ABSTRACT
Resumen Introducción: La sífilis sigue siendo un problema de salud pública en todo el mundo; la precisión de las pruebas de diagnóstico es fundamental para el éxito de su control. Actualmente, hay dos enfoques para el diagnóstico serológico de la sífilis: el algoritmo tradicional y el algoritmo reverso. Objetivo: Analizar las ventajas y desventajas en la implementación del cribado para sífilis con el algoritmo reverso en un laboratorio clínico de pacientes ambulatorios. Materiales y Métodos: Se realizó un estudio de corte transversal analizando 246 sueros reactivos en el cribado sobre un total de 14.700 solicitudes de serología para sífilis. Se utilizaron los ensayos ARCHITECT SyphilisTP, V.D.R.L. y FTA-Abs. Resultados: De los 246 sueros reactivos por ARCHITECT Syphilis TP, 129 fueron reactivos y 117 no reactivos con V.D.R.L., éstos últimos resultaron 97 reactivos y 20 no reactivos por FTA-Abs, sugiriendo falsos positivos (0,13%). Se detectaron dos casos de infección primaria, no detectados con V.D.R.L y un caso de infección primaria en una gestante con un valor alto S/CO y V.D.R.L. de 1 dils. Conclusiones: Entre las ventajas de utilizar el algoritmo reverso se encontró mayor sensibilidad en la detección de sífilis primaria; automatización, trazabilidad, interpretación objetiva y resultados concluyentes.
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.
Subject(s)
Humans , Male , Female , Pregnancy , Adolescent , Adult , Middle Aged , Aged , Aged, 80 and over , Young Adult , Treponema pallidum/isolation & purification , Syphilis Serodiagnosis/methods , Syphilis/diagnosis , Mass Screening/methods , Treponema pallidum/immunology , Algorithms , Cross-Sectional Studies , Sensitivity and Specificity , Luminescent MeasurementsABSTRACT
La sífilis es una enfermedad de transmisión sexual altamente contagiosa con importantes complicaciones, pero con tratamiento efectivo en etapas tempranas. Actualmente, representa un problema de salud pública. La prevalencia reportada en EEUU desde el año 2008 es de 4,5 casos/100.000 habitantes, con una incidencia 10.6 millones de casos cada año, especialmente en hombres que mantienen relaciones sexuales con hombres (HSH) y pacientes portadores de VIH (PVIH). Los métodos diagnósticos basados en test moleculares aún no han sido validados para el diagnóstico de sífilis, lo que ha permitido establecer tres esquemas serológicos con diferentes rendimientos, según prevalencia poblacional. Desde este punto de vista, el screening reverso pareciera ser útil en población de alto riesgo, y el screening tradicional para la población general.
Syphilis is a sexual transmitted disease highly contagious with important complications that can be prevented with an adequate treatment in early stages. Syphilis has become a public health issue, in the USA its incidence has increased from the 2001, with a rate in the 2008 of 4,5 cases/100000 people, with a greater prevalence in men who have sex with men (HSH) and people infected by HIV (PVIH). Despite molecular detection test are used for the diagnostic of many diseases, in syphilis we still using serologist test. There are three different schemes with different per-formance depending in the prevalence of syphilis in the population. In this setting reverse screening is the most adequate method for high prevalence versus traditional method that is better in general population.
Subject(s)
Humans , Syphilis/diagnosis , Mass Screening/methods , Algorithms , Syphilis Serodiagnosis/methods , Syphilis/therapy , Syphilis/epidemiologyABSTRACT
In Florida, where syphilis is a reportable disease, the number of primary and secondary (P&S) syphilis cases has increased from 3,266 in 2008–2010 to 5,340 in 2013–2015, a 63% increase. The objective of this study was to compare the performance and sensitivity of the syphilis reverse algorithm with the traditional algorithm for detecting P&S (infectious) syphilis cases. Clinical specimens from individuals who self-referred for syphilis testing at public health clinics were processed using the traditional algorithm (non-treponemal rapid plasma reagin (RPR) test followed by a confirmatory treponemal (EIA) test) and then further tested with the Architect Syphilis TP (ASTP) immunoassay (Abbott Diagnostics, Chicago, IL, USA) or by RPR confirmation, if needed (reverse algorithm). Of 1,079 specimens, 59 were positive for syphilis. The sensitivity of the reverse algorithm was 98.3% (58/59) and of the traditional algorithm was 72.9% (43/59). Based on clinical evidence, of the 16 traditional algorithm-negative but reverse algorithm-positive cases, 68.8% (11/16) were classified as missed P&S infections (treatment naïve) and 31.2% (5/16) were classified as missed past syphilis (latent or infections with documented linkage to care). The reverse algorithm enables the detection of additional P&S syphilis cases missed by our current traditional algorithm.
Subject(s)
Florida , Immunoassay , Plasma , Public Health , SyphilisABSTRACT
Syphilis can not be cultured in vitro.So far, serologic testing is still regarded as the mainstay for diagnosing syphilis and for monitoring the efficacy of subsequent antibiotic treatment.However, single serological tests have limitations in sensitivity or specificity.Detective algorithms with two or more serological methods will help to improve the effectiveness of syphilis diagnosis, and decrease missed diagnosis and misdiagnosis.This article will review advances on etiological examination, serological tests, and detective algorithms for syphilis.In particular, it specially introduces the merits and demerits of three detective algorithms for syphilis,so as to explore suitable screening methods,and provide basis for relevant administrative departments to formulate related laws, regulations and guidelines for syphilis.
ABSTRACT
BACKGROUND: Automated Mediace Treponema pallidum latex agglutination (TPLA) and Mediace rapid plasma reagin (RPR) assays are used by many laboratories for syphilis diagnosis. This study compared the results of the traditional syphilis screening algorithm and a reverse algorithm using automated Mediace RPR or Mediace TPLA as first-line screening assays in subjects undergoing a health checkup. METHODS: Samples from 24,681 persons were included in this study. We routinely performed Mediace RPR and Mediace TPLA simultaneously. Results were analyzed according to both the traditional algorithm and reverse algorithm. Samples with discordant results on the reverse algorithm (e.g., positive Mediace TPLA, negative Mediace RPR) were tested with Treponema pallidum particle agglutination (TPPA). RESULTS: Among the 24,681 samples, 30 (0.1%) were found positive by traditional screening, and 190 (0.8%) by reverse screening. The identified syphilis rate and overall false-positive rate according to the traditional algorithm were lower than those according to the reverse algorithm (0.07% and 0.05% vs. 0.64% and 0.13%, respectively). A total of 173 discordant samples were tested with TPPA by using the reverse algorithm, of which 140 (80.9%) were TPPA positive. CONCLUSIONS: Despite the increased false-positive results in populations with a low prevalence of syphilis, the reverse algorithm detected 140 samples with treponemal antibody that went undetected by the traditional algorithm. The reverse algorithm using Mediace TPLA as a screening test is more sensitive for the detection of syphilis.