The role of rapid diagnostic point of care IgG/IgM antibody tests in the diagnosis of SARS-CoV-2 infection

Background: Current testing of symptomatic patients for SARS-CoV-2 involves the use of nucleic acid amplification tests, also known as genetic, RNA or PCR to detect viral RNA. The initial use of point-of-care (POC) antibody tests, also known as serological tests in the management of SARS-CoV-2 infection was limited. In this review, we determine the significance of POC antibody serological tests and explore their possible role in the diagnosis and management of patients infected with SARS-CoV-2 virus. Methods: A literature search was conducted in Google Scholar, PubMed, and Embase, and supplemented by searching the Center for Disease Control (CDC), and the Infectious Diseases Society of America (IDSA) websites. We identified 7 articles published in the last 6 months pertaining to the keywords. The sensitivity and specificity of the IgG/IgM antibody tests obtained from these studies were compared and used to determine the clinical importance of the rapid diagnostic antibody test in SARS-CoV-2 infection. Results: Through the literature review, it was found that POC diagnostic antibody tests can be used as an adjuvant with the nucleic acid amplification tests in determining both active and post-exposure antibodies. These rapid antibody IgG/IgM tests had high sensitivity, the ability of a test to correctly identify those with the disease, and high specificity, the ability of the test to correctly identify those without the disease. Conclusion: Emerging studies indicate the importance of POC antibody serological testing as an important diagnostic tool in the current SARS-CoV-2 pandemic. Considering the limitations of the molecular methods of testing, POC antibody tests can help reduce dependency on the molecular assays of testing when used in conjunction with them

Treating Latent Tuberculosis Infection in Newly Arriving Refugees: An Advanced Practice Nurse Initiative at the University of Louisville Global Health Center

Background: A review of newly arriving refugees referred to the local health department for latent tuberculosis infection (LTBI) treatment during 2013-2015 revealed a treatment gap of 73%, supporting the need to identify new approaches to treat vulnerable populations and mirrored results in the literature. Objectives: 1) Describe an advanced practice registered nurse (APRN) led alternative approach to LTBI treatment in the refugee population; and 2) evaluate the impact of a 12-week regimen for LTBI on treatment acceptance, adherence and completion. Methods: During the initial health screening visit, treatment options were provided for those identified with LTBI consisting of either a 12-week regimen requiring weekly directly observed therapy (DOT) or the traditional 9-month treatment. Results: During March-December 2016, 50 refugees were referred and 24/50 were offered a 12-week regimen of Rifapentine and Isoniazid, administered with DOT. 23 of the 24 or 96% completed the entire treatment course. Conclusions: The new LTBI clinic process resulted in an increase in treatment acceptance and completion compared with the historic rate of 27%. Implications for Nursing: APRN initiatives such as this can result in positive benefits to patients and communities while serving to advance the nursing profession in all practice setting

Performance of a SARS-CoV-2 RT-PCR Assay with Non-Traditional Specimen Types

During the first two years of the coronavirus disease 2019 (COVID-19) pandemic, nasopharyngeal (NP) specimens were the gold standard for clinical diagnostic testing. As information about the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing the pandemic continued to be shared, it was clear that the virus could be detected in other specimen types during an active infection. The University of Louisville Infectious Diseases Laboratory accepted non-traditional specimen types, most without a paired, positive NP result, for research purposes only to support local epidemiology efforts. A real-time reverse transcription-polymerase chain reaction (RT-PCR) assay originally validated for NP specimens was used for non-traditional specimen types using a variety of specimen preparation methods. Limit of detection (LOD) studies allowed for direct comparison between NP, sputum, and breast milk specimen types. The primary aim of the study was to determine whether SARS-CoV-2 RNA could be detected in different human specimen types. The results showed that the non-traditional specimens were not inherently inhibitory since SARS-CoV-2 RNA was detected in 36 (14.5%) out of 249 non-traditional specimens, and the limit of detection for SARS-CoV-2 in breast milk and sputum was the same as for NP specimens. SARS-CoV-2 was not detected in 15 breast milk specimens from mothers with positive SARS-CoV-2 NP results. In addition, a direct comparison study showed that NP specimens performed better than paired nasal specimens. In conclusion, by analyzing real-time RT-PCR test results for these non-traditional specimen types, two benefits were realized. Health care providers gained additional epidemiologic information (since information was not to be used for managing or treating patients), and the laboratory gathered important information about specimen types for which complete method validation studies could be pursued in the future

International Infection Control Training Partnerships: Experiences from the Egypt-University of Louisville Collaboration

Background: Healthcare-associated infection (HAI) is a global challenge that represent opportunities for international collaboration. Both the United States and Egypt prioritize HAI reduction as activities of public health importance. These shared priorities provide a foundation for interactive education and training. Objective: In the fall 2018, The United States Agency for International Development (USAID) sought a US training site where a delegation of physicians and nurses from Egypt could receive experiential training regarding HAI and prevention. The objectives of this review are to: 1) outline the training components used for the US-Egypt collaboration held at the University of Louisville in Kentucky; 2) describe the immersive and experiential approaches used to promote interprofessional education in infection control; and 3) identify some of the successes and challenges of this cultural and practice collaboration. Methods: The course curriculum consisted of a 10-day agenda that provided classroom training, live simulation, role playing, and healthcare facility visits all supporting immersive and experiential learning. Evaluation methods were based upon Kirkpatrick’s Model and included individual self-assessments, daily course evaluations, a summative course evaluation, pre-and post-course testing, and action learning plans. Results: The Egyptian cohort consisted of twenty-six physicians and nurses representing twenty-six different healthcare facilities across the country. Participants rated the course highly but had a strong desire for more interactive experiences at the hospitals. Comparing pre- and post-course knowledge, overall knowledge improved in both the physician and nurse groups. Conclusions: Results from this collaboration demonstrate an ability to provide an organized infection prevention and control training course that reached the University of Louisville team goals and met the stated expectations of the course sponsors. Both the University of Louisville team and the Egyptian delegation indicated that a longer planning horizon would have been beneficial

Multistate Hepatitis A Outbreak: Vaccination of Food Service Workers as Part of the Kentucky Outbreak Response

Background: In August 2017, a local outbreak of Hepatitis A was identified among homeless individuals in Louisville, Kentucky. This marked the first cases in what has now become recognized as the largest Hepatitis A outbreak in the US. When infection was identified in a Food Service Worker (FSW), vaccination efforts were expanded to target this group. Objective: The purpose of this study was to describe: 1) the processes used to provide access to Hepatitis A vaccine for FSWs, 2) results from the immunization activities, and 3) lessons learned from the outcomes. Methods: Through a partnership between the Louisville Metro Department of Public Health and Wellness (LMDPHW) and the University of Louisville Division of Infectious Diseases, a novel approach to vaccination was implemented. Access to vaccine was provided via on-site immunization in 66 restaurants and subsequent availability in a pop-up vaccination clinic. Data were collected using the LMDPHW data collection form and included demographics, risk factors for Hepatitis A, and vaccine documentation. Results for those vaccinated March-December 2018 were analyzed using descriptive statistics. Results: On-site vaccination was provided to 1337 FSW at 66 restaurants during the seven (7) week period from March 28-May 15, 2018. This process involved a team of 42 including Advanced Practice Registered Nurses, Registered and Licensed Practical Nurses, Physicians, and UL team members. During the 35 weeks the walk-in clinic has been in operation (May 16-December 31, 2018), 3068 additional FSW were vaccinated for a total of 4405 FSWs vaccinated as part of the outbreak response. Critical partners included the Kentucky Restaurant Association and the Kentucky Nurses Association. Conclusions: This study demonstrated a successful model for vaccination of a novel population during an infectious disease outbreak and the importance of expanding partnership networks to ensure success. The outcomes emphasized the importance of the resources available in the academic community for reliable and consistent public health emergency response

Use of Emergency Department for Care Access by Refugees Resettling in Kentucky, 2015: Findings from the University of Louisville Global Health Center

Background: Kentucky is one of the largest rural resettlement areas for refugees in the US welcoming more than 3,000 refugees and other entrants during 2015. Refugees arrive with a number of chronic health conditions that require ongoing management in a healthcare system where they lack knowledge and ability to navigate. This may encourage them to seek care that is easy to access but episodic and fragmented. The objective of this study was to determine the frequency and reasons for accessing care via a local emergency department by resettling refugees during their first twelve months of resettlement. Methods: Using data from domestic health screening, crossmatching was done with the Emergency Department (ED) database of a local university medical center. Records were reviewed to determine If the ED was accessed for care, day and time care was accessed, chief complaint at the time of ED arrival, discharge diagnosis and final disposition. Results: Of 2616 refugees seen for health screening during 2011-2015, 77 (3%) sought care in the ED at least one time during the twelve months following their arrival, encompassing a total of 96 unique ED visits. Of the 96 ED visits, 83 (86%) were seen and discharged with the remaining 13 (14%) being admitted to ULH or referred for admission to another facility (e.g., mental health). Of the 83 discharged visits, 51 (61%) were determined to be preventable ED visits. Care was accessed more frequently on Monday (19%), Sunday (18%) and Thursday (17%). 57 of the 83 discharged visits (69%) occurred during hours that reflect those common for routine business in a clinic setting (8 AM - 4 PM). Of ED visits during those routine business hours, 34 (60%) were determined to be preventable ED visits. Discussion: This study represents the first published data regarding ED use by refugees resettling into a single community. These data provide insight into the use of an ED as a point of care access and the role that access plays in refugee healthcare, especially during the earliest phase of resettlement. Conclusions: These data may serve to inform development of a refugee-centered medical home with the objective to improve access to coordinated and comprehensive care

Implementation of the Louisville COVID-19 Surveillance Protocol: Experiences from the University of Louisville Center of Excellence for Research in Infectious Diseases [CERID]

The lack of available testing for SARS-CoV-2 has been one of the primary challenges in the development and implementation of a comprehensive approach to infection prevention and transmission in the United States (US). In response to the need for increased testing capacities and capabilities, the University of Louisville (UofL) Division of Infectious Diseases, Center of Excellence for Research in Infectious Diseases (CERID) initiated the Louisville Coronavirus Surveillance Program, a comprehensive approach to surveillance and testing of patients and healthcare workers. The first specimens were accepted on March 12, 2020 and parallel testing was done using a high-capacity testing process and the Division of Infectious Diseases CLIA-certified laboratory to ensure concordant results. Steps in the testing process began with validation of the testing methods and included database development, acceptance of specimens, tracking and cataloging the specimens, testing, and reporting of results. Quality metrics were developed and used to prevent error and facilitate rapid reporting. Between March 12, 2020 and April 30, 2020, more than 5500 tests were performed identifying more than 850 patients and healthcare workers infected with COVID-19 in the Louisville, Kentucky area. Although the process used high-capacity robotics for testing procedures, the methods described here are applicable to settings employing a variety of laboratory testing methods

Implementing a Clinical Research Program in Long Term Care Facilities: Experiences from the University of Louisville Center Excellence for Research in Infectious Diseases [CERID]

Background: According to the US Census Bureau International Report, in 2015, almost nine percent of the world’s population was aged 65 and over. As the worldwide population ages, there is a need to understand how to best care for those individuals. Developing clinical research programs focusing on long term care (LTC) will be critical to defining best practice. Objectives: The objectives of this manuscript are to: 1) outline the challenges identified in performing clinical research in long term care facilities (LTCF), and 2) offer solutions for future clinical research in the LTC environment based upon our experiences. Methods: A research feasibility study was performed in 14 LTCFs in Louisville, Kentucky during 2018. Research questions involving identification of LTCF residents experiencing diarrhea were used as the basis for determining challenges and abilities to perform research in the LTC environment. Results: Challenges to performing clinical research involving an infectious disease were gathered throughout the twenty-week feasibility assessment period and organized into eight distinct yet inter-related areas. These included: 1) facility recruitment; 2) engagement of facility leadership; 3) engagement of facility personnel; 4) identification of research candidates; 5) consenting processes; 6) management of clinical samples; 7) navigating the medical record systems; and 8) study team workflow. Conclusions: This feasibility assessment found that conducting research in LTCFs was very different in almost every aspect from research conducted in the hospital setting. Results from this feasibility assessment will be used as a basis to determine a more comprehensive population-based incidence of C. difficile infection through the City of Louisville Diarrhea (CLOUD) study

Healthcare Workers Hospitalized with COVID-19: Outcomes from the Burden of COVID-19 study at the University of Louisville Center of Excellence for Research in Infectious Diseases [CERID]

Introduction: On March 6, 2020, the current ongoing pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) also known as COVID-19 reached the commonwealth of Kentucky. Within days the first cases of infection and hospitalization were identified among healthcare workers (HCW) in Kentucky, other states in the U.S., and around the world. There is little information available regarding the impact of COVID-19 on the HCW population within this area. The objective of this study is to describe the baseline characteristics of hospitalized HCWs infected with COVID-19. Methods: Data collection was performed as part of a retrospective study of patients hospitalized with COVID-19 in any of nine acute care hospitals in Louisville. COVID-19 infection was confirmed using Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR). Descriptive statistics were performed on clinical and epidemiological characteristics of hospitalized patients with COVID-19 who had indicated healthcare as their occupation. Results: Of the 700 adults hospitalized with COVID-19 from March 7 through July 1, 2020, 23 were HCWs. The mean age was 51 years and 78% were female. The majority of hospitalized HCWs had comorbidities including obesity (70%), hypertension (57%), hyperlipidemia (35%) and diabetes (26%). Common symptoms reported were fever (70%), dyspnea (78%), cough (78%) and fatigue (57%). Nine HCWs (39%) were admitted to the intensive care unit (ICU) and 6 (26%) developed acute respiratory distress syndrome (ARDS). Two (9%) patients developed a new, serious arrhythmia, two sustained cardiac arrest (9%), and two (9%) died in-hospital. Conclusions: Older adult HCWs with underlying health conditions such as obesity and hypertension were more likely to be hospitalized and have severe in-hospital complications. One HCW death due to COVID-19 was identified in this small population. These findings can help to identify and strengthen approaches to protect HCWs from SARS-CoV-2 infection and from long term effects of COVID-19