Homebrew: An economical and sensitive glassmilk-based nucleic-acid extraction method for SARS-CoV-2 diagnostics.

Management of COVID-19 and other epidemics requires large-scale diagnostic testing. The gold standard for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection remains reverse transcription quantitative PCR (qRT-PCR) analysis, which detects viral RNA more sensitively than any other method. However, the resource use and supply-chain requirements of RT-PCR have continued to challenge diagnostic laboratories worldwide. Here, we establish and characterize a low-cost method to detect SARS-CoV-2 in clinical combined nose and throat swabs, allowing for automation in high-throughput settings. This method inactivates virus material with sodium dodecylsulfate (SDS) and uses silicon dioxide as the RNA-binding matrix in combination with sodium chloride (NaCl) and isopropanol. With similar sensitivity for SARS-CoV-2 viral targets but a fraction of time and reagent expenditure compared with commercial kits, our method also enables sample pooling without loss of sensitivity. We suggest that this method will facilitate more economical widespread testing, particularly in resource-limited settings.

Interleukin-1 Beta-Mediated Sex Differences in Kawasaki Disease Vasculitis Development and Response to Treatment.

OBJECTIVE: Kawasaki disease (KD) is the leading cause of acute vasculitis and acquired heart disease in children in developed countries. Notably, KD is more prevalent in males than females. We previously established a key role for IL (interleukin)-1 signaling in KD pathogenesis, but whether this pathway underlies the sex-based difference in susceptibility is unknown. Approach and Results: The role of IL-1 signaling was investigated in the Lactobacillus casei cell wall extract-induced experimental mouse model of KD vasculitis. Five-week-old male and female mice were injected intraperitoneally with PBS, Lactobacillus caseicell wall extract, or a combination of Lactobacillus caseicell wall extract and the IL-1 receptor antagonist Anakinra. Aortitis, coronary arteritis inflammation score and abdominal aorta dilatation, and aneurysm development were assessed. mRNA-seq (messenger RNA sequencing) analysis was performed on abdominal aorta tissue. Publicly available human transcriptomics data from patients with KD was analyzed to identify sex differences and disease-associated genes. Male mice displayed enhanced aortitis and coronary arteritis as well as increased incidence and severity of abdominal aorta dilatation and aneurysm, recapitulating the increased incidence in males that is observed in human KD. Gene expression data from patients with KD and abdominal aorta tissue of Lactobacillus caseicell wall extract-injected mice showed enhanced Il1b expression and IL-1 signaling genes in males. Although the more severe IL-1ß-mediated disease phenotype observed in male mice was ameliorated by Anakinra treatment, the milder disease phenotype in female mice failed to respond. CONCLUSIONS: IL-1ß may play a central role in mediating sex-based differences in KD, with important implications for the use of anti-IL-1ß therapies to treat male and female patients with KD.

Multicenter validation of a new quality of life measure in pediatric lupus.

OBJECTIVE: Pediatric systemic lupus erythematosus (SLE) is a chronic fluctuating disease that significantly impacts quality of life (QOL). There is no pediatric SLE-specific health-related QOL (HRQOL) scale. Our objective was to develop and validate a new pediatric SLE-specific HRQOL scale. METHODS: We developed the Simple Measure of the Impact of Lupus Erythematosus in Youngsters (SMILEY) based on results of qualitative research of children with SLE and their parents. SMILEY has parallel child and parent reports with a 5-faces scale for responses. SMILEY comprises 4 domains: effect on self, limitations, social, and burden of SLE. In this cross-sectional study, we examined face, content, construct, and concurrent validity; internal consistency; test-retest reliability; and child-parent agreement for SMILEY. Children /=0.4); test-retest reliability (intraclass correlation coefficient [ICC] 0.9); and internal consistency (alpha = 0.9). Moderate agreement was found between child and parent SMILEY reports (ICC 0.7, r(s) = 0.5, P < 0.001). CONCLUSION: SMILEY is a brief, easily understood, valid, and reliable pediatric SLE-specific QOL scale. Because SMILEY assesses children's self-perception of QOL as impacted by SLE, we predict that it will have great utility in clinical practice, clinical trials, and outcomes research.

Biopharmaceuticals derived from genetically modified plants.

Modern biotechnology has resulted in a resurgence of interest in the production of new therapeutic agents using botanical sources. With nearly 500 biotechnology products approved or in development globally, and with production capacity limited, the need for efficient means of therapeutic protein production is apparent. Through genetic engineering, plants can now be used to produce pharmacologically active proteins, including mammalian antibodies, blood product substitutes, vaccines, hormones, cytokines, and a variety of other therapeutic agents. Efficient biopharmaceutical production in plants involves the proper selection of host plant and gene expression system, including a decision as to whether a food crop or a non-food crop is more appropriate. Product safety issues relevant to patients, pharmaceutical workers, and the general public must be addressed, and proper regulation and regulatory oversight must be in place prior to commercial plant-based biopharmaceutical production. Plant production of pharmaceuticals holds great potential, and may become an important production system for a variety of new biopharmaceutical products.

Improving pharmacy supply-chain management in the operating room.

Anesthesia services can account for a significant portion of a healthcare organization's costs. Deaconess Hospital of Evansville, Indiana, used a collaborative, multidisciplinary effort to implement process improvements that yielded significant cost savings while improving patient care. Shifting responsibility for drug distribution from the operating room (OR) nurses to a pharmacist, the hospital established a satellite pharmacy service for the OR. As a result, the hospital was able to improve control of drug distribution and record-keeping, reduce turnaround time for medication preparation, lower its medication charge error rate, and increase the percentage of surgeries that start on time. The success of the OR satellite pharmacy led the hospital to expand satellite pharmacy services to labor and delivery, the cardiac cath laboratory, and the intensive care units.

Risk assessment of polymyositis/dermatomyositis after treatment with injectable bovine collagen implants.

BACKGROUND: Questions have been raised about a possible relation between injectable collagen and polymyositis and dermatomyositis (PM/DM). Predictions of the prevalence of PM/DM have been based on anecdotal estimates of the duration of follow-up for the collagen-treated population. OBJECTIVE: Our purpose was to study the duration of follow-up for a large sample of collagen-treated patients. METHODS: Physicians in North America who purchased collagen implants during fiscal year 1988 were categorized according to collagen practice size; one third were randomly invited to participate in the study. RESULTS: Review of 2622 patient records yielded an average duration of follow-up of 4 years. CONCLUSION: Five-year incidence rates were used to estimate the expected number of cases of PM/DM in the collagen-treated population. Through June 1993 the expected number was 30.2. The number of confirmed cases after treatment was seven, less than one fourth of the number of cases expected for a model of the collagen-treated population, matched for age, sex, and race.