"It's Everybody's and It's Nobody's Responsibility": Stakeholder Perspectives on Aboriginal and Torres Strait Islander Health Equity at the Nexus of Chronic Kidney Disease and Oral Health.

INTRODUCTION: The effects of racism, oppression, and colonization in Australia are reflected in the inequitable experience of chronic kidney disease (CKD) among Aboriginal and Torres Strait Islander peoples. Despite having the highest incidence of CKD, Aboriginal and Torres Strait Islander people have the lowest rate of kidney transplant, with poor oral health commonly being an obstacle to receiving a transplant. This research reflects the exploratory phase of a larger project aimed at maximizing oral health outcomes for Aboriginal and Torres Strait Islander people living with CKD in Australia through the provision of culturally secure dental care. METHODS: The present research uses reflexive thematic analysis to analyze qualitative data from yarns, interviews, and focus groups with dental, renal, and Aboriginal and Torres Strait Islander stakeholders to generate a conceptual understanding of equity at the nexus of oral health and kidney health. NVivo software was used for organizing data and an inductive line-by-line coding approach. RESULTS: Twenty-eight stakeholders participated; 12 of the stakeholders identified as Aboriginal and/or Torres Strait Islander, and most were female. Factors at the nexus of oral health and CKD included the continuous effects of colonization, the centrality of cultural security for improved care, as well as several challenges and opportunities at a system level. Challenges included the luxury of oral health access, limited health care team involvement in oral health pathways, high-intensity engagement with medical systems, and no communication between dental and renal teams. Opportunities identified included the role of integrated care, cross-discipline knowledge sharing, Aboriginal and Torres Strait Islander leadership, clear referral pathways, prevention, and assistance with navigating the oral health system. CONCLUSION: We argue that collective responsibility for the oral health of Aboriginal and Torres Strait Islander people living with CKD is required for improved health and eligibility for kidney transplant. Cross-discipline collaboration is required to overcome the rigidness of the current colonial and biomedical model that silos oral health and CKD. KNOWLEDGE TRANSFER STATEMENT: The siloed approach to management of oral health for Aboriginal and Torres Strait Islander peoples with chronic kidney disease results in low knowledge sharing and communication across chronic disease management teams and can prevent kidney transplantation. Collective responsibility for oral health within this context is required to ensure that just and equitable access to kidney transplant can be achieved.

Amivantamab plus lazertinib versus osimertinib in first-line EGFR-mutant advanced non-small-cell lung cancer with biomarkers of high-risk disease: a secondary analysis from MARIPOSA.

BACKGROUND: Amivantamab-lazertinib significantly prolonged progression-free survival (PFS) versus osimertinib in patients with epidermal growth factor receptor (EGFR)-mutant advanced non-small-cell lung cancer [NSCLC; hazard ratio (HR) 0.70; P < 0.001], including those with a history of brain metastases (HR 0.69). Patients with TP53 co-mutations, detectable circulating tumor DNA (ctDNA), baseline liver metastases, and those without ctDNA clearance on treatment have poor prognoses. We evaluated outcomes in these high-risk subgroups. PATIENTS AND METHODS: This analysis included patients with treatment-naive, EGFR-mutant advanced NSCLC randomized to amivantamab-lazertinib (n = 429) or osimertinib (n = 429) in MARIPOSA. Pathogenic alterations were identified by next-generation sequencing (NGS) of baseline blood ctDNA with Guardant360 CDx. Ex19del and L858R ctDNA in blood was analyzed at baseline and cycle 3 day 1 (C3D1) with Biodesix droplet digital polymerase chain reaction (ddPCR). RESULTS: Baseline ctDNA for NGS of pathogenic alterations was available for 636 patients (amivantamab-lazertinib, n = 320; osimertinib, n = 316). Amivantamab-lazertinib improved median PFS (mPFS) versus osimertinib for patients with TP53 co-mutations {18.2 versus 12.9 months; HR 0.65 [95% confidence interval (CI) 0.48-0.87]; P = 0.003} and for patients with wild-type TP53 [22.1 versus 19.9 months; HR 0.75 (95% CI 0.52-1.07)]. In patients with EGFR-mutant, ddPCR-detectable baseline ctDNA, amivantamab-lazertinib significantly prolonged mPFS versus osimertinib [20.3 versus 14.8 months; HR 0.68 (95% CI 0.53-0.86); P = 0.002]. Amivantamab-lazertinib significantly improved mPFS versus osimertinib in patients without ctDNA clearance at C3D1 [16.5 versus 9.1 months; HR 0.49 (95% CI 0.27-0.87); P = 0.015] and with clearance [24.0 versus 16.5 months; HR 0.64 (95% CI 0.48-0.87); P = 0.004]. Amivantamab-lazertinib significantly prolonged mPFS versus osimertinib among randomized patients with [18.2 versus 11.0 months; HR 0.58 (95% CI 0.37-0.91); P = 0.017] and without baseline liver metastases [24.0 versus 18.3 months; HR 0.74 (95% CI 0.60-0.91); P = 0.004]. CONCLUSIONS: Amivantamab-lazertinib effectively overcomes the effect of high-risk features and represents a promising new standard of care for patients with EGFR-mutant advanced NSCLC.

Lip, oral and oropharyngeal cancer incidence among Aboriginal and Torres Strait Islander Peoples: First report from Australian population-based cancer registry, 1999-2018.

BACKGROUND: The Australian Burden of Disease Study has shown that cancer is the single most important entity responsible for the greatest cause of health burden in Australia. Unfortunately, Aboriginal and Torres Strait Islander peoples experience a greater burden of this disease, with cancer of the lung, breast, bowel and prostrate being the most common. Lip, oral cavity and pharyngeal cancer incidence is rapidly rising globally and is now the sixth most common cancer in Australia. This paper aims to summarize, for the first time, the incidence and prevalence trends of lip, oral cavity and pharyngeal cancers in Aboriginal and Torres Strait Islander Australians. METHODS: Data were obtained from the Australian Cancer Database (ACD), which is compiled at the Australian Institute of Health and Welfare (AIHW) from 1999 to 2018 to estimate the incidence and prevalence of certain head and neck cancers (ICD-10 codes C00-C10, C14). The other variables requested were age groups and sex. RESULTS: Results were stratified by ICD-10 code, sex and age group at diagnosis and time period (i.e. grouped years of diagnosis). The total incidence of lip, oral cavity and pharyngeal cancers increased by 1.3 times from 1999 to 2008 (107/100 000) to 2009-2018 (135/100 000). The overall 5-year prevalence of lip, oral cavity and pharyngeal cancers was 0.17% (0.24% for men and 0.09% for women). CONCLUSIONS: The significantly increased incidence of lip, oral cavity and pharyngeal cancers in Aboriginal and Torres Strait Islander peoples in Australia is concerning and should be explored. A targeted, comprehensive and culturally safe model of care for Aboriginal and Torres Strait Islander peoples with lip, oral cavity and pharyngeal cancers is imperative.

Neonatal AKI: An update.

Neonatal acute kidney injury (AKI) is a common complication, especially in the neonatal intensive care unit, that is associated with long term consequences and poor outcomes. Early detection and treatment is critical. Currently, neonatal AKI is defined with urinary markers and serum creatinine, with limitations on early detection and individual treatment. There have been numerous biomarkers and risk factor scores that have been studied for their ability to predict neonatal AKI. To move towards personalized medicine, neonatal AKI must be categorized into phenotypes and subphenotypes that fully encapsulate the diverse causes and specific treatments. This review aims to advance our understanding of neonatal AKI detection through the use of biomarkers, subphenotypes, and phenotypes to move towards personalized treatment strategies.

The role of hyperbaric oxygen in osteoradionecrosis-a prophylactic insight.

BACKGROUND: Osteoradionecrosis (ORN) is an uncommon and debilitating consequence of head and neck radiotherapy and hyperbaric oxygen therapy (HBOT) has been advocated for prophylaxis prior to performing dentoalveolar procedures. The aim of this study was to evaluate a prophylactic HBOT protocol and describe the outcomes of susceptible individuals. METHODS: A retrospective audit of adults who attended the Oral and Maxillofacial Surgery department at the Royal Adelaide Hospital (South Australia) who received dental extractions with a history of radiotherapy to the jaws from 2008 to 2020. Data including demographic information and outcomes of osteoradionecrosis and delayed healing was recorded. RESULTS: A total of 121 individuals were eligible for case note review; 68.6% of individuals were male and 55.4% were aged over 67 years. Osteoradionecrosis occurred in 9.1% of individuals and delayed healing for 3.3%; fifteen individuals (12.4%) were unable to complete the HBOT protocol. The individuals who were diagnosed with ORN had a significant association with age (P = 0.006) and binary analysis showed alcohol consumption to be a significant predictor. CONCLUSIONS: Prophylactic HBOT protocol had a lower proportion of individuals diagnosed with ORN and those who were diagnosed were more likely to be younger males and have current alcohol consumption.

The impact of enzyme replacement therapy on the oral health manifestations of hypophosphatasia among children: a scoping review.

PURPOSE: A scoping review to describe the use of enzyme replacement therapy (ERT) in the form of asfotase alfa to decrease the severity of oral manifestations in children with hypophosphatasia (HPP). METHODS: Six databases were searched using keywords and index terms related to "hypophosphatasia," "children," and "enzyme replacement therapy." Duplicates were removed and two independent reviewers screened the titles and abstracts to identify articles for full-text review. Extracted data was summarised narratively. RESULTS: The systematic search identified 3548 articles, with 171 suitable for full-text review and a final 22 that met inclusion criteria. Enzyme replacement therapy generally resulted in a reduction in the presence and severity of oral manifestations of HPP. However, numerous studies failed to report specific details regarding the nature of oral health outcomes and there were reported cases of further loss of primary teeth. CONCLUSIONS: The available evidence suggests that that ERT in the form of asfotase alfa for HPP in infants and young children leads to improved oral health outcomes. It is recommended that the outcomes are improved with earlier initiation of ERT. Further, well-designed clinical research is required to assess oral health improvements and decreased morbidity associated with the early loss of teeth.

Advertising and general dental practice: how compliant are practice websites in Australia with legal requirements?

BACKGROUND: The Australian Health Practitioner Regulation Agency (AHPRA) requires general dental practitioners (GDPs) to agree to regulatory advertising guidelines on initial registration and annual renewal. The aim of this study was to determine the compliance of GDPs websites to these requirements. METHODS: A representative sample of GDPs websites from each state and territory in Australia was based on the total AHPRA registrant distribution. Assessment of compliance was used across five domains consisting of 17 criteria related to AHPRA's advertising of regulated health services guidelines, as well as section 133 of the National Law. Inter-rater reliability was estimated using Fleiss's Kappa. RESULTS: One hundred and ninety-two GDPs websites were reviewed with 85% non-compliant with at least one of the legal and regulatory requirements relating to advertising. Of these websites, 52% displayed false and misleading information, 12.8% had offers and inducement without clear terms and conditions, 11.5% used written testimonials, 33.9% created unrealistic expectation of benefit and 39.6% encouraged indiscriminate and unnecessary use of health services. CONCLUSIONS: More than 85% of GDP websites in Australia did not comply with legal and regulatory requirements related to advertising. A multi-stakeholder approach involving AHPRA, professional dental bodies and dental registrants is necessary to improve compliance.

Molar-incisor hypomineralisation prevalence in a cohort of Australian children with type 1 diabetes.

PURPOSE: Systemic diseases or drugs administered early in life may cause a disruption in amelogenesis and contribute to the qualitative defect of enamel described as molar-incisor hypomineralisation (MIH). Therefore, an increase in prevalence of MIH in children with type 1 diabetes (T1D) may be expected as this systemic disorder is commonly diagnosed in early childhood. The aim of this study was to determine the prevalence of MIH in a cohort of children with T1D and investigate diagnosis of MIH with T1D factors. METHODS: Cross-sectional study of children with T1D recruited from paediatric diabetes clinics at the Women's and Children's Hospital (South Australia). A detailed medical history, comprehensive dental and MIH examination according to the European Academy of Paediatric Dentistry (EAPD) long form classification was collected for each child. All upper and lower first permanent molars and central incisors were scored. RESULTS: A total number of 73 participants; 35 (47.95%) males were examined including 584 teeth. The mean age of the participants was 13.25 ± 2.58 years, with a mean age of diagnosis 7.75 ± 3.58 years, and a mean HbA1c of 8.5 ± 1.6%. 42 out of 73 children (54.8%) had enamel defects on at least one of the teeth examined. However, 19.2% met the criteria for MIH. Univariate and bivariate analyses were conducted but no significant associations were noted between MIH and risk factors including diabetes control (p > 0.1). CONCLUSION: There was a high prevalence of enamel defects and MIH amongst children with T1D. More research is required to establish association between T1D and MIH.

Quantifying Brain Iron in Hereditary Hemochromatosis Using R2* and Susceptibility Mapping.

BACKGROUND AND PURPOSE: Brain iron dyshomeostasis is increasingly recognized as an important contributor to neurodegeneration. Hereditary hemochromatosis is the most commonly inherited disorder of systemic iron overload. Although there is an increasing interest in excessive brain iron deposition, there is a paucity of evidence showing changes in brain iron exceeding that in healthy controls. Quantitative susceptibility mapping and R2* mapping are established MR imaging techniques that we used to noninvasively quantify brain iron in subjects with hereditary hemochromatosis. MATERIALS AND METHODS: Fifty-two patients with hereditary hemochromatosis and 47 age- and sex-matched healthy controls were imaged using a multiecho gradient-echo sequence at 3T. Quantitative susceptibility mapping and R2* data were generated, and regions within the deep gray matter were manually segmented. Mean susceptibility and R2* relaxation rates were calculated for each region, and iron content was compared between the groups. RESULTS: We noted elevated iron levels in patients with hereditary hemochromatosis compared with healthy controls using both R2* and QSM methods in the caudate nucleus, putamen, pulvinar thalamus, red nucleus, and dentate nucleus. Additionally, the substantia nigra showed increased susceptibility while the thalamus showed an increased R2* relaxation rate compared with healthy controls, respectively. CONCLUSIONS: Both quantitative susceptibility mapping and R2* showed abnormal levels of brain iron in subjects with hereditary hemochromatosis compared with controls. Quantitative susceptibility mapping and R2* can be acquired in a single MR imaging sequence and are complementary in quantifying deep gray matter iron.

Tuberculous meningitis in the elderly.

OBJECTIVE: Although the elderly population remains at high risk for tuberculosis, studies addressing tuberculous meningitis (TBM) in this age group are scarce. The present study aimed to evaluate the spectrum and outcome of geriatric TBM and document differences between older and young patients. METHODS: A prospective cohort study was conducted in the adult TBM patients admitted at PGIMER, Chandigarh (India). Consecutive older patients aged 60 years and above were enrolled from January 2019 to December 2020, and young adults aged 18-59 years were enrolled from July 2019 to December 2019. RESULTS: Fifty-five older patients with a mean age of 66.6 years and 73 young patients with a mean age of 35.1 years were enrolled. At admission, older patients were more likely to have altered mental status (96.4% vs. 78.1%, P = 0.003) and advanced disease with British medical research council staging 2 or 3 (98.2% vs. 89.0%, P = 0.043); however, headache (38.2% vs. 67.1%, P = 0.001), vomiting (18.2% vs. 35.6%, P = 0.030) and fever (80.0% vs. 91.8%, P = 0.052) were less common. Cerebrospinal fluid (CSF) abnormalities were less marked in older patients, with a significant difference in median total cells (70 vs. 110/µl, P = 0.013). Hydrocephalous and infarct were common neuroimaging abnormalities in both groups; however, tuberculomas were significantly less in the elderly (15.1% vs. 35.2%, P = 0.012). Older patients had a significantly low survival rate (56.4% vs. 76.7%, P = 0.021). CONCLUSION: Significant differences in clinical, CSF and radiological characteristics exist between elderly and young TBM patients, with survival remains dismal in the elderly.

Diagnostic accuracy of TB-LAMP assay in patients with pulmonary tuberculosis...a case-control study in northern India.

SETTING: A tertiary care hospital in North India. OBJECTIVE: Tuberculosis (TB) remains a major public health problem in developing countries. The diagnosis of tuberculosis is still challenging in primary care settings in endemic countries like India. WHO has endorsed loop mediated isothermal amplification assay (LAMP) for TB as a replacement for smear microscopy for peripheral settings, however, more data is required to establish the specificity of this modality for the diagnosis of TB. In this study we aim to determine the diagnostic accuracy of the TB-LAMP assay in pulmonary tuberculosis. DESIGN: A total of 236 patients (117 cases suspected of TB and 119 patients with non-TB pulmonary disease) were enrolled between February to July, 2018. Microbiological workups consisting of mycobacterial smear microscopy, culture, Xpert MTB/Rif and TB-LAMP were performed. RESULTS: From 236 samples, 18 (7.6%) were excluded from the study. TB-LAMP and Xpert MTB/RIF were positive in 46 (21.1%) and 49 (22.5%) of the samples, respectively. The sensitivity of Xpert MTB/RIF and TB-LAMP, when culture was taken as a reference standard, was 90% (95%CI: 78.2-96.7) and 82% (95%CI: 68.6...91.4), respectively. The specificity, positive predictive value (PPV), and negative predictive value (NPV) of TB-LAMP assay were 96.8% (95%CI: 92.8...98.9), 89.1% (95%CI: 77.4...95.2), and 94.4% (95%CI: 90.4...96.5), respectively. CONCLUSION: The TB-LAMP assay showed a good specificity and sensitivity for detection ofM. tuberculosis in adults, however, for programmatic implementation, more studies are required to be conducted at peripheral level healthcare settings.

EUGLYCEMIC DIABETIC KETOACIDOSIS (EDKA) IN A PATIENT RECEIVING DAPAGLIFLOZIN.

SGLT-2 inhibitors have gained importance in recent years because of their cardio-protective and reno-protective properties in diabetes. SGLT-2 inhibitors, when introduced in diabetic patients, may cause euglycemic diabetic ketoacidosis. A 55-year-old woman presented with low-grade fever, vomiting, and lethargy. She was started on dapagliflozin two years back. On workup, she was diagnosed with euglycemic diabetic ketoacidosis (EDKA) and was managed accordingly. She improved clinically while her dapagliflozin was stopped. With a literature search, we have identified 15 case reports of EDKA with dapagliflozin since 2015. There are no standard guidelines regarding the monitoring of patients for this rare but potentially morbid complication. Moreover, the exact mechanism for this is unknown. Various precipitating factors are linked with SGLT-2 inhibitors in promoting EDKA. We recommend that customary plans should comprise educating the patient about this rare complication before commencing medication, close follow-up with serial electrolyte monitoring, and discontinuing medications in the state of infection, dehydration and recent surgery and serious illness requiring hospitalization.

HLA Desensitization Based on Results of the Luminex Technique in Kidney Transplant - A Single-center Experience.

BACKGROUND: There is little experience of human leucocyte antigen (HLA) desensitization in India based on the Luminex single-antigen bead (SAB) testing. We retrospectively analyzed our patients, who underwent HLA desensitization based on Luminex SAB results. METHOD: Between 2014 and 2018, patients with complement-dependent cytotoxicity cross-match (CDC-XM) negativity but flow cytometry crossmatch (FC-XM) positivity were further analyzed with Luminex SAB for donor-specific antibodies (DSAs). A total of 12 patients who had DSA mean fluorescent intensity (MFI) of >1000 and <10,000 were included in the study. Our protocol for desensitization consisted of plasmapheresis (PP) followed by low dose intravenous immunoglobulin (IV IG) 100 mg/kg and induction with antithymocyte globulin (ATG). Patients were taken for transplant when either MFI was <1000 and/or FC-XM was negative. RESULTS: All 12 patients were first transplant and 10 had a history of some sensitizing event; pregnancy in 4, blood transfusions in 4, and both in 2 patients. FC-XM was positive for T-cell in 4, B-cell in 6, and both in 2 patients. On evaluation by Luminex SAB, 6 patients had MFI from 1000 to 2000, and 6 had MFI of >2000. All underwent desensitization successfully. Two patients had an increase in posttransplant DSA titers requiring posttransplant PP. The mean follow-up was 26.6 ± 13.9 months. On follow-up, only one patient developed acute T cell-mediated rejection 1 year after transplant, which responded to pulse steroids. There was no graft or patient loss until the last follow-up. CONCLUSION: This study shows that HLA desensitization is feasible and successful in the Indian setting if patients are properly selected.

Association of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium and Ureaplasma species infection and organism load with cervicitis in north Indian population.

Cervicitis is predominantly caused by Neisseria gonorrhoeae and Chlamydia trachomatis, which accounts for almost half of all the cases of cervicitis. The role of newer organisms like Mycoplasma genitalium and Ureaplasma sp. and association of bacterial load with cervicitis are also not well established. So the study aimed to determine the relative frequency of these organisms and their load in association with cervicitis cases from north India. A case-control study involving 300 women was conducted using quantitative real-time PCR from endocervical swabs for identification of organisms and quantification of bacterial load. Among 150 cervicitis cases, C. trachomatis, N. gonorrhoeae, M. genitalium and Ureaplasma parvum were detected in 5 (3·3%), 10 (6·6%), 37(24·6%) and 47 (31·3%) respectively. Old age (<0·001, chi-squared test) and irregular menstrual cycles (<0·001, chi-squared test) were significantly associated with cervicitis. M genitalium was the only organism to be associated significantly with cervicitis with regard to age (<0·031) and symptoms like discharge (P < 0·033, chi-squared test) and dysuria (P < 0·044, chi-squared test) in multivariate analysis. Our finding suggests that the bacterial load of these organisms is not significantly associated with cervicitis. However, we found significant association of M. genitalium infection with clinical characteristics of cervicitis cases.

Subcutaneous emphysema and pneumomediastinum in patients with COVID-19 disease; case series from a tertiary care hospital in Pakistan.

Since December 2019, the clinical symptoms of coronavirus disease 2019 (COVID-19) and its complications are evolving. As the number of COVID patients requiring positive pressure ventilation is increasing, so is the incidence of subcutaneous emphysema (SE). We report 10 patients of COVID-19, with SE and pneumomediastinum. The mean age of the patients was 59 ± 8 years (range, 23-75). Majority of them were men (80%), and common symptoms were dyspnoea (100%), fever (80%) and cough (80%). None of them had any underlying lung disorder. All patients had acute respiratory distress syndrome on admission, with a median PaO2/FiO2 ratio of 122.5. Eight out of ten patients had spontaneous pneumomediastinum on their initial chest x-ray in the emergency department. The median duration of assisted ventilation before the development of SE was 5.5 days (interquartile range, 5-10 days). The highest positive end-expiratory pressure (PEEP) was 10 cmH2O for patients recieving invasive mechanical ventilation, while 8 cmH2O was the average PEEP in patients who had developed subcutaneous emphysema on non-invasive ventilation. All patients received corticosteroids while six also received tocilizumab, and seven received convalescent plasma therapy, respectively. Seven patients died during their hospital stay. All patients either survivor or non-survivor had prolonged hospital stay with an average of 14 days (range 8-25 days). Our findings suggest that it is lung damage secondary to inflammatory response due to COVID-19 triggered by the use of positive pressure ventilation which resulted in this complication. We conclude that the development of spontaneous pneumomediastinum and SE whenever present, is associated with poor outcome in critically ill COVID-19 ARDS patients.

Diagnostic accuracy of Xpert MTB/RIF ultra for detection of Mycobacterium tuberculosis in children: a prospective cohort study.

The Xpert MTB/RIF Ultra is a recent advancement in molecular diagnostics of tuberculosis (TB) with higher sensitivity compared to its predecessor, the Xpert MTB/RIF assay. Prospective studies evaluating the performance of Xpert MTB/RIF Ultra in children with suspected TB are lacking. In this study, we evaluated the Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis in samples from 156 children, of which one was excluded from the analysis. Of the remaining 155 samples, 6·5% (10/155), 21·3% (33/155), 20% (31/155) and 21·9% (34/155) were positive by smear examination, MGIT culture, Xpert MTB/RIF and Xpert MTB/RIF Ultra, respectively. The Xpert MTB/RIF and Xpert MTB/RIF Ultra had a similar overall sensitivity of 81·8% (95% CI: 64·5-93) and 84·8% (95% CI: 68·1-94·9), respectively. In suspected pediatric TB patients, the Xpert MTB/RIF Ultra had higher sensitivity compared to the Xpert MTB/RIF (72·7 vs 63·6). The AUC (area under the curve) of 0·905 for the Xpert MTB/RIF and 0·893 for the Xpert MTB/RIF Ultra indicate similar and good overall performance. Both Xpert assays were found to be equally efficient, however Xpert MTB/RIF Ultra showed better detection rate in suspected TB cases.

Clinical evaluation of serological IgG antibody response on the Abbott Architect for established SARS-CoV-2 infection.

OBJECTIVE: This study aimed to evaluate the diagnostic performance of the Abbott Architect SARS-CoV-2 IgG assay in COVID-19 patients. METHODS: Residual sera from 177 symptomatic SARS-CoV-2-positive patients and 163 non-COVID-19 patients were tested for antibody with the Abbott SARS-CoV-2 IgG assay (Abbott Diagnostics, Chicago, USA). Clinical records for COVID-19 patients were reviewed to determine the time from onset of clinical illness to testing. RESULTS: Specificity of the assay was 100.0% (95%CI: 97.1-100.0%). The clinical sensitivity of the assay varied depending on time from onset of symptoms, increasing with longer periods from the onset of clinical illness. The clinical sensitivity at ≤6 days was 8.6% (7/81; 95%CI: 3.8-17.5%), at 7-13 days 43.6% (17/39; 95%CI: 28.2-60.2%), at 14-20 days 84.0% (21/25; 95%CI: 63.1-94.7%), and at ≥21 days 84.4% (27/32; 95%CI: 66.5-94.1%). Clinical sensitivity was higher in the ≥14-day group compared to <14 days. There were no differences between the 14-20-day and ≥21-days groups; the combined clinical sensitivity for these groups (≥14 days) was 84.2% (49/57; 71.6-92.1%). CONCLUSION: The Abbott SARS-CoV-2 IgG test has high specificity. Clinical sensitivity was limited in the early stages of disease but improved from 14 days after the onset of clinical symptoms.

Hospitalization due to community-acquired pneumonia in patients with chronic obstructive pulmonary disease: incidence, epidemiology and outcomes.

OBJECTIVES: Community-acquired pneumonia (CAP) is an important complication in patients with chronic obstructive pulmonary disease (COPD). This study aimed to define incidence, and outcomes of COPD patients hospitalized with pneumonia in the city of Louisville, and to estimate the burden of disease in the US population. METHODS: This was a secondary analysis of a prospective population-based cohort study of residents in Louisville, Kentucky, 40 years old and older, from 1 June 2014 to 31 May 2016. All adults hospitalized with CAP were enrolled. The annual incidence of pneumonia in COPD patients in Louisville was calculated and the total number of adults with COPD hospitalized in the United States was estimated. Clinical outcomes included time to clinical stability (TCS), length of hospital stay (LOS) and mortality. RESULTS: From a Louisville population of 18 246 patients with COPD, 3419 pneumonia hospitalizations were documented during the 2-year study. The annual incidence was 9369 patients with pneumonia per 100 000 COPD population, corresponding to an estimated 506 953 adults with COPD hospitalized due to pneumonia in the United States. The incidence of CAP in patients without COPD was 509 (95% CI 485-533) per 100 000. COPD patients had a median (interquartile range) TCS and LOS of 2 (1-4) and 5 (3-9) days respectively. The mortality of COPD patients during hospitalization, at 30 days, 6 months and 1 year was 193 of 3419 (5.6%), 400 of 3374 (11.9%), 816 of 3363 (24.3%) and 1104 of 3349 (33.0%), respectively. CONCLUSIONS: There was an annual incidence of 9369 cases of hospitalized CAP per 100 000 COPD patients in the city of Louisville. This was an approximately 18-fold greater incidence of CAP in COPD patients than in those without COPD.

Loop mediated isothermal amplification assay for detection of Trichomonas vaginalis in vaginal swabs among symptomatic women from North India.

Trichomonas vaginalis is one of the most common curable sexually transmitted pathogens infecting both men and women worldwide. Unlike traditional methods such as microscopy and culture, nucleic acid amplification tests rapidly detect this agent, assisting in treatment. Conventional polymerase chain reaction (PCR), the loop-mediated isothermal amplification (LAMP), and the Xpert TV assay were evaluated using 28 microscopy positive T. vaginalis samples and 125 microscopy negative samples from symptomatic females of reproductive age. The sensitivity of all tests was 100% and the specificity was 100%, 100%, and 99·2% for PCR, Xpert TV, and LAMP, respectively. The inter-rater reliability was excellent for PCR: Xpert TV (kappa-coefficient = 1) and good for LAMP assay: Xpert TV/PCR (kappa-coefficient = 0·98) and conventional PCR: LAMP (kappa-coefficient = 0·98). The study highlights the importance of PCR for screening T. vaginalis in women, particularly in laboratories where the Xpert-TV assay is not available or not affordable. The LAMP assay showed a lower positive predictive value which merits further evaluation. SIGNIFICANCE AND IMPACT OF THE STUDY: Trichomonas vaginalis is a common sexually transmitted pathogen associated with considerable morbidity and risk of complications. Due to the limitations of traditional diagnostic modalities, three molecular assays were compared: conventional polymerase chain reaction (PCR), Xpert TV assay, and loop mediated isothermal amplification (LAMP) assay for detecting T. vaginalis in symptomatic females. All tests had a sensitivity of 100% and the inter-rater reliability was excellent for PCR: Xpert TV, and good for LAMP assay: Xpert TV/PCR. The translational impact of this study lies in the possible use of conventional PCR and LAMP in laboratories where the Xpert TV assay is not available or not affordable.