Could body temperature be used as surrogate measure of mRNA-based vaccination efficacy in the general population?

Predicting the humoral, cellular and clinical response to coronavirus disease 2019 (COVID-19) vaccination remains a central aspect for efficiently tackling the ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Several current studies have focused on predicting the clinical response to COVID-19 vaccination by testing both immunological and cellular biomarkers. Nonetheless, this strategy is plagued by a number of drawbacks, so that a "biological marker" which may help predicting vaccine efficacy, efficiently surrogating laboratory-based tests, would be a valuable resource for optimizing vaccine delivery. A number of recent studies, summarized in this clinical practice review, have repeatedly emphasized the existence of a significant relationship between increased body temperature and humoral response after mRNA-based COVID-19 vaccination. Therefore, we put forward the idea that fever should be no longer considered only an adverse (almost undesirable) post-vaccination side effect, wherein its onset may actually reflect enhanced immunological response to vaccine, and its measurement could hence be used for screening at least mRNA-based vaccine immunogenicity in terms of humoral response up to 3 months after mRNA-based COVID-19 vaccination by using specifically validated algorithms incorporating the integrate assessment of body temperature and anti-SARS-CoV-2 antibodies.Copyright © Journal of Laboratory and Precision Medicine. All rights reserved.

Nationwide analysis of COVID-19 death rate throughout the pandemic in Italy

Background: No definitive epidemiological evidence is available on SARS-CoV-2 lethality during the surge of different variants of concern (VoCs) and coronavirus disease 2019 (COVID-19) vaccination in relation to common flu fatality. Methods: We collected and longitudinally analyzed official data about new COVID-19 cases and COVID-9 related deaths throughout the pandemic in Italy, which were then compared with the recent influenza virus-related fatality rate. Results: The mortality rate of COVID-19 has declined from 3.53% during predominance of the ancestral SARS-CoV-2 strain to 0.26–0.21% after surge of the new Omicron sublineages BA.1/2 and BA.4/5, when the nationwide COVID-19 vaccine coverage with primary cycle and booster doses has been concomitantly extended to 90.2% and 84.5% of the general population aged ≥12 years, respectively. The death rate of COVID-19 was approximately 11-fold higher than that of common flu (i.e., 3.53% versus 0.32%) at the beginning of the pandemic, but has then become 36% lower than that caused by the Influenza virus after widespread COVID-19 vaccine coverage, acquisition of natural immunity and surge of Omicron sublineages BA.4/5. Conclusions: Although our findings underpin a reassuring epidemiological scenario, with death rate of COVID-19 currently lower than that of Influenza virus in Italy, we reemphasize the importance of preventing further surge of aggressiveness (and potential lethality) of SARS-CoV-2, especially in the most vulnerable parts of the population. © Journal of Laboratory and Precision Medicine. All rights reserved.

FebriDx for rapid screening of patients with suspected COVID-19 upon hospital admission: systematic literature review and meta-analysis.

A systematic literature review and meta-analysis was undertaken of the lateral flow-based FebriDx immunoassay for triaging patients with suspected coronavirus disease 2019 (COVID-19) upon admission to healthcare facilities. An electronic search was conducted in Scopus and Medline using the keywords 'FebriDx' AND 'COVID-19' OR 'SARS-CoV-2', with no language or date (i.e. up to 4th February 2022) limits, selecting studies where FebriDx was used for triaging patients with suspected COVID-19 in acute care settings, and reporting sufficient data to construct a 2×2 table. Five studies were included in the final analysis, totalling 2309 patients. The pooled diagnostic sensitivity and specificity were 0.91 [95% confidence interval (CI) 0.88-0.93] and 0.92 (95% CI 0.90-0.93), whilst the area under the curve, accuracy and kappa statistics were 0.971 (95% CI 0.962-0.980), 91.4% (95% CI 90.2-92.5%) and 0.762 (95% CI 0.731-0.793), respectively, thus reflecting substantial agreement with reference molecular testing techniques. Negative and positive predictive values were 0.974 (95% CI 0.966-0.981) and 0.742 (95% CI 0.711-0.770), respectively. This pooled analysis demonstrated that FebriDx has clinical value for rapid screening of patients with suspected COVID-19 in acute care settings, especially in regions with high viral circulation in which the pre-test probability is high, and enables prioritization for confirmatory laboratory testing.

Is COVID-19 impacting prostate cancer screening? A survey of prostate-specific antigen test requests during a local outbreak

Background: Although the ongoing pandemic of coronavirus disease 2019 (COVID-19) is directly contributing to negatively affect global health and fitness, the restrictive measures applied for containing the outbreaks are also impacting detection and management of many diseases, including cancers. This study aimed to establish if and how the COVID-19 outbreak may have impacted the practice of routine prostate cancer screening in Verona, Italy. Methods: We searched the laboratory information system of the Service of Laboratory Medicine of the University Hospitals of Verona to identify all test requests for total prostate-specific antigen (PSA) and vitamin D (Vit D;i.e., the locally most requested immunochemical test) for outpatients during the last five years (December 10, 2016, to December 10, 2020). The weekly requests for these tests placed between February 25 and December 9, 2020, were compared to those placed during the same period of previous four years (i.e., 2016-2019). Results: The volume of test requests for both Vit D and PSA did not differ in 2020 compared to previous four years. However, a dramatic decline was observed during the local lockdown period (between March 10 and May 17, 2020), with median decrease of 76% for Vit D and 62% for total PSA, respectively. This reduction was compensated by 13% increase for Vit D and 43% increase for total PSA in post-lockdown period. Conclusion: These results show that the lockdown period established during the first peak of the COVID-19 outbreak in Italy's Verona province was associated with a dramatic decrease in routine prostate cancer screenings.

Healthcare indicators associated with COVID-19 death rates in the European Union.

OBJECTIVES: Identification of environmental and hospital indicators that may influence coronavirus disease 2019 (COVID-19) mortality in different countries is essential for better management of this infectious disease. STUDY DESIGN: Correlation analysis between healthcare system indicators and COVID-19 mortality rate in Europe. METHODS: For each country in the European Union (EU), the date of the first diagnosed case and the crude death rate for COVID-19 were retrieved from the John Hopkins University website. These data were then combined with environmental, hospital and clinical indicators extracted from the European Health Information Gateway of the World Health Organization. RESULTS: The COVID-19 death rate in EU countries (mean 1.9 ± 0.8%) was inversely associated with the number of available general hospitals, physicians and nurses. Significant positive associations were also found with the rate of acute care bed occupancy, as well as with the proportion of population who were aged older than 65 years, overweight or who had cancer. Total healthcare expenditure, public sector health expenditure and the number of hospital and acute care beds did not influence COVID-19 death rate. CONCLUSIONS: Some common healthcare system inadequacies, such as limited numbers of general hospitals, physicians and nurses, in addition to high acute care bed occupancy, may be significant drivers of nationwide COVID-19 mortality rates in EU countries.