Lessons Learned From the Implementation of a Participant-Collected, Mail-Based SARS-CoV-2 Serological Survey in Massachusetts, USA

AbstractThe rapid spread of SARS-CoV-2 is largely driven by pre-symptomatic or mildly symptomatic individuals who transmit the virus. Serological tests to identify antibodies against SARS-CoV-2 are an important tool to characterize subclinical infection exposure, which is critical in determining transmission trajectories and consequent population immunity. During the summer of 2020, a mail-based serological survey with self-collected dried blood spot (DBS) samples was implemented among university affiliates and their household members in Massachusetts, USA. Described here are some of the challenges faced and novel procedures used during the implementation of this study to assess the prevalence of SARS-CoV-2 antibodies amid the global pandemic. Important challenges included remote and contact-minimized participant recruitment, limited availability of commodities and laboratory capacity, a potentially biased sample population, and policy changes impacting the distribution of clinical results to study participants. Methods used to surmount these challenges and lessons learned are presented to inform similar studies. Key lessons relate to the acceptability and feasibility of DBS sampling, supply requirements, the logistics of packing and shipping packages, data linkages to enrolled household members, and the utility of having an on-call nurse available for participant concerns during sample collection.Future studies might consider additional recruitment techniques such as conducting studies during academic semesters when recruiting in a university setting, partnerships with supply and shipping specialists, and using a stratified sampling approach to minimize potential biases in recruitment. This study design highlights the feasibility and acceptability of self-collected bio-samples and has broad applicability for other serological surveys for a range of pathogens.

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Managing Clinical Trials for Alzheimer’s Disease During the COVID-19 Crisis: Experience at Fundació ACE in Barcelona, Spain

Journal of Alzheimer s Disease ◽

10.3233/jad-200750 ◽

2020 ◽

Vol 77 (4) ◽

pp. 1805-1813

Author(s):

Carla Abdelnour ◽

Ester Esteban de Antonio ◽

Alba Pérez-Cordón ◽

Asunción Lafuente ◽

Mar Buendía ◽

...

Keyword(s):

Clinical Trials ◽

Ad Hoc ◽

Strategic Plan ◽

Lessons Learned ◽

Drop Out ◽

Rt Pcr ◽

Serological Tests ◽

Clinical Trial Research ◽

Research Activities ◽

The Impact

Background: The COVID-19 pandemic has brought great disruption to health systems worldwide. This affected ongoing clinical research, particularly among those most vulnerable to the pandemic, like dementia patients. Fundació ACE is a research center and memory clinic based in Barcelona, Spain, one of the hardest-hit countries. Objective: To describe the ad-hoc strategic plan developed to cope with this crisis and to share its outcomes. Methods: We describe participants’ clinical and demographic features. Additionally, we explain our strategic plan aimed at minimizing the impact on clinical trial research activities, which included SARS-CoV-2 RT-PCR and IgG serological tests to all participants and personnel. The outcomes of the plan are described in terms of observed safety events and drop-outs during the study period. Results: A total of 130 patients were participating in 16 active clinical trials in Fundació ACE when the lockdown was established. During the confinement, we performed 1018 calls to the participants, which led to identify adverse events in 26 and COVID-19 symptoms in 6. A total of 83 patients (64%) could restart on-site visits as early as May 11, 2020. All SARS-CoV-2 RT-PCR diagnostic tests performed before on-site visits were negative and only three IgG serological tests were positive. Throughout the study period, we only observed one drop-out, due to an adverse event unrelated to COVID-19. Discussion: The plan implemented by Fundació ACE was able to preserve safety and integrity of ongoing clinical trials. We must use the lessons learned from the pandemic and design crisis-proof protocols for clinical trials.

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Dynamic Response Systems of Healthcare Mask Production to COVID-19: A Case Study of Korea

Systems ◽

10.3390/systems8020018 ◽

2020 ◽

Vol 8 (2) ◽

pp. 18 ◽

Cited By ~ 2

Author(s):

EunSu Lee ◽

Yi-Yu Chen ◽

Melanie McDonald ◽

Erin O’Neill

Keyword(s):

Dynamic Response ◽

Distribution Systems ◽

Lessons Learned ◽

Public And Private ◽

Democratic Leadership ◽

The Public ◽

Response System ◽

Global Pandemic ◽

Production And Distribution ◽

Novel Coronavirus

Korea initiated a new experiment, called a dynamic response system for open democratic societies as a principle to respond to the novel coronavirus (COVID-19). The global pandemic of COVID-19 led to a surge in demand for healthcare medical masks and respirators, and strained the global supply chain of mask production and distribution systems. This study provides a systemic view of critical personal protective equipment for both healthcare staff and the public to stop the spread of COVID-19. This study investigates the dynamic response system of healthcare mask production to the coronavirus and discusses lessons learned in view of systems thinking. The study shows that it is critical to developing a quick and dynamic response system to the evolving market conditions with flexible and agile operations. Visibility with transparency with information sharing with the public is also critical under global pandemic. Due to the shortage of mask supply, smart consumption is required along with collaboration with public and private sectors, as well as global organizations. Democratic leadership and a well-prepared strategic plan for long-term period are essential to the open society to prepare the global pandemic in the future. This study serves as a benchmark for dynamic and timely responses to the global pandemic.

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Effective incorporation of biospecimen collection for translational studies into a phase III trial: The NeoALTTO experience (BIG 01-06).

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.3012 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 3012-3012

Author(s):

Paolo Nuciforo ◽

Jose Jimenez ◽

Claudia Aura ◽

Debora Fumagalli ◽

Marion Maetens ◽

...

Keyword(s):

Clinical Trial ◽

Phase Iii ◽

Sample Population ◽

Sample Collection ◽

Factors Affecting ◽

Rna Integrity ◽

Biospecimen Collection ◽

Long Term Storage ◽

Serial Samples ◽

Rna And Dna

3012 Background: Translational research studies in the context of clinical trials using targeted therapies are essential for the identification of biomarkers of response or resistance. However, many challenges (e.g. logistic, technical) can impede proper biological sample collection. The NEOALTTO study provided an excellent opportunity to address these issues. Methods: In this large neoadjuvant phase III multicenter, multinational clinical trial, serial samples (plasma, serum, frozen and FFPE specimens) from patients with breast cancer were collected in 86 sites (23 countries) at several time points (baseline, week 2 and surgery). Standardized operating procedures were made available to sites together with pre-assembled kits for sample collection, processing, storage, and shipment to reduce the variability and increase compliance with the study protocol. All biospecimens were centralized for long term storage. Baseline fresh/frozen samples were processed for downstream analyses according to a pre-defined workflow. Evaluable sample population (ESP) was determined based on the following criteria: tumor cellularity, RNA integrity (RIN), and yield. Results: A total of 12,193 serial samples from 449 of 455 randomized patients was collected. The overall sample missing rate was 9.5% (includes samples not collected by site, withdrawn patients and pCR). Missing rates were 9%, 8%, 13%, and 9% for plasma, serum, frozen and FFPE specimens, respectively. At least 1 frozen tumor tissue was available for 423 (94%), 431 (96%), and 334 (74%) patients at baseline, week 2, and surgery, respectively. After 2 extraction cycles, 629 and 516 baseline frozen samples were processed for RNA and DNA extraction, respectively. The ESP was 71% (58% when RIN considered) and 80% for downstream RNA- and DNA-based analyses, respectively. Incorrect material, inappropriate sample processing and low or absent tumor cellularity were some of the factors affecting the ESP. Conclusions: These results show that careful upfront logistic and technical planning in NEOALTTO had a significant impact on the compliance and the quality of collected material, which may ultimately result in valuable research data. Clinical trial information: NCT00553358.

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Diagnostic Properties of Three SARS-CoV-2 Antibody Tests

Diagnostics ◽

10.3390/diagnostics11081441 ◽

2021 ◽

Vol 11 (8) ◽

pp. 1441

Author(s):

Suelen Basgalupp ◽

Giovana dos Santos ◽

Marina Bessel ◽

Lara Garcia ◽

Ana Carolina de Moura ◽

...

Keyword(s):

Rapid Test ◽

Epidemiological Studies ◽

Antibody Detection ◽

Sample Collection ◽

Rt Pcr ◽

Igg Antibody ◽

Serological Tests ◽

High Agreement ◽

High Level ◽

Antibody Tests

Serological assays emerged as complementary tools to RT-PCR in the diagnosis of SARS-CoV-2 as well as being needed for epidemiological studies. This study aimed to assess the performance of a rapid test (RT) compared to that of serological tests using finger prick blood samples. A total of 183 samples were evaluated, 88 of which were collected from individuals with negative RT-PCR and 95 from positive RT-PCR individuals. The diagnostic performance of RT (WONDFO®) and LUMIT (PROMEGA®) were compared to that of ELISA (EUROIMMUN®) for detecting antibodies against SARS-CoV-2 according to time from symptoms onset. The IgG antibody tests were detected in 77.4% (LUMIT), 77.9% (RT), and 80.0% (ELISA) of individuals. The detection of antibodies against SARS-CoV-2 increases in accordance with increasing time from symptoms onset. Considering only time from symptoms onset >21 days, the positivity rate ranged from 81.8 to 97.0% between the three tests. The RT and LUMIT showed high agreement with ELISA (agreement = 91.5%, k = 0.83, and agreement = 96.3%, k = 0.9, respectively) in individuals who had symptoms 15 to 21 days before sample collection. Compared to that of the ELISA assay, our results show sensitivity ranged from 95% to 100% for IgG antibody detection in individuals with symptoms onset between 15 and 21 days before sample collection. The specificity was 100% in individuals with symptoms onset >15 days before serological tests. This study shows good performance and high level of agreement of three immunoassays for the detection of SARS-CoV-2 antibodies.

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Serological study on brucellosis in captive elephants (Elephas maximus) and stray dogs in North Thailand

Veterinary World ◽

10.14202/vetworld.2020.1992-1997 ◽

2020 ◽

Vol 13 (9) ◽

pp. 1992-1997

Author(s):

Suchanit Ngamkala ◽

Taweepoke Angkawanish ◽

Weerapun Nokkaew ◽

Nikorn Thongtip

Keyword(s):

Antibody Response ◽

Asian Elephant ◽

Elephas Maximus ◽

Serological Survey ◽

Serological Analysis ◽

Serum Samples ◽

Serological Tests ◽

Asian Elephants ◽

Stray Dogs ◽

North Thailand

Background and Aim: Brucellosis is considered as an important zoonotic disease caused by various strains of Brucella in numerous host species. Although brucellosis has been reported in almost animal species, the relevance of brucellosis infection and diagnostic technique in Asian elephant (Elephas maximus) has been limited. The present serological investigation aimed to investigate the antibody response to Brucella abortus in captive Asian elephants in North Thailand. Moreover, further serological survey was also conducted to detect the antibody response to Brucella canis in stray dogs cohabiting the same area as the elephant herd. Materials and Methods: Serum samples were collected from 40 captive Asian elephants and submitted for serological analysis based on B. abortus antigen using Rose Bengal plate test (RBPT) in combination with ethylenediaminetetraacetic acid-tube agglutination test (EDTA-TAT) as a supplementary test and by commercial indirect enzyme-linked immunosorbent assay (iELISA). In addition, serum samples were also obtained from 16 stray dogs that live nearby the elephant-raising area and were tested using commercial Dot-ELISA based on B. canis antigen. Results: Serological analysis in captive Asian elephants showed 100% seronegative (40/40) from all serological tests response to B. abortus. For stray dogs, 12.5% (2/16) had a low positive reaction response to B. canis. Conclusion: The serological survey for brucellosis in Asian elephant was adapted and applied using RBPT, EDTA-TAT, and iELISA in the present study. For future evaluation, we recommended the use of a combination of serological tests with validation together with comparing by direct detection such as bacterial isolation to provide an appropriate brucellosis surveillance program in Asian elephants. In addition, the surveillance of stray dogs or multispecies habitation should be kept into considerations.

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Youth First: A Canadian Youth-led Initiative in the Midst of the COVID-19 Pandemic

Canadian Journal of Children s Rights / Revue canadienne des droits des enfants ◽

10.22215/cjcr.v8i1.3148 ◽

2021 ◽

Vol 8 (1) ◽

pp. 136-152

Author(s):

Reah (Hyun Ju) Shin ◽

Harleen Kaur ◽

Catherine Howe ◽

Justin Whitty ◽

Kyla Quigley ◽

...

Keyword(s):

Young People ◽

Youth Care ◽

Lessons Learned ◽

Child And Youth Care ◽

Interactive Spaces ◽

Canadian Youth ◽

Global Pandemic ◽

Master Of Arts

This reflection writing was co-written by seven young people and three Master of Arts Child and Youth Care (MA CYC) students from Ryerson University. Our writing centres around a Canadian youth-led initiative called Youth First, developed as a MA CYC placement due to the lack of placement opportunities available during the pandemic. Youth First focused on creating safe and interactive spaces in cyberspace for young people during the pandemic. Through this reflection, we hope to share our experiences, accomplishments, lessons learned and overall reflection of being part of this initiative during a global pandemic.

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Establishment of a Pediatric COVID-19 Biorepository: Unique Considerations and Opportunities for Studying the Impact of the COVID-19 Pandemic on Children

10.21203/rs.3.rs-42030/v1 ◽

2020 ◽

Author(s):

Rosiane Lima ◽

Elizabeth Gootkind ◽

Denis De La Flor ◽

Laura Yockey ◽

Evan Bordt ◽

...

Keyword(s):

Pediatric Population ◽

Urgent Care ◽

Sample Collection ◽

Viral Susceptibility ◽

Global Pandemic ◽

Asymptomatic Children ◽

Successful Establishment ◽

Processing And Storage ◽

Inflammatory Syndrome ◽

The Impact

Abstract Background: COVID-19, the disease caused by the highly infectious and transmissible coronavirus SARS-CoV-2, has quickly become a morbid global pandemic. Although the impact of SARS-CoV-2 infection in children is less clinically apparent, collecting high-quality biospecimens from infants, children and adolescents in a standardized manner during the COVID-19 pandemic is essential to establish a biologic understanding of the disease in the pediatric population. This biorepository enables pediatric centers world-wide to collect samples in a standardized manner to drive forward our understanding of COVID-19 by addressing specific pediatric and neonatal COVID-19-related questions. Methods: A broad study was implemented with strategic enrollment guidelines to include patients seen in urgent care clinics and hospital settings, neonates born to SARS-CoV-2 infected mothers, and asymptomatic children. The methodology described here, details the importance of establishing collaborations between the clinical and research teams to harmonize protocols for patient recruitment and sample collection, processing and storage. Results: Considerations and challenges facing enrollment of neonatal and pediatric cohorts are described. A roadmap is laid out for successful collection, processing, storage and database management of multiple pediatric samples such as blood, nasopharyngeal and oropharyngeal swabs, sputum, saliva, tracheal aspirates, stool, and urine. Using this methodology, we enrolled 327 participants, who provided a total of 972 biospecimens.Conclusions: Pediatric biospecimens will be key in answering questions relating to viral transmission by children, differences between pediatric and adult viral susceptibility, and, immune responses, the impact of maternal SARS-CoV-2 infection on fetal development, and factors driving the Multisystem Inflammatory Syndrome in Children. The specimens in this biorepository will allow necessary comparative studies between children and adults, help determine the accuracy of current pediatric viral testing techniques, in addition to, understanding neonatal exposure to SARS-CoV-2 infection and disease abnormalities. The successful establishment of a pediatric biorepository is critical to provide insight into disease pathogenesis, and subsequently, develop future treatment and vaccination strategies.

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Clinical results of an inactivated anti-brucella vaccine in combination with immunomodulators

Veterinary World ◽

10.14202/vetworld.2020.758-763 ◽

2020 ◽

Vol 13 (4) ◽

pp. 758-763

Author(s):

Fayssal Bouchemla ◽

Valery Alexandrovich Agoltsov ◽

Stepan Yuryevich Veselovsky ◽

Sergey Vasilyevich Larionov ◽

Olga Mikhaylovna Popova ◽

...

Keyword(s):

Rose Bengal ◽

Complement Fixation ◽

Clinical Results ◽

Physiological Solution ◽

The Body ◽

Serological Tests ◽

Humoral Immune ◽

Prophylactic Vaccination ◽

Serological Studies ◽

Immunogenic Properties

Aim: The aim of the study was to obtain a vaccine against animal brucellosis having high immunogenic properties by carrying an evaluation of the effectiveness of split-conjugated animal brucellosis vaccine combined with fosprenil and polypeptide C as a molecular immunomodulatory adjuvant according to the results of serological studies of the blood of animals: Agglutination reaction, complement fixation, and rose Bengal sample. Materials and Methods: Eighteen calves of Holstein Friesians breed, aged 5 months, with a living weight of 100-150 kg, were divided into three groups of six animals each. All animals were healthy and they received a prophylactic vaccination against brucellosis. The dry split-conjugated vaccine against brucellosis in animals was dissolved in saline and for this purpose, 10 ml of saline was poured into the vaccine vial. Then the content was mixed, and afterward 1 ml was used per animal. Fosprenil was used at the rate of 1 kg of animal weight: 100 kg (calf weight) was multiplied by 0.05 (dose/1 kg of animal weight); 5 ml of fosprenil was obtained, which was collected into disposable syringes and intramuscularly sterilely injected into the croup area. Calves in the first group (control) were intramuscularly injected with the vaccine at a dose of 1.0 ml, and fosprenil at a dose of 5.0 ml was administered intramuscularly once to the croup area. Animals from the second group were subcutaneously immunized by the vaccine with polypeptide C at a dose of 1.0 ml. Polypeptide C is a solution that was poured into a vial with a vaccine at a dose of 10.0 ml, the content was mixed, and then calves were injected subcutaneously into the middle third of the neck in 1 ml (10 doses in a vial). Immunization of calves in the third group was carried out with a vaccine, diluted with an isotonic sodium chloride solution of 0.9%, at a dose of 1.0 ml subcutaneously once. At the 14th, 30th, and 90th days after vaccination, a blood sampling was taken for serological tests: Agglutination test, complement fixation test, and rose Bengal test. Results: After conducting serological studies, it was noted that split-conjugated vaccine against animal brucellosis using fosprenil forms antibodies in large titers and they persist for a longer time in the body of animals compared to the other tested vaccine: The first combination with the immunomodulatory polypeptide C and the vaccine only on the physiological solution. Conclusion: The developed complex of split-conjugated vaccine against brucellosis in animals enhances the humoral immune response of the organism against brucellosis and improves the protection of animals against the disease when it is used with the immunomodulatory fosprenil. In the future, we want to expand the use of the resulting complex in the fight against brucellosis on a larger population and to study the change in cellular immunity after the introduction of the resulting complex on an animal organism.

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Limitations of rapid serological testing for SARS-CoV-2 in non-vaccinated patients in acute cardiac care

Srpski medicinski casopis Lekarske komore ◽

10.5937/smclk2-32938 ◽

2021 ◽

Vol 2 (3) ◽

pp. 302-305

Author(s):

Mihajlo Viduljević ◽

Marija Polovina ◽

Milika Ašanin ◽

Igor Mrdović

Keyword(s):

False Negative ◽

Immunological Response ◽

Cardiac Care ◽

Cardiovascular Disorders ◽

Serological Testing ◽

Serological Tests ◽

Negative Results ◽

Global Pandemic ◽

False Negative Results ◽

The City

In December 2019 in the city of Wuhan, in China, the first cases of infection caused by the new SARS-CoV-2 virus appeared, and later on, the disease caused by this virus was named COVID-19. Shortly after this, on March 11 th , 2020, the WHO characterized COVID-19 as a global pandemic. The symptoms of COVID-19 and acute cardiovascular disorders (e.g., heart failure, pulmonary embolism or myocardial ischemia) frequently overlap, which poses a challenge for the establishing of a differential diagnosis in clinical practice. Rapid serological tests, which detect IgM and IgG classes of antibodies for SARS-CoV 2, have been developed with the primary purpose of screening the population's immunological response to the SARS-CoV-2 virus. However, rapid serological tests are often used outside their original purpose, i.e., for the triage of possibly infected, non-vaccinated individuals, because they offer quick results, which may be particularly relevant in emergency settings. If serological testing is used to guide the admission of non-vaccinated patients with acute cardiovascular disorders to either an isolation unit for suspected COVID-19 positive individuals, or to hospital facilities for non-infected patients, it is important to recognize its limitations, in order to reduce the risk of false-positive or false-negative results. Hence, appropriate patient selection and cautious test interpretation is necessary to avoid misdiagnosis. The aim of this paper is to illustrate how serological testing may be used as a screening tool to inform the management of non-vaccinated patients with acute cardiovascular disorders requiring urgent hospital admission. As an illustration, we describe two clinical situations, in which serological testing produced meaningful results.

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Standards of clinical-grade olfactory ensheathing cell culture and quality control (2020 China Version)

Journal of Neurorestoratology ◽

10.26599/jnr.2020.9040023 ◽

2020 ◽

Vol 8 (4) ◽

pp. 217-231

Author(s):

Hongyun Huang ◽

Wenyong Gao ◽

Zhenghui Yan ◽

Aibing Liu ◽

Xijing He ◽

...

Keyword(s):

Cell Culture ◽

Quality Control ◽

Olfactory Bulb ◽

International Association ◽

Clinical Results ◽

Clinical Applications ◽

Clinical Grade ◽

Sample Collection ◽

Olfactory Ensheathing Cell ◽

Management Procedures

Currently, there are many different standards for the quality control of olfactory ensheathing cell (OEC) culture prepared from human olfactory bulb and mucosa. It is challenging to compare the clinical results of OEC treatment from different hospitals. Based on various standards, the Chinese Association of Neurorestoratology (CANR; Preparatory) and China Committee of International Association of Neurorestoratology (IANR-China Committee) organized professional experts in this field to evaluate the data and develop a standard for clinical applications, including donor evaluation, sample collection, cell culture, cell testing, packaging labels, storage, transportation, and quality control of intermediate/finished cell products, as well as training and management procedures for laboratory operators, the use and management of materials and equipment, and routine maintenance of a clean environment. These standards apply to the quality and control of OEC culture using human olfactory bulb and mucosa as the sample source for the member units of the CANR (Preparatory) and IANR-China Committee. It serves as a reference for physicians around the world who perform OEC clinical applications. This standard represents the minimum required standards for quality control when performing clinical-grade OEC cultures in clinical neurorestorative treatments.

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