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Background and Aims: The coronavirus disease 2019 (COVID-19) pandemic is a serious health problem worldwide. Early virus detection is essential for disease control and management. Viral antigen detection by ELISA is a cost-effective, rapid, and accurate antigen diagnostic assay which could facilitate early viral detection., Method: An antigen-capture sandwich ELISA was developed using novel nucleocapsid (NP)-specific mouse monoclonal antibodies (MAbs). The clinical performance of the assay was assessed using 403 positive and 150 negative respiratory samples collected during different SARS-CoV-2 variants outbreaks in Iran., Results: The limit of detection of our ELISA assay was found to be 43.3 pg/ml for recombinant NP. The overall sensitivity and specificity of this assay were 70.72% (95% CI: 66.01-75.12) and 100% (95% CI: 97.57-100), respectively, regardless of Ct values and SARS-CoV-2 variants. There was no significant difference in our assay sensitivity for the detection of Omicron subvariants compared to Delta variant. Assay sensitivity for the BA.5 Omicron subvariant was calculated as 91.89% (95% CI: 85.17-96.23) for samples with Ct values < 25 and 82.70% (95% CI: 75.19-88.71) for samples with Ct values < 30., Conclusion: Our newly developed ELISA method is reasonably sensitive and highly specific for detection of SARS-CoV-2 regardless of the variants and subvariants of the virus., Competing Interests: Declaration of competing interest The authors declare no conflict of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: COVID-19 presents as a mild and less severe respiratory disease among children. However, it is still lethal and could lead to death in paediatric cases. The current study aimed to investigate the clinical characteristics of children and young people hospitalized due to COVID-19 in Qazvin-Iran. We also investigated the risk factors of death due to COVID-19 in paediatric cases., Methods: We performed a retrospective cohort study on 645 children and young people (ages 0-17) hospitalized since the beginning of the COVID-19 pandemic. The cases were confirmed with positive results of reverse transcription-polymerase chain reaction (RT-PCR). The data were retrieved from an electronic database of demographic, epidemiological, and clinical characteristics., Results: The median age of the admitted patients was 4.0 years, 33.6% were under 12 months old, and 53.0% were female. Fever, cough, nausea/vomiting, dyspnoea, and myalgia were the most common symptoms presented by 50.5%, 47.6%, 24.2%, and 23.0% of the patients, respectively. Overall, we observed 16 cases of death and the in-hospital fatality rate was 2.5%. We also found comorbidity as an independent risk factor of death (odds ratio (OR) = 3.8, 95% confidence interval (CI) = 1.2-12.1, P-value = 0.022). Finally, we observed an increased risk of death in patients with dyspnoea (OR = 11.0, 95% CI = 2.8-43.7)., Conclusion: In-hospital mortality was relatively high in paediatric patients who were hospitalized due to COVID-19 in Iran. The risk of hospitalization, ICU admission, and death was higher among children with younger ages, underlying causes, and dyspnoea., Competing Interests: Disclosure of interest: The authors completed the ICMJE Disclosure of Interest Form (available upon request from the corresponding author) and disclose no relevant interests., (Copyright © 2022 by the Journal of Global Health. All rights reserved.)

Objective: The current study aimed to investigate the temporal trend of in-hospital and intensive care unit (ICU) mortality of coronavirus disease 2019 (COVID-19) patients over 6 months in the spring and summer of 2021 in Iran., Design: We performed an observational retrospective cohort study., Setting: Qazvin Province- Iran during 6 month from April to September 2021., Participants: All 14355 patients who were hospitalized with confirmed COVID-19 in hospitals of Qazvin Province., Intervention: No intervention., Main Outcome Measures: The trends of overall in-hospital mortality and ICU mortality were the main outcome of interest. We obtained crude and adjusted in-hospital and ICU mortality rates for each month of admission and over surge and lull periods of the disease., Results: The overall in-hospital mortality, early mortality and ICU mortality were 8.8%, 3.2% and 67.6%, respectively. The trend for overall mortality was almost plateau ranging from 6.5% in July to 10.7% in April. The lowest ICU mortality was 60.0% observed in April, whereas it reached a peak in August (ICU mortality = 75.7%). Admission on surge days of COVID-19 was associated with an increased risk of overall mortality (Odds ratio = 1.3, 95% confidence interval = 1.1, 1.5). The comparison of surge and lull status showed that the odds of ICU mortality in the surge of COVID-19 was 1.7 higher than in the lull period (P-value < 0.001)., Conclusions: We found that the risk of both overall in-hospital and ICU mortality increased over the surge period and fourth and fifth waves of severe acute respiratory syndrome coronavirus 2 infection in Iran. The lack of hospital resources and particularly ICU capacities to respond to the crisis during the surge period is assumed to be the main culprit., (© The Author(s) 2022. Published by Oxford University Press on behalf of International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

In a large-scale study, 128176 non-pregnant patients (228 studies) and 10000 pregnant patients (121 studies) confirmed COVID-19 cases included in this Meta-Analysis. The mean (confidence interval [CI]) of age and gestational age of admission (GA) in pregnant women was 33 (28-37) years old and 36 (34-37) weeks, respectively. Pregnant women show the same manifestations of COVID-19 as non-pregnant adult patients. Fever (pregnant: 75.5%; non-pregnant: 74%) and cough (pregnant: 48.5%; non-pregnant: 53.5%) are the most common symptoms in both groups followed by myalgia (26.5%) and chill (25%) in pregnant and dysgeusia (27%) and fatigue (26.5%) in non-pregnant patients. Pregnant women are less probable to show cough (odds ratio [OR] 0.7; 95% CI 0.67-0.75), fatigue (OR: 0.58; CI: 0.54-0.61), sore throat (OR: 0.66; CI: 0.61-0.7), headache (OR: 0.55; CI: 0.55-0.58) and diarrhea (OR: 0.46; CI: 0.4-0.51) than non-pregnant adult patients. The most common imaging found in pregnant women is ground-glass opacity (57%) and in non-pregnant patients is consolidation (76%). Pregnant women have higher proportion of leukocytosis (27% vs. 14%), thrombocytopenia (18% vs. 12.5%) and have lower proportion of raised C-reactive protein (52% vs. 81%) compared with non-pregnant patients. Leucopenia and lymphopenia are almost the same in both groups. The most common comorbidity in pregnant patients is diabetes (18%) and in non-pregnant patients is hypertension (21%). Case fatality rate (CFR) of non-pregnant hospitalized patients is 6.4% (4.4-8.5), and mortality due to all-cause for pregnant patients is 11.3% (9.6-13.3). Regarding the complications of pregnancy, postpartum hemorrhage (54.5% [7-94]), caesarean delivery (48% [42-54]), preterm labor (25% [4-74]) and preterm birth (21% [12-34]) are in turn the most prevalent complications. Comparing the pregnancy outcomes show that caesarean delivery (OR: 3; CI: 2-5), low birth weight (LBW) (OR: 9; CI: 2.4-30) and preterm birth (OR: 2.5; CI: 1.5-3.5) are more probable in pregnant woman with COVID-19 than pregnant women without COVID-19. The most prevalent neonatal complications are neonatal intensive care unit admission (43% [2-96]), fetal distress (30% [12-58]) and LBW (25% [16-37]). The rate of vertical transmission is 5.3% (1.3-16), and the rate of positive SARS-CoV-2 test for neonates born to mothers with COVID-19 is 8% (4-16). Overall, pregnant patients present with the similar clinical characteristics of COVID-19 when compared with the general population, but they may be more asymptomatic. Higher odds of caesarean delivery, LBW and preterm birth among pregnant patients with COVID-19 suggest a possible association between COVID-19 infection and pregnancy complications. Low risk of vertical transmission is present, and SARS-CoV-2 can be detected in all conception products, particularly placenta and breast milk. Interpretations of these results should be done cautiously due to the heterogeneity between studies; however, we believe our findings can guide the prenatal and postnatal considerations for COVID-19 pregnant patients., (© 2020 John Wiley & Sons Ltd.)

The high transmissibility, mortality, and morbidity rate of the SARS-CoV-2 Delta (B.1.617.2) variant have raised concerns regarding vaccine effectiveness (VE). To address this issue, all publications relevant to the effectiveness of vaccines against the Delta variant were searched in the Web of Science, Scopus, EMBASE, and Medline (via PubMed) databases up to 15 October 2021. A total of 15 studies (36 datasets) were included in the meta-analysis. After the first dose, the VE against the Delta variant for each vaccine was 0.567 (95% CI 0.520–0.613) for Pfizer-BioNTech, 0.72 (95% CI 0.589–0.822) for Moderna, 0.44 (95% CI 0.301–0.588) for AstraZeneca, and 0.138 (95% CI 0.076–0.237) for CoronaVac. Meta-analysis of 2,375,957 vaccinated cases showed that the Pfizer-BioNTech vaccine had the highest VE against the infection after the second dose, at 0.837 (95% CI 0.672–0.928), and third dose, at 0.972 (95% CI 0.96–0.978), as well as the highest VE for the prevention of severe infection or death, at 0.985 (95% CI 0.95–0.99), amongst all COVID-19 vaccines. The short-term effectiveness of vaccines, especially mRNA-based vaccines, for the prevention of the Delta variant infection, hospitalization, severe infection, and death is supported by this study. Limitations include a lack of long-term efficacy data, and under-reporting of COVID-19 infection cases in observational studies, which has the potential to falsely skew VE rates. Overall, this study supports the decisions by public health decision makers to promote the population vaccination rate to control the Delta variant infection and the emergence of further variants. [ABSTRACT FROM AUTHOR]

The current study systematically reviewed, summarized and meta-analyzed the clinical features of the vaccines in clinical trials to provide a better estimate of their efficacy, side effects and immunogenicity. All relevant publications were systematically searched and collected from major databases up to 12 March 2021. A total of 25 RCTs (123 datasets), 58,889 cases that received the COVID-19 vaccine and 46,638 controls who received placebo were included in the meta-analysis. In total, mRNA-based and adenovirus-vectored COVID-19 vaccines had 94.6% (95% CI 0.936–0.954) and 80.2% (95% CI 0.56–0.93) efficacy in phase II/III RCTs, respectively. Efficacy of the adenovirus-vectored vaccine after the first (97.6%; 95% CI 0.939–0.997) and second (98.2%; 95% CI 0.980–0.984) doses was the highest against receptor-binding domain (RBD) antigen after 3 weeks of injections. The mRNA-based vaccines had the highest level of side effects reported except for diarrhea and arthralgia. Aluminum-adjuvanted vaccines had the lowest systemic and local side effects between vaccines' adjuvant or without adjuvant, except for injection site redness. The adenovirus-vectored and mRNA-based vaccines for COVID-19 showed the highest efficacy after first and second doses, respectively. The mRNA-based vaccines had higher side effects. Remarkably few experienced extreme adverse effects and all stimulated robust immune responses. [ABSTRACT FROM AUTHOR]

Background: Those patients with COVID-19 disease that admitted in intensive care unit not only require being constantly monitored, both they also need long lengths of stay in the ICU. One of the factors that play an essential role in monitoring the condition of these patients and their diagnosis is digital medical images; but the proper distribution of these images and how care providers have access to them, especially during the COVID-19 pandemic, is one of the major problems ahead. Objective: The purpose of this study is to design a system for archiving and distributing digital medical images electronically, which can be used to provide image data of patients, especially patients admitted to the intensive care unit to care providers in a way that in addition to improving access, they can use this data in a completely safe, fast and hygienic environment to improve patient care as a decision-making system. Material and Methods: A checklist was devised in order to determine the required fields and the data relevant to the picture archiving and communication system (PACS); next, the visual design of the PACS and a model was carried out based on the corresponding standards. In the next step, the evaluation of the PACS system was performed in a semi-experimental study before - after. Finally, a study was conducted for usability analysis. Results: A Delphi study was conducted and after two rounds, 25 data elements were classified in 5 categories. The second part of the results, i.e. the design of the PACS, provided 10 key performance indicators in 3 categories. The quality of the PACS was approved by the care-providers. Based on the average time of access to images and the length of the patient's stay in the intervention ward and after the establishment of the PACS system showed a reduction of 24.5 minutes and 7.6 days, respectively (p-value<0.0001, p-value=0.028).. Conclusion: The designed PACS achieved its goals regarding the determined indicators of reduction in mortality, reduction in the average time of access to images, and reduction in the average length of stay and the satisfaction of the ICU care-providers about the quality of the PACS. [ABSTRACT FROM AUTHOR]