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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). Commonly used methods for both clinical diagnosis of SARS-CoV-2 infection and management of infected patients involve the detection of viral RNA, but the presence of infectious virus particles is unknown. Viability PCR (v-PCR) uses a photoreactive dye to bind non-infectious RNA, ideally resulting in the detection of RNA only from intact virions. This study aimed to develop and validate a rapid v-PCR assay for distinguishing intact and compromised SARS-CoV-2. Propidium monoazide (PMAxx) was used as a photoreactive dye. Mixtures with decreasing percentages of intact SARS-CoV-2 (from 100% to 0%) were prepared from SARS-CoV-2 virus stock and a clinical sample. Each sample was divided into a PMAxx-treated part and a non-PMAxx-treated part. Reverse transcription-PCR (RT-PCR) using an in-house developed SARS-CoV-2 viability assay was then applied to both sample sets. The difference in intact SARS-CoV-2 was determined by subtracting the cycle threshold (Ct) value of the PMAxx-treated sample from the non-PMAxx-treated sample. Mixtures with decreasing concentrations of intact SARS-CoV-2 showed increasingly lower delta Ct values as the percentage of intact SARS-CoV-2 decreased, as expected. This relationship was observed in both high and low viral load samples prepared from cultured SARS-CoV-2 virus stock, as well as for a clinical sample prepared directly from a SARS-CoV-2 positive nasopharyngeal swab. In this study, a rapid v-PCR assay has been validated that can distinguish intact from compromised SARS-CoV-2. The presence of intact virus particles, as determined by v-PCR, may indicate SARS-CoV-2 infectiousness. IMPORTANCE: This study developed a novel method that can help determine whether someone who has been diagnosed with coronavirus disease 2019 (COVID-19) is still capable of spreading the virus to others. Current tests only detect the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA, but cannot tell whether the particles are still intact and can thus infect cells. The researchers used a dye that selectively blocks the detection of damaged virions and free RNA. They showed that this viability PCR reliably distinguishes intact SARS-CoV-2 capable of infecting from damaged SARS-CoV-2 or free RNA in both cultured virus samples and a clinical sample. Being able to quickly assess contagiousness has important implications for contact tracing and safely ending isolation precautions. This viability PCR technique provides a simple way to obtain valuable information, beyond just positive or negative test results, about the actual risk someone poses of transmitting SARS-CoV-2 through the air or surfaces they come into contact with.
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BACKGROUND: Home-based sampling could create accessible testing opportunities for men who have sex with men (MSM) who use pre-exposure prophylaxis (PrEP). Blood collection is required for the most reliable laboratory results for HIV and syphilis testing. An innovative blood collection method (Tasso+) creates a vacuum and semi-automatically collects larger volumes of blood from the upper arm. This study aimed to assess acceptability and feasibility of this device among PrEP-using MSM and the performance of blood collection. METHODS: Between August 2022 and January 2023, 47 MSM were recruited during their routine PrEP consultations at a Dutch Centre for Sexual Health. Participants tested the method directly after consultation, and an online questionnaire determined acceptability and feasibility. Blood and residual serum volumes were measured after sampling and after HIV and syphilis testing. RESULTS: Of the participants, 87% had a positive attitude toward use of the device, and 77% would use it again for self-sampling at home. Participants rated the use of the blood collection device as easy (96%). On average, 536 µL whole blood (244 µL serum) was collected. All samples were tested for HIV and syphilis, and most samples had sufficient blood for routine HIV (91%) and syphilis testing (89%). Most samples (85%) had 220 µL residual blood, sufficient for further testing (e.g., confirmation). CONCLUSIONS: Blood self-sampling with a method that creates a vacuum from the upper arm is highly acceptable by users and performs well in blood collection for multiple tests. This method has promising potential for use in home-based sexual health care for PrEP-using MSM.
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Infecções por HIV , Homossexualidade Masculina , Profilaxia Pré-Exposição , Sífilis , Humanos , Masculino , Países Baixos , Infecções por HIV/prevenção & controle , Infecções por HIV/diagnóstico , Sífilis/diagnóstico , Sífilis/prevenção & controle , Adulto , Coleta de Amostras Sanguíneas/instrumentação , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Pessoa de Meia-Idade , Estudos de Viabilidade , Autocuidado , Inquéritos e Questionários , Minorias Sexuais e de Gênero , Adulto Jovem , Teste de HIVRESUMO
Introduction: Cross-border mobility (CBM) to visit social network members or for everyday activities is an important part of daily life for citizens in border regions, including the Meuse-Rhine Euroregion (EMR: neighboring regions from the Netherlands, Belgium, and Germany). We assessed changes in CBM during the COVID-19 pandemic and how participants experienced border restrictions. Methods: Impact of COVID-19 on the EMR' is a longitudinal study using comparative cross-border data collection. In 2021, a random sample of the EMR-population was invited for participation in online surveys to assess current and pre-pandemic CBM. Changes in CBM, experience of border restrictions, and associated factors were analyzed using multinomial and multivariable logistic regression analysis. Results: Pre-pandemic, 82% of all 3,543 participants reported any CBM: 31% for social contacts and 79% for everyday activities. Among these, 26% decreased social CBM and 35% decreased CBM for everyday activities by autumn 2021. Negative experience of border restrictions was reported by 45% of participants with pre-pandemic CBM, and was higher (p < 0.05) in Dutch participants (compared to Belgian; aOR= 1.4), cross-border [work] commuters (aOR= 2.2), participants with cross-border social networks of friends, family or acquaintances (aOR= 1.3), and those finding the measures 'limit group size' (aOR= 1.5) and 'minimalize travel' (aOR= 2.0) difficult to adhere to and finding 'minimalize travel' (aOR= 1.6) useless. Discussion: CBM for social contacts and everyday activities was substantial in EMR-citizens, but decreased during the pandemic. Border restrictions were valued as negative by a considerable portion of EMR-citizens, especially when having family or friends across the border. When designing future pandemic control strategies, policy makers should account for the negative impact of CBM restrictions on their citizens.
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COVID-19 , Humanos , COVID-19/epidemiologia , Feminino , Masculino , Bélgica , Adulto , Pessoa de Meia-Idade , Países Baixos , Estudos Longitudinais , Alemanha/epidemiologia , Rede Social , Inquéritos e Questionários , SARS-CoV-2 , Viagem/estatística & dados numéricos , Europa (Continente) , IdosoRESUMO
The CoLab score was developed and externally validated to rule out COVID-19 among suspected patients presenting at the emergency department. We hypothesized a within-patient decrease in the CoLab score over time in an intensive care unit (ICU) cohort. Such a decrease would create the opportunity to potentially rule out the need for isolation when the infection is overcome. Using linear mixed-effects models, data from the Maastricht Intensive Care COVID (MaastrICCht) cohort were used to investigate the association between time and the CoLab score. Models were adjusted for sex, APACHE II score, ICU mortality, and daily SOFA score. The CoLab score decreased by 0.30 points per day (95% CI - 0.33 to - 0.27), independent of sex, APACHE II, and Mortality. With increasing SOFA score over time, the CoLab score decreased more strongly (- 0.01 (95% CI - 0.01 to - 0.01) additional decrease per one-point increase in SOFA score.) The CoLab score decreased in ICU patients on mechanical ventilation for COVID-19, with a one-point reduction per three days, independent of sex, APACHE II, and ICU mortality, and somewhat stronger with increasing multi-organ failure over time. This suggests that the CoLab score would decrease below a threshold where COVID-19 can be excluded.
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COVID-19 , Humanos , Estudos Prospectivos , Cuidados Críticos , APACHE , Unidades de Terapia Intensiva , Estudos Retrospectivos , PrognósticoRESUMO
OBJECTIVES: The present study examines the temporal association between the changes in SARS-CoV-2 viral load during infection and whether the CoLab-score can facilitate de-isolation. METHODS: Nasal swabs and blood samples were collected from ICU-admitted SARS-CoV-2 positive patients at Maastricht UMC+ from March 25, 2020 to October 1, 2021. The CoLab-score was calculated based on 10 blood parameters and age and can range from -43 to 6. Three mixed effects analyses compared patient categories based on initial PCR Ct values (low; Ct≤20, mid; 20>Ct≤30, high; Ct>30), serial PCR Ct values to CoLab-scores over time, and the association between within-patient delta Ct values and CoLab-scores. RESULTS: In 324 patients, the median Ct was 33, and the median CoLab-score was -1.78. Mid (n=110) and low (n=41) Ct-categories had higher CoLab-scores over time (+0.60 points, 95â¯% CI; 0.04-1.17, and +0.28 points, 95â¯% CI -0.49 to 1.04) compared to the high Ct (n=87) category. Over time, higher serial Ct values were associated with lower serial CoLab-scores, decreasing by -0.07 points (95â¯% CI; -0.11 to -0.02) per day. Increasing delta Ct values were associated with a decreasing delta CoLab-score of -0.12 (95â¯% CI; -0.23; -0.01). CONCLUSIONS: The study found an association between lower viral load on admission and reduced CoLab-score. Additionally, a decrease in viral load over time was associated with a decrease in CoLab-score. Therefore, the CoLab-score may make patient de-isolation an option based on the CoLab-score.
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COVID-19 , Unidades de Terapia Intensiva , SARS-CoV-2 , Carga Viral , Humanos , COVID-19/virologia , COVID-19/diagnóstico , SARS-CoV-2/isolamento & purificação , Pessoa de Meia-Idade , Masculino , Feminino , Estudos de Coortes , Idoso , Adulto , HospitalizaçãoRESUMO
Treponema pallidum subsp. pallidum is a fastidious spirochete and the etiologic agent of syphilis, a sexually transmitted infection (STI). Syphilis diagnoses and disease staging are based on clinical findings and serologic testing. Moreover, according to most international guidelines, PCR analysis of swab samples from genital ulcers is included in the screening algorithm where possible. It has been suggested that PCR might be omitted from the screening algorithm due to low added value. As an alternative to PCR, IgM serology might be used. In this study, we wanted to establish the added value of PCR and IgM serology for diagnosing primary syphilis. Added value was defined as finding more cases of syphilis, preventing overtreatment, or limiting the extent of partner notification to more recent partners. We found that both PCR and IgM immunoblotting could aid the timely diagnosis of early syphilis in ~24% to 27% of patients. PCR has the greatest sensitivity and can be applied to cases with an ulcer with suspected reinfection or primary infection. In the absence of lesions, the IgM immunoblot could be used. However, the IgM immunoblot has better performance in cases with suspected primary infection than in reinfections. The target population, testing algorithm, time pressures, and costs should determine whether either test provides sufficient value to be implemented in clinical practice.
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Testes Diagnósticos de Rotina , Imunoglobulina M , Sífilis , Humanos , Immunoblotting/normas , Imunoglobulina M/análise , Reação em Cadeia da Polimerase/normas , Sífilis/diagnóstico , Sífilis/imunologia , Sífilis/microbiologia , Treponema pallidum/genética , Testes Sorológicos/normas , Testes Diagnósticos de Rotina/economia , Testes Diagnósticos de Rotina/métodos , Testes Diagnósticos de Rotina/normas , Sensibilidade e EspecificidadeRESUMO
COVID-19 booster vaccination has shown to add to the protection against infection with SARS-CoV2 and subsequent severe disease. This longitudinal cross-border study aimed to identify factors associated with COVID-19 booster vaccine intentions in an initially vaccinated adult population living in the Meuse-Rhine Euroregion (EMR; including the Netherlands, Belgium, and Germany) and differences between countries. Data collection took place in autumn of 2021 and consisted of online questionnaires sent to a random sample of the population based on governmental registries. Data from 3,319 fully and partially vaccinated adults were used to examine determinants of non-positive intention for a booster vaccination (i.e., uncertain or do not want), using multivariable logistic regression analyses weighted by age group, sex, and country. Compared to German residents, Dutch residents (OR = 2.4) and Belgian residents (OR = 1.4) were more likely to be uncertain or not want to receive a booster vaccine in September-October 2021. Factors independently associated with non-positive intention were female sex (OR = 1.6), absence of comorbidities (OR = 1.3), time since last vaccination less than 3 months ago for those fully vaccinated (OR = 1.6), being partially vaccinated (OR = 3.6), a negative experience with communication of COVID-19 measures (OR = 2.2), and regarding measures as ineffective (OR = 1.1). Results indicate that booster vaccine intentions differ between countries in the cross border Meuse-Rhine Euroregion. Non-positive intention for the booster vaccine is prevalent in all three countries of the EMR, but to a different extent, as shown in this study. Cross-border collaboration and sharing information and knowledge about vaccination strategies could play a role in limiting the impact of COVID-19.
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BACKGROUND: Mycoplasma genitalium (MG) is associated with urethritis in men and weakly associated with pelvic inflammatory disease in women. Mycoplasma genitalium coinfections with Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) are commonly reported; however, little is known about their interaction. One study suggested that MG/NG coinfections might increase the bacterial load of NG, which has been shown to have a higher transmission potential. As even less is known about the impact of a simultaneous MG/CT infection, we assessed whether patients with urogenital MG/CT coinfections have a higher bacterial load than patients with a single infection. METHODS: There were 1673 urogenital samples from patients from a population-based chlamydia study, and our sexually transmitted infection clinic tested for both CT and MG. When positive, the load was quantified. Nonparametric tests compared the CT and MG load, and linear regression analyses tested the association of the CT and MG load within a patient. RESULTS: In 60 MG-positive patients, MG load ranged from 1.7 to 6.0 log10 copies/ml, similar to the CT load distribution. Only 6 patients were MG-positive and CT-negative, but the MG load distribution was similar to that of CT-positive patients (n.s.). The MG and CT load was unrelated in coinfected persons (n.s.). CONCLUSIONS: We found no correlation between the CT and MG load in urogenital samples, and the MG load distribution was similar in CT-positive and CT-negative patients. These results could have implications for the transmission risk of these infections.
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Infecções por Chlamydia , Coinfecção , Infecções por Mycoplasma , Mycoplasma genitalium , Uretrite , Masculino , Humanos , Feminino , Chlamydia trachomatis , Carga Bacteriana , Uretrite/microbiologia , Infecções por Chlamydia/complicações , Infecções por Chlamydia/epidemiologia , Infecções por Chlamydia/microbiologia , Neisseria gonorrhoeae , Infecções por Mycoplasma/complicações , Infecções por Mycoplasma/microbiologia , PrevalênciaRESUMO
INTRODUCTION: To investigate whether biochemical and haematological changes due to the patient's host response (CoLab algorithm) in combination with a SARS-CoV-2 viability PCR (v-PCR) can be used to determine when a patient with COVID-19 is no longer infectious.We hypothesise that the CoLab algorithm in combination with v-PCR can be used to determine whether or not a patient with COVID-19 is infectious to facilitate the safe release of patients with COVID-19 from isolation. METHODS AND ANALYSIS: This study consists of three parts using three different cohorts of patients. All three cohorts contain clinical, vital and laboratory parameters, as well as logistic data related to isolated patients with COVID-19, with a focus on intensive care unit (ICU) stay. The first cohort will be used to develop an algorithm for the course of the biochemical and haematological changes of the host response of the COVID-19 patient. Simultaneously, a second prospective cohort will be used to investigate the algorithm derived in the first cohort, with daily measured laboratory parameters, next to conventional SARS-CoV-2 reverse transcriptase PCRs, as well as v-PCR, to confirm the presence of intact SARS-CoV-2 particles in the patient. Finally, a third multicentre cohort, consisting of retrospectively collected data from patients with COVID-19 admitted to the ICU, will be used to validate the algorithm. ETHICS AND DISSEMINATION: This study was approved by the Medical Ethics Committee from Maastricht University Medical Centre+ (cohort I: 2020-1565/300523) and Zuyderland MC (cohorts II and III: METCZ20200057). All patients will be required to provide informed consent. Results from this study will be disseminated via peer-reviewed journals and congress/consortium presentations.
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COVID-19 , Laboratórios Clínicos , Humanos , Estudos Prospectivos , Estudos Retrospectivos , SARS-CoV-2 , Reação em Cadeia da Polimerase , Unidades de Terapia Intensiva , Algoritmos , Teste para COVID-19 , Estudos Multicêntricos como AssuntoRESUMO
OBJECTIVES: We evaluated COVID-19 symptoms, case fatality rate (CFR), and viral load among all Long-Term Care Facility (LTCF) residents and staff in South Limburg, the Netherlands (February 2020-June 2020, wildtype SARS-CoV-2 Wuhan strain). METHODS: Patient information was gathered via regular channels used to notify the public health services. Ct-values were obtained from the Maastricht University Medical Centre laboratory. Logistic regression analyses were performed to assess associations between COVID-19, symptoms, CFR, and viral load. RESULTS: Of 1,457 staff and 1,540 residents, 35.1% and 45.2% tested positive for COVID-19. Symptoms associated with COVID-19 for female staff were fever, cough, muscle ache and loss of taste and smell. Associated symptoms for men were cough, and loss of taste and smell. Associated symptoms for residents were subfebrility, fatigue, and fever for male residents only. LTCF residents had a higher mean viral load compared to staff. Male residents had a higher CFR (35.8%) compared to women (22.5%). Female residents with Ct-values 31 or less had increased odds of mortality. CONCLUSIONS: Subfebrility and fatigue seem to be associated with COVID-19 in LTCF residents. Therefore, physicians should also consider testing residents who (only) show aspecific symptoms whenever available resources prohibit testing of all residents. Viral load was higher in residents compared to staff, and higher in male residents compared to female residents. All COVID-19 positive male residents, as well as female residents with a medium to high viral load (Ct-values 31 or lower) should be monitored closely, as these groups have an overall increased risk of mortality.
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Ageusia , COVID-19 , Feminino , Masculino , Humanos , COVID-19/epidemiologia , SARS-CoV-2 , Assistência de Longa Duração , Carga Viral , Estudos Retrospectivos , Estudos de Coortes , Tosse , Atenção à Saúde , FadigaRESUMO
We examined the possible sex and age differences in the proportion of experienced Coronavirus Disease 2019 (COVID-19) symptoms in unaware (previously) infected adults, and their uninfected counterparts, estimated by serostatus prior to vaccination, at the end of 2020 (Wuhan strain). A cross-sectional community-based study using a convenience sample of 10 001 adult inhabitants of a southern Dutch province, heavily affected by COVID-19, was conducted. Participants donated a blood sample to indicate past infection by serostatus (positive/negative). Experienced symptoms were assessed by questionnaire, before the availability of the serological test result. Only participants without confirmed SARS-CoV-2 infection were included (n = 9715, age range 18-90 years). The seroprevalence was comparable between men (17.3%) and women (18.0%), and participants aged 18-60 years (17.3%) and aged 60 years and older (18.6%). We showed sex and age differences in the proportion experienced symptoms by serostatus in a large cohort of both unaware (untested) seropositive compared with seronegative reference participants. Irritability only differed by serostatus in men (independent of age), while stomach ache, nausea and dizziness only differed by serostatus in women aged 60 years and older. Besides, the proportion of experiencing pain when breathing and headache differed by serostatus in men aged 18-60 years only. Our study highlights the importance of taking possible sex and age differences into account with respect to acute and long-term COVID-19 outcomes. Identifying symptom profiles for sex and age subgroups can contribute to timely identification of infection, gaining importance once governments currently move away from mass testing again.
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COVID-19 , SARS-CoV-2 , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , COVID-19/epidemiologia , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Soroepidemiológicos , Adulto JovemRESUMO
BACKGROUND: The availability of valid Severe Acute Respiratory Syndrome Coronvirus-2 (SARS-CoV-2) serological tests overcome the problem of underestimated cumulative Coronavirus Disease 2019 (COVID-19) cases during the first months of the pandemic in The Netherlands. The possibility to reliably determine the number of truly infected persons, enabled us to study initial drivers for exposure risk in the absence of routine testing. Numerous activities or circumstances can accelerate virus spread, here defined as exposure factors. Hence, we aimed to evaluate a wide variety of demographic, behavioural and social exposure factors associated with seropositivity during the first eight months of the pandemic in Limburg, The Netherlands. METHODS: SARS-CoV-2 point-seroprevalence was determined cross-sectionally to indicate previous infection in a convenience sample of minimal 10,000 inhabitants of the study province. All adult (18+ years) inhabitants of the study province were eligible to register themselves for participation. Once the initial 10,000 registrations were reached, a reserve list was kept to ensure sufficient participants. Possible exposure factors were mapped by means of an extensive questionnaire. Associated exposure factors were determined using univariable and multivariable logistic regression models. RESULTS: Seropositivity was established in 19.5% (n = 1,948) of the 10,001 participants (on average 49 years old (SD = 15; range 18-90 years), majority women (n = 5,829; 58.3%). Exposure factors associated with seropositivity included current education, working in healthcare and not working from home, and being a member of three or four associations or clubs. Specifically for February-March 2020, visiting an après-ski bar during winter sports in Austria, travelling to Spain, celebrating carnival, and participating in a singing activity or ball sport were associated with seropositivity. CONCLUSIONS: Our results confirm that relevant COVID-19 exposure factors generally reflected circumstances where social distancing was impossible, and the number and duration of contacts was high, in particular for indoor activities.
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COVID-19 , SARS-CoV-2 , Adulto , Anticorpos Antivirais , COVID-19/epidemiologia , Estudos Transversais , Feminino , Humanos , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Pandemias , Estudos SoroepidemiológicosRESUMO
BACKGROUND: Neonates with severe acute respiratory syndrome coronavirus 2 infection are usually asymptomatic or have mild to moderate symptoms. Acute respiratory distress syndrome due to severe acute respiratory syndrome coronavirus 2 with respiratory insufficiency is rare. Therefore, information about the best intensive care strategy for neonates requiring mechanical ventilation is lacking. We report a neonatal case of severe acute respiratory distress syndrome, probably due to vertical transmission of severe acute respiratory syndrome coronavirus 2, complicated by Staphylococcus aureus sepsis. We aim to inform pediatric providers on the clinical course and acute management considerations in coronavirus disease-related neonatal acute respiratory distress syndrome. CASE PRESENTATION: A late preterm (gestational age 36 0/7 weeks) Caucasian girl was born from a severe acute respiratory syndrome coronavirus 2-positive mother and tested positive for severe acute respiratory syndrome coronavirus 2 at 19 hours after birth. She developed acute respiratory distress syndrome requiring intensive care admission and mechanical ventilation. The clinical course was complicated by S. aureus pneumonia and bacteremia. Multimodal management included well-established interventions for respiratory distress syndrome such as surfactant therapy, high-frequency oscillatory ventilation, and inhaled nitric oxide, combined with therapies extrapolated from adult care for severe acute respiratory syndrome coronavirus 2 patients such as dexamethasone, coronavirus disease 2019-specific immunoglobins, and prophylactic low-molecular-weight heparin. The neonate was successfully weaned from the ventilator and improved clinically. CONCLUSION: This case shows a rare but serious neonatal severe acute respiratory syndrome coronavirus 2 infection, leading to severe acute respiratory distress syndrome. Because of limited therapy guidelines for neonates, we suggest multimodal management with awareness of the possibility of S. aureus coinfection, to treat this age group successful.
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COVID-19 , Síndrome do Desconforto Respiratório do Recém-Nascido , Insuficiência Respiratória , COVID-19/complicações , COVID-19/terapia , Criança , Feminino , Humanos , Recém-Nascido , Síndrome do Desconforto Respiratório do Recém-Nascido/etiologia , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia , SARS-CoV-2 , Staphylococcus aureusRESUMO
In response to the worldwide pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the subsequent antibody tests that flooded the market, a nationwide collaborative approach in the Netherlands was employed. Forty-one Dutch laboratories joined forces and shared their evaluation data to allow for the evaluation of a quantity of serological assays for SARS-CoV-2 that exceeds the capacity of each individual laboratory. As of April 2020, these performance data had been aggregated and shared in regularly updated reports with other laboratories, Dutch government, public health organizations, and the public. This frequently updated overview of assay performance increased the efficiency of our national laboratory response, supporting laboratories in their choice and implementation of assays. Aggregated performance data for 47 immunoassays for SARS-CoV-2 showed that none of the evaluated immunoassays that detect only IgM or IgA met the diagnostic criteria, indicating that they are not suitable for diagnosing acute infections. For the detection of IgG, only the Biozek Corona virus COVID rapid test, Euroimmun SARS-CoV-2 IgG, and Wantai SARS-CoV-2 antibody (Ab) ELISA met predefined performance criteria in hospitalized patients where samples were collected 14 days post-onset of symptoms (DPO), while for patients with mild or asymptomatic infections, only the Wantai SARS-CoV-2 Ab ELISA met the predefined performance criteria if samples were collected 14 days postonset. Here, we describe this unique nationwide collaboration during the onset of the COVID-19 pandemic; the collected data and their results are an example of what can be accomplished when forces are joined during a public health crisis.
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COVID-19 , SARS-CoV-2 , Anticorpos Antivirais , Teste para COVID-19 , Humanos , Imunoensaio , Imunoglobulina M , Laboratórios , Estudos Multicêntricos como Assunto , Pandemias , Sensibilidade e EspecificidadeRESUMO
A variety of serological tests have been developed to detect the presence of antibodies against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We evaluated the performance of 18 commercially available SARS-CoV-2 antibody assays. Early (6-8 days after the start of symptoms) and late sera (>14 days) from ICU patients (n=10 and n=16, respectively) and healthcare workers (n=5 and n=9, respectively) were included. Additionally, 22 sera were included to detect potential cross-reactivity. Test characteristics were determined for the 18 assays. In >14 days samples, the Vircell IgG and Wantai Ig ELISAs had superior sensitivity compared to the other ELISAs (96%). Furthermore, the Roche Ig, the Epitope Diagnostics IgM, Wantai IgM, Euroimmun IgG, and IgA all showed a specificity of 100%. The POCTs of Boson Biotech and ACRO Biotech showed the highest sensitivities: 100% and 96% (83.5-99.8), respectively. The POCT of Orient Gene Biotech, VOMED Diagnostics, and Coris-Bioconcept showed highest specificities (100%). For the IgM and IgA assays, the Euroimmun IgA test showed the highest sensitivity in early samples: 46.7% (23.5-70.9) to 53.3% (29.1-76.5). In general, all tests performed better in patients with severe symptoms (ICU patients). We conclude that the Wantai Ig and Vircell IgG ELISAs may be suitable for diagnostic purposes. The IgM/IgA tests performed poorer than their IgG/Ig counterparts but may have a role in diagnoses of SARS-CoV-2 in a population in which the background seroprevalence of IgG high, and IgM and/or IgA may distinguish between acute or past infection.
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Anticorpos Antivirais/sangue , Teste Sorológico para COVID-19 , COVID-19/diagnóstico , Ensaio de Imunoadsorção Enzimática , Humanos , Imunoglobulina A/sangue , Imunoglobulina G/sangue , Imunoglobulina M/sangue , SARS-CoV-2 , Sensibilidade e EspecificidadeRESUMO
Sexual healthcare aims to reduce HIV and sexually transmitted infections (STIs) by promoting testing and prevention. To better reach men who have sex with men (MSM), additional strategies are needed. Here, we describe development of an intervention, which is part of a broader HIV/STI home-care program, targeted to reach MSM and motivate them to use self-sampling tests. Self-sampling includes blood sampling (finger prick) for HIV, hepatitis B, and syphilis, and a urine sample and oral and anorectal swab samples for chlamydia and gonorrhea. Intervention mapping, a systematic six-step approach, was used to guide the development process: (1) needs assessment including interviews with MSM, (2) create a matrix of change, (3) selection of theory-based methods and practical strategies, (4) intervention development, (5) implementation plan, and (6) evaluation (not included in this paper). Stakeholders were involved to increase program support and feasibility. The needs assessment revealed that testing barriers among MSM related to stigma, time, and privacy concerns. Barriers among healthcare providers related to time, competing priorities, lack of expertise, and guideline restrictions. Included intervention components are designed to overcome these barriers, e.g., engaging role models, with a website with a role model story, and providing tailored information. Methods to reach MSM were a variety of information channels (posters, flyers, and audio-visual displays) and delivery modes, such as advertisements on websites and invitational cards (online and paper) distributed by healthcare providers and MSM themselves (social network testing/peer testing). Our intervention aims to encourage MSM to engage in testing, re-testing, and providing a test to peer MSM. Evidence-based methods to overcome barriers were included to reach and motivate an increased number of MSM. Using intervention mapping stimulated systematic evidence-based decision making and adapting the intervention to the target audience and setting. The next step (step 6) is to implement and evaluate the intervention.
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The one-stage treatment of chronic osteomyelitis with S53P4 bioactive glass (BAG) granules has shown excellent results. However, these granules possess suboptimal handling properties. Therefore, new injectable S53P4 putty materials have been developed by the incorporation of a synthetic binder to contain glass granules. The goal of the current study was to assess their potential to eradicate five clinically relevant pathogens: methicillin sensitive Staphylococcus aureus (MSSA), methicillin resistant Staphylococcus aureus (MRSA), Enterococcus coli (E. coli), Enterococcus faecalis (E. faecalis), and Pseudomonas aeruginosa (P. aeruginosa). As a control, S53P4 granules (500-800 µm) and S66 glass (< 45 µm) were used. To evaluate the antimicrobial properties, the materials were cultured with the pathogens in a Müller-Hinton II broth for a week with daily colony forming unit (CFU) counting. One of the tested putty formulations was observed to reduce the number of CFU/mL compared to a negative control (no material, only pathogen in broth) for E. coli, E. faecalis and P. aeruginosa. However, none of the tested putty formulations was able to completely eradicate the pathogens in the broths, which would be needed for safe infection treatment. The results obtained for the control materials were unexpected. S66 glass showed full eradication of P. aeruginosa and reduced the number of CFUs of other pathogens, while the S53P4 granules did not show eradication. The observations on the loose S53P4 granules in this study contradict available literature, which needs further investigation. The results obtained in this study also stretch the importance for a better understanding of the underlying antimicrobial mechanism of S53P4 BAG and how this is related to the dosage. In addition, it should be elucidated how these antimicrobial properties are affected by changes in the material formulation, for example by addition of binders to improve the handling properties or by changing the surface area.
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We describe a delayed hepatitis B seroprotection 12â¯weeks after the primary vaccination schedule in a 57-year-old male with smoldering multiple myeloma. Based on undetectable anti-HBs antibodies 6â¯weeks after the third vaccination, the index person was previously considered to be a hepatitis B vaccine non-responder. Because hepatitis B vaccination started in the 1980s, many hepatitis B vaccine non-responders have received a revaccination regimen. If more cases of genuine delayed hepatitis B seroprotection surface in patients with hematologic malignancies, delayed seroprotection should be considered before the commencement of hepatitis B revaccination.