Diagnostic accuracy of SARS-CoV-2 saliva antigen testing in a real-life clinical setting.

BACKGROUND: SARS-CoV-2 antigen tests with saliva facilitate examination in settings that lack trained personnel. However, little is known about the diagnostic accuracy in real-life clinical settings. Therefore, we studied the diagnostic accuracy of a saliva antigen test in diagnosing SARS-CoV-2 infection in a primary/secondary care testing facility. METHODS: Individuals who presented at a COVID-19 testing facility affiliated with a Swiss university hospital were prospectively recruited (n=377). Saliva specimen was obtained, and the PCL Inc. COVID19 Gold antigen test was conducted in parallel with 2 real-time polymerase chain reaction (RT-PCR) assays from a nasopharyngeal swab. RESULTS: RT-PCR results were positive in 53 individuals, corresponding to a prevalence of 14.1% (missing material in 1 individual). The PCL saliva antigen test was positive in 22 individuals (5.8%) and negative in 354 (93.9%). The sensitivity of the saliva antigen test was 30.2% (95% confidence interval 18.3, 44.3), both overall and in symptomatic individuals. The specificity was 98.1% (96.0, 99.3). CONCLUSIONS: The diagnostic accuracy of a SARS-CoV-2 saliva antigen test in a primary/secondary care testing facility was remarkably lower than that reported in the manufacturer's specifications.

Serological testing for SARS-CoV-2 antibodies in clinical practice: A comparative diagnostic accuracy study.

BACKGROUND: Serological tests are a powerful tool in the monitoring of infectious diseases and the detection of host immunity. However, manufacturers often provide diagnostic accuracy data generated through biased studies, and the performance in clinical practice is essentially unclear. OBJECTIVES: We aimed to determine the diagnostic accuracy of various serological testing strategies for (a) identification of patients with previous coronavirus disease-2019 (COVID-19) and (b) prediction of neutralizing antibodies against SARS-CoV-2 in real-life clinical settings. METHODS: We prospectively included 2573 consecutive health-care workers and 1085 inpatients with suspected or possible previous COVID-19 at a Swiss University Hospital. Various serological immunoassays based on different analytical techniques (enzyme-linked immunosorbent assays, ELISA; chemiluminescence immunoassay, CLIA; electrochemiluminescence immunoassay, ECLIA; and lateral flow immunoassay, LFI), epitopes of SARS-CoV-2 (nucleocapsid, N; receptor-binding domain, RBD; extended RBD, RBD+; S1 or S2 domain of the spike [S] protein, S1/S2), and antibody subtypes (IgG, pan-Ig) were conducted. A positive real-time PCR test from a nasopharyngeal swab was defined as previous COVID-19. Neutralization assays with live SARS-CoV-2 were performed in a subgroup of patients to assess neutralization activity (n = 201). RESULTS: The sensitivity to detect patients with previous COVID-19 was ≥85% in anti-N ECLIA (86.8%) and anti-S1 ELISA (86.2%). Sensitivity was 84.7% in anti-S1/S2 CLIA, 84.0% in anti-RBD+LFI, 81.0% in anti-N CLIA, 79.2% in anti-RBD ELISA, and 65.6% in anti-N ELISA. The specificity was 98.4% in anti-N ECLIA, 98.3% in anti-N CLIA, 98.2% in anti-S1 ELISA, 97.7% in anti-N ELISA, 97.6% in anti-S1/S2 CLIA, 97.2% in anti-RBD ELISA, and 96.1% in anti-RBD+LFI. The sensitivity to detect neutralizing antibodies was ≥85% in anti-S1 ELISA (92.7%), anti-N ECLIA (91.7%), anti-S1/S2 CLIA (90.3%), anti-RBD+LFI (87.9%), and anti-RBD ELISA (85.8%). Sensitivity was 84.1% in anti-N CLIA and 66.2% in anti-N ELISA. The specificity was ≥97% in anti-N CLIA (100%), anti-S1/S2 CLIA (97.7%), and anti-RBD+LFI (97.9%). Specificity was 95.9% in anti-RBD ELISA, 93.0% in anti-N ECLIA, 92% in anti-S1 ELISA, and 65.3% in anti-N ELISA. Diagnostic accuracy measures were consistent among subgroups. CONCLUSIONS: The diagnostic accuracy of serological tests for SARS-CoV-2 antibodies varied remarkably in clinical practice, and the sensitivity to identify patients with previous COVID-19 deviated substantially from the manufacturer's specifications. The data presented here should be considered when using such tests to estimate the infection burden within a specific population and determine the likelihood of protection against re-infection.

A systematic review and metanalysis of diagnostic yield of BAL for detection of SARS-CoV-2.

BACKGROUND: The gold standard for diagnosing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is microbiological confirmation by reverse transcriptase-polymerase chain reaction (RT-PCR)1 most commonly done using oropharyngeal (OP) and nasopharyngeal swabs (NP). But in suspected cases, where these samples are false-negative, bronchoalveolar lavage (BAL) may prove diagnostic. OBJECTIVES: Hence, the diagnostic yield of BAL for detection of SARS-CoV-2 in cases of non-diagnostic upper respiratory tract samples is reviewed. METHODS: Databases such as MEDLINE, Scopus, and Google Scholar were searched using a systematic search strategy. The current study has been in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines and has been registered with the International Prospective Registry of Systematic Reviews (CRD42020224088). RESULTS: 911 records were identified at initial database extraction, of which 317 duplicates were removed and, 596 records were screened for inclusion eligibility. We included total 19 studies in the systematic review, and 17 were included in metanalysis. The pooled estimate of SARS-CoV-2 positivity in BAL was 11% (95%CI: 0.01-0.24). A sensitivity analysis also showed that the results appear to be robust and minimal risk of bias amongst the studies. CONCLUSION: The current study demonstrates that BAL can be used to diagnose additional cases primary disease and superadded infections in patients with severe COVID-19 lower respiratory tract infection.

The impact of COVID-19 in medical practice. A review focused on Urology

ABSTRACT COVID-19 pandemic is a rapidly spreading virus that is changing the World and the way doctors are practicing medicine. The huge number of patients searching for medical care and needing intensive care beds led the health care system to a burnout status especially in places where the care system was already overloaded. In this setting, and also due to the absence of a specific treatment for the disease, health authorities had to opt for recommending or imposing social distancing to relieve the health system and reduce deaths. All other medical specialties nondirectly related to the treatment of COVID-19 had to interrupt or strongly reduce their activities in order to give room to seriously ill patients, since no one knows so far the real extent of the virus damage on human body and the consequences of doing non deferrable procedures in this pandemic era. Despite not been a urological disease, the urologist needs to be updated on how to deal with these patients and how to take care of himself and of the medical team he works with. The aim of this article is to review briefly some practical aspects of COVID-19 and its implications in the urological practice in our country.

Accuracy of serological testing for SARS-CoV-2 antibodies: First results of a large mixed-method evaluation study.

BACKGROUND: Serological immunoassays that can identify protective immunity against SARS-CoV-2 are needed to adapt quarantine measures, assess vaccination responses, and evaluate donor plasma. To date, however, the utility of such immunoassays remains unclear. In a mixed-design evaluation study, we compared the diagnostic accuracy of serological immunoassays that are based on various SARS-CoV-2 proteins and assessed the neutralizing activity of antibodies in patient sera. METHODS: Consecutive patients admitted with confirmed SARS-CoV-2 infection were prospectively followed alongside medical staff and biobank samples from winter 2018/2019. An in-house enzyme-linked immunosorbent assay utilizing recombinant receptor-binding domain (RBD) of the SARS-CoV-2 spike protein was developed and compared to three commercially available enzyme-linked immunosorbent assays (ELISAs) targeting the nucleoprotein (N), the S1 domain of the spike protein (S1), and a lateral flow immunoassay (LFI) based on full-length spike protein. Neutralization assays with live SARS-CoV-2 were performed. RESULTS: One thousand four hundred and seventy-seven individuals were included comprising 112 SARS-CoV-2 positives (defined as a positive real-time PCR result; prevalence 7.6%). IgG seroconversion occurred between day 0 and day 21. While the ELISAs showed sensitivities of 88.4% for RBD, 89.3% for S1, and 72.9% for N protein, the specificity was above 94% for all tests. Out of 54 SARS-CoV-2 positive individuals, 96.3% showed full neutralization of live SARS-CoV-2 at serum dilutions ≥ 1:16, while none of the 6 SARS-CoV-2-negative sera revealed neutralizing activity. CONCLUSIONS: ELISAs targeting RBD and S1 protein of SARS-CoV-2 are promising immunoassays which shall be further evaluated in studies verifying diagnostic accuracy and protective immunity against SARS-CoV-2.

The impact of COVID-19 in medical practice. A review focused on Urology.

COVID-19 pandemic is a rapidly spreading virus that is changing the World and the way doctors are practicing medicine. The huge number of patients searching for medical care and needing intensive care beds led the health care system to a burnout status especially in places where the care system was already overloaded. In this setting, and also due to the absence of a specific treatment for the disease, health authorities had to opt for recommending or imposing social distancing to relieve the health system and reduce deaths. All other medical specialties non-directly related to the treatment of COVID-19 had to interrupt or strongly reduce their activities in order to give room to seriously ill patients, since no one knows so far the real extent of the virus damage on human body and the consequences of doing non deferrable procedures in this pandemic era. Despite not been a urological disease, the urologist needs to be updated on how to deal with these patients and how to take care of himself and of the medical team he works with. The aim of this article is to review briefly some practical aspects of COVID-19 and its implications in the urological practice in our country.

Implementation and strategies to ensure adequate coordination within a Urology Department during the COVID-19 pandemic.

PURPOSE: to provide an update on the management of a Urology Department during the COVID-19 outbreak, suggesting strategies to optimize assistance to the patients, to implement telemedicine and triage protocols, to define pathways for hospital access, to reduce risk of contagious inside the hospital and to determine the role of residents during the pandemic. MATERIALS AND METHODS: In May the 6th 2020 we performed a review of the literature through online search engines (PubMed, Web of Science and Science Direct). We looked at recommendations provided by the EAU and ERUS regarding the management of urological patients during the COVID-19 pandemic. The main aspects of interest were: the definition of deferrable and non-deferrable procedures, Personal Protective Equipment (PPE) and hospital protocols for health care providers, triage, hospitalization and surgery, post-operative care training and residents' activity. A narrative summary of guidelines and current literature for each point of interest was performed. CONCLUSION: In the actual Covid-19 scenario, while the number of positive patients globally keep on rising, it is fundamental to embrace a new way to deliver healthcare and to overcome challenges of physical distancing and self-isolation. The use of appropriate PPE, definite pathways to access the hospital, the implementation of telemedicine protocols can represent effective strategies to carry on delivering healthcare.

Exploring Urological Experience in the COVID-19 Outbreak: American Confederation of Urology (CAU) Survey.

PURPOSE: To explore the current situation faced by Latin American urology departments during the COVID-19 Outbreak in terms of knowledge, actions, prioritization of urology practices, and implementation of internal clinical management protocols for inpatients and outpatients. MATERIAL AND METHODS: A non-validated, structured, self-administered, electronic survey with 35 closed multiple choice questions was conducted in Spanish, Portuguese, Italian, and English and Deutsch versions from April 1st to April 30th, 2020. The survey was distributed through social networks and the official American Confederation of Urology (CAU) website. It was anonymous, mainly addressed to Latin American urologists and urology residents. It included 35 questions exploring different aspects: 1) Personal Protective Equipment (PPE) and internal management protocols for healthcare providers; 2) Priority surgeries and urological urgencies and 3) Inpatient and outpatient care. RESULTS: Of 864 surveys received, 846 had at least 70% valid responses and were included in the statistical analyses. Surveys corresponded to South America in 62% of the cases, Central America and North America in 29.7%. 12.7% were residents. Regarding to PPE and internal management protocols, 88% confirmed the implementation of specific protocols and 45.4% have not received training to perform a safe clinical practice; only 2.3% reported being infected with COVID-19. 60.9% attended urgent surgeries. The following major uro-oncologic surgeries were reported as high priority: Radical Nephrectomy (RN) 58.4%, and Radical Cystectomy (RC) 57.3%. When we associate the capacity of hospitalization (urologic beds available) and percentage of high-priority surgery performed, we observed that centers with fewer urological beds (10-20) compared to centers with more urological beds (31-40) performed more frequently major urologic cancer surgeries: RN 54.5% vs 60.8% (p=0.0003), RC 53.1% vs 64.9% (p=0.005) respectively. CONCLUSIONS: At the time of writing (May 13th 2020) our data represents a snapshot of COVID-19 outbreak in Latin American urological practices. Our findings have practical implications and should be contextualized considering many factors related to patients and urological care: The variability of health care scenarios, institutional capacity, heterogeneity and burden of urologic disease, impact of surgical indications and decision making when prioritizing and scheduling surgeries in times of COVID-19 pandemic.

The Psychosocial Impact of COVID-19 on health care workers.

At the end of 2019, a disease was identified, COVID-19, caused by a new type of easy and fast spreading virus, which led to the beginning of a worldwide pandemic. One of the most exposed groups to the virus and its psychosocial consequences is the healthcare workers, due to their implication in caring for affected people. Health workers are exposed to a fast and unpredictable situation that requires more human resources and materials than usual, however, the lack of means on account to this situation entails an increased probability of suffering different consequences, including the burnout syndrome, to which, generally, this professionals are already vulnerable. In addition, quarantine is added as a measure to prevent the spread of the pandemic, which is another handicap for healthcare workers. Quarantine means these professionals are more likely to suffer the foreseeable psychological consequences in general population, specifically, it has been observed that Post-Traumatic Stress Disorder (PTSD) is more prevalent, because of the stress load of the situation experienced.

Emergency Surgery in Urology during the COVID-19 Pandemic.

Proposal: To highlight the indications for emergency surgery during the 2019 Coronavirus pandemic (COVID-19) that support recommendations published in mid-March 2020 by the American Confederation of Urology on its website. MATERIALS AND METHODS: A bibliographic search was conducted in PubMed and Cochrane Library to perform a non-systematic review, using key words: Urology, Emergency and COVID-19, to determine recommendations for patients that should receive emergency care due to urological pathology. RESULTS: The main recommendations and protocols in the management of different urological emergencies during the COVID-19 pandemic are reviewed and discussed. CONCLUSIONS: We are living a new condition with the COVID-19 pandemic, which obliges urologists to conform to the guidelines that appear on a daily basis formulated by multidisciplinary surgical groups to manage urological emergencies. Consequently, in this time of health crisis, we must adapt to the resources available, implementing all biosecurity measures to protect patients and all health personnel who are in charge of patient management.

Impact of Covid-19 on the urology service in United States: perspectives and strategies to face a Pandemic.

Over the course of several weeks following the first diagnosed case of COVID-19 in the U.S., the virus rapidly spread across our communities. It became evident that the pandemic was going to place a severe strain on all components of the U.S. healthcare system, and we needed to adapt our daily practices, training and education. In the present paper we discuss four pillars to face a pandemic: surgical and outpatients service, tele-medicine and tele-education. In the face of unprecedented risks in providing adequate health care to our patients during this current, evolving public health crisis of COVID-19, alternative patient management tools such as telemedicine services, allow clinicians to maintain necessary patient rapport with their healthcare provider when required. As a subspecialty, urology should take full advantage of telehealth and tele-education at this juncture. As tele-urology and tele-education can obviate the potential drawbacks of "social distancing" as it pertains to healthcare, the platform can also reduce the risk of COVID-19 spread, without compromising quality urological care and educational efforts. Telehealth can bring urologists and their patients together, perhaps closer than ever.

Impact of COVID-19 Pandemic on Ibero-American Urology Residents: Perspective of American Confederation of Urology (CAU)

ABSTRACT Introduction: Since World Health Organization (WHO) declared COVID-19 as a global pandemic, urology services have developed strategies to prioritize and not to differ urgent and oncological patient's medical attention, in order to optimize resources and decrease infection probability among staff and patients. This unprecedented situation has generated a decrease in assistance and academic activities in most medical residences. The aim of this manuscript is to evaluate the impact of this health crisis on training programs through a survey addressed to urology medical residents. Materials and Methods: Cross sectional designed study, with multiple-choice non validated survey answered online by residents. Questionnaire was developed through the CAU EDUCACION platform. Results: A total of 148 responses from 18 countries coming from Latin America and Spain answering the survey. Of total, 82% answered that the activity of their urology department was significantly reduced, attending only urgent surgical pathologies, 15 % that, the urology activity has been closed completely and the staff was assigned to COVID-19 patients care, 3% continue with the regular clinic activity. Likewise, 75% stated that their surgical training has been completely affected, 93% receive urological information through tools such as Skype, ZOOM meeting, Cisco Webex, being Webinar modality the most used. Despite technological boom, 65% answered their academic training has been partially or completely affected. Most of the surveyed residents consider that period of residence should be extended to retrieve the educational targets. Conclusion: This unprecedented reality is negatively impacting the heterogeneous residency programs that American Confederation of Urology (CAU) nucleates. It is necessary to continue with technological innovation and allocate time and resources to easily generate accessible tools to favor the training of future urologists.

COVID-19: Measures to prevent hospital contagion. what do urologists need to know?

ABSTRACT A new outbreak of respiratory infection caused by the novel coronavirus in late December 2019 in China caused standards of medical care to change not only for related areas but for the entire healthcare system, and when the WHO declared COVID-19 a pandemic new strategies of patient care had to be defined initially to optimize resources to confront the pandemic and then to protect healthcare personnel. As urologists, we must be involved in these new standards, since without an effective vaccine the risk of contagion is high; thus, the purpose of this review is to have orientation on the measures urologists should take in their everyday clinical practice.

Treatment and research lines for the patient with COVID-19. What do we have and where are we going?

ABSTRACT Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) represents the most significant global public health crisis of this generation. From the beginning of the pandemic, several publications and on-line resources about different treatment lines have been done, and development effort in response to the COVID-19 pandemic to investigate potential therapies is unprecedented. Unfortunately, until now, there is not enough evidence to recommend any specific anti-COVID19 treatment. Randomized clinical trials and high-quality evidence, even in the middle of a pandemic, are needed. We provide a review of the latest published literature on the therapeutic strategies and current investigational lines for SARS-CoV-2.

Exploring Urological Experience in the COVID-19 Outbreak: American Confederation of Urology (CAU) Survey

ABSTRACT Purpose: To explore the current situation faced by Latin American urology departments during the COVID-19 Outbreak in terms of knowledge, actions, prioritization of urology practices, and implementation of internal clinical management protocols for inpatients and outpatients. Material and Methods: A non-validated, structured, self-administered, electronic survey with 35 closed multiple choice questions was conducted in Spanish, Portuguese, Italian, and English and Deutsch versions from April 1st to April 30th, 2020. The survey was distributed through social networks and the official American Confederation of Urology (CAU) website. It was anonymous, mainly addressed to Latin American urologists and urology residents. It included 35 questions exploring different aspects: 1) Personal Protective Equipment (PPE) and internal management protocols for healthcare providers; 2) Priority surgeries and urological urgencies and 3) Inpatient and outpatient care. Results: Of 864 surveys received, 846 had at least 70% valid responses and were included in the statistical analyses. Surveys corresponded to South America in 62% of the cases, Central America and North America in 29.7%. 12.7% were residents. Regarding to PPE and internal management protocols, 88% confirmed the implementation of specific protocols and 45.4% have not received training to perform a safe clinical practice; only 2.3% reported being infected with COVID-19. 60.9% attended urgent surgeries. The following major uro-oncologic surgeries were reported as high priority: Radical Nephrectomy (RN) 58.4%, and Radical Cystectomy (RC) 57.3%. When we associate the capacity of hospitalization (urologic beds available) and percentage of high-priority surgery performed, we observed that centers with fewer urological beds (10-20) compared to centers with more urological beds (31-40) performed more frequently major urologic cancer surgeries: RN 54.5% vs 60.8% (p=0.0003), RC 53.1% vs 64.9% (p=0.005) respectively. Conclusions: At the time of writing (May 13th 2020) our data represents a snapshot of COVID-19 outbreak in Latin American urological practices. Our findings have practical implications and should be contextualized considering many factors related to patients and urological care: The variability of health care scenarios, institutional capacity, heterogeneity and burden of urologic disease, impact of surgical indications and decision making when prioritizing and scheduling surgeries in times of COVID-19 pandemic.

Emergency Surgery in Urology during the COVID-19 Pandemic

ABSTRACT Proposal: To highlight the indications for emergency surgery during the 2019 Coronavirus pandemic (COVID-19) that support recommendations published in midMarch 2020 by the American Confederation of Urology on its website. Materials and Methods: A bibliographic search was conducted in PubMed and Cochrane Library to perform a non-systematic review, using key words: Urology, Emergency and COVID-19, to determine recommendations for patients that should receive emergency care due to urological pathology. Results: The main recommendations and protocols in the management of different urological emergencies during the COVID-19 pandemic are reviewed and discussed. Conclusions: We are living a new condition with the COVID-19 pandemic, which obliges urologists to conform to the guidelines that appear on a daily basis formulated by multidisciplinary surgical groups to manage urological emergencies. Consequently, in this time of health crisis, we must adapt to the resources available, implementing all biosecurity measures to protect patients and all health personnel who are in charge of patient management.