Impact of influenza related hospitalization in Spain: characteristics and risk factor of mortality during five influenza seasons (2016 to 2021).

Background: Estimating the global influenza burden in terms of hospitalization and death is important for optimizing prevention policies. Identifying risk factors for mortality allows for the design of strategies tailored to groups at the highest risk. This study aims to (a) describe the clinical characteristics of hospitalizations with a diagnosis of influenza over five flu seasons (2016-2017 to 2020-2021), (b) assess the associated morbidity (hospitalization rates and ICU admissions rate), mortality and cost of influenza hospitalizations in different age groups and (c) analyze the risk factors for mortality. Methods: This retrospective study included all hospital admissions with a diagnosis of influenza in Spain for five influenza seasons. Data were extracted from the Spanish National Surveillance System for Hospital Data from 1 July 2016 to 30 June 2021. We identified cases coded as having influenza as a primary or secondary diagnosis (International Classification of Diseases, 10th revision, J09-J11). The hospitalization rate was calculated relative to the general population. Independent predictors of mortality were identified using multivariable logistic regression. Results: Over the five seasons, there were 127,160 hospitalizations with a diagnosis of influenza. The mean influenza hospitalization rate varied from 5/100,000 in 2020-2021 (COVID-19 pandemic) to 92.9/100,000 in 2017-2018. The proportion of influenza hospitalizations with ICU admission was 7.4% and was highest in people aged 40-59 years (13.9%). The case fatality rate was 5.8% overall and 9.4% in those aged 80 years or older. Median length of stay was 5 days (and 6 days in the oldest age group). In the multivariable analysis, independent risk factors for mortality were male sex (odds ratio [OR] 1.14, 95% confidence interval [95% CI] 1.08-1.20), age (<5 years: OR 1; 5-19 years: OR 2.02, 95%CI 1.17-3.49; 20-39 years: OR 4.11, 95% CI 2.67-6.32; 40-59 years: OR 8.15, 95% CI 5.60-11.87; 60-79 years: OR 15.10, 95% CI 10.44-21.84; ≥80 years: OR 33.41, 95% CI 23.10-48.34), neurological disorder (OR 1.97, 95% CI 1.83-2.11), heart failure (OR 1.85, 95% CI 1.74-1.96), chronic kidney disease (OR 1.33, 95% CI 1.25-1.41), chronic liver disease (OR 2.95, 95% CI 2.68-3.27), cancer (OR 1.85, 95% CI 1.48-2.24), coinfection with SARS-CoV2 (OR 3.17, 95% CI 2.34-4.28), influenza pneumonia (OR 1.76, 95% CI 1.66-1.86) and admission to intensive care (OR 7.81, 95% CI 7.31-8.36). Conclusion: Influenza entails a major public health burden. People aged over 60-and especially those over 80-show the longest hospital stays. Age is also the most significant risk factor for mortality, along with certain associated comorbidities.

Infección leve por SARS-CoV-2 en pacientes vulnerables: implantación de una vía clínica de tratamiento precoz / Mild SARS-CoV-2 infection in vulnerable patients: Implementation of a clinical pathway for early treatment

Introducción: El objetivo del manuscrito es describir la vía clínica de tratamiento precoz de pacientes con infección aguda por SARS-CoV-2 y evaluar los primeros resultados de su implementación. Métodos: Estudio descriptivo y retrospectivo de la implementación de una vía clínica de tratamiento en pacientes no hospitalizados (del 1 de enero al 30 de junio de 2022). Elaboración de vía clínica: sistemas de detección y derivación desde Atención Primaria, Servicio de Urgencias, especialidades médicas y sistema de detección automatizada; evaluación clínica y administración de tratamiento en hospital de día COVID-19, y seguimiento clínico posterior. Variables explicativas: demográficas, comorbilidad, estado vacunal, vías de derivación y administración de tratamiento. Variables de resultado: hospitalización y muerte a los 30 días, toxicidad grado 2-3 relacionada con el tratamiento. Resultados: Se administró tratamiento a 262 pacientes (53,4% mujeres, mediana de edad 60 años). Criterio de indicación de tratamiento: inmunosupresión (68,3%), y la combinación de edad, estado vacunal y comorbilidad en el resto. El 47,3% de los pacientes recibieron remdesivir, el 35,9% nirmatrelvir/ritonavir, el 13,4% sotrovimab y el 2,4% tratamiento combinado, con una mediana de 4 días tras el inicio de síntomas. El 6,1% de los pacientes precisó ingreso hospitalario, el 3,8% por progresión de COVID-19. Ningún paciente falleció. El 18,7% presentaron toxicidad grado 2-3: 89,8% disgeusia y sabor metálico relacionado con nirmatrelvir/ritonavir. Siete pacientes interrumpieron tratamiento por toxicidad. Conclusión: La creación e implementación de una vía clínica para pacientes no hospitalizados con infección por SARS-CoV-2 es efectiva y permite la accesibilidad temprana y la equidad de los tratamientos actualmente disponibles.(AU)

Introduction: The objective of this report is to describe the clinical pathway for early treatment of patients with acute SARS-CoV-2 infection and to evaluate the first results of its implementation. Methods: This is a descriptive and retrospective study of the implementation of a clinical pathway of treatment in outpatients (January 1 to June 30, 2022). Clinical pathway: detection and referral systems from Primary Care, Emergency services, hospital specialities and an automated detection system; clinical evaluation and treatment administration in the COVID-19 day-hospital and subsequent clinical follow-up. Explanatory variables: demographics, comorbidity, vaccination status, referral pathways and treatment administration. Outcome variables: hospitalization and death within 30 days, grade 2–3 toxicity related to treatment. Results: Treatment was administered to 262 patients (53.4% women, median age 60 years). The treatment indication criteria were immunosuppression (68.3%), and the combination of age, vaccination status and comorbidity in the rest; 47.3% of the patients received remdesivir, 35.9% nirmatrelvir/ritonavir, 13.4% sotrovimab and 2.4% combined treatment with a median of 4 days after symptom onset. Hospital admission was required for 6.1% of the patients, 3.8% related to COVID-19 progression. No patient died. Toxicity grade 2–3 toxicity was reported in 18.7%, 89.8% dysgeusia and metallic tasted related nirmatrelvir/ritonavir. Seven patients discontinued treatment due to toxicity. Conclusion: The creation and implementation of a clinical pathway for non-hospitalized patients with SARS-CoV-2 infection is effective and it allows early accessibility and equity of currently available treatments.(AU)

[Positioning proposal on the recommendations for the use of masks in health centers after the cessation of the mandatory use in Spain]. / Propuesta de posicionamiento sobre las recomendaciones para el uso de mascarillas en los centros sanitarios tras el cese de la obligatoriedad de su uso en España.

Since the beginning of the COVID-19 pandemic in March 2020, the use of masks has been a fundamental pillar for controlling the transmission of SARS-CoV-2 in different areas. Its mandatory nature has been regulated by different regulations, and its effectiveness in reducing the transmission of SARS-CoV-2 and other respiratory viruses has been strongly proven. In this regard, the beneficial impact stands out in healthcare centers where it has been shown to reduce the transmission of respiratory infections, both in patients and healthcare professionals. This document proposes recommendations for the use of masks in health centers at the current time when we find ourselves with an end to the mandatory use of masks in Spain. They are aimed at healthcare professionals, patients and companions/visitors and aim to protect them from acquiring acute respiratory infections as a result of the complex relationships established in the healthcare field.

Desde el inicio de la pandemia de la COVID-19 en marzo de 2020, el uso de la mascarilla ha constituido un pilar fundamental para el control de la transmisión del SARS-CoV-2 en diferentes ámbitos. Su obligatoriedad ha sido regulada por diferentes normativas, y la efectividad de la misma para la reducción de la transmisión del SARS-CoV-2 y de otros virus respiratorios ha sido fuertemente probada. Al respecto, destaca el impacto beneficioso en los centros sanitarios en los que ha demostrado reducir la transmisión de las infecciones respiratorias, tanto en pacientes como en profesionales sanitarios. Este documento plantea una propuesta de recomendaciones para el uso de la mascarilla en los centros sanitarios en el momento actual en el que nos encontramos con un cese de la obligatoriedad de su uso en España. Están dirigidas a profesionales sanitarios, pacientes y acompañantes/visitantes y pretenden protegerles de adquirir infecciones respiratorias agudas como consecuencia de las complejas relaciones establecidas en el ámbito sanitario.

Propuesta de posicionamiento sobre las recomendaciones para el uso de mascarillas en los centros sanitarios tras el cese de la obligatoriedad de su uso en España / Positioning proposal on the recommendations for the use of masks in health centers after the cessation of the mandatory use in Spain

Desde el inicio de la pandemia de la COVID-19 en marzo de 2020, el uso de la mascarilla ha constituido un pilar fundamental para el control de la transmisión del SARS-CoV-2 en diferentes ámbitos. Su obligatoriedad ha sido regulada por diferentes normativas, y la efectividad de la misma para la reducción de la transmisión del SARS-CoV-2 y de otros virus respiratorios ha sido fuertemente probada. Al respecto, destaca el impacto beneficioso en los centros sanitarios en los que ha demostrado reducir la transmisión de las infecciones respiratorias, tanto en pacientes como en profesionales sanitarios. Este documento plantea una propuesta de recomendaciones para el uso de la mascarilla en los centros sanitarios en el momento actual en el que nos encontramos con un cese de la obligatoriedad de su uso en España. Están dirigidas a profesionales sanitarios, pacientes y acompañantes/visitantes y pretenden protegerles de adquirir infecciones respiratorias agudas como consecuencia de las complejas relaciones establecidas en el ámbito sanitario.(AU)

Since the beginning of the COVID-19 pandemic in March 2020, the use of masks has been a fundamental pillar for controlling the transmission of SARS-CoV-2 in different areas. Its mandatory nature has been regulated by different regulations, and its effectiveness in reducing the transmission of SARS-CoV-2 and other respiratory viruses has been strongly proven. In this regard, the beneficial impact stands out in healthcare centers where it has been shown to reduce the transmission of respiratory infections, both in patients and healthcare professionals. This document proposes recommendations for the use of masks in health centers at the current time when we find ourselves with an end to the mandatory use of masks in Spain. They are aimed at healthcare professionals, patients and companions/visitors and aim to protect them from acquiring acute respiratory infections as a result of the complex relationships established in the healthcare field.(AU)

Cytokine profile levels and their relationship with parasitemia and cardiomyopathy in people with Chagas disease in Spain. A prospective observational study.

Immunoregulatory networks may have a role in controlling parasitemia in the chronic phase of human Chagas disease. The aim was to describe the serum cytokine profile of Trypanosoma cruzi in chronically infected patients and to evaluate its relationship with parasitemia and Chagas cardiomyopathy.This prospective observational study included adult patients with chronic Chagas disease. Demographic and clinical data were collected, and peripheral blood samples were used to perform T. cruzi real-time polymerase chain reaction (RT-PCR) and determine the serum cytokine profile.Fifty-eight patients were included; 17 (29.3%) had positive RT-PCR results. This group had a higher median concentration of TNF-α (p = 0.003), IL-6 (p = 0.021), IL-4 (p = 0.031), IL-1ß (p = 0.036), and IL-17A (p = 0.043) than those with a negative RT-PCR. Patients with cardiac involvement had a higher median concentration of IL-5 (p = 0.016) than those without.These results reinforce the key role that cytokines play in Chagas disease patients with parasitemia and cardiac involvement.

The CARBA-MAP study: national mapping of carbapenemases in Spain (2014-2018).

Introduction: Infections caused by carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant Pseudomonas aeruginosa, including isolates producing acquired carbapenemases, constitute a prevalent health problem worldwide. The primary objective of this study was to determine the distribution of the different carbapenemases among carbapenemase-producing Enterobacterales (CPE, specifically Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae complex, and Klebsiella aerogenes) and carbapenemase-producing P. aeruginosa (CPPA) in Spain from January 2014 to December 2018. Methods: A national, retrospective, cross-sectional multicenter study was performed. The study included the first isolate per patient and year obtained from clinical samples and obtained for diagnosis of infection in hospitalized patients. A structured questionnaire was completed by the participating centers using the REDCap platform, and results were analyzed using IBM SPSS Statistics 29.0.0. Results: A total of 2,704 carbapenemase-producing microorganisms were included, for which the type of carbapenemase was determined in 2692 cases: 2280 CPE (84.7%) and 412 CPPA (15.3%), most often using molecular methods and immunochromatographic assays. Globally, the most frequent types of carbapenemase in Enterobacterales and P. aeruginosa were OXA-48-like, alone or in combination with other enzymes (1,523 cases, 66.8%) and VIM (365 cases, 88.6%), respectively. Among Enterobacterales, carbapenemase-producing K. pneumoniae was reported in 1821 cases (79.9%), followed by E. cloacae complex in 334 cases (14.6%). In Enterobacterales, KPC is mainly present in the South and South-East regions of Spain and OXA-48-like in the rest of the country. Regarding P. aeruginosa, VIM is widely distributed all over the country. Globally, an increasing percentage of OXA-48-like enzymes was observed from 2014 to 2017. KPC enzymes were more frequent in 2017-2018 compared to 2014-2016. Discussion: Data from this study help to understand the situation and evolution of the main species of CPE and CPPA in Spain, with practical implications for control and optimal treatment of infections caused by these multi-drug resistant organisms.

Mild SARS-CoV-2 infection in vulnerable patients: implementation of a clinical pathway for early treatment.

INTRODUCTION: The objective of this report is to describe the clinical pathway for early treatment of patients with acute SARS-CoV-2 infection and to evaluate the first results of its implementation. METHODS: This is a descriptive and retrospective study of the implementation of a clinical pathway of treatment in outpatients (January 1 to June 30 2022). Clinical pathway: detection and referral systems from Primary Care, Emergency services, hospital specialities and an automated detection system; clinical evaluation and treatment administration in the COVID-19 day-hospital and subsequent clinical follow-up. Explanatory variables: demographics, comorbidity, vaccination status, referral pathways and treatment administration. OUTCOME VARIABLES: hospitalization and death with 30 days, grade 2-3 toxicity related to treatment. RESULTS: Treatment was administered to 262 patients (53,4% women, median age 60 years). The treatment indication criteria were immunosupression (68,3%), and the combination of age, vaccination status and comorbidity in the rest 47,3% of the patients s received remdesivir, 35,9% nirmatrelvir/ritonavir, 13,4% sotrovimab and 2,4% combined treatment with a median of 4 days after symptom onset. Hospital admission was required for 6,1% of the patients, 3,8% related to progression COVID-19. No patient died. Toxicity grade 2-3 toxicity was reported in 18,7%, 89,8% dysgeusia and metallic tasted related nirmatrelvir/ritonavir. Seven patients discontinued treatment due to toxicity. CONCLUSION: The creation and implementation of a clinical pathway for non-hospitalized patients with SARS-CoV-2 infection is effective and it allows early accessibility and equity of currently available treatments.

Susceptibility to hepatitis B virus infection in adults living in Spain.

BACKGROUND: A protective hepatitis B virus (HBV) vaccine has been available for four decades. Universal HBV vaccination of infants is recommended by the WHO since the 1990s. Furthermore, HBV immunization is advised for all adults with high-risk behaviours and no seroprotection. However, HBV vaccine coverage remains globally suboptimal. The advent of new more efficacious trivalent HBV vaccines has renewed the interest in HBV vaccination. At present, the extent of current HBV susceptibility in adults remains unknown in Spain. METHODS: HBV serological markers were assessed on a large and representative sample of adults in Spain, including blood donors and individuals belonging to high-risk groups. Serum HBsAg, anti-HBc and anti-HBs were tested in specimens collected during the last couple of years. RESULTS: From 13 859 consecutive adults tested at seven cities across the Spanish geography, overall 166 (1.2%) had positive HBsAg. Past HBV infection was recognized in 14% and prior vaccine immunization in 24%. Unexpectedly, 37% of blood donors and 63% of persons belonging to high-risk groups had no serum HBV markers and therefore were potentially HBV susceptible. CONCLUSION: Roughly 60% of adults living in Spain seem to be HBV susceptible. Waning immunity might be more common than expected. Hence, HBV serological testing should be performed at least once in all adults regardless of risk exposures. HBV vaccine full courses or boosters should be administered to all adults lacking serological evidence of HBV protection.

[Mild SARS-CoV-2 infection in vulnerable patients: implementation of a clinical pathway for early treatment]. / Infección leve por SARS-CoV-2 en pacientes vulnerables: implantación de una vía clínica de tratamiento precoz.

INTRODUCTION: The objective of this report is to describe the clinical pathway for early treatment of patients with acute SARS-CoV-2 infection and to evaluate the first results of its implementation. METHODS: This is a descriptive and retrospective study of the implementation of a clinical pathway of treatment in outpatients (January 1 to June 30 2022). Clinical pathway: detection and referral systems from Primary Care, Emergency services, hospital specialities and an automated detection system; clinical evaluation and treatment administration in the COVID-19 day-hospital and subsequent clinical follow-up. Explanatory variables: demographics, comorbidity, vaccination status, referral pathways and treatment administration. OUTCOME VARIABLES: hospitalization and death with 30 days, grade 2-3 toxicity related to treatment. RESULTS: Treatment was administered to 262 patients (53,4% women, median age 60 years). The treatment indication criteria were immunosupression (68,3%), and the combination of age, vaccination status and comorbidity in the rest47,3% of the patients s received remdesivir, 35,9% nirmatrelvir/ritonavir, 13,4% sotrovimab and 2,4% combined treatment with a median of 4 days after symptom onset. Hospital admission was required for 6,1% of the patients, 3,8% related to progression COVID-19. No patient died. Toxicity grade 2-3 toxicity was reported in 18,7%, 89,8% dysgeusia and metallic tasted related nirmatrelvir/ritonavir. Seven patients discontinued treatment due to toxicity. CONCLUSION: The creation and implementation of a clinical pathway for non-hospitalized patients with SARS-CoV-2 infection is effective and it allows early accessibility and equity of currently available treatments.

Efectividad de la vacuna BNT162b2 para prevenir la COVID-19 en personal sanitario / Effectiveness of BNT162b2 vaccine to preventing COVID-19 in healthcare personnel

Objetivo: Conocer la efectividad de la vacuna BNT162b2 en personal sanitario de un departamento de salud. Método: Estudio de casos y controles con prueba negativa. Se incluyó personal sanitario con sospecha de COVID-19 y personal sanitario que fue contacto estrecho de casos de COVID-19 entre el 25 de enero y el 6 de junio de 2021. Se les realizó prueba de reacción en cadena de la polimerasa (PCR) para SARS-CoV-2; aquellos con PCR positiva fueron considerados casos y aquellos con PCR negativa fueron considerados controles. Se calculó la efectividad vacunal ajustada (EVa) para prevenir casos de COVID-19 y su intervalo de confianza del 95% (IC95%), mediante la fórmula EV = (1 − odds ratio) × 100. Resultados: Se incluyeron 624 profesionales sanitarios; de ellos, 43 (6,9%) casos y 581 (93,1%) controles. La EVa de la pauta completa fue del 96,3% (IC95%: 82,5-99,2) y la de la pauta incompleta del 68,0% (IC95%: 30,0-85,4). Conclusiones: La administración de la pauta completa de vacuna es efectiva para la prevención de casos de COVID-19 en el personal sanitario. (AU)

Objective: To assess the effectiveness of the vaccine against SARS-CoV-2 (BNT162b2) in healthcare personnel of a health department. Method: Test-negative case̶control study. Healthcare personnel with suspected COVID-19 and healthcare personnel close contacts of COVID-19 cases were included between January 27th and June 6 th, 2021. They were PCR tested for SARS-CoV-2; those with positive PCR were considered cases and those with negative PCR were considered controls. The adjusted vaccine effectiveness (aVE) to prevent COVID-19 cases and their 95% confidence interval (95%CI) were calculated using the formula VE = (1 − odds ratio) × 100. Results: 624 healthcare personnel were included, of which 43 (6.9%) were considered cases and 581 (93.8%) controls. The aVE of the complete regimen was 96.3% (95%CI: 82.5̶99.2). The aVE of the incomplete pattern was 68.0% (95%CI: 30.0̶85.4). Conclusions: The administration of the complete pattern of BNT162b2 vaccine against SARS-CoV-2 is effective for the prevention of cases of COVID-19 in healthcare personnel. (AU)

Evaluación clínica de un nuevo método molecular para la detección de microorganismos multirresistentes / Clinical evaluation of a new molecular method for the detection of multidrug-resistant microorganisms

Introducción: El objetivo fue realizar la validación clínica del sistema molecular AMR Direct Flow Chip® para la detección de genes de resistencia a antimicrobianos partiendo de aislados bacterianos en cultivo, así como de hisopos de muestras nasales o rectales. Métodos: El ensayo AMR es una PCR multiplex seguida de hibridación reversa tipo dot blot en arrays de ADN completamente automatizada mediante la plataforma HS24, con un tiempo de realización de 3h. Se realizó la validación preclínica con 104 cepas bacterianas caracterizadas y posteriormente se analizaron 210 muestras de hisopos nasales o rectales. Resultados: La sensibilidad y la especificidad del ensayo preclínico fueron del 100%, identificando correctamente las 104 cepas. En la validación clínica, la sensibilidad fue del 100% y la especificidad fue del 100% en muestras rectales y del 97% en hisopos nasales. Conclusiones: El sistema AMR Direct Flow Chip® es un sistema rápido y eficaz para la detección de microorganismos multirresistentes a partir de muestras rectales y nasales.(AU)

Introduction The main objective of this work is to carry out the clinical validation of the trial with the AMR Direct Flow Chip® starting from either nasal swabs, rectal swabs directly or from isolated strains to detect antibiotic resistance genes. Methods: We developed the preclinical validation of the assay with 104 known bacterial isolates. A total of 210 nasal or rectal swab samples were analyzed. The AMR assay is based on multiplex PCR followed by reverse dot blot hybridization on DNA arrays fully automated by using the HS24 platform. The completion time of the full analysis is 3 hours. Results :Both the sensitivity and specificity of the preclinical assay were 100%, with the 104 samples correctly identified. In the clinical validation, the sensitivity was 100% and the specificity was between 100% in rectal swabs and 97% in nasal swabs. Conclusions: The AMR Direct Flow Chip® is a rapid and effective assay for the detection of multidrug-resistant microorganisms from nasal and rectal swab samples.(AU)

Clinical evaluation of a new molecular method for the detection of multidrug-resistant microorganisms.

INTRODUCTION: The main objective of this work is to carry out the clinical validation of the trial with the AMR Direct Flow Chip starting from either nasal swabs, rectal swabs directly or from isolated strains to detect antibiotic resistance genes. METHODS: We developed the preclinical validation of the assay with 104 known bacterial isolates. A total of 210 nasal or rectal swab samples were analyzed. The AMR assay is based on multiplex PCR followed by reverse dot blot hybridization on DNA arrays fully automated by using the HS24 platform. RESULTS: Both the sensitivity and specificity of the preclinical assay were 100%, with the 104 samples correctly identified. In the clinical validation, the sensitivity was 100% and the specificity was between 100% in nasal swabs and 97% in rectal swabs. CONCLUSIONS: The AMR Direct Flow Chip® is a rapid and effective assay for the detection of multidrug-resistant microorganisms (MDR) from nasal and rectal swab samples.

Effectiveness of the systematic use of antimicrobial filters in the water taps of critical care units for the prevention of healthcare-associated infections with Pseudomonas aeruginosa.

BACKGROUND: Pseudomonas aeruginosa (PA) is the third leading aetiological agent in healthcare-associated infections (HAIs) and the one most frequently found in patients with pneumonia associated with mechanical ventilation. In intensive care units (ICU), its appearance is associated with higher mortality, an increase in the days spent on ventilation, and hospital stay length and costs. Thus, evaluating strategies for preventing these infections is essential for their control. Therefore, our objective was to evaluate the effectiveness of the systematic use of antimicrobial filters in preventing PA infections in critical care units. METHODS: This was an open experimental crossover study. A total of 2,156 patients admitted for more than 24 hours in critical care units were included, 1,129 of them in units with filters, and 1,027 in units without filters. The study groups were followed-up for 24 months and HAIs were checked for the presence of PA. Chi-squared test were used to compare the rate of HAIs between groups and we calculated 95% confidence intervals adjusted by Poisson regression for the rate ratio (RR) of the association magnitude. RESULTS: Both groups were homogeneous in terms of intrinsic and extrinsic patient factors. The incidence of PA infections in the units with filters was 5.5 cases/1,000 hospitalized days and 5.4/1,000 hospitalized days for the units without water filters (RR = 1.09 [0.67-1.79]). CONCLUSIONS: Routine placing antimicrobial filters in the water taps in critical care units was not an effective means of preventing the emergence of HAIs caused by PA.

Detection of Neutralizing Antibodies against SARS-CoV-2 Post-Vaccination in Health Care Workers of a Large Tertiary Hospital in Spain by Using a Rapid Test LFIC and sVNT-ELISA.

The presence of neutralizing antibodies (NAbs) against SARS-CoV-2 represent a surrogate marker of immunologic protection in populations at high risk of infection such as healthcare workers caring for hospitalized patients with COVID-19. As recommended by CDC and the European CDC, the use of rapid diagnostic tests during population-based evaluations offers an opportunity to identify individuals with serologic evidence of natural infection or who have undergone vaccination. We carried out a cross-sectional study to assess the presence of neutralizing antibodies against SARS-CoV-2 among medical providers at an intensive care unit of a large referral hospital in Alicante, Spain. In addition, we tested for the presence of neutralizing antibodies compared to serum of uninfected individuals from a Biobank. We were also interested in evaluating the use of a rapid lateral flow immunochromatography (LFIC) test against a surrogate ELISA viral neutralization test (sVNT). This rapid test demonstrated a specificity of 1.000 95% CI (0.91-1.00) and the sensitivity of 0.987 95% CI (0.93-1.00). The negative predictive value was 95%. After six months, this rapid test demonstrated that those immunized with two doses of BioNTech/Pfizer vaccine, maintained optimal levels of neutralizing antibodies. We concluded that all Health Care Workers develop NAbs and the use of this rapid immunochromatographic test represents a potential tool to be used in population-based studies to detect serological antibody responses to vaccination. Vaccination policies could benefit from this tool to assess additional doses of vaccine or boosters among high-risk populations.

Coronavirus Disease Transmission Prevented in an Endoscopy Unit with Universal Protective Measures and No Systematic Preprocedural Testing.

BACKGROUND AND AIMS: Even after two years of pandemic, there are still uncertainties on how to proceed when we schedule endoscopic procedures. During the COVID-19 pandemic, some scientific societies recommended universal preprocedural testing for all patients. However, other societies recommended against and considered enough to maintain strict infection control strategies. Our aim was to evaluate this approach in order to see if it was safe for both patients and healthcare workers to proceed with the endoscopies without performing a systematic PCR on all patients. METHODS: Retrospective chart review of all patients undergoing endoscopy without preprocedural COVID testing at our center from March 2020 to May 2021. PCR tests performed in the patients receiving an endoscopic procedure were analyzed, and patients who tested positive between 14 days before and after the endoscopic procedure were selected. The registry of the endoscopy unit members participating in these procedures was also analyzed. RESULTS: A total of 10,132 procedures were performed in the unit with 26 patients infected with SARS-CoV-2. Nineteen of these procedures were performed in patients with unknown SARS-CoV-2 carrier status. In 23 (88.5%) cases, transmission occurred through social or familial contact, and in 3 (11.5%), transmission occurred in the hospital. Four health care workers became infected during this period and none of them were related to the endoscopic procedures performed in patients with COVID-19. CONCLUSIONS: SARS-CoV-2 positive testing in asymptomatic ambulatory patients is rare and the adequate use of individual protective measures emerges as the main way to control the spread of COVID-19 infection in endoscopy centers.

[Effectiveness of BNT162b2 vaccine to preventing COVID-19 in healthcare personnel]. / Efectividad de la vacuna BNT162b2 para prevenir la COVID-19 en personal sanitario.

OBJECTIVE: To assess the effectiveness of the vaccine against SARS-CoV-2 (BNT162b2) in healthcare personnel of a health department. METHOD: Test-negative case̶control study. Healthcare personnel with suspected COVID-19 and healthcare personnel close contacts of COVID-19 cases were included between January 27th and June 6th, 2021. They were PCR tested for SARS-CoV-2; those with positive PCR were considered cases and those with negative PCR were considered controls. The adjusted vaccine effectiveness (aVE) to prevent COVID-19 cases and their 95% confidence interval (95%CI) were calculated using the formula VE=(1-odds ratio)×100. RESULTS: 624 healthcare personnel were included, of which 43 (6.9%) were considered cases and 581 (93.8%) controls. The aVE of the complete regimen was 96.3% (95%CI: 82.5̶99.2). The aVE of the incomplete pattern was 68.0% (95%CI: 30.0̶85.4). CONCLUSIONS: The administration of the complete pattern of BNT162b2 vaccine against SARS-CoV-2 is effective for the prevention of cases of COVID-19 in healthcare personnel.

[Sero-epidemiological study of SARS-CoV-2 infection among healthcare personnel in a healthcare department]. / Estudio de sero-epidemiología de la infección por SARS-CoV-2 en profesionales sanitarios de un departamento sanitario.

OBJECTIVE: Estimate IgG antibody prevalence against SARS-CoV-2 in healthcare personnel (HCP) of a healthcare department (HD). METHOD: Prevalence study. The presence of IgG antibodies against SARS-CoV-2 was determined in HCP of the HD. Enzyme linked immunosorbent assays (ELISA) tests were used. Field work took place from April 24, 2020 to May 8, 2020. The age, sex, occupation (physician, nurse, etc.) and the work area (Primary Care, Emergency Room, etc.) were gathered. The IgG antibody prevalence was then calculated with its 95% confidence interval (95% CI). To study the association between HCP characteristics and the presence IgG the Chi Square test was used, and to study the magnitude of association, the Odds Ratio (95% CI) was calculated. RESULTS: Of the 4813 HCP in the HD, 4179 (87,1%) participated. Of these, 73,3% (3065) were women and 26,7% (1114) men. The global prevalence of IgG antibodies against SARS-CoV-2 was 6,6% (95% CI: 5,8-7,3). There were statistically significant differences depending on the occupation, from 8,7% (95% CI: 6,9-10,6) on medics down to 3,2% (95% CI: 1,0-8,0) on personnel not associated with health care. The other characteristics did not associate significantly to antibody presence against SARS-CoV-2. CONCLUSION: The SARS-CoV-2 infection frequency in HCP is similar to the estimated in the general population for big cities in Spain. This highlights the effectiveness of the infection control and prevention programme in this healthcare department targeted at healthcare personnel.

Sero-epidemiological study of SARS-CoV-2 infection among healthcare personnel in a healthcare department.

OBJECTIVE: Estimate IgG antibody prevalence against SARS-CoV-2 in healthcare personnel (HCP) of a healthcare department (HD). METHOD: Prevalence study. The presence of IgG antibodies against SARS-CoV-2 was determined in HCP of the HD. Enzyme linked immunosorbent assays (ELISA) tests were used. Field work took place from April 24, 2020 to May 8, 2020. The age, sex, occupation (physician, nurse, etc.) and the work area (Primary Care, Emergency Room, etc.) were gathered. The IgG antibody prevalence was then calculated with its 95% confidence interval (95% CI). To study the association between HCP characteristics and the presence IgG the Chi Square test was used, and to study the magnitude of association, the Odds Ratio (95% CI) was calculated. RESULTS: Of the 4813 HCP in the HD, 4179 (87,1%) participated. Of these, 73,3% (3065) were women and 26,7% (1114) men. The global prevalence of IgG antibodies against SARS-CoV-2 was 6,6% (95% CI: 5,8-7,3). There were statistically significant differences depending on the occupation, from 8,7% (95% CI: 6,9-10,6) on medics down to 3,2% (95% CI: 1,0-8,0) on personnel not associated with health care. The other characteristics did not associate significantly to antibody presence against SARS-CoV-2. CONCLUSION: The SARS-CoV-2 infection frequency in HCP is similar to the estimated in the general population for big cities in Spain. This highlights the effectiveness of the infection control and prevention programme in this healthcare department targeted at healthcare personnel.

Estudio de sero-epidemiología de la infección por SARS-CoV-2 en profesionales sanitarios de un departamento sanitario / Sero-epidemiological study of SARS-CoV-2 infection among healthcare personnel in a healthcare department

Objetivo: Estimar la prevalencia de anticuerpos IgG frente a SARS-CoV-2 en profesionales sanitarios (PS) de un departamento sanitario (DS). Métodos: Estudio de prevalencia. Se determinó la presencia de anticuerpos IgG frente a SARS-CoV-2 en los PS del DS. La determinación se realizó mediante la técnica de ELISA. El trabajo de campo se realizó del 24 de abril de 2020 al 8 de mayo de 2020. Se recogieron edad, sexo, estamento (facultativo, enfermería, etc.) y área de trabajo (atención primaria, urgencias, etc.). Se calculó la prevalencia de anticuerpos IgG frente a SARS-CoV-2 con su intervalo de confianza al 95% (IC95%). Para estudiar la asociación entre las características de los PS y la presencia de IgG se utilizó la prueba de la ji cuadrado y para cuantificar la magnitud de asociación se calculó la odds ratio (IC95%). Resultados: De los 4.813 PS del DS participaron 4.179 (87,1%). De estos, el 73,3% (3.065) eran mujeres y el 26,7% (1.114) hombres. La prevalencia global de presencia de anticuerpos IgG frente a SARS-CoV-2 fue del 6,6% (IC95%: 5,8-7,3). Hubo diferencias estadísticamente significativas según estamento, oscilando del 8,7% (IC95%: 6,9-10,6) en facultativos al 3,2% (IC95%: 1,0-8,0) en otro personal no sanitario. El resto de características no se asociaron de forma significativa a la presencia de anticuerpos frente a SARS-CoV-2. Conclusión: La frecuencia de infección por SARS-CoV-2 en PS es similar a la estimada para la población general en grandes ciudades en España, lo que orienta sobre la efectividad del programa de prevención y control de infecciones dirigido a los profesionales sanitarios en este DS.(AU)

Objective: Estimate IgG antibody prevalence against SARS-CoV-2 in healthcare personnel (HCP) of a healthcare department (HD). Method: Prevalence study. The presence of IgG antibodies against SARS-CoV-2 was determined in HCP of the HD. Enzyme linked immunosorbent assays (ELISA) tests were used. Field work took place from April 24, 2020 to May 8, 2020. The age, sex, occupation (physician, nurse, etc.) and the work area (Primary Care, Emergency Room, etc.) were gathered. The IgG antibody prevalence was then calculated with its 95% confidence interval (95%CI). To study the association between HCP characteristics and the presence IgG the Chi Square test was used, and to study the magnitude of association, the Odds Ratio (95%CI) was calculated. Results: Of the 4813 HCP in the HD, 4179 (87,1%) participated. Of these, 73,3% (3065) were women and 26,7% (1114) men. The global prevalence of IgG antibodies against SARS-CoV-2 was 6,6% (95%CI: 5,8-7,3). There were statistically significant differences depending on the occupation, from 8,7% (95%CI: 6,9-10,6) on medics down to 3,2% (95%CI: 1,0-8,0) on personnel not associated with health care. The other characteristics did not associate significantly to antibody presence against SARS-CoV-2. Conclusion: The SARS-CoV-2 infection frequency in HCP is similar to the estimated in the general population for big cities in Spain. This highlights the effectiveness of the infection control and prevention programme in this healthcare department targeted at healthcare personnel.(AU)

[Effectiveness of the first dose of BNT162b2 vaccine to preventing covid-19 in healthcare personnel.] / Efectividad de la primera dosis de vacuna BNT162b2 para prevenir la COVID-19 en personal sanitario.

OBJECTIVE: A first protective dose of vaccine may allow delaying the second dose in a context of low supply. The objective is to assess the effectiveness of a single dose of vaccine against SARS-CoV-2 (BNT162b2) after twelve days of its administration in healthcare personnel (HCP) of a Health Department. METHODS: A case-control study was made. HCP with suspected COVID-19 and HCP close contacts of COVID-19 cases were included between January 27 and February 7, 2021. They were PCR tested for SARS-CoV-2; those with positive PCR were considered cases and those with negative PCR were considered controls. The crude (VE) and adjusted (VEa) vaccine effectiveness to prevent COVID-19 cases and their 95% confidence interval were calculated using the formula VE = (1-Odds ratio) x 100. RESULTS: 268 HCP were included, of which 70 (26.1%) were considered cases and 198 (73.9%) controls. The frequency of vaccine exposure in cases was 55.7% vs. 69.7% in controls (p=0.035). The VEa of the first vaccine dose was 52.6% (95%CI: 1.1-77.3). The VEa in the subgroup of HCP studied for suspected disease was 74.6% (CI95%: 38.4-89.5). CONCLUSIONS: One dose of BNT162b2 vaccine against SARS-CoV-2 offers early protection after twelve days of administration. These data could be considered to adapt strategies and consider postponing the second dose in situations of limited vaccine supply in order to achieve the maximum number of people covered with a first dose.

OBJETIVO: Una primera dosis de vacuna protectora permitiría aplazar la segunda dosis en un contexto de suministro escaso. El objetivo de este trabajo fue conocer la efectividad de una dosis de vacuna frente a SARS-CoV-2 (BNT162b2) tras doce días de su administración en personal sanitario (PS) de un Departamento de Salud. METODOS: Se realizó un estudio de casos y controles. Se incluyó a PS con sospecha de COVID-19 y PS que tuvo contactos estrechos con casos de COVID-19 entre el 27 de enero y el 7 de febrero de 2021. Se les realizó una PCR para determinar SARS-CoV-2; aquellos con PCR positiva fueron considerados casos y aquellos con PCR negativa fueron considerados controles. Se calculó la efectividad vacunal cruda (EV) y ajustada (EVa) para prevenir casos de COVID-19 y su intervalo de confianza al 95%, mediante la fórmula EV = (1-Odds ratio) x 100. RESULTADOS: Fueron incluidos 268 PS, de los cuales 70 (26,1%) fueron considerados casos y 198 (73,9%) controles. La frecuencia de exposición a la vacuna en los casos fue del 55,7% frente al 69,7% en los controles (p=0,035). La EVa de la primera dosis de vacuna fue del 52,6% (IC95%: 1,1-77,3). La EVa en el subgrupo de PS estudiados por sospecha de enfermedad fue del 74,6% (IC95%: 38,4-89,5). CONCLUSIONES: Una dosis de vacuna BNT162b2 frente a SARS-CoV-2 ofrece protección temprana tras doce días de su administración. Estos datos podrían considerarse para adaptar estrategias y valorar aplazar la segunda dosis en situaciones de limitación de suministro de vacuna, con el fin de conseguir el máximo número de personas cubiertas con una primera dosis.