Performance and Implementation Evaluation of the Abbott BinaxNOW Rapid Antigen Test in a High-Throughput Drive-Through Community Testing Site in Massachusetts.

Rapid diagnostic tests (RDTs) for SARS-CoV-2 antigens (Ag) that can be performed at point of care (POC) can supplement molecular testing and help mitigate the COVID-19 pandemic. Deployment of an Ag RDT requires an understanding of its operational and performance characteristics under real-world conditions and in relevant subpopulations. We evaluated the Abbott BinaxNOW COVID-19 Ag card in a high-throughput, drive-through, free community testing site in Massachusetts using anterior nasal (AN) swab reverse transcriptase PCR (RT-PCR) for clinical testing. Individuals presenting for molecular testing in two of seven lanes were offered the opportunity to also receive BinaxNOW testing. Dual AN swabs were collected from symptomatic and asymptomatic children (≤18 years of age) and adults. BinaxNOW testing was performed in a testing pod with temperature/humidity monitoring. One individual performed testing and official result reporting for each test, but most tests had a second independent reading to assess interoperator agreement. Positive BinaxNOW results were scored as faint, medium, or strong. Positive BinaxNOW results were reported to patients by phone, and they were instructed to isolate pending RT-PCR results. The paired RT-PCR result was the reference for sensitivity and specificity calculations. Of 2,482 participants, 1,380 adults and 928 children had paired RT-PCR/BinaxNOW results and complete symptom data. In this study, 974/1,380 (71%) adults and 829/928 (89%) children were asymptomatic. BinaxNOW had 96.5% (95% confidence interval [CI], 90.0 to 99.3) sensitivity and 100% (95% CI, 98.6 to 100.0) specificity in adults within 7 days of symptoms and 84.6% (95% CI, 65.1 to 95.6) sensitivity and 100% (95% CI, 94.5 to 100.0) specificity in children within 7 days of symptoms. Sensitivity and specificity in asymptomatic adults were 70.2% (95% CI, 56.6 to 81.6) and 99.6% (95% CI, 98.9 to 99.9), respectively, and in asymptomatic children, they were 65.4% (95% CI, 55.6 to 74.4) and 99.0% (95% CI, 98.0 to 99.6), respectively. By cycle threshold (CT ) value cutoff, sensitivity in all subgroups combined (n = 292 RT-PCR-positive individuals) was 99.3% with CT values of ≤25, 95.8% with CT values of ≤30, and 81.2% with CT values of ≤35. Twelve false-positive BinaxNOW results (out of 2,308 tests) were observed; in all 12, the test bands were faint but otherwise normal and were noted by both readers. One invalid BinaxNOW result was identified. Interoperator agreement (positive versus negative BinaxNOW result) was 100% (n = 2,230/2,230 double reads). Each operator was able to process 20 RDTs per hour. In a separate set of 30 specimens (from individuals with symptoms ≤7 days) run at temperatures below the manufacturer's recommended range (46 to 58.5°F), sensitivity was 66.7% and specificity 95.2%. BinaxNOW had very high specificity in both adults and children and very high sensitivity in newly symptomatic adults. Overall, 95.8% sensitivity was observed with CT values of ≤30. These data support public health recommendations for use of the BinaxNOW test in adults with symptoms for ≤7 days without RT-PCR confirmation. Excellent interoperator agreement indicates that an individual can perform and read the BinaxNOW test alone. A skilled laboratorian can perform and read 20 tests per hour. Careful attention to temperature is critical.

Home Parenteral Nutrition in Patients with Advanced Cancer: A Systematic Review and Meta-Analysis.

The use of home parenteral nutrition (HPN) in patients with incurable cancer remains controversial with significant variation worldwide. We aimed to systematically evaluate the literature from 1960 to 2018 examining the use of HPN in advanced cancer patients for all intestinal failure indications and assess the potential benefits/burdens of HPN in this cohort of patients. The primary end point was survival and secondary end points were quality of life and nutritional/performance status. Meta-analysis was performed with a random effects model, where suitable. Of 493 studies retrieved, 22 met the quality inclusion criteria. Studies were mainly conducted in Western countries (Italy, USA, Canada, Germany), including a total of 3564 patients (mean age 57.8 years). Mean duration for HPN was 5.0 mo. Mean overall survival was 7.3 mo. Patients with improved performance status survived for longer on HPN. Quality of life was sparsely reported though there was no observed negative impact of PN. HPN-related complications were reported in eight studies only and were mainly catheter-related blood stream infections. In conclusion, HPN is used for several indications in advanced cancer, though there is significant heterogeneity of results. Disparities in geographical distribution of the studies may reflect variation in accessing HPN.

Clinical and Nutritional Care Pathways of Patients with Malignant Bowel Obstruction: A Retrospective Analysis in a Tertiary UK Center.

We describe a retrospective cohort study of patients with malignant bowel obstruction to examine their nutritional care pathways between 1.1.16 and 31.12.16 with readmissions until 31.12.17. Data were analyzed by comparing patients who were referred (R) and not referred (NR) for PN. We identified 72 patients with 117 MBO admissions (mean ± SD age:63.1 ± 13.1yrs, 79% female). 24/72 patients were in R group. Predominant primary malignancies were gynaecological and lower-gastrointestinal cancers (76%). 83% patients had metastases (61% sub-diaphragmatically). All patients were at high-risk of malnutrition and baseline mean weight loss was 7%. Discussion of PN at multidisciplinary team meeting (MDT) (22% vs.5%, P = 0.02) and dietetic contact (94% vs. 41%, P < 0.0001) were more likely to occur in the R group. In 13/69 MBO admissions in NR group, reasons for non-referral were unclear. Median baseline and follow-up weight was similar (55-55.8 kg). Overall survival was 4.7 (1.4-15.2)months, with no differences by referral groups. We compared a sub-sample of patients who 'may have' required PN (n = 10) vs. those discharged on home PN (n = 10) and found greater survival in the HPN group (323vs.91 day, P < 0.01). Our findings highlight disparity in care pathways suggesting that nutritional care should be integrated into clinical management discussion(s) at MDT to ensure equal access to nutritional services.

Chronic obstructive pulmonary disease exacerbation episodes derived from electronic health record data validated using clinical trial data.

PURPOSE: To validate an algorithm for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) episodes derived in an electronic health record (EHR) database, against AECOPD episodes collected in a randomized clinical trial using an electronic case report form (eCRF). METHODS: We analyzed two data sources from the Salford Lung Study in COPD: trial eCRF and the Salford Integrated Record, a linked primary-secondary routine care EHR database of all patients in Salford. For trial participants, AECOPD episodes reported in eCRF were compared with algorithmically derived moderate/severe AECOPD episodes identified in EHR. Episode characteristics (frequency, duration), sensitivity, and positive predictive value (PPV) were calculated. A match between eCRF and EHR episodes was defined as at least 1-day overlap. RESULTS: In the primary effectiveness analysis population (n = 2269), 3791 EHR episodes (mean [SD] length: 15.1 [3.59] days; range: 14-54) and 4403 moderate/severe AECOPD eCRF episodes (mean length: 13.8 [16.20] days; range: 1-372) were identified. eCRF episodes exceeding 28 days were usually broken up into shorter episodes in the EHR. Sensitivity was 63.6% and PPV 71.1%, where concordance was defined as at least 1-day overlap. CONCLUSIONS: The EHR algorithm performance was acceptable, indicating that EHR-derived AECOPD episodes may provide an efficient, valid method of data collection. Comparing EHR-derived AECOPD episodes with those collected by eCRF resulted in slightly fewer episodes, and eCRF episodes of extreme lengths were poorly captured in EHR. Analysis of routinely collected EHR data may be reasonable when relative, rather than absolute, rates of AECOPD are relevant for stakeholders' decision making.

Association of body fat with stress levels and dietary intakes in Indian women.

A cross-sectional study of 605 women (aged 18-50 years) conducted from January 2013 to June 2014 in Gujarat, India assessed stress, dietary intakes and body fat percentage (PBF), and the inter-relationship of PBF with stress, dietary fat, and carbohydrates. The population was categorized according to PBF cutoffs for Asians. A generalized linear regression model adjusted for age was performed to assess the relationship of stress, fat, and carbohydrate intakes with PBF. PBF had a significant positive association with stress level (p = .02) and carbohydrate intake (p = .008); fat intake was not significantly associated (p = .8). Women with moderate PBF consumed significantly less carbohydrates (mean = 152.3 ± 13.3 gm/1000 kcal/day, p < .05) and had lower stress scores (mean = 9.7 ± 4.2, p < .05) than women with high PBF (mean carbohydrate intake = 156.2 ± 10.8 gm/1000 kcal/day; mean stress score = 10.9 ± 4.4) and very high PBF (mean carbohydrate intake = 156.8 ± 11.6 gm/1000 kcal/day; mean stress score = 11.2 ± 4.2). We conclude that PBF has a positive association with stress and dietary carbohydrate; women with higher stress and carbohydrate intake are more likely to accumulate higher body fat as compared to women with less stress and low carbohydrate intake.

Correct use and ease of use of a placebo dry powder inhaler in subjects with asthma and chronic obstructive pulmonary disease.

Correct use and ease of use of a placebo dry powder inhaler was evaluated in two single-arm, United States-multicenter, phase-IV studies in adults with asthma ( n = 259) or chronic obstructive pulmonary disease (COPD; n = 278) who were receiving maintenance inhaler therapy. Subjects demonstrating correct placebo inhaler use within three attempts at screening were instructed to take once-daily inhalations from the inhaler for 28 ± 2 days (continuing usual maintenance), followed by randomization to complete one of two versions of an ease-of-use questionnaire and reassessment for correct inhaler use. At study end, 96% asthma/93% COPD subjects rated the placebo inhaler as "easy" or "very easy" to use while demonstrating correct use. Furthermore, 99% asthma/99% COPD subjects indicated it was "easy" or "very easy" to determine number of doses remaining, and 81%/84%, respectively, indicated they would be "likely" or "very likely" to request their current medication in the inhaler, if available. Adverse event (AE) rates were 12% asthma/15% COPD, most frequently headache (3%/3%). Treatment-related AEs were reported in one subject with asthma (cough) and four subjects with COPD (cough, n = 3; back pain, n = 1). At study end, most subjects with asthma or COPD operated the placebo inhaler correctly and found it easy to use.

Performance Status, Prognostic Scoring, and Parenteral Nutrition Requirements Predict Survival in Patients with Advanced Cancer Receiving Home Parenteral Nutrition.

We describe a cohort of Home Parenteral Nutrition (HPN) patients with advanced cancer in order to identify factors affecting prognosis. Demographic, anthropometric, biochemical and medical factors, Karnofsky Performance Status (KPS), Glasgow Prognostic Score (GPS), and PN requirements were recorded. Univariate and multivariate analyses were performed including Kaplan-Meier curves, Cox Regression, and correlation analyses. In total, 107 HPN patients (68 women, 39 men, mean age 57 yr) with advanced cancer were identified. The main indications for HPN were bowel obstruction (74.3%) and high output ostomies (14.3%). Cancer cachexia was present in 87.1% of patients. The hazard ratio (HR) for upper gastrointestinal and "other" cancers vs. gynaecological malignancy was 1.75 (p = 0.077) and 2.11 (p = 0.05), respectively. KPS score, GPS, PN volume, and PN potassium levels significantly predicted survival (HRKPS ≥50 vs <50 = 0.47; HRGPS = 2 vs. GPS = 0 = 3.19). In multivariate analysis, KPS and GPS remained significant predictors (p < 0.05), whilst PN volume reached borderline significance (p = 0.094). Survival was not significantly affected by the presence of metastatic disease, previous or concurrent surgery, chemo-radiotherapy, or indication for HPN (p > 0.05). Most patients passed away in their homes or hospice (77.9%). Performance status, prognostic scoring, and PN requirements may predict survival in patients with advanced cancer receiving HPN.

A Randomized Clinical Trial Comparing the ELLIPTA and HandiHaler Dry Powder Inhalers in Patients With COPD: Inhaler-Specific Attributes and Overall Patient Preference.

This randomised, open-label, cross-over, placebo-containing inhaler study assessed patient preference indicators for ELLIPTA and HandiHaler dry powder inhalers in patients with COPD (NCT02786927; GSK identifier: 204983). The primary objective of this study was to assess patient preference between ELLIPTA and HandiHaler based on the number of steps needed to use the inhaler. Eligible patients ≥40 years of age with COPD were randomised 1:1 to receive their current COPD medication plus a placebo-containing ELLIPTA or HandiHaler inhaler once daily for 7 ± 2 days (treatment period 1); this was followed by a 7 ± 2-day placebo treatment with the alternative inhaler. A 5-item questionnaire assessed inhaler-related patient preferences. A total of 212 patients (mean age, 65.1 years) were enrolled at 22 US sites; 73% had a COPD duration ≥5 years. Median (range) exposure was 8 ( 5 , 13 ) days for ELLIPTA and 8 ( 1 , 16) days for HandiHaler. Significantly more patients preferred ELLIPTA to HandiHaler in terms of the number of steps to use and all secondary attributes (size, comfort of the mouthpiece, remaining doses, and ease of use of the two inhalers; all p < 0.001). Similar results were observed irrespective of the order of inhaler use. Eighteen patients (8%) reported at least one AE and two (<1%) patients reported four non-fatal SAEs; none were related to the study treatment. Patient attitude toward a particular inhaler and their experiences in using it can affect adherence to therapy, which can in turn strongly influence effectiveness of inhaled medications. This study uses a robust methodology to assess patient preference.

Impact of occupation on stress and anxiety among Indian women.

The objectives of this study were to: (1) assess the prevalence of anxiety and stress in Indian women; and (2) evaluate the relationship of occupation to the prevalence of anxiety and stress. A cross-sectional study was performed from January 2013 to June 2014, on women (aged 18-50 years) randomly selected from different occupations in Gujarat, India. Anxiety was evaluated using Spielberg's State and Trait Anxiety Inventory scale and stress was assessed using the International Stress Management Association questionnaire. Serum cortisol concentration was measured in a sub-sample. The association of occupation with stress and anxiety was analyzed by a generalized linear model adjusted for age. Among all participants, 26% were the most prone and 66% were somewhat more prone to stress; 35% of women showed high anxiety levels. Homemakers had 1.2 times higher anxiety and 1.3 times higher stress than working women (p < .05). Prevalence of stress (37%, p < .001) and anxiety (40%, p = .068) were also higher in homemakers compared to working women and students. Serum cortisol levels did not differ significantly (p > .05) by occupation. This study revealed high prevalence rates of stress and anxiety in Indian women. Involvement in activities outside the home may help women to reduce stress.

Exosome encased spherical nucleic acid gold nanoparticle conjugates as potent microRNA regulation agents.

Exosomes are a class of naturally occurring nanomaterials that play crucial roles in the protection and transport of endogenous macromolecules, such as microRNA and mRNA, over long distances. Intense effort is underway to exploit the use of exosomes to deliver synthetic therapeutics. Herein, transmission electron microscopy is used to show that when spherical nucleic acid (SNA) constructs are endocytosed into PC-3 prostate cancer cells, a small fraction of them (<1%) can be naturally sorted into exosomes. The exosome-encased SNAs are secreted into the extracellular environment from which they can be isolated and selectively re-introduced into the cell type from which they were derived. In the context of anti-miR21 experiments, the exosome-encased SNAs knockdown miR-21 target by approximately 50%. Similar knockdown of miR-21 by free SNAs requires a ≈3000-fold higher concentration.

Nutritional care pathways in cancer patients with malignant bowel obstruction: A retrospective multi-centre study.

INTRODUCTION: Variation in access to parenteral nutrition (PN) in patients with intestinal failure secondary to malignant bowel obstruction (MBO) exists due to differing practice, beliefs and resource access. We aimed to examine differences in nutritional care pathways and outcomes, by referral to nutrition team for PN in patients with MBO. METHODS: This is a retrospective cohort study of MBO adults admitted to eight UK hospitals within a year and 1 year follow-up. Demographic, nutritional and medical data were analysed by comparing patients referred (R) or not referred (NR) for PN. Differences between groups were tested by Kruskal-Wallis, Chi-Squared tests and multi-level regression and survival using Cox regression. RESULTS: 232 patients with 347 MBO admissions [median 66yr, (IQR: 55-74yrs), 67 % female], 79/232 patients were referred for PN (R group). Underlying primary malignancies of gynaecological and gastrointestinal origin predominated (71 %) and 78 % with metastases. Those in the NR group were found to be older, weigh more on admission, and more likely to be treated conservatively compared to those in the R group. For 123 (35 %) admissions, patients were referred to a nutrition team, and for 204 (59 %) admissions, patients were reviewed by a dietician. Multi-disciplinary team discussion and dietetic contact were more likely to occur in the R group-123/347 admissions (R vs NR group: 27 % vs. 7 %, P = 0.001; 95 % vs 39 %, P < 0.0001). Median admission weight loss was 8 % (IQR: 0 to 14). 43/123 R group admissions received inpatient PN only, with 32 patients discharged or already established on home parenteral nutrition. Overall survival was 150 days (126-232) with no difference between R/NR groups. CONCLUSION: In this multi-centre study evaluating nutritional care management of patients with malignant bowel obstruction, only 1 in 3 admissions resulted in a referral to the nutrition team for PN, and just over half were reviewed by a dietician. Further prospective research is required to evaluate possible consequences of these differential care pathways on clinical outcomes and quality of life.

Preserving rural school health during the COVID-19 pandemic: Indigenous citizen scientist perspectives from a qualitative study.

This qualitative study is part of Smart Indigenous Youth, a digital health community trial involving rural schools in Saskatchewan, Canada. Secondary school administrators and educators were engaged as citizen scientists in rural Indigenous communities to understand rapid decision-making processes for preserving school health during the COVID-19 pandemic, and to inform evidence-based safe school policies and practices. After COVID-19 restrictions were implemented, key informant interviews and focus groups were conducted with school administrators and educators, respectively, to understand the impact of school responses and decision-making processes. Two independent reviewers conducted thematic analyses and compared themes to reach consensus on a final shortlist. Four main themes emerged from the administrator interviews, and six main themes were identified from the educator focus group discussions which revealed a pressing need for mental health supports for students and educators. The study findings highlight the challenges faced by schools in rural and remote areas during the COVID-19 pandemic, including school closures, students' reactions to closures, measures taken by schools to preserve health during the pandemic, and different approaches to implement for future closures. Citizen scientists developed a set of recommendations, including the need for structured communication, reflection meetings, adequate funding, and external monitoring and evaluation to guide evidence-based safe school policies and practices during the pandemic.

Factors Associated with Significant Weight Loss in Hospitalised Patients with COVID-19: A Retrospective Cohort Study in a Large Teaching Hospital.

SARS-CoV-2 infection (COVID-19) is associated with malnutrition risk in hospitalised individuals. COVID-19 and malnutrition studies in large European cohorts are limited, and post-discharge dietary characteristics are understudied. This study aimed to assess the rates of and risk factors for ≥10% weight loss in inpatients with COVID-19, and the need for post-discharge dietetic support and the General Practitioner (GP) prescription of oral nutritional supplements, during the first COVID-19 wave in a large teaching hospital in the UK. Hospitalised adult patients admitted between March and June 2020 with a confirmed COVID-19 diagnosis were included in this retrospective cohort study. Demographic, anthropometric, clinical, biochemical, and nutritional parameters associated with ≥10% weight loss and post-discharge characteristics were described. Logistic regression models were used to identify risk factors for ≥10% weight loss and post-discharge requirements for ongoing dietetic input and oral nutritional supplement prescription. From the total 288 patients analysed (40% females, 72 years median age), 19% lost ≥ 10% of their admission weight. The length of hospital stay was a significant risk factor for ≥10% weight loss in multivariable analysis (OR 1.22; 95% CI 1.08-1.38; p = 0.001). In addition, ≥10% weight loss was positively associated with higher admission weight and malnutrition screening scores, dysphagia, ICU admission, and artificial nutrition needs. The need for more than one dietetic input after discharge was associated with older age and ≥10% weight loss during admission. A large proportion of patients admitted to the hospital with COVID-19 experienced significant weight loss during admission. Longer hospital stay is a risk factor for ≥10% weight loss, independent of disease severity, reinforcing the importance of repeated malnutrition screening and timely referral to dietetics.

Nanoparticle shape anisotropy dictates the collective behavior of surface-bound ligands.

We report on the modification of the properties of surface-confined ligands in nanoparticle systems through the introduction of shape anisotropy. Specifically, triangular gold nanoprisms, densely functionalized with oligonucleotide ligands, hybridize to complementary particles with an affinity that is several million times higher than that of spherical nanoparticle conjugates functionalized with the same amount of DNA. In addition, they exhibit association rates that are 2 orders of magnitude greater than those of their spherical counterparts. This phenomenon stems from the ability of the flat, extended facets of nonspherical nanoparticles to (1) support more numerous ligand interactions through greater surface contact with complementary particles, (2) increase the effective local concentration of terminal DNA nucleotides that mediate hybridization, and (3) relieve the conformational stresses imposed on nanoparticle-bound ligands participating in interactions between curved surfaces. Finally, these same trends are observed for the pH-mediated association of nanoparticles functionalized with carboxylate ligands, demonstrating the generality of these findings.

Polystyrene microsphere-ferritin conjugates: a robust phantom for correlation of relaxivity and size distribution.

In vivo iron load must be monitored to prevent complications from iron overload diseases such as hemochromatosis or transfusion-dependent anemias. While liver biopsy is the gold standard for determining in vivo iron load, MRI offers a noninvasive approach. MR phantoms have been reported that estimate iron concentration in the liver and mimic relaxation characteristics of in vivo deposits of hemosiderin. None of these phantoms take into account the size distribution of hemosiderin, which varies from patient to patient based on iron load. We synthesized stable and reproducible microsphere-ferritin conjugates (ferribeads) of different sizes that are easily characterized for several parameters that are necessary for modeling such as iron content and bead fraction. T(1) s and T(2) s were measured on a 1.41-T low-resolution NMR spectrometer and followed a size-dependent trend. Ferribeads imaged at 4.7 and 14.1 T showed that signal intensities are dependent on the distribution of ferritin around the bead rather than the iron concentration alone. These particles can be used to study the effects of particle size, ferritin distribution, and bead fraction on proton relaxation and may be of use in mimicking hemosiderin in a phantom for estimating iron concentration.

Duplex end breathing determines serum stability and intracellular potency of siRNA-Au NPs.

Structural requirements of siRNA-functionalized gold nanoparticles (siRNA-Au NPs) for Dicer recognition and serum stability were studied. We show that the 3' overhang on the nucleic acids of these particles is preferentially recognized by Dicer but also makes the siRNA duplexes more susceptible to nonspecific serum degradation. Dicer and serum nucleases show lower preference for blunt duplexes as opposed to those with 3' overhangs. Importantly, gold nanoparticles functionalized with blunt duplexes with relatively less thermal breathing are up to 15 times more stable against serum degradation without compromising Dicer recognition. This increased stability leads to a 300% increase in cellular uptake of siRNA-Au NPs and improved gene knockdown.

Peptide antisense nanoparticles.

We have designed a heterofunctionalized nanoparticle conjugate consisting of a 13-nm gold nanoparticle (Au NP) containing both antisense oligonucleotides and synthetic peptides. The synthesis of this conjugate is accomplished by mixing thiolated oligonucleotides and cysteine-terminated peptides with gold nanoparticles in the presence of salt, which screens interactions between biomolecules, yielding a densely functionalized nanomaterial. By controlling the stoichiometry of the components in solution, we can control the surface loading of each biomolecule. The conjugates are prepared easily and show perinuclear localization and an enhanced gene regulation activity when tested in a cellular model. This heterofunctionalized structure represents a new strategy for preparing nanomaterials with potential therapeutic applications.

Perceived acceptability of partial enteral nutrition (PEN) using oral nutritional supplement drinks in adolescent and adult Crohn's disease outpatients: A feasibility study.

BACKGROUND AND AIMS: Studies, mainly in Japanese cohorts, have shown that partial enteral nutrition (PEN) including oral nutritional supplement (ONS) drinks can prolong disease remission and increase drug effectiveness in Crohn's disease (CD). Acceptability is a key feasibility parameter to determine whether PEN is a viable treatment option in UK CD patients. We report the results of a single centre cross-sectional feasibility study carried out to investigate perceived acceptability of PEN using ONS drinks and whether ONS preference varies with sex, nutritional status or phenylthiocarbamide (PTC) sensitivity. METHODS: Patients with a confirmed CD diagnosis were recruited using convenience sampling from an adult and adolescent gastroenterology outpatient clinic over 3 years. Blind taste testing of 5 polymeric ONS drinks were conducted using a validated 9-point hedonic rating scale followed by completion of an acceptability questionnaire based on the preferred ONS drink. A subset of patients took home the preferred ONS drink for a 7-day ONS study. RESULTS: 105 CD patients (55 males), aged 34.9 (±15.4) years were recruited and 28 patients completed the 7-day ONS study. Overall impression scores did not significantly vary with nutritional status, sex, BMI, handgrip strength (HGS), mid-upper arm circumference (MUAC) or PTC sensitivity. Ensure plus milkshake™ rated highest for overall impression (6.5, p=<0.0001) and all other organoleptic properties (p < 0.0001). The main perceived benefits of using ONS drinks as PEN related to assurance of nutrient intake (89%), convenience (86%), and improvement of gut symptoms (85%). The main perceived barriers related to reduction in pleasure from eating and drinking (56%), struggling with drink storage (54%) having less energy and feeling more tired than if eating 3 solid meals daily (52%). 65% of patients would consider using ONS drinks as PEN as a maintenance treatment option. 81% of patients felt confident-very confident about consuming ONS drinks daily as PEN for three months but this dropped to 64% and 37% at 6 and 12 months, respectively. There was a significant drop in perceived ease of use of ONS drinks as PEN after the 7-day ONS study (P = 0.01). CONCLUSION: Use of ONS drinks as PEN have high perceived benefits and appear to be a feasible option for short-term use of 3-6 months in CD patients. However, confidence in long-term use of ONS drinks as PEN is low mainly due to the perceived social impact. Future studies should assess longer trial periods and volume of ONS drinks to increase the validity of these findings.

Performance and Operational Evaluation of the Access Bio CareStart Rapid Antigen Test in a High-Throughput Drive-Through Community Testing Site in Massachusetts.

BACKGROUND: To facilitate deployment of point-of-care testing for severe acute respiratory syndrome coronavirus 2, we evaluated the Access Bio CareStart COVID-19 Antigen test in a high-throughput, drive-through, free community testing site using anterior nasal (AN) swab reverse-transcription polymerase chain reaction (RT-PCR) for clinical testing. METHODS: Consenting symptomatic and asymptomatic children (≤18 years) and adults received dual AN swabs. CareStart testing was performed with temperature/humidity monitoring. All tests had 2 independent reads to assess interoperator agreement. Patients with positive CareStart results were called and instructed to isolate pending RT-PCR results. The paired RT-PCR result was the reference for sensitivity and specificity calculations. RESULTS: Of 1603 participants, 1245 adults and 253 children had paired RT-PCR/CareStart results and complete symptom data. Eighty-three percent of adults and 87% of children were asymptomatic. CareStart sensitivity/specificity were 84.8% (95% confidence interval [CI], 71.1-93.7)/97.2% (95% CI, 92.0-99.4) and 85.7% (95% CI, 42.1-99.6)/89.5% (95% CI, 66.9-98.7) in adults and children, respectively, within 5 days of symptoms. Sensitivity/specificity were 50.0% (95% CI, 41.0-59.0)/99.1% (95% CI, 98.3-99.6) in asymptomatic adults and 51.4% (95% CI, 34.4-68.1)/97.8% (95% CI, 94.5-99.4) in asymptomatic children. Sensitivity in all 234 RT-PCR-positive people was 96.3% with cycle threshold (Ct) ≤25, 79.6% with Ct ≤30, and 61.4% with Ct ≤35. All 21 false-positive CareStart tests had faint but normal bands. Interoperator agreement was 99.5%. Operational challenges included identification of faint test bands and inconsistent swab elution volumes. CONCLUSIONS: CareStart had high sensitivity in people with Ct ≤25 and moderate sensitivity in symptomatic people overall. Specificity was unexpectedly lower in symptomatic versus asymptomatic people. Excellent interoperator agreement was observed, but operational challenges indicate that operator training is warranted.

Comprehensive evaluation of bronchoalveolar lavage from patients with severe COVID-19 and correlation with clinical outcomes.

Information on bronchoalveolar lavage (BAL) in patients with COVID-19 is limited, and clinical correlation has not been reported. This study investigated the key features of BAL fluids from COVID-19 patients and assessed their clinical significance. A total of 320 BAL samples from 83 COVID-19 patients and 70 non-COVID-19 patients (27 patients with other respiratory viral infections) were evaluated, including cell count/differential, morphology, flow cytometric immunophenotyping, and immunohistochemistry. The findings were correlated with clinical outcomes. Compared to non-COVID-19 patients, BAL from COVID-19 patients was characterized by significant lymphocytosis (p < 0.001), in contrast to peripheral blood lymphopenia commonly observed in COVID-19 patients and the presence of atypical lymphocytes with plasmacytoid/plasmablastic features (p < 0.001). Flow cytometry and immunohistochemistry demonstrated that BAL lymphocytes, including plasmacytoid and plasmablastic cells, were composed predominantly of T cells with a mixture of CD4+ and CD8+ cells. Both populations had increased expression of T-cell activation markers, suggesting important roles of helper and cytotoxic T-cells in the immune response to SARS-CoV-2 infection in the lung. More importantly, BAL lymphocytosis was significantly associated with longer hospital stay (p < 0.05) and longer requirement for mechanical ventilation (p < 0.05), whereas the median atypical (activated) lymphocyte count was associated with shorter hospital stay (p < 0.05), shorter time on mechanical ventilation (p < 0.05) and improved survival. Our results indicate that BAL cellular analysis and morphologic findings provide additional important information for diagnostic and prognostic work-up, and potential new therapeutic strategies for patients with severe COVID-19.