Clinical Evaluation of the Abbott Alinity SARS-CoV-2 Spike-Specific Quantitative IgG and IgM Assays among Infected, Recovered, and Vaccinated Groups.

The coronavirus disease 19 (COVID-19) pandemic continues to impose a significant burden on global health infrastructure. While identification and containment of new cases remain important, laboratories must now pivot and consider an assessment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunity in the setting of the recent availability of multiple COVID-19 vaccines. Here, we have utilized the latest Abbott Alinity semiquantitative IgM and quantitative IgG spike protein (SP) serology assays (IgMSP and IgGSP) in combination with Abbott Alinity IgG nucleocapsid (NC) antibody test (IgGNC) to assess antibody responses in a cohort of 1,236 unique participants comprised of naive, SARS-CoV-2-infected, and vaccinated (including both naive and recovered) individuals. The IgMSP and IgGSP assays were highly specific (100%) with no cross-reactivity to archived samples collected prior to the emergence of SARS-CoV-2, including those from individuals with seasonal coronavirus infections. Clinical sensitivity was 96% after 15 days for both IgMSP and IgGSP assays individually. When considered together, the sensitivity was 100%. A combination of NC- and SP-specific serologic assays clearly differentiated naive, SARS-CoV-2-infected, and vaccine-related immune responses. Vaccination resulted in a significant increase in IgGSP and IgMSP values, with a major rise in IgGSP following the booster (second) dose in the naive group. In contrast, SARS-CoV-2-recovered individuals had several-fold higher IgGSP responses than naive following the primary dose, with a comparatively dampened response following the booster. This work illustrates the strong clinical performance of these new serological assays and their utility in evaluating and distinguishing serological responses to infection and vaccination.

Expanding COVID-19 Vaccine Availability: Role for Combined Orthogonal Serology Testing (COST).

BACKGROUND: The persisting Coronavirus disease 2019 (COVID-19) pandemic and limited vaccine supply has led to a shift in global health priorities to expand vaccine coverage. Relying on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) molecular testing alone cannot reveal the infection proportion, which could play a critical role in vaccination prioritization. We evaluated the utility of a combination orthogonal serological testing (COST) algorithm alongside RT-PCR to quantify prevalence with the aim of identifying candidate patient clusters to receive single and/or delayed vaccination. METHODS: We utilized 108,505 patients with suspected COVID-19 in a retrospective analysis of SARS-CoV-2 RT-PCR vs. IgG-nucleocapsid (IgGNC) antibody testing coverage in routine practice for the estimation of prevalence. Prospectively, an independent cohort of 21,388 subjects was simultaneously tested by SARS-CoV-2 RT-PCR and IgGNC to determine the prevalence. We used 614 prospective study subjects to assess the utility of COST (IgGNC, IgM-spike (IgMSP), and IgG-spike (IgGSP)) in establishing the infection proportion to identify a single-dose vaccination cohort. RESULTS: Retrospectively, we observed a 6.3% (6871/108,505) positivity for SARS-CoV-2 RT-PCR, and only 2.3% (2533/108,505) of cases had paired IgGNC serology performed. Prospectively, IgGNC serology identified twice the number of COVID-positive cases in relation to RT-PCR alone. COST further increased the number of detected positive cases: IgGNC+ or IgMSP+ (18.0%); IgGNC+ or IgGSP+ (23.5%); IgMSP+ or IgGSP+ (23.8%); and IgGNC+ or IgMSP+ or IgGSP+ (141/584 = 24.1%). CONCLUSION: COST may be an effective tool for the evaluation of infection proportion and thus could define a cohort for a single dose and/or delayed vaccination.

Epidemiology of eating disorders in primary care in children and young people: a Clinical Practice Research Datalink study in England.

OBJECTIVES: Examination of current temporal trends and clinical management patterns of eating disorders (ED) in primary care is lacking. We aimed to calculate annual incidence rates of EDs in primary care by age, sex and deprivation. We also explored the care received through referrals, psychotropic prescriptions and associated secondary care service use. PARTICIPANTS AND SETTINGS: A retrospective electronic cohort study was conducted using the Clinical Practice Research Datalink in those aged 11-24 years between 2004 and 2014 in England (n=1 135 038). RESULTS: A total of 4775 individuals with a first ever recorded ED diagnosis were identified. The crude incidence rate was 100.1 per 100 000 person years at risk (95% CI 97.2 to 102.9). Incidence rates were highest in females (189.3 per 100 000 person years, 95% CI 183.7 to 195.0, n=4336), 16-20 years of age (141.0 per 100 000 person years, 95% CI 135.4 to 146.9, n=2348) and individuals from the least deprived areas (115.8 per 100 000 person years (95% CI 109.3 to 122.5, n=1203). Incidence rates decreased across the study period (incidence rate ratio (IRR) 0.6, 95% CI 0.5 to 0.8), particularly for individuals with bulimia nervosa (IRR 0.5, 95% CI 0.3 to 0.7) and from the most deprived areas (IRR 0.5, 95% CI 0.4 to 0.7). A total of 17.4% (95% CI 16.3 to 18.5, n=831) of first ever recorded ED cases were referred from primary to secondary care. 27.1% (95% CI 25.9 to 28.4, n=1294) of individuals had an inpatient admission 6 months before or 12 months after an incident ED diagnosis and 53.4% (95% CI 52.0 to 54.9, n=2550) had an outpatient attendance. Antidepressants were the most commonly prescribed psychotropic medication. CONCLUSIONS: New ED presentations in primary care are reducing. Understanding the cause of this decrease (coding behaviours, changes in help-seeking or a genuine reduction in new cases) is important to plan services, allocate resources and deliver effective care.

Count me in: using a patient portal to minimize implicit bias in clinical research recruitment.

OBJECTIVE: Determine whether women and men differ in volunteering to join a Research Recruitment Registry when invited to participate via an electronic patient portal without human bias. MATERIALS AND METHODS: Under-representation of women and other demographic groups in clinical research studies could be due either to invitation bias (explicit or implicit) during screening and recruitment or by lower rates of deciding to participate when offered. By making an invitation to participate in a Research Recruitment Registry available to all patients accessing our patient portal, regardless of demographics, we sought to remove implicit bias in offering participation and thus independently assess agreement rates. RESULTS: Women were represented in the Research Recruitment Registry slightly more than their proportion of all portal users (n = 194 775). Controlling for age, race, ethnicity, portal use, chronic disease burden, and other questionnaire use, women were statistically more likely to agree to join the Registry than men (odds ratio 1.17, 95% CI, 1.12-1.21). In contrast, Black males, Hispanics (of both sexes), and particularly Asians (both sexes) had low participation-to-population ratios; this under-representation persisted in the multivariable regression model. DISCUSSION: This supports the view that historical under-representation of women in clinical studies is likely due, at least in part, to implicit bias in offering participation. Distinguishing the mechanism for under-representation could help in designing strategies to improve study representation, leading to more effective evidence-based recommendations. CONCLUSION: Patient portals offer an attractive option for minimizing bias and encouraging broader, more representative participation in clinical research.

Children's surgery: a national survey of consultant clinical practice.

OBJECTIVES: To survey clinical practice and opinions of consultant surgeons and anaesthetists caring for children to inform the needs for training, commissioning and management of children's surgery in the UK. DESIGN: The National Confidential Enquiry into Patient Outcome and Death (NCEPOD) hosted an online survey to gather data on current clinical practice of UK consultant surgeons and anaesthetists caring for children. SETTING: The questionnaire was circulated to all hospitals and to Anaesthetic and Surgical Royal Colleges, and relevant specialist societies covering the UK and the Channel Islands and was mainly completed by consultants in District General Hospitals. PARTICIPANTS: 555 surgeons and 1561 anaesthetists completed the questionnaire. RESULTS: 32.6% of surgeons and 43.5% of anaesthetists considered that there were deficiencies in their hospital's facilities that potentially compromised delivery of a safe children's surgical service. Almost 10% of all consultants considered that their postgraduate training was insufficient for current paediatric practice and 20% felt that recent Continued Professional Development failed to maintain paediatric expertise. 45.4% of surgeons and 39.2% of anaesthetists considered that the current specialty curriculum should have a larger paediatric component. Consultants in non-specialist paediatric centres were prepared to care for younger children admitted for surgery as emergencies than those admitted electively. Many of the surgeons and anaesthetists had <4 h/week in paediatric practice. Only 55.3% of surgeons and 42.8% of anaesthetists participated in any form of regular multidisciplinary review of children undergoing surgery. CONCLUSIONS: There are significant obstacles to consultant surgeons and anaesthetists providing a competent surgical service for children. Postgraduate curricula must meet the needs of trainees who will be expected to include children in their caseload as consultants. Trusts must ensure appropriate support for consultants to maintain paediatric skills and provide the necessary facilities for a high-quality local surgical service.