since new RPR reagents that are stable at room temperature have become commercially available, as have solar-powered rotators and simple, rapid point-of-care treponemal tests that use whole blood and do not require electricity or equipment. These will be valuable tools for preventing or eliminating congenital syphilis. The development of a non-invasive rapid treponemal test that distinguishes between active and past infections remains a high priority in areas where syphilis is endemic.
eClinicalMedicine, 2020
Background: Current point-of-care tests (POCT) for syphilis, based on the detection of Treponema pallidum (TP) total antibodies, have limited capacity in distinguishing between active and past/treated syphilis. We report the development and early evaluation of a new prototype POCT based on the detection of TP-IgA antibodies, a novel biomarker for active syphilis. Methods: The TP-IgA POCT (index test) was developed in response to the World Health Organisation (WHO) target product profile (TPP) for a POCT for confirmatory syphilis testing. Two sub-studies were conducted consecutively using 458 pre-characterised stored plasma samples in China (sub-study one, addressing the criteria for the WHO TPP), and 503 venous blood samples collected from pregnant/postpartum women in South Africa (sub-study two, addressing potential clinical utility). Performance of the index test was assessed against standard laboratory-based serology using a combination of treponemal (TPHA) and non-treponemal (rapid plasma reagin [RPR]) tests. Findings: In sub-study one, the index test demonstrated 96¢1% (95%CI=91¢7%-98¢5%) sensitivity and 84¢7% (95%CI=80¢15À88¢6%) specificity for identification of active syphilis (TPHA positive, RPR positive). It correctly identified 71% (107/150) samples of past-treated syphilis (TPHA positive, RPR negative). In sub-study two, the index test achieved 100% (95%CI=59%-100%) sensitivity for active syphilis and correctly identified all nine women with past syphilis. Interpretation: The TP-IgA POCT has met the WHO TPP for a POCT for diagnosis of active syphilis and demonstrated its potential utility in a clinical setting. Future studies are warranted to evaluate field performance of the final manufactured test. Funding: Saving Lives at Birth: Grand Challenge for Development, Thrasher Research Fund, and the Victorian Government Operational Infrastructure Scheme.
Indian journal of sexually transmitted diseases
Syphilis is one of the most common preventable causes of adverse effects during pregnancy. Antenatal screening prevents the delay between diagnosis and treatment there by reducing the risk of congenital syphilis. The objective of this study was to evaluate the utility of an immunochromatographic assay as a point of care test for antenatal screening of syphilis. Sera of 200 antenatal mothers were evaluated for serodiagnosis of syphilis by the venereal disease research laboratory (VDRL), Treponema pallidum hemagglutination assay (TPHA) and SD BIOLINE Syphilis 3.0 test. The performance of SD BIOLINE Syphilis 3.0 test was compared with VDRL as screening assay and TPHA as a confirmatory test. The antenatal prevalence of syphilis was found to be 2% by both VDRL and TPHA. The sensitivity, specificity, positive predictive value, and the negative predictive value of SD BIOLINE Syphilis 3.0 test were 75%, 100%, 100%, and 99.45%, respectively. Antenatal screening and treatment of maternal syph...
BMJ Open , 2018
Objectives: To undertake a systematic review and meta-analysis to evaluate the test performance including sensitivity and specificity of rapid immunochromatographic syphilis (ICS) point-of-care (POC) tests at antenatal clinics compared with reference standard tests (non-treponemal (TP) and TP tests) for active syphilis in pregnant women. Methods: Five electronic databases were searched (PubMed, EMBASE, CRD, Cochrane Library and LILACS) to March 2016 for diagnostic accuracy studies of ICS test and standard reference tests for syphilis in pregnant women. Methodological quality was assessed using QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies). A bivariate meta-analysis was undertaken to generate pooled estimates of diagnostic parameters. Results were presented using a coupled forest plot of sensitivity and specificity and a scatter plot. Results: The methodological quality of the five included studies with regards to risk of bias and applicability concern judgements was either low or unclear. One study was judged as high risk of bias for patient selection due to exclusion of pregnant women with a previous history of syphilis, and one study was judged at high risk of bias for study flow and timing as not all patients were included in the analysis. Five studies contributed to the meta-analysis, providing a pooled sensitivity and specificity for ICS of 0.85 (95% CrI: 0.73 to 0.92) and 0.98 (95% CrI: 0.95 to 0.99), respectively. Conclusions: This review and meta-analysis observed that rapid ICS POC tests have a high sensitivity and specificity when performed in pregnant women at antenatal clinics. However, the methodological quality of the existing evidence base should be taken into consideration when interpreting these results.
Retrospective analysis of the serologic response to the treatment of syphilis during pregnancy
Infectious Diseases in Obstetrics and Gynecology, 1997
Objective: The purpose of this study was to assess the effect of several maternal variables on the serologic response following the treatment of syphilis in pregnancy. Methods: A 5-year chart review identified 95 patients coded with syphilis at Hermann Hospital. Inclusion criteria were 1) serologically confirmed syphilis infection during the index pregnancy, 2) complete treatment during the index pregnancy, and 3) minimum of one follow-up rapid plasma reagin (RPR) titer. Forty-nine of 95 patients met the inclusion criteria. Treatment response was evaluated by comparing each post-treatment titer of a patient to her pretreatment titer. Each comparison was considered an "observation." Each observation was classified as either a positive response (->4-fold titer decline) or a negative response (<4-fold titer decline). Maternal variables assessed included 1) prior history of syphilis untreated or incompletely treated prior to the index pregnancy, 2) gestational age, 3) titer level, 4) unknown duration, 5) positive response at 1 month, 6) positive response at 2 months, 7) positive response at >3 months, and 8) race. Results: A positive response following treatment was significantly more likely if there was no prior history of syphilis or if there was a high initial RPR titer (>32). Only 33/54 (61%) observations at or greater than 3 months had a positive response. Conclusions: Our study suggests that an absence of a history of syphilis and an initial high RPR