ABSTRACT
BACKGROUND: The coronavirus disease 2019 pandemic imposed multiple restrictions on health care services. OBJECTIVE: To investigate the impact of the pandemic on Allergy & Immunology (A&I) services in the United Kingdom. METHODS: A national survey of all A&I services registered with the Royal College of Physicians and/or the British Society for Allergy and Clinical Immunology was carried out. The survey covered staffing, facilities, personal protective equipment, appointments & patient review, investigations, treatments, and research activity. Weeks commencing February 3, 2020 (pre-coronavirus disease), April 6, 2020, and May 8, 2020, were used as reference points for the data set. RESULTS: A total of 99 services participated. There was a reduction in nursing, medical, administrative, and allied health professional staff during the pandemic; 86% and 92% of A&I services continued to accept nonurgent and urgent referrals, respectively, during the pandemic. There were changes in immunoglobulin dose and infusion regimen in 67% and 14% of adult and pediatric services, respectively; 30% discontinued immunoglobulin replacement in some patients. There was a significant (all variables, P ≤ .0001) reduction in the following: face-to-face consultations (increase in telephone consultations), initiation of venom immunotherapy, sublingual and subcutaneous injection immunotherapy, anesthetic allergy testing, and hospital procedures (food challenges, immunoglobulin and omalizumab administration); and a significant increase (P ≤ .0001) in home therapy for immunoglobulin and omalizumab. Adverse clinical outcomes were reported, but none were serious. CONCLUSIONS: The pandemic had a significant impact on A&I services, leading to multiple unplanned pragmatic amendments in service delivery. There is an urgent need for prospective audits and strategic planning in the medium and long-term to achieve equitable, safe, and standardized health care.
Subject(s)
Allergy and Immunology/organization & administration , COVID-19/epidemiology , Delivery of Health Care , Pandemics , Pediatrics/organization & administration , SARS-CoV-2 , Adult , COVID-19/diagnosis , Child , Humans , Hypersensitivity/diagnosis , Hypersensitivity/therapy , State Medicine , Surveys and Questionnaires , United KingdomABSTRACT
We describe scalable and cost-efficient production of full length, His-tagged severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike glycoprotein trimer by Chinese hamster ovary (CHO) cells that can be used to detect SARS-CoV-2 antibodies in patient sera at high specificity and sensitivity. Transient production of spike in both human embryonic kidney (HEK) and CHO cells mediated by polyethyleneimine was increased significantly (up to 10.9-fold) by a reduction in culture temperature to 32°C to permit extended duration cultures. Based on these data GS-CHO pools stably producing spike trimer under the control of a strong synthetic promoter were cultured in hypothermic conditions with combinations of bioactive small molecules to increase yield of purified spike product 4.9-fold to 53 mg/L. Purification of recombinant spike by Ni-chelate affinity chromatography initially yielded a variety of co-eluting protein impurities identified as host cell derived by mass spectrometry, which were separated from spike trimer using a modified imidazole gradient elution. Purified CHO spike trimer antigen was used in enzyme-linked immunosorbent assay format to detect immunoglobulin G antibodies against SARS-CoV-2 in sera from patient cohorts previously tested for viral infection by polymerase chain reaction, including those who had displayed coronavirus disease 2019 (COVID-19) symptoms. The antibody assay, validated to ISO 15189 Medical Laboratories standards, exhibited a specificity of 100% and sensitivity of 92.3%. Our data show that CHO cells are a suitable host for the production of larger quantities of recombinant SARS-CoV-2 trimer which can be used as antigen for mass serological testing.