Evaluation of five immunoassays and one lateral flow immunochromatography for anti-SARS-CoV-2 antibodies detection.

INTRODUCTION: In order to deal with the current pandemic caused by the novel SARS-CoV-2 coronavirus several serological immunoassays have been recently developed with the objective of being used as a complementary diagnostic tool and to support the RT-PCR technique currently considered the "gold-standard" method. However, these new assays need to be evaluated and validated. The purpose of this study was to assess the performance of five immunoassays (two ELISA and three CLIA assays) and one rapid immunochromatographic test for the detection of anti-SARS-CoV-2 antibodies. METHODS: Five semiquantitative immunoassays (MENARINI®, PALEX®, VIRCLIA®, ROCHE® and SIEMENS®) and one lateral flow rapid test (WONDFO®) were performed. A total of 124 samples were studied. Case serum samples (n=78) were obtained from COVID-19 patients confirmed by real-time RT-PCR/epidemiological-clinical-radiological criteria, and control non-SARS-CoV-2 samples (n=46) belonged to healthy healthcare workers involved in a seroprevalence study. RESULTS: Overall, the tests showed sensitivities around 70-90% and specificities greater than 95%, including the immunochromatographic test. In addition, we observed very good agreements among them, being better for the detection of IgG than for IgM antibodies (Cohen's kappa index of 0.95 for VIRCLIA® IgG with ROCHE®), as well as good diagnostic power of the tests as determined by the ROC curves. CONCLUSIONS: This study demonstrates the proper performance of the different immunoassays in order to be applied in the clinical practice as support in the diagnostic approach and in the development of vaccines and seroepidemiological studies of COVID-19.

Evaluation of five immunoassays and one lateral flow immunochromatography for anti-SARS-CoV-2 antibodies detection / Evaluación de cinco inmunoensayos y una inmunocromatografía de flujo lateral para la detección de anticuerpos anti-SARS-CoV-2

Introduction: In order to deal with the current pandemic caused by the novel SARS-CoV-2 coronavirus several serological immunoassays have been recently developed with the objective of being used as a complementary diagnostic tool and to support the RT-PCR technique currently considered the “gold-standard” method. However, these new assays need to be evaluated and validated. The purpose of this study was to assess the performance of five immunoassays (two ELISA and three CLIA assays) and one rapid immunochromatographic test for the detection of anti-SARS-CoV-2 antibodies. Methods: Five semiquantitative immunoassays (MENARINI®, PALEX®, VIRCLIA®, ROCHE® and SIEMENS®) and one lateral flow rapid test (WONDFO®) were performed. A total of 124 samples were studied. Case serum samples (n=78) were obtained from COVID-19 patients confirmed by real-time RT-PCR/epidemiological-clinical-radiological criteria, and control non-SARS-CoV-2 samples (n=46) belonged to healthy healthcare workers involved in a seroprevalence study. Results: Overall, the tests showed sensitivities around 70–90% and specificities greater than 95%, including the immunochromatographic test. In addition, we observed very good agreements among them, being better for the detection of IgG than for IgM antibodies (Cohen's kappa index of 0.95 for VIRCLIA® IgG with ROCHE®), as well as good diagnostic power of the tests as determined by the ROC curves. Conclusions: This study demonstrates the proper performance of the different immunoassays in order to be applied in the clinical practice as support in the diagnostic approach and in the development of vaccines and seroepidemiological studies of COVID-19.(AU)

Introducción: Para hacer frente a la pandemia actual causada por el nuevo coronavirus SARS-CoV-2 se han desarrollado recientemente varios inmunoensayos serológicos con el objetivo de ser utilizados como herramienta diagnóstica complementaria y apoyar la técnica de RT-PCR actualmente considerada como el “estándar de oro”. Sin embargo, estos nuevos ensayos deben evaluarse y validarse. El objetivo de este estudio fue evaluar cinco inmunoensayos (dos ELISA y tres ensayos CLIA) y una prueba inmunocromatográfica rápida para la detección de anticuerpos anti-SARS-CoV-2. Métodos: Se utilizaron cinco inmunoensayos semicuantitativos (MENARINI®, PALEX®, VIRCLIA®, ROCHE® y SIEMENS®) y un test de inmunocromatografía rápida (WONDFO®). Se estudiaron un total de 124 muestras. Las muestras de suero (n=78) se obtuvieron de pacientes COVID-19 confirmados por RT-PCR en tiempo real/criterios epidemiológicos-clínico-radiológicos. Las muestras control negativas (n=46) pertenecieron a personal sanitario involucrado en un estudio de seroprevalencia. Resultados: En general, las pruebas mostraron sensibilidades en torno al 70-90% y especificidades superiores al 95%, incluso la prueba inmunocromatográfica. Además, observamos muy buenas concordancias entre ellas, presentando mayores sensibilidades para la detección de anticuerpos IgG que para IgM (índice kappa de Cohen de 0,95 para VIRCLIA® IgG con ROCHE®), así como un buen poder diagnóstico de las técnicas determinado por las curvas ROC. Conclusiones: Este estudio demuestra el buen rendimiento de los diferentes inmunoensayos para ser empleados en la práctica clínica como apoyo en el proceso de diagnóstico, en el desarrollo de vacunas y estudios seroepidemiológicos de COVID-19.(AU)

Evaluation of five immunoassays and one lateral flow immunochromatography for anti-SARS-CoV-2 antibodies detection.

INTRODUCTION: In order to deal with the current pandemic caused by the novel SARS-CoV-2 coronavirus several serological immunoassays have been recently developed with the objective of being used as a complementary diagnostic tool and to support the RT-PCR technique currently considered the "gold-standard" method. However, these new assays need to be evaluated and validated. The purpose of this study was to assess the performance of five immunoassays (two ELISA and three CLIA assays) and one rapid immunochromatographic test for the detection of anti-SARS-CoV-2 antibodies. METHODS: Five semiquantitative immunoassays (MENARINI®, PALEX®, VIRCLIA®, ROCHE® and SIEMENS®) and one lateral flow rapid test (WONDFO®) were performed. A total of 124 samples were studied. Case serum samples (n=78) were obtained from COVID-19 patients confirmed by real-time RT-PCR/epidemiological-clinical-radiological criteria, and control non-SARS-CoV-2 samples (n=46) belonged to healthy healthcare workers involved in a seroprevalence study. RESULTS: Overall, the tests showed sensitivities around 70-90% and specificities greater than 95%, including the immunochromatographic test. In addition, we observed very good agreements among them, being better for the detection of IgG than for IgM antibodies (Cohen's kappa index of 0.95 for VIRCLIA® IgG with ROCHE®), as well as good diagnostic power of the tests as determined by the ROC curves. CONCLUSIONS: This study demonstrates the proper performance of the different immunoassays in order to be applied in the clinical practice as support in the diagnostic approach and in the development of vaccines and seroepidemiological studies of COVID-19.

False-seronegative HCV infection motivated by interference with cryoglobulins.

Objectives: Cryoglobulins (CGs) are serum proteins that undergo a reverse cold-induced precipitation in vitro. The CGs are a well-known cause of analytical interferences in several laboratory tests, leading to spurious results. With this in view, we present a case of a patient initially misdiagnosed due to CGs interference in Hepatitis C Virus (HCV) serology. Case presentation: We report a case of a woman of advanced age affected by acute renal failure that required urgent haemodialysis. In the absence of infections and other causes of CGs production, a diagnosis of acute renal failure secondary to essential cryoglobulinemia was established. However, an unexpected positive HCV viral load was encountered. At this point, a false-seronegative HCV infection conditioned to CGs interference in vitro was suspected, confirmed by repeating serology in pre-warmed serum. Finally, the patient was correctly diagnosed with HCV-secondary cryoglobulinemia. Conclusions: As shown in the case, the presence of CGs in blood may represent a challenge for the correct interpretation of several laboratory tests. The identification of CGs and the pre-treatment of serum are decisive to avoid spurious results and reach a genuine diagnosis.

Spontaneous repigmentation of silvery hair in an infant with congenital hydrops fetalis and hypoproteinemia.

Silvery hair is a characteristic finding of 3 rare autosomal recessive disorders: Chédiak-Higashi syndrome (CHS), Elejalde syndrome (ES), and Griscelli syndrome (GS). We report the case of a 2-month-old male infant with transient silvery hair and generalized hypopigmentation of the skin and eyes who did not have one of these classic causative disorders. The patient was delivered at 35 weeks' gestation with congenital hydrops fetalis associated with a chromosomal abnormality (46,XY,add[2],[p23]), hypothyroidism, hypoproteinemia, and hypogammaglobulinemia. Over the course of follow-up, spontaneous brown repigmentation of the silvery hair was noted. We concluded that the silvery hair was induced by hypoproteinemia secondary to congenital hydrops fetalis.

Valoración del riesgo de exposicióna medicamentos citostáticos en elHospital General de Ciudad Real / Valoration of the risk of exposition to cytostatic medications in the Hospital of Ciudad Real

Durante el año 2007-2008, se realiza un estudio del riesgo de exposición a medicamentos citostáticos para valorar: Las áreas en las cuales se manipulan citostáticos ,las tareas con riesgo de exposición, el personal expuesto en cada uno de los procedimientos de trabajo y los EPIs que se utilizan en cada tarea, con la finalidad de determinar las medidas preventivas a adoptar tanto colectivas como individuales, para minimizar el riesgo de exposición de los trabajadores en toda la cadena de manipulación de citostáticos (AU)

During the year 2007-2008, is carried out a study from the exposition risk to cytostatic medications to value: The areas in which are manipulated cytostatic, the tasks with exposition risk, the personnel exposed in each one of the working up and the EPIs that are used in each task, with the purpose of determining the preventive measures so much collective as singular to adopt to minimize the risk of the workers’ exposition in the whole chain of manipulation of cytostatic (AU)

Plan de prevención de alergia al látex en el área sanitaria de Ciudad Real / No disponible

Durante el año 2004 se instaura un Plan de Prevención de Alergia al Látex en el Área Sanitaria de Ciudad Real para cumplir con el Plan de Calidad del Servicio de Salud de Castilla la Mancha. Este plan se desarrollaría en tres vías de actuación y de forma simultánea, conteniendo medidas colectivas para intentar reducir el riesgo de sensibilización (formación e información de los trabajadores para el uso racional del guante y sustitución de los guantes de látex no estériles por vinilo o nitrilo), y medidas preventivas individuales tras la identificación, valoración y registro de los trabajadores alérgicos

During the year 2004 a Plan of Prevention of Allergy is established to the Latex in the Sanitary Area of Ciudad Real to fulfill the Plan of Quality of the Service of Health of Castilla la Mancha. This plan would be developed in three performance roads and in a simultaneous way, containing collective measures to try to reduce the risk of sensitization (formation and the workers' information for the rational use of the glove and substitution of the non-sterile latex gloves for vinyl or nitrile), and individual preventive measures after the identification, valuation and the allergic workers' registration

Adecuación de puesto de trabajo en el ámbito sanitario / No disponible

Todos los trabajadores tienen derecho a una adaptación de su puesto de trabajo a sus especiales condiciones derivadas de sensibilidades o problemas específicos de salud, llegando al cambio de puesto de trabajo cuando esto no sea posible. El objetivo de este trabajo, es articular un protocolo, con las actividades a realizar por el Servicio de Prevención de Riesgos Laborales encaminadas a la consecución de ese fin, realizar un estudio de todas las adecuaciones realizadas en el periodo que va desde enero de 2001 a junio de 2006 y establecer el perfil de trabajador que más solicitudes de adecuación presenta en nuestro hospital

All the workers are entitled to an adaptation from their workstation to their special derived conditions of sensibilities or specific problems of health, arriving to the workstation change when this is not possible. The objective of this work, is to articulate a protocol, with the activities to carry out for the Service of Prevention of Labor Risks guided to the attainment of that end, to carry out a study of all the adaptations carried out in the period that goes from January of 2001 to June of 2006 and worker's profile that more adaptation applications present in our hospital to settle down