Comparative analysis of eleven SARS-CoV-2 immunoassays and neutralisation data: time to enhance standardisation and correlation of protection.

BACKGROUND: To infer a reliable SARS-CoV-2 antibody protection level from a serological test, an appropriate quantitative threshold and solid equivalence across serological tests are needed. Additionally, tests should show a solid correlation with neutralising assays and with the protection observed in large population cohorts even against emerging variants. OBJECTIVES: We studied convalescent and vaccinated populations using 11 commercial antibody assays. Results were compared to evaluate discrepancies across tests. Neutralisation capacity was measured in a subset of the samples with a lentiviral-based assay. METHODS: Serum from convalescent (n = 121) and vaccinated individuals (n = 471, 260 with Comirnaty, 110 with Spikevax, and 96 with Vaxzevria) was assessed using 11 different assays, including two from Abbott, Euroimmun, Liaison, Roche, and Vircell, and one from Siemens. A spike protein-lentiviral vector with a fluorescent reporter was used for neutralisation assay of serum from convalescent (n = 26) and vaccinated (n = 39) individuals. RESULTS: Positivity ranged between 81.3 and 94.3% after infection and 99.4 and 99.7% after vaccination, depending on the assay. Both cohorts showed a high level of qualitative agreement across tests (Fleiss' kappa = 0.598 and 0.719 for convalescent and vaccinated respectively). Spikevax vaccine recipients showed the highest level of antibodies in all tests. Effectiveness of each test predicting SARS-CoV-2 neutralising capacity depended on assay type and target, with CLIA and anti-S being more effective than ELISA and anti-N assays, respectively. CONCLUSIONS: High-throughput immunoassays are good predictors of neutralising capacity. Updated targets and better standardisation would be required to find an effective correlate of protection, especially to account for antibodies against new variants.

Dispersal history of SARS-CoV-2 in Galicia, Spain.

The dynamics of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission are influenced by a variety of factors, including social restrictions and the emergence of distinct variants. In this study, we delve into the origins and dissemination of the Alpha, Delta, and Omicron-BA.1 variants of concern in Galicia, northwest Spain. For this, we leveraged genomic data collected by the EPICOVIGAL Consortium and from the GISAID database, along with mobility information from other Spanish regions and foreign countries. Our analysis indicates that initial introductions during the Alpha phase were predominantly from other Spanish regions and France. However, as the pandemic progressed, introductions from Portugal and the United States became increasingly significant. The number of detected introductions varied from 96 and 101 for Alpha and Delta to 39 for Omicron-BA.1. Most of these introductions left a low number of descendants (<10), suggesting a limited impact on the evolution of the pandemic in Galicia. Notably, Galicia's major coastal cities emerged as critical hubs for viral transmission, highlighting their role in sustaining and spreading the virus. This research emphasizes the critical role of regional connectivity in the spread of SARS-CoV-2 and offers essential insights for enhancing public health strategies and surveillance measures.

Dispersal history of SARS-CoV-2 in Galicia, Spain.

The dynamics of SARS-CoV-2 transmission are influenced by a variety of factors, including social restrictions and the emergence of distinct variants. In this study, we delve into the origins and dissemination of the Alpha, Delta, and Omicron variants of concern in Galicia, northwest Spain. For this, we leveraged genomic data collected by the EPICOVIGAL Consortium and from the GISAID database, along with mobility information from other Spanish regions and foreign countries. Our analysis indicates that initial introductions during the Alpha phase were predominantly from other Spanish regions and France. However, as the pandemic progressed, introductions from Portugal and the USA became increasingly significant. Notably, Galicia's major coastal cities emerged as critical hubs for viral transmission, highlighting their role in sustaining and spreading the virus. This research emphasizes the critical role of regional connectivity in the spread of SARS-CoV-2 and offers essential insights for enhancing public health strategies and surveillance measures.

Anal Dysplasia Screening in People Living with HIV: Long-Term Follow-Up in a Large Cohort from Northwest Spain.

Anal squamous cell carcinoma (SCC) is not a common disease in the general population, although its incidence is higher in people living with human immunodeficiency virus (PLWH). Anal SCC is caused by human papillomavirus (HPV) infection and arises from premalignant lesions termed squamous intraepithelial lesions (SILs). SIL surveillance programs are based on the early detection and treatment of SILs, especially those with a higher risk of transforming into cancer. An anal surveillance program has been under development in our institution since 2011. In this context, we performed a retrospective cohort study at the anal dysplasia unit of Álvaro-Cunqueiro Hospital (Spain). Epidemiological and clinical data were gathered from our Infectious Diseases Sample Collection (an open sample cohort including PLWH) from January 2011 to January 2022. A total of 493 PLWH were considered, 122 (24.7%) of whom were diagnosed with anal dysplasia at baseline, including 2 cases of anal SCC. Briefly, most of individuals were young men (median age, 38 years old) born in Spain (76%), whose vaccination rate before their inclusion in the program was scarce (<3%). Throughout the study period, 81 (16.4%) cases were diagnosed with high-grade squamous-intraepithelial lesions (HSILs) and 3 with anal SCC. At the baseline, severe immunosuppression (i.e., nadir CD4+ lymphocyte count below 200 cell/µL), and prior diagnosis of condyloma acuminata were more frequent within the group with SILs. Conversely, the baseline CD4+ lymphocyte count was similar among both groups. HPV-16 was related to a higher risk of HSILs (odds ratio: 2.76). At the end of the follow-up, 385 PLWH had been retained in care; one patient had died of anal cancer. Anal dysplasia was common (25% of cases), especially among patients infected by HPV-16, diagnosed with condyloma acuminata, and who were severely immunosuppressed. HPV-16 was the main risk factor for the presentation of HSILs.

Influence of perinatal and childhood exposure to tobacco and mercury in children's gut microbiota.

Background: Early life determinants of the development of gut microbiome composition in infants have been widely investigated; however, if early life pollutant exposures, such as tobacco or mercury, have a persistent influence on the gut microbial community, its stabilization at later childhood remains largely unknown. Objective: In this exposome-wide study, we aimed at identifying the contribution of exposure to tobacco and mercury from the prenatal period to childhood, to individual differences in the fecal microbiome composition of 7-year-old children, considering co-exposure to a width of established lifestyle and clinical determinants. Methods: Gut microbiome was studied by 16S rRNA amplicon sequencing in 151 children at the genus level. Exposure to tobacco was quantified during pregnancy through questionnaire (active tobacco consumption, second-hand smoking -SHS) and biomonitoring (urinary cotinine) at 4 years (urinary cotinine, SHS) and 7 years (SHS). Exposure to mercury was quantified during pregnancy (cord blood) and at 4 years (hair). Forty nine other potential environmental determinants (12 at pregnancy/birth/infancy, 15 at 4 years and 22 at 7 years, such as diet, demographics, quality of living/social environment, and clinical records) were registered. We used multiple models to determine microbiome associations with pollutants including multi-determinant multivariate analysis of variance and linear correlations (wUnifrac, Bray-Curtis and Aitchison ß-diversity distances), single-pollutant permutational multivariate analysis of variance adjusting for co-variates (Aitchison), and multivariable association model with single taxa (MaAsLin2; genus). Sensitivity analysis was performed including genetic data in a subset of 107 children. Results: Active smoking in pregnancy was systematically associated with microbiome composition and ß-diversity (R2 2-4%, p < 0.05, Aitchison), independently of other co-determinants. However, in the adjusted single pollutant models (PERMANOVA), we did not find any significant association. An increased relative abundance of Dorea and decreased relative abundance of Akkermansia were associated with smoking during pregnancy (q < 0.05). Discussion: Our findings suggest a long-term sustainable effect of prenatal tobacco exposure on the children's gut microbiota. This effect was not found for mercury exposure or tobacco exposure during childhood. Assessing the role of these exposures on the children's microbiota, considering multiple environmental factors, should be further investigated.

Prevalencia y distribución de los genotipos del virus de la hepatitis C en Galicia durante el periodo 2000-2015 / Prevalence and distribution of hepatitis C virus genotypes in Galicia during the period 2000-2015

INTRODUCCIÓN: Presentamos el mayor estudio realizado en Galicia sobre prevalencia y distribución de genotipos/subtipos del VHC. MÉTODOS: Estudio retrospectivo recopilando al total de pacientes crónicamente infectados por VHC entre el 1 de enero del 2000 y el 31 de diciembre del 2015 en 3 de las principales áreas sanitarias: Santiago, Pontevedra y Vigo. Recogimos datos sobre prevalencia y distribución de genotipos/subtipos, vías de transmisión, género, edad y coinfección con VIH/VHB. RESULTADOS: Reclutamos a 4.469 pacientes, con una mediana de edad 50 años (RIC 57-45), el 72,3% hombres, el 0,4% coinfectado con otro genotipo, el 20,6% coinfectado con VIH y un 35,2% con VHB. Transmisión parenteral (83,1%), desconocida (15,3%), sexual (1,4%) y vertical (0,2%). Distribución de genotipos: 62,9% VHC-1 (29,2% VHC-1a y 31,9% VHC-1b), 3,4% VHC-2, 21,0% VHC-3, 12,6% VHC-4 y 0,1% VHC-5. CONCLUSIÓN: La distribución de genotipos muestra diferencias significativas respecto a la observada en España. Dicha distribución varía con la edad, el género, la coinfección con VIH o VHB, y dentro de áreas geográficas

INTRODUCTION: We present the largest study conducted in Galicia on the prevalence and distribution of HCV genotypes/subtypes. METHODS: Retrospective study collecting the total number of patients chronically infected by HCV between 2000.01.01 to 2015.12.31 in 3 of the main health areas: Santiago, Pontevedra and Vigo. RESULTS: We collected a total of 4469 patients. The median age was 50 years (IQR 57-45), 72,3% were men, 0,4% were coinfected with another genotype, 20,6% were coinfected with HIV and 35.2% with HBV. The main route of transmission was parenteral (83,1%), followed by unknown (15,3%), sexual (1,4%) and vertical (0,2%). The distribution of genotypes was: 62,9% HCV-1 (29,2% HCV-1a and 31,9% HCV-1b), 3,4% HCV-2, 21,0% HCV-3, 12,6% HCV-4 and 0,1% HCV-5. CONCLUSION: The distribution of genotypes in Galicia shows significant differences with respect to that observed in Spain. This distribution varies with age, gender, coinfection with HIV and/or HBV, and within geographical areas

Diagnóstico microbiológico de la infección por virus del papiloma humano / Microbiological diagnosis of human papilloma virus infection

La infección por el virus del papiloma humano (VPH) es la infección de transmisión sexual más frecuente en el mundo. Este virus ocasiona generalmente lesiones benignas, como verrugas genitales, pero también su persistencia ocasiona procesos malignos, como cáncer de cuello de útero (CCU) y, menos frecuentemente, anal, vaginal y de la cavidad orofaríngea. El CCU es una enfermedad muy severa, con alta mortalidad en muchos países. El cribado de CCU con citología ha tenido mucho éxito en estos últimos años, pero hay innumerable evidencia científica para que sea sustituida por la detección del VPH como prueba inicial. Para esto, hay en el mercado gran cantidad de técnicas, siendo aconsejable utilizar sistemas automáticos y pruebas aprobadas por la FDA. Un nuevo algoritmo basado en la detección individualizada de los genotipos 16 y 18 presentes en el 70% de los CCU ha sido propuesto por expertos y su implantación será inmediata en algunos países (AU)

Infection with human papillomavirus (HPV) is the leading cause of sexually transmitted infection worldwide. This virus generally causes benign lesions, such as genital warts, but persistent infection may lead to cervical cancer, anal cancer, vaginal cancer, and oropharyngeal cancer, although less frequently. Cervical cancer is a severe disease with a high mortality in some countries. Screening with cytology has been very successful in the last few years, but nowadays there are numerous studies that confirm that cytology should be replaced with the detection of HPV as a first line test in population based screening. There are several commercially available FDA approved tests for screening of cervical cancer. A new strategy, based on individual detection of the high risk genotypes HPV16 and HPV18, present in 70% of cervical cancer biopsies, has been proposed by some experts, and is going to be implemented in most countries in the future (AU)

Cervical intraepithelial neoplasia grade 2 or worse in Galicia, Spain: HPV 16 prevalence and vaccination impact / Neoplasia intraepitelial cervical de grado 2 o peor en Galicia (España): prevalencia de HPV 16 e impacto vacunal

INTRODUCTION: The etiology of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) can influence the efficacy of Public Health preventive strategies. This study aimed to determine the high-risk papillomavirus (HR-HPV) prevalence in CIN2+ cases in unvaccinated women in Galicia (Spain), the expected impact of bivalent vaccination, and the distribution of HPV 16 in squamous lesions. MATERIAL AND METHODS: Ninety-four histologically confirmed cases of CIN2+ (2009-2010) were retrospectively studied: 23 CIN2, 58 CIN3− squamous carcinoma in situ (CIN3-CIS), 5 adenocarcinoma in situ (AIS), and 8 invasive squamous cervical cancer (SCC). Linear Array HPV Genotyping Test (Roche Diagnostics, Mannheim, Germany) was performed on the cervical specimens. Bivalent vaccination impact was calculated, based on regional vaccination coverage data, local HR-HPV prevalence, and reported efficacy (direct and cross-protection) of the vaccine. RESULTS: HR-HPV prevalence was 96.8%. The most frequent genotypes were HPV 16 (48.8-58.2%) and HPV 31 (9.3%-12.1%), considering single infections or single-multiple infections, respectively (hierarchical attribution). In squamous lesions, HPV 16 prevalence in women younger than 45 years of age increased in severe lesions (CIN3-CIS/SCC, OR 4.2), and was higher than in older women (OR 5.5). The vaccine could reduce the cumulative incidence of CIN2+ by 50.6% (direct protection), or by 62.7% (direct and cross-protection). CONCLUSION: HPV vaccination could have a great impact in women younger than 45 years of age due to the high prevalence of HPV 16 in their lesions

INTRODUCCIÓN: La etiología de la neoplasia intraepitelial cervical de grado 2 o peor (CIN2+) influirá en la eficacia de las estrategias preventivas de Salud Pública. Se pretende conocer la prevalencia de papilomavirus de alto riesgo (VPH-AR) en CIN2+ en mujeres no vacunadas en Galicia (España), el impacto esperado de la vacunación bivalente y la distribución del VPH 16 en lesiones escamosas. MATERIAL Y MÉTODOS: Se estudiaron retrospectivamente 94 casos confirmados histológicamente de CIN2+ (2009-2010): 23 CIN2, 58 CIN3- carcinoma escamoso in situ (CIN3-CIS), 5 adenocarcinoma in situ (AIS) y 8 carcinoma escamoso invasivo (CES). Se utilizó Linear Array VPH Genotyping Test (Roche Diagnostics, Mannheim, Alemania) en muestras cervicales. El impacto de la vacunación se calculó según la cobertura vacunal autonómica, la prevalencia local de VPH-AR y datos publicados de eficacia (protección directa y cruzada). RESULTADOS: La prevalencia de VPH-AR fue del 96,8%. Los genotipos más frecuentes fueron HPV 16 (48,8-58,2%) y HPV 31 (9,3-12,1%) considerando infecciones simples o infecciones simples-múltiples, respectivamente (atribución jerárquica). En lesiones escamosas, la prevalencia de VPH 16 en mujeres de hasta 45 años aumentó con la severidad de las lesiones (CIN3-CIS/CES; OR 4,2) y fue mayor que en las mujeres mayores (OR 5,5). La vacuna podría reducir la incidencia acumulada de CIN2+ un 50,6% (protección directa) o un 62,7% (protección directa y cruzada). CONCLUSIÓN: La vacunación frente al VPH podría tener un gran impacto en mujeres menores de 45 años debido a la alta prevalencia de VPH 16 en las lesiones que presentan

Varicela recurrente en una mujer con linfoma del manto / Recurrent varicella in a woman with mantle cell lymphoma

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