An update from Minnesota on the seroprevalence of COVID-19 immunoglobulin G in our adult population

Background: Since the onset of the COVID-19 global pandemic in 2019, much has been learned about the clinical course and epidemiology of SARS-CoV-2 in the cystic fibrosis (CF) population. Because of the severity of illness seen in this population during the H1N1 pandemic, people with CF were initially thought to be at greater risk of severe disease [1], but this community has shown significant resilience without clear evidence of more-severe COVID pneumonia [2]. The reasons for this are probably multifactorial, including younger age and long-standing infectious riskmitigation practices such as social distancing and handwashing. Method(s): Individuals aged 12 and older who receive care at the Minnesota CF Center provided virtual consent and completed a brief online survey detailing possible exposures, symptoms of COVID-19, and behavioral data (e.g., handwashing, remote work opportunities, social-distancing practices). We extracted additional data from the electronic medical record to further risk stratify our patient cohort, including age, body mass index, sex, forced expiratory volume in 1 second, CF transmembrane conductance regulator modulator use, and diabetes. Participants were evaluated for COVID-19 immunoglobulin G (IgG) at the time of enrollment (0 months) and 6 and 12 months after enrollment. Result(s): Data were obtained 120 enrollees with an average age of 37;50% were female. Preliminary data show that 25 (20.1%) of those tested had evidence of a natural COVID infection (IgG+ pre-vaccination or nucleocapsid Ab+). Two of these were hospitalized with COVID pneumonia between December 2020 and October 2021. Induced IgG ranged between 0 and 12 months' duration. At this time, 85% of the enrolled participants have been vaccinated against SARS-CoV-2: 67% with Pfizer-BioNTech, 25% with Moderna, and 9% with Johnson & Johnson. This is significantly higher than the vaccination rate of the general population in Minnesota, currently 66%. Conclusion(s): As SARS-CoV-2 evolves, so too must our understanding of its natural history in people with CF. Our study shows that induced immunity through vaccination results in prolonged (12 months) IgG production in a subset of patients. The higher vaccination rate in the CF population along with infection risk-reduction practices have all helped reduce disease severity from COVID-19. Copyright © 2022, European Cystic Fibrosis Society. All rights reserved

Improving mycobacterial sputum culture collection in adult patients during the highly effective modulator therapy era

Background: Taking annual mycobacterial sputum cultures (MSCx) is a best practice standard for surveillance of nontuberculous mycobacterium (NTM) infection. MSCx collection among sputum-producing people with CF (PwCF) is essential for early identification and management of NTM. Initiation of highly effective modulator therapy (HEMT), elexacaftor/ tezacaftor/ivacaftor in 2019, resulted in a reduction in sputum production in PwCF. The concurrent emergence of the COVID-19 pandemic led to a shift from in-person to virtual clinic visits. These two events led to a dramatic decline in the rate of MSCx collection at our center-from 52.7% (2019) to 26.5% (2020) based on our CF Patient Registry report. We used a multidisciplinary approach to evaluate and implement continuous quality improvement (CQI) measures with the aim of increasing MSCx collection from 52.7% to 65% in 12 months. Eligibility was defined as producing 1 mL or more of sputum and no MSCx within the past 12 months. Method(s): The Minnesota CF Center care team consists of multidisciplinary specialties and approximately 450 PwCF. The CQI team generated the aim and developed a process map highlighting key stakeholders and barriers to MSCx collection. The team used a plan-do-study-act (PDSA) model to optimize key steps involved in MSCx collection. The first PDSA model included microbiology lab leadership identifying optimal (5-10 mL) and acceptable (>=1 mL) sputum volumes to avoid rejected specimens. Next, providers approved a new protocol to prioritize first sputum collection for MSCx and subsequent collection for CF bacterial cultures in eligible PwCF. Development of a certified medical assistant flowchart guided determination of eligibility for MSCx collection (Figure 1). Certified medical assistant then used a paper tool to document eligibility, specimen type, and lab orders placed for PwCF in clinic during the 4-week PDSA cycle. The paper tool was adapted using electronic health record (EHR) capabilities to generate date of last MSCx and allow electronic documentation of specimen collection type and orders placed. Result(s):With the use of HEMT, the percentage of sputum-producing PwCF declined from 74% to 40%. Use of process mapping and paper tool identified barriers to collecting MSCx in our clinic. Workflows were established through recurrent PDSA cycles to identify actionable interventions (education of lab personnel, paper tool, EHR documentation), which has led to collection of 53% of eligible samples-up from 26.5% in 2020 and on Figure 1 : Certified medical assistant (CMA) flowchart for mycobacterial sputum culture (MSCx) collection to determine patient eligibility and order placement(Figure Presented) track for 65% MSCx collection for the year. The paper tool revealed that the greatest barrier to obtaining MSCx was lab cancellation. By November, the team will complete another PDSA cycle after further lab education with the aim of decreasing the number of MSCx that the lab erroneously rejects. Conclusion(s): Despite the reduction in sputum production after use of HEMT, approximately 40% of PwCF still produce sufficient sputum for MSCx monitoring. Applying effective CQI tools including process mapping, PDSA cycles, pareto charts, and run charts to implement an improved, standardized workflow can increase the rate of MSCx, which will aid in detection and management of NTM infections and inform the epidemiology of NTM in the era of HEMT Copyright © 2022, European Cystic Fibrosis Society. All rights reserved

Prevalence of sars-cov-2 igg antibodies in patients with cystic fibrosis at the minnesota cystic fibrosis center in the first 6 months of known virus in the state and in follow-up (6 months and 1 year)

RATIONALE: Since the first known US case of COVID-19 (Coronavirus Disease 2019) was reported in early 2020, little was known about the prevalence in the cystic fibrosis (CF) population. CF is a genetic disorder caused by more than 1700 different mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene resulting in a wide spectrum of disease phenotypes. As the majority of individuals with CF have chronic lung disease, this population is considered to be high risk for severe disease if infected with any virus, especially that of SARS-CoV 2 (severe acute respiratory syndrome coronavirus 2). As the number of cases in the US nears 18 million and the number of deaths in the US is currently reported at greater than 318,000, the prevalence of COVID-19 in the CF population remains largely unknown although the clinical course for those infected is becoming more clear. To date, the Cystic Fibrosis Foundation reported 344 cases of COVID-19 in the US and 3 people who have died, giving a case fatality rate of 0.9%. METHODS: Early in the course of the pandemic, we began studying the exposures, and symptoms of people with CF to evaluate the prevalence of COVID-19 IgG antibody in patients who receive care at the MN CF Center. Individuals >/= 12 years of age completed a brief, online survey detailing possible exposures, symptoms of COVID-19, and behavioral data (e.g. social distancing practices). We extracted additional data through the electronic medical record (EMR) to identify risk factors for COVID-19 IgG development including age, BMI, sex, FEV1 (forced expiratory volume in 1 second), CFTR modulator use, diabetes. Participants were evaluated for COVID-19 IgG at the time of enrollment (0 months) and the natural history of COVID-19 IgG will be further elucidated with additional Ab testing at 6 months and 12 months post-enrollment. RESULTS: Early data includes 75 enrollees with an average age of 35 years. 51% of participants are female. Of those tested, 9.5% had a positive COVID IgG test. 83% of those individuals tested positive for COVID with PCR analysis. CONCLUSION: SARS-CoV-2 is becoming more prevalent in the state of MN and the prevalence of COVID-19 IgG in individuals with cystic fibrosis suggest similar exposure as the general community. Additional data collection at 6 months and 12 months will identify the natural progression of IgG immunity in in CF patients in response to COVID-19.