Evaluation of Six Commercial Mid- to High-Volume Antibody and Six Point-of-Care Lateral Flow Assays for Detection of SARS-CoV-2 Antibodies.

Coronavirus disease (COVID) serological tests are essential to determine the overall seroprevalence of a population and to facilitate exposure estimates within that population. We performed a head-to-head assessment of enzyme immunoassays (EIAs) and point-of-care lateral flow assays (POCTs) to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies. Demographics, symptoms, comorbidities, treatment, and mortality of patients whose sera were used were also reviewed. Six EIAs (Abbott, Affinity, Bio-Rad, DiaSorin, Euroimmun, and Roche) and six POCTs (BTNX, Biolidics, Deep Blue, Genrui, Getein BioTech, and Innovita) were evaluated for the detection of SARS-CoV-2 antibodies in known COVID-19-infected individuals. Sensitivity of EIAs ranged from 50 to 100%, with only four assays having overall sensitivities of >95% after 21 days after symptom onset. Notably, cross-reactivity with other respiratory viruses (parainfluenza virus [PIV-4] [n = 5], human metapneumovirus [hMPV] [n = 3], rhinovirus/enterovirus [n = 1], CoV-229E [n = 2], CoV-NL63 [n = 2], and CoV-OC43 [n = 2]) was observed; however, overall specificity of EIAs was good (92 to 100%; all but one assay had specificity above 95%). POCTs were 0 to 100% sensitive >21 days after onset, with specificity ranging from 96 to 100%. However, many POCTs had faint banding and were often difficult to interpret. Serology assays can detect SARS-CoV-2 antibodies as early as 10 days after symptom onset. Serology assays vary in their sensitivity based on the marker (IgA/IgM versus IgG versus total) and by manufacturer; however, overall only 4 EIAs and 4 POCTs had sensitivities of >95% >21 days after symptom onset. Cross-reactivity with other seasonal coronaviruses is of concern. Serology assays should not be used for the diagnosis of acute infection but rather in carefully designed serosurveys to facilitate understanding of seroprevalence in a population and to identify previous exposure to SARS-CoV-2.

Diabetes specialist intervention in general practices in areas of deprivation and ethnic diversity: A qualitative evaluation (QUAL-ECLIPSE).

AIM: To assess patients' and healthcare professionals' perspectives of a specialist-led Diabetes Risk-based Assessment Clinic (DIRAC) for people with diabetes at high risk of complications (PWDHRC) in areas of deprivation in Coventry, UK. METHODS: A qualitative evaluation of a pilot trial, comprising a specialist team intervention (DIRAC), was undertaken in seven GP practices through observations of weekly virtual or occasional face-to-face patient consultations and monthly interventionists' meetings. Semi-structured interviews were carried out post-intervention, with PWDHRC, primary care clinicians and diabetes specialists (interventionists). Thematic analyses of observations and interviews were undertaken. KEY FINDINGS: Over 12 months, 28 DIRAC clinics comprising 154 patient consultations and five interventionists' meetings, were observed. 19 interviews were undertaken, PWDHRC experienced 'culturally-sensitive care from a specialist-led clinic intervention encompassing integrated care. This model of care was recommended at GP practice level, all participants (PWDHRC, primary care clinicians and diabetes specialist interventionists) felt upskilled to deal with complex diabetes care. The EMIS and ECLIPSE technologies utilised during the intervention were perceived to positively contribute to diabetes management of PWDHRC despite reservations around cost and database. CONCLUSION: The specialist-led DIRACs were largely appreciated by study participants. These qualitative data support the trial progressing to a full-service evaluation.