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1.
JMIR Public Health Surveill ; 7(6): e27189, 2021 06 03.
Article in English | MEDLINE | ID: covidwho-2197904

ABSTRACT

BACKGROUND: During the COVID-19 pandemic, swab tests proved to be effective in containing the infection and served as a means for early diagnosis and contact tracing. However, little evidence exists regarding the correct timing for the execution of the swab test, especially for asymptomatic individuals and health care workers. OBJECTIVE: The objective of this study was to analyze changes in the positive findings over time in individual SARS-CoV-2 swab tests during a health surveillance program. METHODS: The study was conducted with 2071 health care workers at the University Hospital of Verona, with a known date of close contact with a patient with COVID-19, between February 29 and April 17, 2020. The health care workers underwent a health surveillance program with repeated swab tests to track their virological status. A generalized additive mixed model was used to investigate how the probability of a positive test result changes over time since the last known date of close contact, in an overall sample of individuals who tested positive for COVID-19 and in a subset of individuals with an initial negative swab test finding before being proven positive, to assess different surveillance time intervals. RESULTS: Among the 2071 health care workers in this study, 191 (9.2%) tested positive for COVID-19, and 103 (54%) were asymptomatic with no differences based on sex or age. Among 49 (25.7%) cases, the initial swab test yielded negative findings after close contact with a patient with COVID-19. Sex, age, symptoms, and the time of sampling were not different between individuals with an initial negative swab test finding and those who initially tested positive after close contact. In the overall sample, the estimated probability of testing positive was 0.74 on day 1 after close contact, which increased to 0.77 between days 5 and 8. In the 3 different scenarios for scheduled repeated testing intervals (3, 5, and 7 days) in the subgroup of individuals with an initially negative swab test finding, the probability peaked on the sixth, ninth and tenth, and 13th and 14th days, respectively. CONCLUSIONS: Swab tests can initially yield false-negative outcomes. The probability of testing positive increases from day 1, peaking between days 5 and 8 after close contact with a patient with COVID-19. Early testing, especially in this final time window, is recommended together with a health surveillance program scheduled in close intervals.


Subject(s)
COVID-19 Nucleic Acid Testing/statistics & numerical data , COVID-19/diagnosis , Health Personnel/statistics & numerical data , Adult , COVID-19/epidemiology , COVID-19/transmission , Contact Tracing/methods , False Negative Reactions , Female , Humans , Infectious Disease Transmission, Patient-to-Professional/statistics & numerical data , Italy/epidemiology , Male , Middle Aged , Pandemics , SARS-CoV-2 , Time Factors
2.
JMIR Public Health Surveill ; 7(9): e28005, 2021 09 21.
Article in English | MEDLINE | ID: covidwho-2141326

ABSTRACT

BACKGROUND: The clinical, laboratory, and imaging features of COVID-19 disease are variable. Multiple factors can affect the disease progression and outcome. OBJECTIVE: This study aimed to analyze the clinical, laboratory, and imaging features of COVID-19 in Jordan. METHODS: Clinical, laboratory, and imaging data were collected for 557 confirmed COVID-19 patients admitted to Prince Hamzah Hospital (PHH), Jordan. Analysis was performed using appropriate statistical tests with SPSS version 24. RESULTS: Of the 557 COVID-19 polymerase chain reaction (PCR)-positive cases admitted to PHH, the mean age was 34.4 years (SD 18.95 years; range 5 weeks to 87 years), 86.0% (479/557) were male, 41% (29/70) were blood group A+, and 57.1% (93/163) were overweight or obese. Significant past medical history was documented in 25.9% (144/557), significant surgical history in 12.6% (70/557), current smoking in 14.9% (83/557), and pregnancy in 0.5% (3/557). The mean duration of hospitalization was 16.4 (SD 9.3; range 5 to 70) days; 52.6% (293/557) were asymptomatic, and 12.9% (72/557) had more than 5 symptoms, with generalized malaise and dry cough the most common symptoms. Only 2.5% (14/557) had a respiratory rate over 25 breaths/minute, and 1.8% (10/557) had an oxygen saturation below 85%. Laboratory investigations showed a wide range of abnormalities, with lymphocytosis and elevated C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and D-dimer the most common abnormalities. Ground glass opacity was the most common imaging finding. Men had a significantly higher frequency of symptoms, incidence of smoking, reduced hemoglobin, increased monocyte %, elevated creatinine levels, and intensive care unit admissions compared with women (P<.05). Hospitalization duration was associated with increased age, male gender, symptom score, history of smoking, elevated systolic blood pressure, elevated respiratory rate, and elevated monocyte %, CRP, ESR, creatinine, and D-dimer (P<.05). CONCLUSIONS: Most COVID-19 cases admitted to PHH were asymptomatic. Variabilities in symptoms, signs, laboratory results, and imaging findings should be noted. Increased age, male gender, smoking history, and elevated inflammatory markers were significantly associated with longer duration of hospitalization.


Subject(s)
COVID-19/diagnosis , COVID-19/therapy , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/diagnostic imaging , COVID-19/epidemiology , Child , Child, Preschool , Cohort Studies , Cross-Sectional Studies , Female , Hospitalization/statistics & numerical data , Humans , Infant , Jordan/epidemiology , Laboratories , Male , Middle Aged , Pregnancy , Young Adult
3.
Cell Stem Cell ; 27(4): 508-510, 2020 10 01.
Article in English | MEDLINE | ID: covidwho-2132437

ABSTRACT

COVID-19 has unfortunately halted lab work, conferences, and in-person networking, which is especially detrimental to researchers just starting their labs. Through social media and our reviewer networks, we met some early-career stem cell investigators impacted by the closures. Here, they introduce themselves and their research to our readers.

4.
Egypt Heart J ; 72: 58, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-2098496

ABSTRACT

BACKGROUND: Wellens' syndrome is known to be associated with left anterior descending artery occlusion that could lead to an extensive anterior wall myocardial infarction. Thus, emergency cardiac catheterization is needed. However, during coronavirus disease 2019 (COVID-19) pandemic, it is recommended for hemodynamically stable acute coronary syndrome patients with COVID-19 infection to be treated conservatively in an isolated hospital ward. CASE PRESENTATION: We report an 85-year-old patient with chief complaints of typical, squeezing chest pain in the past 4 h. The patient had a high fever, dyspnea, sore throat, and fatigue for 3 days. He had previously come into contact with COVID-19 positive relatives. The patient was hemodynamically stable and pulmonary auscultation revealed coarse rales in the entire lung. Electrocardiography (ECG) evaluation during the pain episode showed non-specific ST-T changes in lead V2-V5. After sublingual nitrate was administered, ECG evaluation during the pain-free period revealed a biphasic T wave inversion in lead V2 and V3. Laboratory workup showed elevated cardiac marker and leucopenia with neutrophilia and lymphopenia. Rapid immunochromatographic test and initial severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription-polymerase chain reaction (RT-PCR) evaluation from nasopharyngeal swab showed negative results. However, radiographic evaluations suggest the diagnosis of COVID-19 infection. While waiting for the second RT-PCR evaluation, the patient was diagnosed with Wellens' syndrome with suspected COVID-19 infection. The patient was treated conservatively according to national guidelines and scheduled for elective cardiac catheterization. On the third day, the patient felt better and insisted on being discharged home. Ten days after discharged, the patient died of myocardial infarction. CONCLUSION: Emergency cardiac catheterization should be done for patient with Wellens' syndrome, regardless of the COVID-19 infection status.

5.
Curr Probl Cardiol ; 46(3): 100715, 2021 Mar.
Article in English | MEDLINE | ID: covidwho-2095230

ABSTRACT

The World Health Organization (WHO) announced that the novel coronavirus pneumonia pandemic caused by SARS-CoV-2 was classified as a public health emergency of international concern on January 30, 2020 Egypt's health ministry had announced the first case in the country at Cairo International Airport involving a Chinese national on 14 February 2020. Case decisions in the cath labs should be individualized, taking into account the risk of 2019 novel coronavirus (COVID-19) exposure versus the risk of delay in diagnosis or therapy. In patients with known or suspected COVID-19 and ischemic heart disease, the balance of staff exposure and patient benefit will need to be weighed carefully. AIM OF THE WORK: Analyzing and assessing the impact of COVID 19 pandemic on the: (1) volume, type of patients, and the different procedures performed. (2) The changes in management trends of cardiologists in the cath labs. RESULTS: This study has surveyed 30 cath labs distributed all over Egypt during COVID-19 pandemic with 43.35% in urban area and 56.7% in rural areas. Only 63.3% of surveyed centers were well equipped to deal with COVID-19 active patients and full personal protective equipment was worn in only 6.7% of patients. A decrease in the volume of new acute coronary syndrome (ACS) patients, ST-elevation myocardial infarction patients and primary percutaneous coronary intervention (PCI) was recorded in 80%, 83%, and 80% of the surveyed centers respectively. Regarding the delay in the invasive management for patients with ACS due to diagnostic testing, there was 100% delay in all surveyed centers with 70% of centers suffering from delay in primary PCI due to awaited testing. On the other hand, there was a decrease in the volume of patients receiving elective procedures in 83.3% of cath labs. CONCLUSION: The management trends in the current Egyptian survey were significantly impacted during COVID-19 pandemic. Primary PCI volume much reduced and takes longer time than should be.


Subject(s)
Acute Coronary Syndrome/therapy , COVID-19/epidemiology , Cardiac Catheterization/methods , Disease Management , Pandemics , SARS-CoV-2 , ST Elevation Myocardial Infarction/therapy , Acute Coronary Syndrome/epidemiology , Cross-Sectional Studies , Egypt/epidemiology , Female , Humans , Male , Middle Aged , ST Elevation Myocardial Infarction/epidemiology
6.
J Med Virol ; 93(2): 886-891, 2021 02.
Article in English | MEDLINE | ID: covidwho-1898895

ABSTRACT

Italy was one of the most affected nations by coronavirus disease 2019 outside China. The infections, initially limited to Northern Italy, spread to all other Italian regions. This study aims to provide a snapshot of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) epidemiology based on a single-center laboratory experience in Rome. The study retrospectively included 6565 subjects tested for SARS-CoV-2 at the Laboratory of Virology of Sapienza University Hospital in Rome from 6 March to 4 May. A total of 9995 clinical specimens were analyzed, including nasopharyngeal swabs, bronchoalveolar lavage fluids, gargle lavages, stools, pleural fluids, and cerebrospinal fluids. Positivity to SARS-CoV-2 was detected in 8% (527/6565) of individuals, increased with age, and was higher in male patients (P < .001). The number of new confirmed cases reached a peak on 18 March and then decreased. The virus was detected in respiratory samples, in stool and in pleural fluids, while none of gargle lavage or cerebrospinal fluid samples gave a positive result. This analysis allowed to gather comprehensive information on SARS-CoV-2 epidemiology in our area, highlighting positivity variations over time and in different sex and age group and the need for a continuous surveillance of the infection, mostly because the pandemic evolution remains unknown.


Subject(s)
COVID-19 , Pandemics , SARS-CoV-2/pathogenicity , Adolescent , Adult , Aged , Aged, 80 and over , Bronchoalveolar Lavage Fluid/virology , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19 Testing , Child , Child, Preschool , Feces/virology , Female , Hospitals, University , Humans , Infant , Infant, Newborn , Laboratories , Male , Middle Aged , Nasopharynx/virology , Pleural Effusion/virology , Retrospective Studies , Reverse Transcriptase Polymerase Chain Reaction , Rome/epidemiology , SARS-CoV-2/genetics , Severity of Illness Index
7.
PLoS One ; 16(4): e0250853, 2021.
Article in English | MEDLINE | ID: covidwho-1833535

ABSTRACT

BACKGROUND: Infection by SARS-CoV-2 in domestic animals has been related to close contact with humans diagnosed with COVID-19. Objectives: To assess the exposure, infection, and persistence by SARS-CoV-2 of dogs and cats living in the same households of humans that tested positive for SARS-CoV-2, and to investigate clinical and laboratory alterations associated with animal infection. METHODS: Animals living with COVID-19 patients were longitudinally followed and had nasopharyngeal/oropharyngeal and rectal swabs collected and tested for SARS-CoV-2. Additionally, blood samples were collected for laboratory analysis, and plaque reduction neutralization test (PRNT90) to investigate specific SARS-CoV-2 antibodies. RESULTS: Between May and October 2020, 39 pets (29 dogs and 10 cats) of 21 patients were investigated. Nine dogs (31%) and four cats (40%) from 10 (47.6%) households were infected with or seropositive for SARS-CoV-2. Animals tested positive from 11 to 51 days after the human index COVID-19 case onset of symptoms. Three dogs tested positive twice within 14, 30, and 31 days apart. SARS-CoV-2 neutralizing antibodies were detected in one dog (3.4%) and two cats (20%). In this study, six out of thirteen animals either infected with or seropositive for SARS-CoV-2 have developed mild but reversible signs of the disease. Using logistic regression analysis, neutering, and sharing bed with the ill owner were associated with pet infection. CONCLUSIONS: The presence and persistence of SARS-CoV-2 infection have been identified in dogs and cats from households with human COVID-19 cases in Rio de Janeiro, Brazil. People with COVID-19 should avoid close contact with their pets during the time of their illness.


Subject(s)
COVID-19/epidemiology , COVID-19/veterinary , Pets/virology , Animals , Animals, Domestic/virology , Antibodies, Neutralizing/immunology , Antibodies, Viral/immunology , Brazil/epidemiology , Cat Diseases , Cats , Dog Diseases , Dogs , Longitudinal Studies , Prevalence , SARS-CoV-2/pathogenicity
8.
Acta Inform Med ; 29(1): 4-9, 2021 Mar.
Article in English | MEDLINE | ID: covidwho-1811116

ABSTRACT

BACKGROUND: Universities have halted non-essential services, with many restricting campus-based teaching, and continuing courses through online resources, including (controversially) lab-work. Such technologically enhanced approaches have been proven to have high levels of engagement among university students. OBJECTIVE: This study focuses on the perception of quality of online learning by first-year university students, between two semesters, amidst the COVID-19 pandemic. METHODS: A 24-item questionnaire was designed with Likert response scale. It consisted of general perception questions of academic life and questions specific to the quality of delivery of a specific class. Eighty one eligible students were asked to fill the same questionnaire for each semester. Students' responses and their grades from the final exams in each semester were compared. RESULTS: Out of 81 eligible students, 75.31% of students responded to the survey. They were less interested in their studies in the second "online" semester (p=0.05). Students expressed dissatisfaction with the quality of online classes (p=0.03). Academic life fulfillment was also affected (p=0.02). Students' perception of the amount of free time they had between semesters did not change significantly (p=0.16). Students appeared dissatisfied with their active participation during the online class (p=0.007), even though they felt less stressed attending lectures from home (p=0.041). However, they found that workload was bearable and similar between semesters (p=0.83). Students also had significantly more trouble concentrating during online lectures (p<0.001). Students' grades significantly improved by an average of 1.07 (out of 10) in the final exams at the end of the second semester (p<0.001). CONCLUSION: These unprecedented circumstances require innovation and cooperation on the part of university programs to maintain rigorous standards of higher education, taking into account students' evolving perception and needs.

9.
Lancet Microbe ; 1(7): e300-e307, 2020 11.
Article in English | MEDLINE | ID: covidwho-1795951

ABSTRACT

BACKGROUND: Access to rapid diagnosis is key to the control and management of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Laboratory RT-PCR testing is the current standard of care but usually requires a centralised laboratory and significant infrastructure. We describe our diagnostic accuracy assessment of a novel, rapid point-of-care real time RT-PCR CovidNudge test, which requires no laboratory handling or sample pre-processing. METHODS: Between April and May, 2020, we obtained two nasopharyngeal swab samples from individuals in three hospitals in London and Oxford (UK). Samples were collected from three groups: self-referred health-care workers with suspected COVID-19; patients attending emergency departments with suspected COVID-19; and hospital inpatient admissions with or without suspected COVID-19. For the CovidNudge test, nasopharyngeal swabs were inserted directly into a cartridge which contains all reagents and components required for RT-PCR reactions, including multiple technical replicates of seven SARS-CoV-2 gene targets (rdrp1, rdrp2, e-gene, n-gene, n1, n2 and n3) and human ribonuclease P (RNaseP) as sample adequacy control. Swab samples were tested in parallel using the CovidNudge platform, and with standard laboratory RT-PCR using swabs in viral transport medium for processing in a central laboratory. The primary analysis was to compare the sensitivity and specificity of the point-of-care CovidNudge test with laboratory-based testing. FINDINGS: We obtained 386 paired samples: 280 (73%) from self-referred health-care workers, 15 (4%) from patients in the emergency department, and 91 (23%) hospital inpatient admissions. Of the 386 paired samples, 67 tested positive on the CovidNudge point-of-care platform and 71 with standard laboratory RT-PCR. The overall sensitivity of the point-of-care test compared with laboratory-based testing was 94% (95% CI 86-98) with an overall specificity of 100% (99-100). The sensitivity of the test varied by group (self-referred healthcare workers 94% [95% CI 85-98]; patients in the emergency department 100% [48-100]; and hospital inpatient admissions 100% [29-100]). Specificity was consistent between groups (self-referred health-care workers 100% [95% CI 98-100]; patients in the emergency department 100% [69-100]; and hospital inpatient admissions 100% [96-100]). Point of care testing performance was similar during a period of high background prevalence of laboratory positive tests (25% [95% 20-31] in April, 2020) and low prevalence (3% [95% 1-9] in inpatient screening). Amplification of viral nucleocapsid (n1, n2, and n3) and envelope protein gene (e-gene) were most sensitive for detection of spiked SARS-CoV-2 RNA. INTERPRETATION: The CovidNudge platform was a sensitive, specific, and rapid point of care test for the presence of SARS-CoV-2 without laboratory handling or sample pre-processing. The device, which has been implemented in UK hospitals since May, 2020, could enable rapid decisions for clinical care and testing programmes. FUNDING: National Institute of Health Research (NIHR) Imperial Biomedical Research Centre, NIHR Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at Oxford University in partnership with Public Health England, NIHR Biomedical Research Centre Oxford, and DnaNudge.


Subject(s)
COVID-19 , SARS-CoV-2 , COVID-19/diagnosis , Humans , Point-of-Care Testing , RNA, Viral/genetics , Sensitivity and Specificity
10.
J Neurosurg ; : 1-7, 2021 Apr 23.
Article in English | MEDLINE | ID: covidwho-1770979

ABSTRACT

OBJECTIVE: Aerosol-generating procedures, including endoscopic endonasal surgery (EES), are a major risk for physicians during the COVID-19 pandemic. Techniques for reducing aerosolization and risk of transmission of COVID-19 during these procedures would be valuable to the neurosurgical community. The authors aimed to simulate the generation of small-particle aerosols during EES and craniectomy in order to develop methods to reduce the spread of aerosolized particles, and to test the effectiveness of these methods. METHODS: This study was performed at the Anatomical Laboratory for Visuospatial Innovations in Otolaryngology and Neurosurgery at The Ohio State University. The following two scenarios were used to measure three different particle sizes (0.3, 2.5, and 10 µm) generated: 1) drilling frontotemporal bone, simulating a craniectomy; and 2) drilling sphenoid bone, simulating an endonasal approach. A suction mask device was created with the aim of reducing particle release. The presence of particles was measured without suction, with a single Frazier tip suction in the field, and with the suction mask device in addition to the Frazier suction tip. Particles were measured 12 cm from the craniectomy or endonasal drilling region. RESULTS: In the absence of any aerosol-reducing devices, the number of particles measured during craniectomy was significantly higher than that generated by endonasal drilling. This was true regardless of the particle size measured (0.3 µm, p < 0.001; 2.5 µm, p < 0.001; and 10 µm, p < 0.001). The suction mask device reduced the release of particles of all sizes measured in the craniectomy simulation (0.3 µm, p < 0.001; 2.5 µm, p < 0.001; and 10 µm, p < 0.001) and particles of 0.3 µm and 2.5 µm in the single Frazier suction simulation (0.3 µm, p = 0.031; and 2.5 µm, p = 0.026). The suction mask device further reduced the release of particles of all sizes during EES simulation (0.3 µm, p < 0.001; and 2.5 µm, p < 0.001) and particles of 0.3 µm and 2.5 µm in the single Frazier suction simulation (0.3 µm, p = 0.033; and 2.5 µm, p = 0.048). Large particles (10 µm) were not detected during EES. CONCLUSIONS: The suction mask device is a simple and effective means of reducing aerosol release during EES, and it could potentially be used during mastoidectomies. This could be a valuable tool to reduce the risk of procedure-associated viral transmission during the COVID-19 pandemic.

11.
Ann Intern Med ; 172(11): 726-734, 2020 06 02.
Article in English | MEDLINE | ID: covidwho-1726732

ABSTRACT

Diagnostic testing to identify persons infected with severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) infection is central to control the global pandemic of COVID-19 that began in late 2019. In a few countries, the use of diagnostic testing on a massive scale has been a cornerstone of successful containment strategies. In contrast, the United States, hampered by limited testing capacity, has prioritized testing for specific groups of persons. Real-time reverse transcriptase polymerase chain reaction-based assays performed in a laboratory on respiratory specimens are the reference standard for COVID-19 diagnostics. However, point-of-care technologies and serologic immunoassays are rapidly emerging. Although excellent tools exist for the diagnosis of symptomatic patients in well-equipped laboratories, important gaps remain in screening asymptomatic persons in the incubation phase, as well as in the accurate determination of live viral shedding during convalescence to inform decisions to end isolation. Many affluent countries have encountered challenges in test delivery and specimen collection that have inhibited rapid increases in testing capacity. These challenges may be even greater in low-resource settings. Urgent clinical and public health needs currently drive an unprecedented global effort to increase testing capacity for SARS-CoV-2 infection. Here, the authors review the current array of tests for SARS-CoV-2, highlight gaps in current diagnostic capacity, and propose potential solutions.


Subject(s)
Coronavirus Infections/diagnosis , Pneumonia, Viral/diagnosis , Betacoronavirus , Biomarkers/blood , COVID-19 , COVID-19 Testing , COVID-19 Vaccines , Clinical Laboratory Techniques , Humans , Pandemics , Point-of-Care Testing , Radiography, Thoracic , Real-Time Polymerase Chain Reaction , SARS-CoV-2 , Serologic Tests , Specimen Handling/methods
12.
Rev Sci Tech ; 40(1): 189-203, 2021 Jun.
Article in English, French | MEDLINE | ID: covidwho-1727118

ABSTRACT

The validation of diagnostic methods (and the subsequent results generated by a laboratory) are improved through participation in inter-laboratory comparisons (IC), such as proficiency-testing (PT) programmes and other exercises referred to as 'ring tests' or 'ring trials' (RTs). This is a requirement to comply with international quality standards. Validating a method is a continuous process and taking part in ongoing PT programmes supports the management of a method's life cycle, providing continuing assessment of fitness (sometimes referred to as the 'validation retention status'). Proficiency-testing panel designs ensure that the methods used, particularly diagnostic specificity and sensitivity, are suitably challenged. Appraising PT results over time can illustrate whether the laboratory's performance is stable, improving or worsening, and proficiency tests can also highlight variations in the performance of assays. The development of new proficiency tests can support the implementation of novel diagnostics technologies, such as whole genome sequencing and point-of-care testing, and assist in cross-sectoral partnerships focusing on One Health approaches, which are high on the agenda for infectious disease control. For example, the rapid design and distribution of emergency exempted assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) means that these assays were not as rigorously evaluated as assays for established infectious diseases. Therefore, participation in PT programmes for SARS-CoV-2 is essential to understand the performance of these assays. While other mechanisms help to underpin laboratory activities, PT has been, and should remain, an integral part of laboratory quality assurance. Resources must be directed towards increasing and improving the quality of PT (for example, availability and accessibility of suitable biological and reference materials are essential for a PT provider to execute its duties), to support established and novel methods such as genomic and point-of-care tests.


Les procédures de validation des méthodes de diagnostic (et les résultats obtenus par la suite par les laboratoires) peuvent être améliorées en participant à des comparaisons inter-laboratoires, sous forme notamment de programmes d'aptitude inter-laboratoires ou d'autres exercices désignés collectivement sous l'appellation d'essais comparatifs inter-laboratoires (ring trials en anglais). Cette participation constitue une obligation au regard de la conformité avec les normes internationales de qualité. La validation d'une méthode est un processus continu et la participation à des programmes d'aptitude inter-laboratoires offre des garanties quant à la gestion du cycle de vie de la méthode considérée, car elle se traduit par une évaluation continue de l'aptitude à l'emploi du test (également désignée comme la « conservation de son statut de validation ¼). Les panels des essais d'aptitude sont conçus de manière à garantir que les méthodes utilisées font l'objet d'essais appropriés, en particulier concernant leur spécificité et sensibilité diagnostiques. L'appréciation des résultats des essais d'aptitude dans le temps permet d'établir si les performances d'un laboratoire restent stables, s'améliorent ou se dégradent ; les essais d'aptitude mettent également en lumière les éventuelles variations dans les performances d'un essai. La mise au point de nouveaux essais d'aptitude peut encourager l'utilisation de technologies de diagnostic innovantes, par exemple le séquençage du génome entier et les tests utilisables sur le lieu des soins, et faciliter les partenariats intersectoriels axés sur des approches Une seule santé, qui figurent parmi les grandes priorités en matière de lutte contre les maladies infectieuses. Par exemple, la conception et la distribution rapides de tests de détection du coronavirus 2 du syndrome respiratoire aigu sévère (SARS-CoV-2) suivant un protocole d'exception imposé par l'urgence signifient que ces tests n'ont pas fait l'objet d'une évaluation aussi rigoureuse que les tests de détection de maladies infectieuses bien établies. Par conséquent, la participation à des programmes d'essais d'aptitude pour le SARS-CoV-2 est essentielle pour déterminer précisément les performances de ces tests. S'il existe d'autres mécanismes permettent d'étayer les activités d'un laboratoire, les essais d'aptitude ont été et doivent continuer à être une partie intégrante de l'assurance qualité des laboratoires. Il convient d'affecter des ressources à l'accroissement du nombre d'essais d'aptitude et à l'amélioration de leur qualité (il est notamment essentiel que les fournisseurs de tests d'aptitude puissent se procurer facilement des matériels biologiques et réactifs de référence appropriés afin de mener à bien leur tâche), de manière à soutenir aussi bien les méthodes classiques que celles qui procèdent d'innovations comme les tests génomiques et ceux utilisables sur le lieu des soins.


La validación de métodos de diagnóstico (y de los subsiguientes resultados obtenidos por un laboratorio) mejora con la participación en procesos de comparación entre laboratorios, como pueden ser los programas de pruebas de competencia u otros procesos denominados globalmente "pruebas interlaboratorios". Se trata de un requisito de obligado cumplimiento según dictan las normas internacionales de calidad. La validación de un método es un proceso permanente y, en este sentido, el hecho de tomar parte en programas continuos de pruebas de competencia ayuda a gestionar un método de prueba durante todo su ciclo de vida, aportando en todo momento una evaluación de su nivel de idoneidad (lo que a veces se denomina también el "estado de retención de la validación"). El diseño de paneles de pruebas de competencia sirve para garantizar que los métodos empleados, y en particular su especificidad y sensibilidad de diagnóstico, sean convenientemente evaluados. El análisis de los resultados de pruebas de competencia a lo largo del tiempo puede indicar si el laboratorio se mantiene en niveles estables de rendimiento o si este mejora o empeora. Las pruebas de competencia también pueden poner de manifiesto variaciones en el rendimiento de un ensayo. La creación de nuevas pruebas de competencia puede contribuir a la implantación de novedosas tecnologías de diagnóstico, como la secuenciación de genoma completo o las pruebas practicadas en el punto de consulta, y ayudar a trabajar en alianzas intersectoriales desde planteamientos en clave de "Una sola salud", extremo este de lo más prioritario en los planes de lucha contra las enfermedades infecciosas. Valga como ejemplo la celeridad con que se han concebido y distribuido ensayos aplicables al coronavirus del síndrome respiratorio agudo severo de tipo 2 (SARS-CoV-2), con las exenciones propias de un procedimiento de urgencia, lo que supone que estos ensayos no hayan pasado por un proceso de evaluación tan riguroso como el que se aplica a patógenos infecciosos más antiguos. Por ello, en el caso concreto del SARS-CoV-2, la participación en programas de pruebas de competencia es fundamental para aprehender el rendimiento que ofrecen estos ensayos. Si bien hay otros mecanismos que ayudan a reforzar el trabajo de laboratorio, las pruebas de competencia han sido, y deben seguir siendo, parte integrante de la garantía de calidad que ofrece un laboratorio. Para potenciar el uso de métodos ya arraigados o novedosos, como puedan ser la genómica o las pruebas en el punto de consulta, es preciso dedicar recursos a la realización de un mayor número de pruebas de competencia de mejor calidad (la existencia de material biológico y de referencia adecuado y la facilidad de acceso a él, por ejemplo, son sendos factores básicos para que un proveedor de pruebas de competencia pueda cumplir su cometido).


Subject(s)
COVID-19 , SARS-CoV-2 , Animals , COVID-19/veterinary , Laboratories , Reference Standards
13.
Oral Maxillofac Surg ; 26(1): 105-111, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1680899

ABSTRACT

PURPOSE: Dysgeusia and anosmia have been liked to COVID-19 infection. The aim of this study is to study the prevalence of dysgeusia and anosmia in COVID-19 patients treated at the University of Florida Health Center and establish the odds of having an olfactory and gustatory disorder with a confirmed COVID-19 infection. METHODS: This is a retrospective cross-sectional study utilizing the University of Florida Health Center patients' registry i2b2 platform to search for ICD 10 diagnoses of COVID-19 infection and taste and smell disturbances. We assessed the odds ratio for patients with dysgeusia and anosmia having a laboratory-confirmed COVID-19 infection using a logistic regression model adjusting for gender, race, age, and comorbidity conditions. P < 0.05 was deemed significant. RESULTS: Out of 889 individuals that tested positive for COVID-19, 12.88% were diagnosed with taste and smell disturbances. The odds ratio for COVID-19 for people with dysgeusia and anosmia was 39.107. After adjusting for sex, age, and race, it was 41.9, 37, and 34.2, respectively. CONCLUSION: Taste and smell disturbances in COVID-19 are not anecdotal. It is paramount that oral and maxillofacial surgeons include taste and smell disturbances in the history and physical examination as these symptoms are suspicious of active COVID-19 infection. Patients presenting with an olfactory and gustatory disorder should undergo further evaluations for COVID-19 infection and oral and maxillofacial surgeons should enhance the personal protective equipment used when treating these patients to prevent further spread of the infection and protect other healthcare members.


Subject(s)
COVID-19 , Olfaction Disorders , Anosmia , Cross-Sectional Studies , Dysgeusia/epidemiology , Dysgeusia/etiology , Humans , Olfaction Disorders/epidemiology , Oral and Maxillofacial Surgeons , Pandemics , Retrospective Studies , SARS-CoV-2
14.
PLoS One ; 16(3): e0247758, 2021.
Article in English | MEDLINE | ID: covidwho-1574068

ABSTRACT

ß2-microglobulin (ß2-m), a 11.8 kDa protein, pairs non-covalently with the α3 domain of the major histocompatibility class (MHC) I α-chain and is essential for the conformation of the MHC class I protein complex. Shed ß2-m is measurable in circulation, and various disorders are accompanied by increases in ß2-m levels, including several viral infections. Therefore, we explored whether ß2-m levels could also be elevated in Coronavirus disease 2019 (Covid-19) and whether they predict disease severity. Serum ß2-m levels were measured in a cohort of 34 patients infected with SARS-CoV-2 on admission to a tertiary care hospital in Riyadh, Saudi Arabia, as well as in an approximately age-sex matched group of 34 uninfected controls. Mean ß2-m level was 3.25±1.68 mg/l (reference range 0.8-2.2 mg/l) in patients (mean age 48.2±21.6) and 1.98±0.61 mg/l in controls (mean age 48.2±21.6). 17 patients (mean age 36.9± 18.0) with mean ß2-m levels of 2.27±0.64 mg/l had mild disease by WHO severity categorization, 12 patients (mean age 53.3±18.1) with mean ß2-m levels of 3.57±1.39 mg/l had moderate disease, and five patients (of whom 2 died; mean age 74.4±13.8) with mean ß2-m levels of 5.85±1.85 mg/l had severe disease (P < = 0.001, by ANOVA test for linear trend). In multivariate ordinal regression ß2-m levels were the only significant predictor of disease severity. Our findings suggest that higher ß2-m levels could be an early indicator of severity of disease and predict outcome of Covid-19. As the main limitations of the study are a single-center study, sample size and ethnicity, these results need confirmation in larger cohorts outside the Arabian Peninsula in order to delineate the value of ß2-m measurements. The role of ß2-m in the etiology and pathogenesis of severe Covid-19 remains to be elucidated.


Subject(s)
COVID-19/blood , Severity of Illness Index , beta 2-Microglobulin/blood , Adult , Aged , Aged, 80 and over , Biomarkers/blood , COVID-19/diagnosis , Cohort Studies , Comorbidity , Female , Humans , Male , Middle Aged , Prognosis , Saudi Arabia
15.
J Risk Uncertain ; 62(1): 89-112, 2021.
Article in English | MEDLINE | ID: covidwho-1549499

ABSTRACT

While much literature has focused on preferences regarding risk, preferences over skewness also have significant economic implications. An important and understudied aspect of skewness preferences is how they affect risk taking. In this paper, we design a novel laboratory experiment that elicits certainty equivalents over lotteries where the variance and skewness of the outcomes are orthogonal to each other. This design enables us to cleanly measure both skewness seeking/avoiding and risk taking behavior, and their interaction, without needing to make parametric assumptions. Our experiment includes both left- and right-skewed lotteries. The results reveal that the majority of subjects are skewness avoiding risk takers who correspondingly also take more risk when facing less skewed lotteries. Our second contribution is to link these choices to individual rank-dependent utility preference parameters estimated using a separate lottery choice protocol. Using a latent-class model, we are able to identify two classes of subjects: skewness avoiders with the classic inverse s-shaped probability weighting function and skewness neutral subjects that do not have an inverse s-shaped probability weighting function. Our results thus demonstrate the link between probability distortion and skewness seeking/avoidance choices. They also highlight the importance of accounting for individual heterogeneity. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11166-021-09345-w.

16.
Lancet Oncol ; 22(6): 765-778, 2021 06.
Article in English | MEDLINE | ID: covidwho-1531901

ABSTRACT

BACKGROUND: The efficacy and safety profiles of vaccines against SARS-CoV-2 in patients with cancer is unknown. We aimed to assess the safety and immunogenicity of the BNT162b2 (Pfizer-BioNTech) vaccine in patients with cancer. METHODS: For this prospective observational study, we recruited patients with cancer and healthy controls (mostly health-care workers) from three London hospitals between Dec 8, 2020, and Feb 18, 2021. Participants who were vaccinated between Dec 8 and Dec 29, 2020, received two 30 µg doses of BNT162b2 administered intramuscularly 21 days apart; patients vaccinated after this date received only one 30 µg dose with a planned follow-up boost at 12 weeks. Blood samples were taken before vaccination and at 3 weeks and 5 weeks after the first vaccination. Where possible, serial nasopharyngeal real-time RT-PCR (rRT-PCR) swab tests were done every 10 days or in cases of symptomatic COVID-19. The coprimary endpoints were seroconversion to SARS-CoV-2 spike (S) protein in patients with cancer following the first vaccination with the BNT162b2 vaccine and the effect of vaccine boosting after 21 days on seroconversion. All participants with available data were included in the safety and immunogenicity analyses. Ongoing follow-up is underway for further blood sampling after the delayed (12-week) vaccine boost. This study is registered with the NHS Health Research Authority and Health and Care Research Wales (REC ID 20/HRA/2031). FINDINGS: 151 patients with cancer (95 patients with solid cancer and 56 patients with haematological cancer) and 54 healthy controls were enrolled. For this interim data analysis of the safety and immunogenicity of vaccinated patients with cancer, samples and data obtained up to March 19, 2021, were analysed. After exclusion of 17 patients who had been exposed to SARS-CoV-2 (detected by either antibody seroconversion or a positive rRT-PCR COVID-19 swab test) from the immunogenicity analysis, the proportion of positive anti-S IgG titres at approximately 21 days following a single vaccine inoculum across the three cohorts were 32 (94%; 95% CI 81-98) of 34 healthy controls; 21 (38%; 26-51) of 56 patients with solid cancer, and eight (18%; 10-32) of 44 patients with haematological cancer. 16 healthy controls, 25 patients with solid cancer, and six patients with haematological cancer received a second dose on day 21. Of the patients with available blood samples 2 weeks following a 21-day vaccine boost, and excluding 17 participants with evidence of previous natural SARS-CoV-2 exposure, 18 (95%; 95% CI 75-99) of 19 patients with solid cancer, 12 (100%; 76-100) of 12 healthy controls, and three (60%; 23-88) of five patients with haematological cancers were seropositive, compared with ten (30%; 17-47) of 33, 18 (86%; 65-95) of 21, and four (11%; 4-25) of 36, respectively, who did not receive a boost. The vaccine was well tolerated; no toxicities were reported in 75 (54%) of 140 patients with cancer following the first dose of BNT162b2, and in 22 (71%) of 31 patients with cancer following the second dose. Similarly, no toxicities were reported in 15 (38%) of 40 healthy controls after the first dose and in five (31%) of 16 after the second dose. Injection-site pain within 7 days following the first dose was the most commonly reported local reaction (23 [35%] of 65 patients with cancer; 12 [48%] of 25 healthy controls). No vaccine-related deaths were reported. INTERPRETATION: In patients with cancer, one dose of the BNT162b2 vaccine yields poor efficacy. Immunogenicity increased significantly in patients with solid cancer within 2 weeks of a vaccine boost at day 21 after the first dose. These data support prioritisation of patients with cancer for an early (day 21) second dose of the BNT162b2 vaccine. FUNDING: King's College London, Cancer Research UK, Wellcome Trust, Rosetrees Trust, and Francis Crick Institute.


Subject(s)
COVID-19 Vaccines/therapeutic use , COVID-19/immunology , Neoplasms/immunology , Adult , Aged , Aged, 80 and over , Antibodies, Viral/blood , COVID-19/blood , COVID-19/complications , COVID-19/virology , COVID-19 Vaccines/immunology , Dose-Response Relationship, Immunologic , Female , Humans , Immunogenicity, Vaccine/immunology , London/epidemiology , Male , Middle Aged , Neoplasms/blood , Neoplasms/complications , Neoplasms/virology , Prospective Studies , SARS-CoV-2 , Wales
17.
Turk J Med Sci ; 51(4): 1665-1674, 2021 08 30.
Article in English | MEDLINE | ID: covidwho-1526879

ABSTRACT

Background/aim: Coronavirus disease 2019 (COVID-19) is a disease with a high rate of progression to critical illness. However, the predictors of mortality in critically ill patients admitted to the intensive care unit (ICU) are not yet well understood. In this study, we aimed to investigate the risk factors associated with ICU mortality in our hospital. Materials and methods: In this single-centered retrospective study, we enrolled 86 critically ill adult patients with COVID-19 admitted to ICU of Dokuz Eylül University Hospital (Izmir, Turkey) between 18 March 2020 and 31 October 2020. Data on demographic information, preexisting comorbidities, treatments, the laboratory findings at ICU admission, and clinical outcomes were collected. The chest computerized tomography (CT) of the patients were evaluated specifically for COVID-19 and CT score was calculated. Data of the survivors and nonsurvivors were compared with survival analysis to identify risk factors of mortality in the ICU. Results: The mean age of the patients was 71.1 ± 14.1 years. The patients were predominantly male. The most common comorbidity in patients was hypertension. ICU mortality was 62.8%. Being over 60 years old, CT score > 15, acute physiology and chronic health evaluation (APACHE) II score ≥ 15, having dementia, treatment without favipiravir, base excess in blood gas analysis ≤ ­2.0, WBC > 10,000/mm3, D-dimer > 1.6 µg/mL, troponin > 24 ng/L, Na ≥ 145 mmol/L were considered to link with ICU mortality according to Kaplan­Meier curves (log-rank test, p < 0.05). The APACHE II score (HR: 1.055, 95% CI: 1.021­1.090) and chest CT score (HR: 2.411, 95% CI:1.193­4.875) were associated with ICU mortality in the cox proportional-hazard regression model adjusted for age, dementia, favipiravir treatment and troponin. Howewer, no difference was found between survivors and nonsurvivors in terms of intubation timing. Conclusions: COVID-19 patients have a high ICU admission and mortality rate. Studies in the ICU are also crucial in this respect. In our study, we investigated the ICU mortality risk factors of COVID-19 patients. We determined a predictive mortality model consisting of APACHE II score and chest CT score. It was thought that this feasible and practical model would assist in making clinical decisions.


Subject(s)
COVID-19/diagnostic imaging , COVID-19/mortality , Critical Care/methods , Hospital Mortality , Intubation, Intratracheal/methods , Tomography, X-Ray Computed/methods , Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Intensive Care Units , Intubation, Intratracheal/statistics & numerical data , Lung/diagnostic imaging , Male , Middle Aged , Retrospective Studies , Risk Factors , SARS-CoV-2 , Survival Analysis , Time Factors , Turkey/epidemiology , Young Adult
18.
Cardiovasc Res ; 117(9): 2045-2053, 2021 07 27.
Article in English | MEDLINE | ID: covidwho-1526155

ABSTRACT

Although coronavirus disease 2019 seems to be the leading topic in research number of outstanding studies have been published in the field of aorta and peripheral vascular diseases likely affecting our clinical practice in the near future. This review article highlights key research on vascular diseases published in 2020. Some studies have shed light in the pathophysiology of aortic aneurysm and dissection suggesting a potential role for kinase inhibitors as new therapeutic options. A first proteogenomic study on fibromuscular dysplasia (FMD) revealed a promising novel disease gene and provided proof-of-concept for a protein/lipid-based FMD blood test. The role of NADPH oxidases in vascular physiology, and particularly endothelial cell differentiation, is highlighted with potential for cell therapy development. Imaging of vulnerable plaque has been an intense field of research. Features of plaque vulnerability on magnetic resonance imaging as an under-recognized cause of stroke are discussed. Major clinical trials on lower extremity peripheral artery disease have shown added benefit of dual antithrombotic (aspirin plus rivaroxaban) treatment.


Subject(s)
Aortic Diseases , Biomedical Research/trends , Peripheral Vascular Diseases , Animals , Aortic Diseases/diagnosis , Aortic Diseases/epidemiology , Aortic Diseases/genetics , Aortic Diseases/therapy , COVID-19 , Clinical Trials as Topic , Diffusion of Innovation , Humans , Peripheral Vascular Diseases/diagnosis , Peripheral Vascular Diseases/epidemiology , Peripheral Vascular Diseases/genetics , Peripheral Vascular Diseases/therapy , Prognosis
19.
Clin Infect Dis ; 73(10): 1831-1839, 2021 11 16.
Article in English | MEDLINE | ID: covidwho-1522142

ABSTRACT

BACKGROUND: Monitoring of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody prevalence can complement case reporting to inform more accurate estimates of SARS-CoV-2 infection burden, but few studies have undertaken repeated sampling over time on a broad geographic scale. METHODS: We performed serologic testing on a convenience sample of residual serum obtained from persons of all ages, at 10 sites in the United States from 23 March through 14 August 2020, from routine clinical testing at commercial laboratories. We standardized our seroprevalence rates by age and sex, using census population projections and adjusted for laboratory assay performance. Confidence intervals were generated with a 2-stage bootstrap. We used bayesian modeling to test whether seroprevalence changes over time were statistically significant. RESULTS: Seroprevalence remained below 10% at all sites except New York and Florida, where it reached 23.2% and 13.3%, respectively. Statistically significant increases in seroprevalence followed peaks in reported cases in New York, South Florida, Utah, Missouri, and Louisiana. In the absence of such peaks, some significant decreases were observed over time in New York, Missouri, Utah, and Western Washington. The estimated cumulative number of infections with detectable antibody response continued to exceed reported cases in all sites. CONCLUSIONS: Estimated seroprevalence was low in most sites, indicating that most people in the United States had not been infected with SARS-CoV-2 as of July 2020. The majority of infections are likely not reported. Decreases in seroprevalence may be related to changes in healthcare-seeking behavior, or evidence of waning of detectable anti-SARS-CoV-2 antibody levels at the population level. Thus, seroprevalence estimates may underestimate the cumulative incidence of infection.


Subject(s)
COVID-19 , SARS-CoV-2 , Antibodies, Viral , Bayes Theorem , Child , Humans , Seroepidemiologic Studies , United States/epidemiology , Utah
20.
Rev Mal Respir ; 38(9): 936-941, 2021 Nov.
Article in French | MEDLINE | ID: covidwho-1521503

ABSTRACT

INTRODUCTION: "Anti-pollution" masks are a form of personal protective equipment intended to ensure filtration of ambient particulate air pollution. STATE OF THE ART: Although according to tests performed in the lab, their filtration power is high, the filtering efficiency of these masks in real conditions of use, that is to say, during physical effort, is generally lower than that established in the laboratory and this information is rarely available on commercial products on sale. Clinical studies, which are rarely double-blind, demonstrate a lower incidence of symptoms and a somewhat better cardiac performance when exercise is performed while wearing a mask. For short-term use, the tolerance of these masks is fair. PERSPECTIVES: There is room for technical improvements in mask design improved fitting to the face, lowering inspiratory resistance and dead space, as well as preventing the accumulation of humidity on the mask. Manufacturers should include information in their packaging on the filtering power and design masks usable by children. Clinical studies should be performed to assess the long-term safety and effectiveness of mask in susceptible populations, especially people with asthma. CONCLUSION: Anti-pollution filtering face piece respirators have a theoretical high filtering power towards particles, but their efficiency in real-life conditions is more limited. Because such devices may confer to users a false sense of protection, the French agency on environment and health do not support their use.


Subject(s)
COVID-19 , Masks , Child , Filtration , Humans , Personal Protective Equipment , Randomized Controlled Trials as Topic , SARS-CoV-2
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