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Validation of the SureFast® SARS-CoV-2 Plus Test Method for the Detection of SARS-CoV-2 Virus on Stainless Steel Surfaces: AOAC Performance Tested MethodSM 022102

J AOAC Int. 2021 Apr 8:qsab049. doi: 10.1093/jaoacint/qsab049. Online ahead of print.

ABSTRACT

BACKGROUND: The SureFast® SARS-CoV-2 PLUS Test is a reverse transcription qPCR (RT-qPCR) assay for the direct, qualitative detection of novel coronavirus (SARS-CoV-2) RNA from stainless steel environmental sample swabs.

OBJECTIVE: To validate the SureFast® SARS-CoV-2 PLUS Kit as part of the AOAC Research Institute’s Emergency Response Validation Performance Tested Method SM program.

METHODS: The SureFast® SARS-CoV-2 PLUS Kit was evaluated for specificity using in silico analysis of 15,764 SARS-CoV-2 sequences and 65 exclusivity organisms (both near neighbors and background organisms) using the ThermoBLAST program. The candidate method was evaluated in an unpaired study design for one environmental surface (stainless steel) and compared to the U.S. Centers for Disease Control and Prevention 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, Instructions for Use (Revision 4, Effective 6/12/2020).

RESULTS: Results of the in silico analysis demonstrated 99.99% selectivity of the method in being able to detect target sequences of the known CoV-2 genomes and discriminate them from near neighbors. In the matrix study, the candidate method demonstrated statistically significant better recovery of the target analyte than the PCR detection reference method.

CONCLUSIONS: The SureFast® SARS-CoV-2 PLUS Kit is a rapid and accurate method that can be utilized by food producers to detect the causative agent of COVID-19 on stainless steel contact surfaces.

HIGHLIGHTS: SureFast® SARS-CoV-2 PLUS test method is highly specific for primer/probe binding to the E target genome region for the SARS-CoV-2 virus, 99.99% binding specificity using in silico analysis.

PMID:33831212 | DOI:10.1093/jaoacint/qsab049

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A Swept source optical coherence tomography angiography study: Imaging artifacts and comparison of non-perfusion areas with fluorescein angiography in diabetic macular edema

PLoS One. 2021 Apr 8;16(4):e0249918. doi: 10.1371/journal.pone.0249918. eCollection 2021.

ABSTRACT

PURPOSE: Swept Source Optical coherence tomography angiography (SS-OCTA) is a novel technique to visualize perfusion and vascular changes like ischemia in patients with diabetic retinopathy. The aim of this study was to compare non-perfusion areas on conventional fluorescein angiography (FA) with those on SS-OCTA using detailed manual annotation in patients with diabetic macular edema (DME) and to evaluate possible artifacts caused by DME on SS-OCTA.

METHODS: 27 eyes of 21 patients with DME were analyzed in this prospective, cross-sectional study; on all, standard ophthalmological examination, SS-OCTA and FA imaging were performed. Early-phase FA and SS-OCTA images were analyzed for capillary dropout and foveal avascular zone (FAZ) was measured on both modalities. Artifacts in SS-OCTA imaging caused by DME were marked and analyzed.

RESULTS: The mean age of the patients was 62.6 ± 11.5 years. On FA the mean size of the annotated non-perfusion areas was 0.14 ± 0.31 mm2 whereas the mean size in SS-OCTA was 0.04 ± 0.13 mm2; areas marked on FA were statistically significantly larger than on SS-OCTA (p<0.01). Mean size of FAZs was similar between FA and OCTA images. (p = 0.91). Seven eyes (25.9 percent) showed imaging artifacts due to DME in SS-OCTA.

CONCLUSION: SS-OCTA is a valid tool to analyze capillary perfusion status of patients with DME, although areas of non-perfusion were measured smaller than in conventional FA. More non-perfusion areas were found on SS-OCTA images. FAZ measurements were similar using the two modalities. However, SS-OCTA is prone to artifacts and therefore requires reviewing of imaging results: up to 25 percent of the analyzed eyes showed artifacts on OCTA, which occurred in the areas of diabetic macular edema and did not correspond to capillary drop out.

PMID:33831123 | DOI:10.1371/journal.pone.0249918

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Factors influencing place of delivery: Evidence from three south-Asian countries

PLoS One. 2021 Apr 8;16(4):e0250012. doi: 10.1371/journal.pone.0250012. eCollection 2021.

ABSTRACT

BACKGROUND: High maternal mortality is still a significant public health challenge in many countries of the South-Asian region. The majority of maternal deaths occur due to pregnancy and delivery-related complications, which can mostly be prevented by safe facility delivery. Due to the paucity of existing evidence, our study aimed to examine the factors associated with place of delivery, including women’s preferences for such in three selected South-Asian countries.

METHODS: We extracted data from the most recent demographic and health surveys (DHS) conducted in Bangladesh (2014), Nepal (2016), and Pakistan (2017-18) and analyzed to identify the association between the outcome variable and socio-demographic characteristics. A total of 16,429 women from Bangladesh (4278; mean age 24.57 years), Nepal (3962; mean age 26.35 years), and Pakistan (8189; mean age 29.57 years) were included in this study. Following descriptive analyses, bivariate and multivariate logistic regressions were conducted.

RESULTS: Overall, the prevalence of facility-based delivery was 40%, 62%, and 69% in Bangladesh, Nepal, and Pakistan, respectively. Inequity in utilizing facility-based delivery was observed for women in the highest wealth quintile. Participants from Urban areas, educated, middle and upper household economic status, and with high antenatal care (ANC) visits were significantly associated with facility-based delivery in all three countries. Interestingly, watching TV was also found as a strong determinant for facility-based delivery in Bangladesh (aOR = 1.31, 95% CI:1.09-1.56, P = 0.003), Nepal (aOR = 1.42, 95% CI:1.20-1.67, P<0.001) and Pakistan (aOR = 1.17, 95% CI: 1.03-1.32, P = 0.013). Higher education of husband was a significant predictor for facility delivery in Bangladesh (aOR = 1.73, 95% CI:1.27-2.35, P = 0.001) and Pakistan (aOR = 1.19, 95% CI: 0.99-1.43, P = 0.065); husband’s occupation was also a significant factor in Bangladesh (aOR = 1.30, 95% CI:1.04-1.61, P = 0.020) and Nepal (aOR = 1.26, 95% CI:1.01-1.58, P = 0.041).

CONCLUSION: Our findings suggest that the educational status of both women and their husbands, household economic situation, and the number of ANC visits influenced the place of delivery. There is an urgent need to promote facility delivery by building more birthing facilities, training and deployment of skilled birth attendants in rural and hard-to-reach areas, ensuring compulsory female education for all women, encouraging more ANC visits, and providing financial incentives for facility deliveries. There is a need to promote facility delivery by encouraging health facility visits through utilizing social networks and continuing mass media campaigns. Ensuring adequate Government funding for free maternal and newborn health care and local community involvement is crucial for reducing maternal and neonatal mortality and achieving sustainable development goals in this region.

PMID:33831127 | DOI:10.1371/journal.pone.0250012

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The Causal Interpretation of “Overall Vaccine Effectiveness” in Test-Negative Studies

Am J Epidemiol. 2021 Apr 8:kwab101. doi: 10.1093/aje/kwab101. Online ahead of print.

ABSTRACT

Test-negative studies are commonly used to estimate influenza vaccine effectiveness (VE). In a typical study, an “overall VE” estimate may be reported based on data from the entire sample. However, there may be heterogeneity in VE, particularly by age. We therefore discuss the potential for a weighted average of age-specific VE estimates to provide a more meaningful measure of overall VE. We illustrate this perspective first using simulations to evaluate how overall VE would be biased when certain age groups are over-represented. We found unweighted overall VE estimates tended to be higher than weighted VE when children were over-represented and lower when elderly were over-represented. Then we extracted published estimates from the US Flu VE network, in which children are overrepresented, and some discrepancy between unweighted and weighted overall VE was observed. Differences in weighted versus unweighted overall VE could translate to substantial differences in the interpretation of individual risk reduction in vaccinated persons, and the total averted disease burden at the population level. Weighting overall estimates should be considered in VE studies in future.

PMID:33831173 | DOI:10.1093/aje/kwab101

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Vancomycin-resistant enterococci and coagulase-negative staphylococci prevalence among patients attending at Felege Hiwot Comprehensive Specialized Hospital, Bahir Dar, Ethiopia

PLoS One. 2021 Apr 8;16(4):e0249823. doi: 10.1371/journal.pone.0249823. eCollection 2021.

ABSTRACT

BACKGROUND: Vancomycin resistant enterococci (VRE) and vancomycin resistance coagulase negative staphylococci (VRCoNS) are common pathogens causing difficult to treat health care associated infections (HAI). Hence, the World Health Organization listed VRE as one of the high priority pathogens for new antibiotic discovery and antimicrobial resistance surveillance. Despite this, data on the prevalence of VRE and VRCoNS in Ethiopia is scarce. Thus, the present study determined prevalence of VRE and VRCoNS among patients attending Felege-Hiwot comprehensive specialized hospital, Ethiopia.

METHODS: A hospital based cross-sectional study was conducted on 384 patients selected conveniently from February to March 2020. Data on demographic and clinical variables were collected using a structured questionnaire by face-to-face interview. Simultaneously urine, venous blood and wound swab were collected and processed following standard bacteriological technique. Antimicrobial susceptibility test was performed by minimum inhibitory concentration method using E-test for vancomycin and Kirby-Bauer disc diffusion method for other classes of antibiotics. Data was entered and analyzed using SPSS version 23. Logistic regression was performed to identify factors associated with VRE infection. P. value < 0.05 was considered as statistically significant.

RESULTS: The prevalence of enterococci and CoNS were 6.8% and 12% respectively. The prevalence of VRE was 34.61% (9/26), while all CoNS (46 isolates) were susceptible to vancomycin. The majority (66.7%) of VRE was isolated from blood samples. Furthermore all VRE (100%), 58.8% of vancomycin susceptible enterococci and 45.7% of CoNS were multidrug resistant (MDR). Having educational level of secondary school and below (AOR = 12.80, CI = 1.149-142.5), previous exposure to catheterization (AOR = 56.0, CI = 4.331-724.0) and previous antibiotic use practice (AOR = 26.25, CI = 3.041-226.2) were a significant associated explanatory factor for VRE infection.

CONCLUSIONS: The prevalence of vancomycin resistance enterococci, which is also multidrug resistant, was significantly high. Though no vancomycin resistance CoNS detected, the MDR level of CoNS was high. Thus to limit enterococci and CoNS infections and MDR development, focused infection prevention measures should be implemented.

PMID:33831089 | DOI:10.1371/journal.pone.0249823

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Occupational and environmental asbestos exposure and the risk of lung cancer in Korea: A case-control study in South Chungcheong Province of Korea

PLoS One. 2021 Apr 8;16(4):e0249790. doi: 10.1371/journal.pone.0249790. eCollection 2021.

ABSTRACT

Despite the use of large amounts of asbestos in the 1990s, few studies have been conducted in Korea on occupational and environmental asbestos exposure and lung cancer risk. The main aim of this study was to estimate the risk of lung cancer development caused by occupational and environmental asbestos exposures in residents of South Chungcheong Province, where about half of the asbestos mines in Korea operated. We conducted a case-control study, for which the information on asbestos exposure history and demographic characteristics was provided by the Environmental Health Center for asbestos of Soonchunhyang University Cheonan Hospital. After adjusting for all covariates, the odds ratios for lung cancer tended to increase with higher exposure probability for both occupational as well as environmental asbestos. The relative risk of occupational asbestos exposure was higher than that of environmental exposure; the interaction of co-exposure was not statistically significant. The estimated means of the latency period were significantly shorter in participants who were engaged in the production of asbestos-containing products and in those who lived near asbestos industries as compared to other groups.

PMID:33831090 | DOI:10.1371/journal.pone.0249790

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Sex-differences in circulating biomarkers during acute myocardial infarction: An analysis from the SWEDEHEART registry

PLoS One. 2021 Apr 8;16(4):e0249830. doi: 10.1371/journal.pone.0249830. eCollection 2021.

ABSTRACT

BACKGROUND: Sex-differences in the pathobiology of myocardial infarction are well established but incompletely understood. Improved knowledge on this topic may help clinicians to improve management of men and women with myocardial infarction.

METHODS: In this registry-based cohort study (SWEDEHEART), we analyzed 175 circulating biomarkers reflecting various pathobiological axes in 856 men and 243 women admitted to Swedish coronary care units because of myocardial infarction. Two multimarker panels were applied (Proximity Extension Assay [Olink Bioscience], Multiple Reaction Monitoring mass spectrometry). Lasso analysis (penalized logistic regression), multiple testing-corrected Mann-Whitney tests and Cox regressions were used to assess sex-differences in the concentrations of these biomarkers and their implications on all-cause mortality and major adverse events (median follow-up up to 6.6 years).

RESULTS: Biomarkers provided a very high discrimination between both sexes, when considered simultaneously (c-statistics 0.972). Compared to women, men had higher concentrations of six biomarkers with the most pronounced differences seen for those reflecting atherogenesis, myocardial necrosis and metabolism. Women had higher concentrations of 14 biomarkers with the most pronounced differences seen for those reflecting activation of the renin-angiotensin-aldosterone axis, inflammation and for adipokines. There were no major variations between sexes in the associations of these biomarkers with outcome.

CONCLUSIONS: Severable sex-differences exist in the expression of biomarkers in patients with myocardial infarction. While these differences had no impact on outcome, our data suggest the presence of various sex-related pathways involved in the development of coronary atherosclerosis, the progression to plaque rupture and acute myocardial damage, with a greater heterogeneity in women.

PMID:33831096 | DOI:10.1371/journal.pone.0249830

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Condom application skills and self-efficacy in youth: A systematic review and meta-analysis

PLoS One. 2021 Apr 8;16(4):e0249753. doi: 10.1371/journal.pone.0249753. eCollection 2021.

ABSTRACT

Globally, and in the United States (U.S.) specifically, rates of reported sexually transmitted infections (STIs) have been steadily increasing and are especially high among youth aged 13-25 years. Using condoms correctly and consistently is an effective STI prevention measure for sexually active youth, yet public health endeavors tend to focus only on condom use consistency. Directly measuring condom application is challenging and expensive. Alternative tools evaluate this behaviour, but little evidence exists on the appropriateness of these instruments in measuring application skills. This systematic review and meta-analysis examined the association between condom application skills and self-efficacy. We conducted a search of several databases as well as unpublished works. Studies were included if they were in English, examined youth aged 13-25 years, and were available between 1992 and 2019. The authors screened 630 titles and abstracts for initial inclusion criteria. A full-text review of 30 studies was conducted. The authors included 19 studies in the systematic review and 5 studies were included in the meta-analysis. Both a fixed- and random-effects model (Q = .2321, I2 = 0%) yielded a medium-sized statistically non-significant association (r = 0.217) between skills and self-efficacy. Despite the small sample size, findings suggest that skills and self-efficacy may not be as interchangeable as previously assumed when assessing condom application. Implications for future research are discussed.

PMID:33831080 | DOI:10.1371/journal.pone.0249753

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Corneal transplantation activity in Catalonia, Spain, from 2011 to 2018: Evolution of indications and surgical techniques

PLoS One. 2021 Apr 8;16(4):e0249946. doi: 10.1371/journal.pone.0249946. eCollection 2021.

ABSTRACT

PURPOSE: To report corneal transplant activity carried out in Catalonia (Spain) and the evolving indications for keratoplasty over an 8-year period.

METHODS: Annual reports from the Catalan Transplant Organization, Spain, on corneal graft indications and techniques from 2011 to 2018 were reviewed.

RESULTS: A total of 9457 keratoplasties were performed in Catalonia, from January 2011 to December 2018. The most frequent indications were bullous keratopathy (BK; 20.5%), Fuchs endothelial dystrophy (FED; 17.9%), re-graft (13.7%), and keratoconus (11.3%). Penetrating keratoplasty (PKP) accounted for 63.4% of all performed keratoplasties. Since the introduction of eye bank precut tissue for Descemet stripping automated endothelial keratoplasty (DSAEK) in 2013 and for Descemet membrane endothelial keratoplasty (DMEK) in 2017 the number of endothelial keratoplasties has drastically increased. An increasing trend of posterior lamellar techniques over the total of keratoplasties was found (p<0.001). Endothelial keratoplasties for different endothelial diseases indications (BK, FED, and re-graft), also showed and increasing trend (p<0.001). DMEK is the technique with the highest increase (statistically significantly different from linearity) over other endothelial keratoplasties in FED (p<0.001) but not in BK (p = 0.67) or re-grafts (p = 0.067).

CONCLUSION: Endothelial diseases represented the top indication for keratoplasty over the 8-year period. PKP is still the most used technique in Catalonia, but endothelial keratoplasties and especially DMEK showed a significant increasing trend over the last years. This is congruent with the main rationale nowadays for keratoplasties: to customize and transplant as less tissue as possible. Therefore, the availability of precut tissue could have definitely enforced such approach.

PMID:33831081 | DOI:10.1371/journal.pone.0249946

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Global biochemical analysis of plasma, serum and whole blood collected using various anticoagulant additives

PLoS One. 2021 Apr 8;16(4):e0249797. doi: 10.1371/journal.pone.0249797. eCollection 2021.

ABSTRACT

INTRODUCTION: Analysis of blood for the evaluation of clinically relevant biomarkers requires precise collection and sample handling by phlebotomists and laboratory staff. An important consideration for the clinical application of metabolomics are the different anticoagulants utilized for sample collection. Most studies that have characterized differences in metabolite levels in various blood collection tubes have focused on single analytes. We define analyte levels on a global metabolomics platform following blood sampling using five different, but commonly used, clinical laboratory blood collection tubes (i.e., plasma anticoagulated with either EDTA, lithium heparin or sodium citrate, along with no additive (serum), and EDTA anticoagulated whole blood).

METHODS: Using an untargeted metabolomics platform we analyzed five sample types after all had been collected and stored at -80°C. The biochemical composition was determined and differences between the samples established using matched-pair t-tests.

RESULTS: We identified 1,117 biochemicals across all samples and detected a mean of 1,036 in the sample groups. Compared to the levels of metabolites in EDTA plasma, the number of biochemicals present at statistically significant different levels (p<0.05) ranged from 452 (serum) to 917 (whole blood). Several metabolites linked to screening assays for rare diseases including acylcarnitines, bilirubin and heme metabolites, nucleosides, and redox balance metabolites varied significantly across the sample collection types.

CONCLUSIONS: Our study highlights the widespread effects and importance of using consistent additives for assessing small molecule levels in clinical metabolomics. The biochemistry that occurs during the blood collection process creates a reproducible signal that can identify specimens collected with different anticoagulants in metabolomic studies.

IMPACT STATEMENT: In this manuscript, normal/healthy donors had peripheral blood collected using multiple anticoagulants as well as serum during a fasted blood draw. Global metabolomics is a new technology being utilized to draw clinical conclusions and we interrogated the effects of different anticoagulants on the levels of biochemicals from each of the donors. Characterizing the effects of the anticoagulants on biochemical levels will help researchers leverage the information using global metabolomics in order to make conclusions regarding important disease biomarkers.

PMID:33831088 | DOI:10.1371/journal.pone.0249797