Antigen Detection Tests for SARS-CoV-2: a systematic review and meta-analysis on real world data.

Background and aim Rapid antigen detection (RAD) tests on nasopharyngeal specimens have been recently made available for SARS-CoV-2 infections, and early studies suggested their potential utilization as rapid screening and diagnostic testing. The present systematic review and meta-analysis was aimed to assess available evidence and to explore the reliability of antigenic tests in the management of the SARS-CoV-2 pandemic. MATERIALS AND METHODS: We reported our meta-analysis according to the PRISMA statement. We searched Pubmed, Embase, and pre-print archive medRxiv.og for eligible studies published up to November 5th, 2020. Raw data included true/false positive and negative tests, and the total number of tests. Sensitivity and specificity data were calculated for every study, and then pooled in a random-effects model. Heterogeneity was assessed using the I2 measure. Reporting bias was assessed by means of funnel plots and regression analysis. RESULTS: Based on 25 studies, we computed a pooled sensitivity of 72.8% (95%CI 62.4-81.3), a specificity of 99.4% (95%CI 99.0-99.7), with high heterogeneity and risk of reporting bias. More precisely, RAD tests exhibited higher sensitivity on samples with high viral load (i.e. <25 Cycle Threshold; 97.6%; 95%CI 94.1-99.0), compared to those with low viral load (≥25 Cycle Threshold; 43.6%; 95% 27.6-61.1). DISCUSSION: As the majority of collected reports were either cohort or case-control studies, deprived of preventive power analysis and often oversampling positive tests, overall performances may have been overestimated. Therefore, the massive referral to antigenic tests in place of RT-qPCR is currently questionable, and also their deployment as mass screening test may lead to intolerable share of missing diagnoses. On the other hand, RAD tests may find a significant role in primary care and in front-line settings (e.g. Emergency Departments). (www.actabiomedica.it).

Epidemiological assessment of the first COVID-19 epidemic wave in Lombardy. A systematic review.

BACKGROUND AND AIM: After the first cases of COVID-19 detected in Wuhan (China), the virus rapidly spread in the world, so much so that on February 20 the first autochthonous case was officially identified in Italy. However, this person had no apparent history of travel abroad or contact with people tested positive for the virus. For this reason, the aim of this literature review was to reconstruct the epidemiological dynamics of the first wave of SARS-CoV-2 infection in the Lombardy Region. METHODS: To this end, a systematic review was carried out on PubMed/MEDLINE and EMBASE, and on grey literature. All article assessing incidence, mortality and hospitalizations by Lombardy province and municipality, and the impact of the main containment and organizational measures were considered eligible. In addition, data on general mortality and mortality due to COVID-19, hospital admission, and serological and environmental were also retrieved. RESULTS: From the included studies, it emerged that Lombardy was the first European region in which the virus began to circulate as early as January 2020 (and probably even earlier). Despite the high number of cases and deaths recorded, the reproduction number observed in Lombardy Region was, at the beginning of March 2020, the same (or lower) than in other regions. CONCLUSIONS: In conclusion, data of the first epidemic wave in Lombardy, compared to other Italian and foreign regions, highlight the extreme criticality of having had the first autochthonous case (and the first substantial outbreaks) when knowledge was still scarce and individual prevention measures were not widespread.

RT-qPCR assays based on saliva rather than on nasopharyngeal swabs are possible but should be interpreted with caution: results from a systematic review and meta-analysis.

BACKGROUND AND AIM OF THE WORK: The ongoing pandemic has elicited an increasing interest regarding the SARS-CoV-2 viral RNA detection in saliva specimens rather than through nasopharyngeal swabs. Our aim was to conduct a meta-analysis on the sensitivity and specificity of SARS-CoV-2 viral RNA detection through RT-qPCR based on salivary specimens compared to conventional nasopharyngeal swabs. METHODS: We reported our meta-analysis according to the PRISMA statement. We searched Pubmed, Embase, and pre-print archive medRxiv.og for eligible studies published up to June 1st, 2020. Raw data included true/false positive and negative tests, and the total number of tests. Sensitivity and specificity data were calculated for every study, and then pooled in a random-effects model. Heterogeneity was assessed using the I2 measure. Reporting bias was assessed by means of funnel plots and regression analysis. RESULTS: The systematic review eventually retrieved 14 studies including a total of 15 estimates, the were included in quantitative synthesis. We found a pooled specificity of 97.7% (95%CI 93.8-99.2) and a pooled sensitivity of 83.4% (95%CI 73.1-90.4), with an overall agreement assessed by means of Cohen's kappa equals to 0.750, 95%CI 0.62-0.88 (i.e. moderate agreement), with high heterogeneity and risk of reporting bias. CONCLUSIONS: In conclusion, diagnostic tests based on salivary specimens are somewhat reliable, but relatively few studies have been carried out. Moreover, such studies are characterized by low numbers and low sample power. Therefore, the of salivary samples is currently questionable for clinical purposes and cannot substitute other more conventional RT-qPCR based on nasopharyngeal swabs.

Mandate or Not Mandate: Knowledge, Attitudes, and Practices of Italian Occupational Physicians towards SARS-CoV-2 Immunization at the Beginning of Vaccination Campaign.

Vaccinations used to prevent coronavirus disease (COVID-19)-the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-are critical in order to contain the ongoing pandemic. However, SARS-CoV-2/COVID-19 vaccination rates have only slowly increased since the beginning of the vaccination campaign, even with at-risk workers (e.g., HCWs), presumptively because of vaccine hesitancy. Vaccination mandates are considered instrumental in order to rapidly improve immunization rates (but they minimize the impact of vaccination campaigns). In this study, we investigated the acceptance (i.e., knowledge, attitudes, and practices) from occupational physicians (OPs)) in regard to SARS-CoV-2/COVID-19 vaccination mandates. A total of 166 OPs participated in an internet-based survey by completing structured questionnaires. Adequate, general knowledge of SARS-CoV-2/COVID-19 was found in the majority of OPs. High perception of SARS-CoV-2 risk was found in around 80% of participants (79.5% regarding its occurrence, 81.9% regarding its potential severity). SARS-CoV-2/COVID-19 vaccination was endorsed by 90.4% of respondents, acceptance for SARS-CoV-2 vaccine was quite larger for mRNA formulates (89.8%) over adenoviral ones (59.8%). Endorsement of vaccination mandates was reported by 60.2% of respondents, and was more likely endorsed by OPs who exhibited higher concern for SARS-CoV-2 infection occurrence (odds ratio 3.462, 95% confidence intervals 1.060-11.310), who were likely to accept some sort of payment/copayment for SARS-CoV-2/COVID-19 vaccination (3.896; 1.607; 9.449), or who were more likely to believe HCWs not vaccinates against SARS-CoV-2 as unfit for work (4.562; 1.935; 10.753). In conclusion, OPs exhibited wide acceptance of SARS-CoV-2/COVID-19 vaccinations, and the majority endorsed vaccination mandates for HCWs, which may help improve vaccination rates in occupational settings.

Inappropriate risk perception for SARS-CoV-2 infection among Italian HCWs in the eve of COVID-19 pandemic.

Sir, Italy has been recently involved in the outbreak of severe interstitial pneumonia associated with the previously unknown Coronavirus SARS-CoV-2 (1,2). Even before the notification of the first autochthonous cases, the SARS-CoV-2 associated syndrome (COVID-19) had raised an intense attention in the public opinion (3), with a counterproductive over-abundance of mixed quality information. As even Italian healthcare workers (HCWs) were not spared by subsequent misunderstandings and knowledge gaps during the previous influenza pandemic of 2009 (4), we performed a web-based survey (Google® Modules), specifically aimed to characterize knowledge status and risk perceptions in a sample from participating to 6 Facebook discussion groups (181,684 total unique members at the time of the study). The questionnaire was made available between February 1st and 7th, 2020, i.e. around 2 weeks before the first COVID-19 was officially diagnosed in Italian residents.   Overall, the sampled population included 2106 respondents (Table 1), and 39.3% were HCWs. Even though HCWs were more likely to exhibit a better understanding of SARS-CoV-2/COVID-19 related issues (aOR 2.195, 95%CI 1.809 to 2.664), they were not exempt for misunderstandings, particularly on actual incidence and lethality of COVID-19. Interestingly, most of respondents were aware of the main clinical features of COVID-19, with HCWs more frequently acknowledging that the COVID-19 may run pauci- or even asymptomatic (86.3% vs. 79.1%), resembling an Influenza-Like Illness (i.e. fever, cough, headache, etc.), with a potential latency up to 14 days (85·9% vs· 80·3%), eventually spreading by droplets (98.5% vs. 92.7%) rather through running water (92.3% vs· 79.8%), or blood/body fluids (88.0% vs. 70.4%).   Retrospectively, the assessment of preventive measures and risk perception appears somewhat worrisome. For instance, while HCWs were more likely to acknowledge as an appropriate preventive measure wearing a filtering mask (i.e. N95/FFP2/3 mask; aOR 2.296, 95%CI 1.507 to 3.946), around » of HCWs failed to recognize the importance of such personal protective equipment, while 7.4% felt as appropriate the wearing of a surgical mask. Moreover, not only COVID-19 was appropriately acknowledged as a severe disease by only 62.0% of respondents, with no differences between HCWs and non-HCWs, but an even smaller share (i.e. 8.0%) reported any concern for being infected by SARS-CoV-2 in Italy. In fact, at the time of the survey SARS-CoV-2 was more properly associated with international travelers (26.7%).   Our results are therefore of certain interests for several reasons. First at all, early epidemiological reports on the Italian cases of COVID-19 hint towards some failures in the initial management of incident cases (5-6). In fact, in our survey a large share of respondents substantially overlooked the risk to interact with SARS-CoV-2 positive subjects, that was otherwise perceived as a not-so-severe disease (i.e. "nothing more than a seasonal flu", as often described in some social media) (7). Moreover, around a 1/3 of HCWs participating to the study presumptively did not use proper personal protective equipment for the airways interacting with possible COVID-19 cases, either underestimating the infection risk or being unable to recognize early symptoms. Actually, the base of evidence shared by participants at the time of the study substantially ignored that COVID-19 may be characterized by dermatologic and gastro-intestinal symptoms (8-9). As most of infections may be actually pauci- or asymptomatic, such early exposure in the healthcare settings may have contributed to the quick spreading of SARS-CoV-2 epidemic in Northern Italy.   Therefore, despite the intrinsic limits of a convenience sampling, web-based survey (10), our study stresses the importance to improve the overall quality of information on COVID-19 conveyed not only in HCWs, but also in the general population. Moreover, our data may contribute to clarify the early stages of SARS-CoV-2 pandemic in Italy.