How to design and implement a university-based COVID-19 testing programme? An evaluation of a novel RT-LAMP COVID-19 testing programme in a UK university.

BACKGROUND: Little is known about how asymptomatic testing as a method to control transmission of COVID-19 can be implemented, and the prevalence of asymptomatic infection within university populations. The objective of this study was to investigate how to effectively set-up and implement a COVID-19 testing programme using novel reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) technology and to quantify the scale of asymptomatic infection on a university campus. METHODS: An observational study to describe the set-up and implementation of a novel COVID-19 testing programme on a UK university campus between September and December 2020. RT-LAMP testing was used to identify asymptomatic cases. RESULTS: A total of 1,673 tests were performed using RT-LAMP during the study period, of which 9 were positive for COVID-19, giving an overall positivity rate of 0.54%, equivalent to a rate in the tested population of 538 cases per 100,000 over the duration of testing. All positive tests were found to be positive on RT-PCR testing, giving a false positive rate of 0%. CONCLUSIONS: This study shows that it is possible to rapidly setup a universal university testing programme for COVID-19 in collaboration with local healthcare providers using RT-LAMP testing. Positive results were comparable to those in the local population, though with a different peak of infection. Further research to inform the design of the testing programme includes focus groups of those who underwent testing and further interrogation of the demographics of those opting to be tested to identify potential access problems or inequalities.

A rapid RT-LAMP SARS-CoV-2 screening assay for collapsing asymptomatic COVID-19 transmission.

PURPOSE: To demonstrate the diagnostic performance of rapid SARS-CoV-2 RT-LAMP assays, comparing the performance of genomic versus sub-genomic sequence target with subsequent application in an asymptomatic screening population. METHODS: RT-LAMP diagnostic specificity (DSe) and sensitivity (DSe) was determined using 114 RT-PCR clinically positive and 88 RT-PCR clinically negative swab samples processed through the diagnostic RT-PCR service within the University Hospitals of Leicester NHS Trust. A swab-based RT-LAMP SARS-CoV-2 screening programme was subsequently made available to all staff and students at the University of Leicester (Autumn 2020), implemented to ISO 15189:2012 standards using NHS IT infrastructure and supported by University Hospital Leicester via confirmatory NHS diagnostic laboratory testing of RT-LAMP 'positive' samples. RESULTS: Validation samples reporting a Ct < 20 were detected at 100% DSe and DSp, reducing to 95% DSe (100% DSp) for all samples reporting a Ct < 30 (both genomic dual sub-genomic assays). Advisory screening identified nine positive cases in 1680 symptom free individuals (equivalent to 540 cases per 100,000) with results reported back to participants and feed into national statistics within 48 hours. CONCLUSION: This work demonstrates the utility of a rapid RT-LAMP assay for collapsing transmission of SARS-CoV-2 in an asymptomatic screening population.

Design and implementation of a university-based COVID-19 testing programme: an observational study

Background Little is known about how asymptomatic testing as a method to control the transmission of COVID-19 can be successfully implemented, and the prevalence of asymptomatic infection within university populations. The aim of this study was to describe the methodology of implementing a novel asymptomatic mass testing programme, and to report the number of positive cases diagnosed during the study period. To our knowledge, this study is the first to report prevalence of asymptomatic COVID-19 infection within a UK university population using reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) as a molecular diagnostic tool. Methods An observational study was undertaken to describe the set-up and implementation of a novel COVID-19 testing programme on a UK university campus between Sept 28 and Dec 18, 2020. Students and staff members volunteered for testing throughout the term. The programme used RT-LAMP testing to identify asymptomatic cases within the population. Any positive cases received RT-PCR testing to confirm the result using the current gold-standard testing methodology. Findings 1673 tests were done using RT-LAMP during the study period, of which nine were positive for COVID-19. This gave an overall positivity rate of 0·54%, equivalent to a rate in the tested population of 538 cases per 100 000 over the duration of testing. All positive tests were also found to be positive on RT-PCR testing, giving a false positive rate of 0%. Uptake was affected by changes to delivery of university teaching, leading to lower attendance on campus throughout the term. Interpretation This study shows that it is possible to rapidly set up a universal university testing programme for COVID-19 in collaboration with local health-care providers using RT-LAMP testing, with full concordance between RT-LAMP testing and RT-PCR testing on positive RT-LAMP results. Positive results were similar to those in the local population, although with a different weekly peak of infection. Funding None.

Association of maternal lipid profile and gestational diabetes mellitus: A systematic review and meta-analysis of 292 studies and 97,880 women.

BACKGROUND: Gestational Diabetes Mellitus (GDM) is the most prevalent metabolic disorder during pregnancy, however, the association between dyslipidaemia and GDM remains unclear. METHODS: We searched Medline, Scopus, Web of Science, Cochrane, Maternity and Infant Care database (MIDIRS) and ClinicalTrials.gov up to February 2021 for relevant studies which reported on the circulating lipid profile during pregnancy, in women with and without GDM. Publications describing original data with at least one raw lipid [triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), or very low-density lipoprotein cholesterol (VLDL-C)] measurement were retained. Data extraction was performed using a piloted data extraction form. The protocol was registered with PROSPERO (CRD42019139696). FINDINGS: A total of 292 studies, comprising of 97,880 pregnant women (28232 GDM and 69,648 controls) were included. Using random-effects meta-analysis models to pool study estimates, women with GDM had significantly higher (by 20%) TG levels, with a pooled weighted mean difference between GDM and non-GDM pregnancies of 0.388 mM (0.336, 0.439, p < 0.001). Further analyses revealed elevated TG levels occur in the first trimester and persist afterwards. Meta-regression analyses showed that differences in TG levels between women with GDM and healthy controls were significantly associated with age, BMI, study continent, OGTT procedure, and GDM diagnosis criteria. INTERPRETATION: Elevated lipids, particularly, TG, are associated with GDM.

Management of a delivery suite during the COVID-19 epidemic.

BACKGROUND: Since the first report of the new coronavirus (COVID-19) infection in December of 2019, it has become rapidly prevalent and been declared as a Public Health Emergency of International Concern by the World Health Organization. There are quite a few cases reported involving delivery with COVID-19 infection, but little valuable suggestion was provided about what healthcare providers of obstetrics and neonatology should do in their clinic practice for unknown status or presumed negative women. Here, we summarized the current practice of delivery management in China that successfully prevented rapid increase in adverse pregnancy outcomes and nosocomial infection in departments of obstetrics and neonatology during the pandemic of COVID-19.