Real-world evaluation of the Lucira Check-It COVID-19 loop-mediated amplification (LAMP) test.

IMPORTANCE: In hospitals during the COVID-19 pandemic, laboratory testing was important to reduce SARS-CoV-2 transmissions, while facilitating patient flow in the emergency department and pre-operative settings, and allowing for the safe return to work of exposed healthcare workers. Delayed test results from laboratory nucleic acid amplification tests (NAATs) posed a barrier to maximizing efficient patient flow and minimizing staffing shortages. This quality improvement project sought to evaluate the analytical and clinical performance of the Lucira Check-It COVID-19 Test, a point-of-care test that used NAAT technology, in the perioperative setting, emergency department, and community testing sites. We found the Lucira Check-It to have comparable performance to laboratory NAATs. It can be employed with little training for specimen collection, processing, and interpretation, and at a cost justifiable from the resources saved from avoiding sample transport and laboratory testing.

Lyme Disease, Anaplasmosis, and Babesiosis, Atlantic Canada.

In July 2021, a PCR-confirmed case of locally acquired Babesia microti infection was reported in Atlantic Canada. Clinical features were consistent with babesiosis and resolved after treatment. In a region where Lyme disease and anaplasmosis are endemic, the occurrence of babesiosis emphasizes the need to enhance surveillance of tickborne infections.

Case finding and therapy for chronic viral hepatitis in primary care (HepFREE): a cluster-randomised controlled trial.

BACKGROUND: The prevalence of viral hepatitis (hepatitis B virus and hepatitis C virus) in migrants is higher than among the general population in many high-income countries. We aimed to determine whether incentivising and supporting primary-care physicians in areas with a high density of migrants increases the numbers of adult migrants screened for viral hepatitis. METHODS: HepFREE was a multicentre, open, cluster-randomised controlled trial in general practices in areas of the UK with a high density of migrants (Bradford, Yorkshire, and northeast and southeast London). Participants were adult patients (aged 18 years or older) in primary care, who had been identified as a first or second generation migrant from a high-risk country. General practices were randomly assigned (1:2:2:2:2) to an opportunistic screening (control) group or to one of four targeted screening (interventional) groups: standard (ie, hospital-based) care and a standard invitation letter; standard care and an enhanced invitation letter; community care and a standard invitation letter; or community care and an enhanced invitation letter. In control screening, general practitioners (GPs) were given a teaching session on viral hepatitis and were asked to test all registered migrants. In the intervention, GPs were paid a nominal sum for setting up searches of records, reimbursed for signed consent forms, and supported by a dedicated clinician. Patients who were eligible for testing and tested positive for viral hepatitis in the intervention groups were eligible to enrol in a second embedded trial of community versus hospital based care. The primary outcomes were the proportion of patients eligible for screening, the proportion of those eligible who were sent an invitation letter in the intervention groups, the uptake of viral hepatitis screening (in the intention-to-treat population), the proportion of patients who tested positive for viral hepatitis, the proportion who complied with treatment, and the cost-effectiveness of the intervention. This trial is registered with ISRCTN, number ISRCTN54828633. FINDINGS: Recruitment and testing ran from Oct 31, 2013, to Feb 4, 2017, and each practice recruited for 18 consecutive calendar months. We approached 70 general practices in three areas with a high density of migrants, of which 63 general practices agreed to participate. Five practices withdrew and 58 practices were randomly assigned: eight to control and 50 to an intervention. In control practices, 26 046 (38·4%) of 67 820 patients who were initially registered were eligible for testing, as were 152 321 (43·3%) of 351 710 patients in the interventional groups in London and Bradford. Of 51 773 randomly selected eligible patients in the intervention groups in London and Bradford, letters were sent to 43 585 (84·2%) patients. In the eight control general practices, screening was taken up by 543 (1·7%) of 31 738 eligible participants, which included 5692 newly registered patients. However, in the 50 general practices that used the intervention, screening was taken up by 11 386 (19·5%) of 58 512 eligible participants (including 6739 newly registered patients; incidence rate ratio 3·70, 95% CI 1·30-10·51; p=0·014) and this intervention was cost-effective. 720 (4·5%) of 15 844 patients who received a standard letter versus 1032 (3·7%) of 28 095 patients who received the enhanced letter were tested (0·70, 0·38-1·31; p=0·26). In the control group, 17 patients tested positive for viral hepatitis, as did 220 patients (one with a co-infection) in the intervention groups. In the embedded study, 220 patients were randomly assigned to either hospital-based care or community care; 80 (87·9%) of 91 patients in the hospital setting complied with treatment versus 105 (81·4%) of 129 patients in the community setting. The intervention was cost-effective at willingness to pay thresholds in excess of £8540. One serious adverse event (thyroiditis) was noted. INTERPRETATION: Screening migrants for viral hepatitis in primary care is effective if doctors are incentivised and supported. Community care is expensive and there is no evidence that this offers benefits in this setting or that bespoke invitation letters add value. We suggest that bespoke invitation letters should not be used, and we suggest that outreach, community-based services for migrants should not be developed. FUNDING: National Institute for Health Research.

Prediction of clinical peanut allergy status among children in Hamilton, Ontario using chart review data collected during 2012-2015.

BACKGROUND: Peanut sensitization does not necessarily indicate clinical peanut allergy, and uncertainty as to whether or not there is true peanut allergy can lead to increased anxiety and decreased quality of life for patients and their families. The gold standard for diagnosing clinical peanut allergy is the oral food challenge, but this method is time-consuming and can cause severe allergic reactions. It would therefore be beneficial to develop a tool for predicting clinical peanut allergy in peanut-sensitized individuals whose peanut allergy status is unknown so as to better determine who requires an oral food challenge for diagnosis. METHODS: Two separate studies were conducted. In Study 1, we recruited 100 participants from the allergy clinic at McMaster University and community allergy outpatient clinics in the greater Hamilton area. We examined 18 different variables from participants and used univariate and multivariable logistic regression analysis to determine how well these variables, singly and in combination, were able to predict clinical peanut allergy status. In Study 2, we conducted a retrospective chart review of a second cohort of 194 participants to investigate the reproducibility of our findings. This was a matched case-control study where 97 peanut-allergic participants were gender- and age-matched to 97 non-allergic control participants. RESULTS: Peanut skin prick test wheal size was the best predictor of clinical peanut allergy in both study cohorts. For every 1 mm increase in wheal size, the odds ratio of an individual having clinical peanut allergy was 2.36 in our first cohort and 4.85 in our second cohort. No other variable approached the predictive power of wheal size. CONCLUSIONS: Peanut skin prick test wheal size is a robust predictor of clinical peanut reactivity. The findings of this study may be useful in guiding clinician decision-making regarding peanut allergy diagnostics.

Immunization with chlamydial type III secretion antigens reduces vaginal shedding and prevents fallopian tube pathology following live C. muridarum challenge.

Chlamydia trachomatis infections in women are often asymptomatic and if left untreated can lead to significant late sequelae including pelvic inflammatory disease and tubal factor infertility. Vaccine development efforts over the past three decades have been unproductive and there is no vaccine approved for use in humans. The existence of serologically distinct strains or serovars of C. trachomatis mandates a vaccine that will provide protection against multiple serovars. Chlamydia spp. use a highly conserved type III secretion system (T3SS) composed of both structural and effector proteins which is an essential virulence factor for infection and intracellular replication. In this study we evaluated a novel fusion protein antigen (BD584) which consists of three T3SS proteins from C. trachomatis (CopB, CopD, and CT584) as a potential chlamydial vaccine candidate. Intranasal immunization with BD584 elicited serum neutralizing antibodies that inhibited C. trachomatis infection in vitro. Following intravaginal challenge with C. muridarum, immunized mice had a 95% reduction in chlamydial shedding from the vagina at the peak of infection and cleared the infection sooner than control mice. Immunization with BD584 also reduced the rate of hydrosalpinx by 87.5% compared to control mice. Together, these results suggest that highly conserved proteins of the chlamydial T3SS may represent good candidates for a Chlamydia vaccine.

Peptide Immunotherapy; short but long lasting?

Allergen immunotherapy (AIT) with whole allergens or allergen extracts has been in use for more than one hundred years. It is clinically efficacious and disease-modifying. However, AIT is also associated with a significant adverse events profile, including the potential to cause severe, systemic allergic reactions. One alternative to traditional whole-antigen AIT is peptide immunotherapy, which uses small synthetic peptide immunoregulatory epitopes (SPIRE) representing T cell epitopes from the allergen of interest. Peptide immunotherapy is being developed for the treatment of allergic and autoimmune diseases where pathogenesis is T cell-dependent. Short, soluble, monomeric peptide fragments avoid the problem of IgE-mediated adverse events (since the peptides will not cross-link allergen-specific IgE on the surface of effector cells such as mast cells and basophils). However, such peptides retain the capability to induce T cell tolerance and immunoregulation. In early clinical trials, efficacy has been demonstrated months to years after the cessation of a short course of treatment, supporting the conclusion that this approach is disease-modifying, changing the natural history of the disease. The improved safety profile of short peptides allows for larger molar-equivalent doses to be administered in shorter time frames than AIT; treatment can be completed in as few as four intradermal injections, while efficacy persists for two years or more.

The identification of eosinophilic gastroenteritis in prednisone-dependent eosinophilic bronchitis and asthma.

This case reports the unique association of eosinophilic gastrointestinal disease with eosinophilic bronchitis, asthma and chronic rhinosinusitis and some features of lymphocytic hypereosinophilic syndrome, describes a diagnostic protocol for patients with asthma and persistent eosinophilic bronchitis, and suggests that the use of a novel EPX-mAb provides a reliable method to identify eosinophilic inflammation.