Assessing operational readiness: Regulatory landscape and compliance in zimbabwe for medical devices and in vitro diagnostic medical devices.

The regulation of medical devices and In Vitro Diagnostic (IVD) medical devices have lagged significantly, especially in low- and middle-income countries. Disparities in regulating medical and IVD medical devices in Africa are below the global average. This may translate to poor access to quality-assured medical and IVD devices, resulting in undesirable health outcomes. Operational readiness to regulate medical and IVD devices at the Medicines Control Authority of Zimbabwe (MCAZ) was assessed. The aim was to determine the strengths and gaps and propose an action plan that can be monitored and evaluated to assess progress over time. We used the World Health Organization (WHO) Global Benchmarking Tool for medical devices and IVDs methodology to evaluate regulatory oversight of these products. Purposive sampling was used for data collection using researcher-administered global benchmarking tool factsheets and document reviews to evaluate the implementation of the regulatory functions. The regulatory functions assessed were the National Regulatory System, Registration and Market Authorization, Vigilance, Market Surveillance and Control, Licensing Establishment, Regulatory Inspection, Laboratory Testing, and Clinical Trials Oversight. The MCAZ attained maturity level 1, with a regulatory system score of 79%, registration and market authorization 44%, vigilance 27%, market surveillance and control 40%, licensing establishment 62%, regulatory inspection 68%, laboratory testing 88%, and clinical trials 18%. Condoms and gloves were the only regulated medical devices in Zimbabwe. IVDs were not regulated by the MCAZ. This review showed that the regulatory system is not robust, fit for purpose, responsive, transparent, or proportionate to the risk classification of medical devices and IVDs. It is crucial to amend the Medicines and Allied Substance Control Act to incorporate the definition and classification of medical devices and IVDs, regulatory authority establishment, licensing and registration, quality management system, conformity assessment, post-market surveillance, labeling and instructions for use, capacity building and training, and international harmonization.

[Discussion on Technical Evaluation of Tongue Diagnosis Equipment of Traditional Chinese Medicine].

This study briefly introduces the tongue diagnostic equipment of traditional Chinese medicine. It analyzes and discusses the key points of technical evaluation of tongue diagnostic equipment from the aspects of product name, performance parameters, image processing functions, product use methods, clinical evaluation, etc. It analyzes the safety risks and effectiveness indicators of tongue diagnostic equipment, hoping to bring some help to the gradual standardization of tongue diagnostic equipment and the registration of enterprises.

Accessible medical diagnostic equipment in primary care: Assessing its geographic distribution for disability equity.

BACKGROUND: Height adjustable examination tables, accessible weight scales, and lifts for transferring individuals on/off examination equipment enable delivery of equitable health care to persons with mobility impairment. Because most Medicaid-covered patients must utilize a managed care network, network providers with accessible medical diagnostic equipment (MDE) at proximate locations for travel time and distance are necessary. Network density and distribution of accessible MDE has not been studied. OBJECTIVE: This descriptive research examined geographic network adequacy by comparing the density of persons with mobility impairments and location of Medicaid managed care practices with accessible MDE in Los Angeles County. METHODS: Medicaid managed care practices with MDE were mapped by ZIP Codes shaded to indicate the number of persons with mobility impairment. Zero-inflated negative binomial regression examined ZIP Code population characteristics as potential predictors of accessible MDE presence. Data sources were: (1) 2013-2016 primary care facility audit of Medicaid managed care network providers in LA County, aggregated by ZIP Code, and (2) LA County ZIP Code characteristics from the 2016 American Community Survey. ArcGIS was used for mapping and MPlus for the regression analysis. RESULTS: No consistent association between the size of the mobility limited population, demographic characteristics, and presence of accessible MDE was observed or measured by regression. The observed low MDE density suggests network adequacy likely is not achieved in LA County. CONCLUSIONS: Actions by state and federal agencies are necessary to increase accessible MDE and network adequacy by enforcing existing non-discrimination law and Medicaid regulations.

Novel Diagnosis Technologies for a Lack of Oil Lubrication in Gearmotor Systems, Based on Motor Current Signature Analysis.

Due to the wide use of gearmotor systems in industry, many diagnostic techniques have been developed/employed to prevent their failures. An insufficient lubrication of gearboxes of these machines could shorten their life and lead to catastrophic failures and losses, making it important to ensure a required lubrication level. For the first time in worldwide terms, this paper proposed to diagnose a lack of gearbox oil lubrication using motor current signature analysis (MCSA). This study proposed, investigated, and experimentally validated two new technologies to diagnose a lack of lubrication of gear motor systems based on MCSA. Two new diagnostic features were extracted from the current signals of a three-phase induction motor. The effectiveness of the proposed technologies was evaluated for different gear lubrication levels and was compared for three phases of motor current signals and for a case of averaging the proposed diagnostic features over three phases. The results confirmed a high effectiveness of the proposed technologies for diagnosing a lack of oil lubrication in gearmotor systems. Other contributions were as follows: (i) it was shown for the first time in worldwide terms, that the motor current nonlinearity level increases with the reduction of the sgearbox oil level; (ii) novel experimental validations of the proposed two diagnostic technologies via comprehensive experimental trials (iii) novel experimental comparisons of the diagnosis effectiveness of the proposed two diagnostic technologies.

National inventory of authorized diagnostic imaging equipment in Ghana: data as of September 2020.

Introduction: to address the challenge of inadequate and non-equitable distribution of diagnostic imaging equipment, countries are encouraged to evaluate the distribution of installed systems and undertake adequate monitoring to ensure equitability. Ghana´s medical imaging resources have been analyzed in this study and evaluated against the status in other countries. Methods: data on registered medical imaging equipment were retrieved from the database of the Nuclear Regulatory Authority and analyzed. The equipment/population ratio was mapped out graphically for the 16 regions of Ghana. Comparison of the equipment/population ratio was made with the situation in other countries. Results: six hundred and seventy-four diagnostic imaging equipment units from 266 medical imaging facilities (2.5 units/facility), comprising computed tomography (CT), general X-ray, dental X-ray, single-photon emission computed tomography (SPECT) gamma camera, fluoroscopy, mammography and magnetic resonance imaging (MRI) were surveyed nationally. None of the imaging systems measured above the Organization for Economic Co-operation and Development (OECD) average imaging units per million populations (u/mp). The overall equipment/population ratio estimated nationally was 21.4 u/mp. Majority of the imaging systems were general X-ray, installed in the Greater Accra and Ashanti regions. The regional estimates of equipment/population ratios were Greater Accra (49.6 u/mp), Ashanti (22.4 u/mp), Western (21.4 u/mp), Eastern (20.6 u/mp), Bono East (20.0 u/mp), Bono (19.2 u/mp), Volta (17.9 u/mp), Upper West (16.7 u/mp), Oti (12.5 u/mp), Central (11.9 u/mp), Northern (8.9 u/mp), Ahafo (8.9 u/mp), Upper East (6.9 u/mp), Western North (6.7 u/mp), Savannah (5.5 u/mp) and North-East (1.7 u/mp). Conclusion: medical imaging equipment shortfall exist across all imaging modalities in Ghana. A wide inter-regional disparity in the distribution of medical imaging equipment exists contrary to WHO´s recommendation for equitable distribution. A concerted national plan will be needed to address the disparity.

Comparación entre el análisis automático y manual de 301 poligrafías respiratorias domiciliarias con ApneaLink / Comparison between automatic and manual scoring of 301 home respiratory polygraphs with ApneaLink device

Resumen Introducción: El síndrome de apnea obstructiva del sueño (SAOS) se asocia a aumento de morbimortalidad cardiovascular y metabólica, y a mala calidad de vida. Su diagnóstico y tratamiento eficaz mejora la salud individual y pública. Objetivo: evaluar concordancia entre análisis automático versus manual del dispositivo ApneaLink para diagnosticar y clasificar SAOS en pacientes con sospecha clínica. Material y Método: Evaluación retrospectiva de 301 poligrafías respiratorias del HOSCAR. Se mide correlación, acuerdo general y concordancia entre parámetros obtenidos manual y automáticamente usando coeficiente de Pearson, coeficiente de correlación intraclase y gráfico de Bland y Altman. Resultados: En 11,3% de casos el análisis automático interpreto erróneamente la señal de flujo. No hubo diferencias significativas entre índices de apnea-hipopnea automático (AHIa 18,9 ± 17,5) y manual (AHIm 20,8 ± 19,4) r + 0,97 (95% CI: 0,9571 a 0,9728; p < 0,0001) y tampoco entre la saturación mínima de oxígeno automática (82,1 ± 7,6) y manual (83,1 ± 6,8) r + 0,85 (95% CI: 0,8108 a 0,8766; p < 0,0001). No hubo buena correlación entre análisis automático y manual en clasificación de apneas centrales, r + 0,51 (95% CI: 0,4238 a 0,5942; p < 0,0001). Hubo subestimación de gravedad de SAOS por análisis automático: en 11% de casos. Conclusión: El diagnóstico entregado automáticamente por ApneaLink podría aceptarse sin confirmación manual adicional solamente en casos clasificados como severos. Para AHI menores se requeriría confirmación mediante análisis manual de experto.

Abstract Introduction: Obstructive sleep apnea syndrome (OSAS) is associated with increased cardiovascular and metabolic morbidity and mortality, and poor quality of life. Its effective diagnosis and treatment improve individual and public health. Aim: To evaluate concordance between automatic versus manual analysis of the ApneaLink device to diagnose and classify OSAS in patients with clinical suspicion. Material and Method: Retrospective evaluation of 301 respiratory polygraphs from HOSCAR. Correlation, general agreement and concordance between parameters obtained manually and automatically are measured using Pearson's coefficient, intraclass correlation coefficient, and Bland and Altman graph. Results: In 11.3% of cases, the automatic analysis misinterpreted the flow signal. There were no significant differences between automatic (AHIa 18.9 ± 17.5) and manual (AHIm 20.8 ± 19.4) apnea-hypopnea indices r + 0.97 (95% CI:0.9571 to 0.9728, p < 0.0001) and nor between automatic (82.1 ± 7.6) and manual (83.1 ± 6.8) minimum oxygen saturation r + 0.85 (95% CI: 0.8108 to 0.8766, p < 0.0001). There was no good correlation between automatic and manual analysis in the classification of central apneas, r + 0.51(95% CI:0.4238 to 0.5942, p < 0.0001). There was an underestimation of the severity of OSAS by automatic analysis in 11% of cases. Conclusion: The diagnosis delivered automatically by ApneaLink could be accepted without additional manual confirmation only in cases classified as severe. For minors AHI, confirmation through manual expert analysis would be required.

Home sleep apnea testing: an accuracy study.

AIM: There are no studies comparing tests performed at home with those carried out in the laboratory, using the same device. The only studies that have been performed have compared the device used at home with the standard polygraph used in the laboratory. The purpose of this study was therefore to verify the accuracy of the home diagnosis of obstructive sleep apnea syndrome (OSAS) via unassisted type 2 portable polysomnography, compared with polysomnography using the same equipment in a sleep laboratory. METHODS: To avoid any possible order effect on the apnea-hypopnea index (AHI), we randomly created two groups of 20-total 40 patients, according to the test sequence. One of the groups had the first test at home and the second test in the laboratory (H-L); the other group had the first test in the laboratory and the second at home (L-H). The second test always took place on the night immediately following the first test. All polysomnographic monitoring was undertaken with the same equipment, an Embletta X100 system (Embla, Natus Inc., Middleton, USA). The Embletta X100 is a portable polygraph that records eleven polygraph signs: (1) electroencephalogram C4/A; (2) electroencephalogram O2/M1; (3) submental EMG; (4) electrooculogram of the right side; (5) nasal cannula (air flow); (6) respiratory effort against a plethysmographic chest strap; (7) respiratory effort against an abdominal plethysmographic belt; (8) heart rate; (9) saturation of oxyhemoglobin; (10) snoring; and (11) body position. RESULTS: There was no difference in sleep efficiency between the group monitored in the laboratory and the group tested at home (p = 0.30). There was no difference in total sleep time (p = 0.11) or sleep latency (p = 0.52), or in the latency in phases N2 and N3 between the monitoring in the laboratory and at home (N2 p = 0.24; N3 p = 0.09). Some differences occurred regarding the PSG that took place at home, with longer duration of wake after sleep onset (WASO) and longer latency for REM sleep, due to failure of the patient to start the monitoring by pressing the "events" button on the device. In the distribution of sleep phases, there was no difference between the group monitored in the laboratory and the group tested at home. CONCLUSION: Results from home sleep monitoring correlate well with the laboratory "gold standard" and may be an option for diagnosing OSAS in selected patients.

Reliability of shoulder rotation movement measured by the smartphone clinometer application / Confiabilidade da medida de movimento de rotação do ombro mensurada pelo aplicativo clinômetro para smartphone

Goniometry is widely used to measure range of motion (ROM), but requires skill and training. In this sense, smartphone apps appear as an alternative. The objective was to assess the reliability and validity of shoulder rotation measurements using a smartphone clinometer app. This study approved by Ethical and Research Committee of the University of Pernambuco. Thirty six (36) healthy and physically active adolescents and young adults participated in the study. In the measurement each volunteer performed external (ER) and internal (IR) rotation of the shoulder in the supine and side lying positions. The shoulder rotation ROM was measured by a goniometer and an application. ER and IR were measured in two days by two evaluators. Reliability was determined using intraclass correlation coefficient (ICC), standard error of measurement (SEM) and minimum detectable change (MDC). Validity was assessed using Pearson's correlation coefficients. Both devices had excellent intra- and inter-examiner reliability levels in most evaluations. However, the goniometer showed moderate inter-examiner reliability in measuring the internal rotation performed in the lying position (ICC 0.61 to 0.67). The app showed inter-examiner reliability ranging from fair to moderate for the same measurements (ICC 0.35 to 0.61). Significant differences were observed between the values recorded by the two instruments for all measurements performed (p <0.001). A strong correlation was observed between measurements in the supine and side lying positions with the goniometer and a smartphone clinometer app (r> 0.85). The application presented excellent reliability levels as well as demonstrated a high correlation with the goniometer. However, the assessment of IR lying down position should be avoided. (AU)

A goniometria é muito usada para medir a amplitude de movimento (ADM), mas requer habilidade e treinamento. Nesse sentido, os aplicativos para smartphones aparecem como uma alternativa. O objetivo foi avaliar a confiabilidade e a validade das medidas de rotação do ombro usando um aplicativo clinômetro de smartphone. Este estudo foi provado pelo Comitê de Ética da Universidade de Pernambuco. Participaram do estudo trinta e seis (36) adolescentes e adultos jovens, saudáveis e fisicamente ativos. Na intervenção, cada voluntário realizou rotação externa (RE) e interna (RI) do ombro nas posições em supino e decúbito lateral. A ADM de rotação do ombro foi medida por um goniômetro e um aplicativo. RE e RI foram medidas em dois dias por dois avaliadores. A confiabilidade foi determinada usando coeficiente de correlação intraclasse (CCI), erro padrão de medição (EPM) e mudança mínima detectável (MMD). A validade foi avaliada usando os coeficientes de correlação de Pearson. Ambos os dispositivos apresentaram excelentes níveis de confiabilidade intra e interexaminadores na maioria das avaliações. No entanto, o goniômetro apresentou confiabilidade interexaminadores moderada na medição da rotação interna realizada na posição deitada (ICC 0,61 a 0,67). O aplicativo mostrou confiabilidade interexaminadores variando de ruim a moderada para as mesmas medidas (ICC 0,35 a 0,61). Diferenças significativas foram observadas entre os valores registrados pelos dois instrumentos para todas as medidas realizadas (p <0,001). Uma forte correlação foi observada entre as medidas nas posições supina e deitada de lado com o goniômetro e o aplicativo clinômetro para smartphone (r> 0,85). O aplicativo apresentou excelentes níveis de confiabilidade, bem como demonstrou uma alta correlação com o goniômetro. No entanto, a avaliação da RI na posição deitada deve ser evitada. (AU)

Requirements for Supporting Diagnostic Equipment of Respiration Process in Humans.

There is abundant worldwide research conducted on the subject of the methods of human respiration process examination. However, many of these studies describe methods and present the results while often lacking insight into the hardware and software aspects of the devices used during the research. This paper's goal is to present new equipment for assessing the parameters of human respiration, which can be easily adopted for daily diagnosis. This work deals with the issue of developing the correct method of obtaining measurement data. The requirements of the acquisition parameters are clearly pointed out and examples of the medical applications of the described device are shown. Statistical analysis of acquired signals proving its usability is also presented. In the examples of selected diseases of the Upper Respiratory Tract (URT), the advantages of the developed apparatus for supporting the diagnosis of URT patency have been proven.

Reliability and diagnostic performance of a new blood ketone and glucose meter in humans.

BACKGROUND: Accurate and reliable monitoring of blood ketone and glucose levels is useful for athletes adhering to a ketogenic diet who want to verify that they are in a state of ketosis and, therefore, accruing performance adaptations. However, the cost of devices and testing materials may prohibit their use. More affordable field testing systems are available, but their accuracy and reliability remain in question. The objectives of this study were to evaluate the agreement between a previously validated ketone and glucose meter (Meter 1 - Precision Xtra) and a more affordable meter that has not been validated (Meter 2 - Keto-Mojo), and also to assess the diagnostic performance of Meter 2 for identifying nutritional ketosis. METHODS: Thirteen participants (7 females and 6 males; 21.6 ± 3.0 years old) visited the laboratory three times in this randomized, double-blind cross-over design study. Ketone and glucose levels were measured with Meter 1 and Meter 2 twice before and twice after ingestion of a racemic ketone, natural ketone, or maltodextrin supplement. Intraclass correlation coefficient (ICC) estimates and their 95% confidence intervals were calculated to evaluate interrater reliability for Meter 1 and Meter 2. Bland-Altman plots were constructed to visually assess the agreement between devices. Area under the ROC curve analysis was performed to evaluate the diagnostic ability of Meter 2 to detect nutritional ketosis at a threshold ketone level of 0.5 mM as identified by Meter 1. RESULTS: Reliability between the meters was excellent for measuring ketones (ICC = .968; .942-.981) and good for measuring glucose (ICC = .809; .642-.893), though the Bland-Altman plot revealed substantial differences in agreement for measuring glucose. Area under the ROC curve (Area = 0.913; 0.828-0.998) was excellent for diagnosing nutritional ketosis. CONCLUSIONS: Both Meter 1 and Meter 2 displayed excellent agreement between each other for ketone measurement. Meter 2 also displayed an excellent level of accuracy for diagnosing nutritional ketosis at a threshold value of 0.5 mM, making it an effective and affordable alternative to more expensive testing devices.

Pediatric Dual-Energy X-Ray Absorptiometry in Japan: A Proposal for Shared Access to Equipment.

BACKGROUND: Regular assessment of bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) is essential for detecting glucocorticoid-induced osteoporosis in juvenile-onset autoimmune diseases. Z-score is used to standardize osteoporosis assessment in children and is evaluated with only one of three devices in Japan. The purpose of this study was to determine how many Japanese medical facilities for pediatric rheumatic diseases were unable to use Z-scores to evaluate osteoporosis. METHODS: Electronic questionnaires were distributed between 2017 and 2019 to hospitals belonging to the Pediatric Rheumatology Association of Japan and to university hospitals and public children's hospitals that provide medical care for pediatric rheumatic diseases. The questionnaire inquired about the location of DXA measurement, manufacturer (Hologic, GE healthcare, Hitachi), and measurement site, and the answers were collected using Google Forms. Statcel 4 was used for analysis. RESULTS: Overall, 120 facilities responded to the survey, of which 117 had DXA. In the remaining three facilities, DXA was not installed in two and was out of order in one. Bone loss in childhood was evaluated using a Z-score calculated from age-based reference values; however, 30% of hospitals without HOLOGIC DXA could not evaluate osteoporosis by Z-score in Japanese childhood. The characteristics of the hospitals enrolled in this study did not bias the selection of Hologic DXA. CONCLUSIONS: Neighboring institutions should consider sharing access to Hologic DXA equipment, to ensure use of uniform reference values. GE BMD reference values should be established for Japanese children.

Is naso-pharyngeal swab always safe for SARS-CoV-2 testing? An unusual, accidental foreign body swallowing.

Long and sharp objects can be foreign body intentionally or accidentally ingested. Timing of endoscopy relies on foreign body shape and size, localization in gastrointestinal tract, patient's clinical conditions, occurrence of symptoms, or onset of complications. We present a case of a 47-year-old male with no known comorbidity, who accidentally swallowed a portion of a naso-pharyngeal swab half-broken during the second diagnostic test for SARS-CoV-2. The intact swab had a total length of 15 cm and was made of wood. The patient was asymptomatic, laboratory tests were normal, and neck-chest-abdominal X-ray and CT scan were negative for major complications. Upper gastrointestinal endoscopy was promptly performed to prevent the long sharp swab from crossing the pylorus leading to serious complications and, therefore, risk surgical intervention. The patient was intubated and the procedure was carried out under general anesthesia. In the gastric body, broken naso-pharyngeal swab was detected among the food debris, and using a latex rubber hood, the 7.5 cm foreign body was removed with a retrieval alligator-tooth forceps. Our hospital is located in a high-risk area of COVID-19 outbreak where many naso-pharyngeal swabs are performed, and to our knowledge, this is the first report of swab ingestion during SARS-CoV-2 test.

Analgesia nociception index as a tool to predict hypotension after spinal anaesthesia for elective caesarean section.

Arterial hypotension is the main disadvantage of spinal anaesthesia (SA) for caesarean delivery with deleterious effects on maternal-foetal outcomes. Recently, a non-invasive device 'analgesia nociception index' (ANI) has been developed to evaluate the parasympathetic component of the nervous autonomous system. The aim of this study was to evaluate the ability of ANI to predict the risk of hypotension after SA for elective caesarean section. One hundred patients scheduled for elective caesarean delivery under SA were recruited in this observational prospective study. Hemodynamic and ANI parameters were recorded in supine position (TB), in sitting position (T0), after induction of SA (T1) and then every three minutes (T2, T3, Tn) until the end of surgery or having resort to ephedrine. After SA, women were classified into two groups according to occurrence of hypotension (group H, n = 80) or not (group C, n = 20). The variations of ANI between T2 and T0 were significantly higher in the group H as compared to the control group. A threshold of 4.5 points decrease in instantaneous ANI value could predict maternal hypotension. ANI is a simple and effective tool in predicting the risk of SA-related hypotension.Impact statementWhat is already known on this subject? Arterial hypotension is the main disadvantage of spinal anaesthesia for caesarean delivery with deleterious effects on maternal-foetal outcomes. The balance between the sympathic and parasympathic systems could be used to predict the onset of hypotension following spinal anaesthesia. Analgesia nociception index (ANI) is an index calculated based on heart rate variability HRV analysis, designed originally to evaluate the antinociception/Nociception balance.What do the results of this study add? We have shown that the analysis of HRV with ANI was a predictor of maternal hypotension after spinal anaesthesia.What are the implications of these findings for clinical practice and/or further research? ANI is an effective tool in predicting the risk of spinal anaesthesia-related hypotension. These findings are of potential clinical importance in the obstetrical anaesthesia setting. Further studies are required in order to implement this simple tool and optimise prophylactic measures especially vasopressors.

Accommodating patients with obesity and mobility difficulties: Observations from physicians.

BACKGROUND: Given the growing population of U.S. adults with obesity and mobility disability, physicians will need to accommodate these patients. OBJECTIVE: To explore attitudes and practices of US physicians related to caring for patients with obesity and mobility disability. METHODS: Three open-ended, semi-structured, web-based focus group interviews with practicing physicians in selected specialties, which reached data saturation. Interviews were video recorded and transcribed for qualitative, conventional content analysis. Measurements included commonly expressed themes around caring for patients with obesity. RESULTS: Physicians recognized obesity as a disability that poses challenges to high quality, safe, and efficient patient care. Observations coalesced around four themes: (1) difficulty routinely tracking weight; (2) reluctance to transfer obese patients to exam tables; (3) barriers to diagnostic testing; and (4) weight stigma. Physicians described difficulties accurately assessing weight, performing complete physical examinations, arranging diagnostic imaging, and providing prenatal care for obese patients. Lack of accessible medical diagnostic equipment impeded care for patients with obesity. Other participants did not contest comments of individual participants' that suggested weight stigma. CONCLUSIONS: Our findings suggest that important gaps may remain in providing equitable access to care for patients with obesity, requiring additional training and accessible medical diagnostic equipment to safely accommodate these patients.

Portable Rabies Virus Sequencing in Canine Rabies Endemic Countries Using the Oxford Nanopore MinION.

As countries with endemic canine rabies progress towards elimination by 2030, it will become necessary to employ techniques to help plan, monitor, and confirm canine rabies elimination. Sequencing can provide critical information to inform control and vaccination strategies by identifying genetically distinct virus variants that may have different host reservoir species or geographic distributions. However, many rabies testing laboratories lack the resources or expertise for sequencing, especially in remote or rural areas where human rabies deaths are highest. We developed a low-cost, high throughput rabies virus sequencing method using the Oxford Nanopore MinION portable sequencer. A total of 259 sequences were generated from diverse rabies virus isolates in public health laboratories lacking rabies virus sequencing capacity in Guatemala, India, Kenya, and Vietnam. Phylogenetic analysis provided valuable insight into rabies virus diversity and distribution in these countries and identified a new rabies virus lineage in Kenya, the first published canine rabies virus sequence from Guatemala, evidence of rabies spread across an international border in Vietnam, and importation of a rabid dog into a state working to become rabies-free in India. Taken together, our evaluation highlights the MinION's potential for low-cost, high volume sequencing of pathogens in locations with limited resources.

The architecture of corneal stromal striae on optical coherence tomography and histology in an animal model and in humans.

The purpose of this study was to use a portable optical coherence tomography (OCT) for characterization of corneal stromal striae (CSS) in an ovine animal model and human corneas with histological correlation, in order to evaluate their architectural pattern by image analysis. Forty-six eyes from female adult sheep (older than 2 years), and 12 human corneas, were included in our study. The eyes were examined in situ by a portable OCT, without enucleation. All OCT scans were performed immediately after death, and then the eyes were delivered to a qualified histology laboratory. In the ovine animal model, CSS were detected with OCT in 89.1% (41/46) of individual scans and in 93.4% (43/46) of histological slices. In human corneas, CSS were found in 58.3% (7/12) of cases. In both corneal types, CSS appeared as "V"- or "X"-shaped structures, with very similar angle values of 70.8° ± 4° on OCT images and 71° ± 4° on histological slices (p ≤ 0.01). Data analysis demonstrated an excellent degree of reproducibility and inter-rater reliability of measurements (p < 0.001). The present study demonstrated that by using a portable OCT device, CSS can be visualized in ovine and human corneas. This finding suggests their generalized presence in various mammals. The frequent observation, close to 60%, of such collagen texture in the corneal stroma, similar to a 'truss bridge' design, permits to presume that it plays an important structural role, aimed to distribute tensile and compressive forces in various directions, conferring resilience properties to the cornea.

A notação logarítmica como opção de registro objetivo da estesiometria: um estudo piloto / THE LOGARITHMIC NUMBER AS AN OPTION OF OBJECTIVE REGISTRATION OF ESTESIOMETRY: A PILOT STUDY

Introdução: A Avaliação objetiva é um valioso recurso na pesquisa. Contudo, o estesiômetro provê informações por cores. Objetivo: Apresentar a conversão logarítmica dos valores nominais do estesiômetro como opção representativa de registro na avaliação de prejuízo tátil. Método: Estudo Piloto aprovado com parecer nº 1.337. 714, realizado de agosto de 2018 a julho de 2019. Valores nominais (gF) dos monofilamentos do estesiômetro foram convertidos em logaritmo, o procedimento serviu para o registro e o acompanhamento de pacientes cerebrovasculares em reabilitação (n=13), comparado ao controle (n=10), para notações de qualidade, acurácia e poder de inferências dos dados na representação do estado tátil. Statistical analysis performed by the GraphPad Prism 6.0 Program. Resultados: As opções numéricas trabalhadas conseguem representar a percepção da sensibilidade tátil, sendo que a conversão em logaritmo demonstra objetividade, sensibilidade, coerência e consistência para gerar mais inferências. Conclusão: A notação logarítmica para registro da sensibilidade é uma opção versátil de análise e interpretação dos dados na pesquisa em reabilitação.