Manual de procesos y procedimientos para análisis clínicos de muestras biológicas / Manual of processes and procedures for clinical analysis of biological simples

El presente manual de procesos y procedimientos documenta las principales actividades de atención integral que se ofrecen al usuario interno y externo para el análisis clínico de muestras biológicas, como parte del proceso de atención en salud integral e integrada a la persona en el curso de vida, describe el sistema de operación de los servicios ofrecidos para el análisis clínico de estas muestras en los establecimientos de salud, mediante el enfoque por procesos, fomentando el desarrollo organizacional y el mejoramiento continuo para el cumplimiento de la misión institucional

This manual of processes and procedures documents the main comprehensive care activities offered to the internal and external user for the clinical analysis of biological samples, as part of the process of comprehensive and integrated health care for the person in the course of life, describes the system of operation of the services offered for the clinical analysis of these samples in health establishments, through the process approach, fostering organizational development and continuous improvement for the fulfilment of the institutional misión

Development and Implementation of a Standard Format for Clinical Laboratory Test Results.

OBJECTIVES: Surprisingly, laboratory results, the principal output of clinical laboratories, are not standardized. Thus, laboratories frequently report results with identical meaning in different formats. For example, laboratories report a positive pregnancy test as "+," "P," or "Positive." To assess the feasibility of a widespread implementation of a result standard, we (1) developed a standard result format for common laboratory tests and (2) implemented a feedback system for clinical laboratories to view their unstandardized results. METHODS: In the largest integrated health care system in America, 130 facilities had the opportunity to collaboratively develop the standard. For 15 weeks, clinical laboratories received a weekly report of their unstandardized results. At the study's conclusion, laboratories were compared with themselves and their peers by metrics that reflected their unstandardized results. RESULTS: We rereviewed 156 million test results and observed a 51% decline in the rate of unstandardized results. The number of facilities with fewer than 23 unstandardized results per 100,000 (Six Sigma σ > 5) increased by 58% (52 to 82 facilities; ß = 1.79; P < .001). CONCLUSIONS: This study demonstrated significant improvement in the standardization of clinical laboratory results in a relatively short time. The laboratory community should create and promulgate a standardized result format.

Sense and nonsense concerning biotin interference in laboratory tests.

INTRODUCTION: Biotin supplementation (mainly OTC preparations) has gained popularity. There are concerns about biotin interference in immunoassays and potential misdiagnosis, especially since the discovery of high dose therapy in MS. This review summarizes the dangers of biotin usage and possible countermeasures. METHODS: Immunoassays design determines whether positive or negative analytical errors may occur. Techniques using biotinylated reagent and biotin binding proteins may generate errors. In sandwich immunoassays, biotin causes lowered results. Competitive immunoassays are more vulnerable: biotin usage causes false increased results. The interference is platform dependent. Parameters vary in their susceptibility: a combination of false positives and negatives mimicking a coherent profile is dangerous, e.g. combining falsely lowered TSH with falsely elevated FT4/FT3 mimicking hyperthyreosis. Other susceptible parameters are thyroglobulin, DHEA-S, estradiol, testosterone, ferritin, progesterone, Vitamin D, Vitamin B12, PSA, PTH, LH, FSH, Troponins I and T, Pro-BNP. Digoxin and PSA may also be affected. Tumor markers and ß-hCG are robust. Inserts of serological markers of HIV, hepatitis B and C warn for biotin interference. RESULTS: Manufacturers have made assays less vulnerable for biotin interference. In doubtful cases, it is helpful to determine testosterone in females and estrogen in males. Both are elevated if biotin interference is present. Biotin supplementation should be discontinued. However, this is impossible in MS patients needing biotin, as interrupting this medication is discouraged. CONCLUSIONS: Solutions to overcome this interference are: informing patients prior to analysis (avoiding peak biotin values when sampling), choice of appropriate immunoassays, and use of biotin removing steps prior to analysis.

Consideration for the validation of clinical laboratory methods in nonclinical fields.

In new drug development, cells or animals are treated with the selected candidate compound to confirm its efficacy and safety in nonclinical studies. Clinical laboratory tests are carried out using samples from experimental animals in these studies. The clinical laboratory test method validation in nonclinical fields should be conducted keeping in mind that the circumstances differ from those in clinical settings. However, the validation procedures have not been systematically integrated into any standard. The considerations in this paper set out systematically practical guidance for the validation of quantitative analytical methods for fluid samples collected from animal studies, for the purpose of ensuring that laboratory test method validation is conducted in nonclinical fields at an enough level.

Hipossuficiência de vitamina D em pacientes atendidos em um laboratório de análises clínicas de Salvador, Bahia / Vitamin D hypo-sufficiency in patients attended in a clinical analysis laboratory in Salvador city, Bahia

Objetivo: Avaliar a frequência de hipossuficiência em vitamina D em soteropolitanos atendidos em um laboratório de análises clínicas de Salvador entre os anos de 2015 e 2018. Métodos: Trata-se de um estudo de corte transversal, retrospectivo, com amostra de conveniência. Foram prospectados dados sobre a dosagem de 25-hidróxi-vitamina D (OH25) de pacientes atendidos no Laboratório de Análises Clínicas da Associação de Pais e Amigos dos Excepcionais (APAE). As análises estatísticas foram realizadas no software GraphPad Prism a partir da estratificação por níveis séricos de vitamina D, gênero, faixa etária e procedência do paciente. Os valores de referência utilizados na análise da vitamina D estão em consonância com as recomendações da Sociedade Brasileira de Endocrinologia. Resultados: Foram analisados 2.263 pacientes com idade entre 1 e 99 anos (mediana = 53; IQ= 35 e 64), sendo 82,39% do sexo feminino. Dentre as 1.863 mulheres analisadas, 602 (32,31%) desvelaram níveis deficientes e 731 (39,24%) insuficientes. Entre os homens, 105 (26,38%) foram categorizados como deficientes e 150 (37,69%) insuficientes. Crianças menores de 12 anos exibiram os maiores níveis de vitamina D (mediana = 32,69) e adultos com mais de 80 anos apresentaram os menores níveis (mediana = 20,95). Todos os grupos etários evidenciaram mais de 40% dos indivíduos com hipossuficiência em vitamina D. Conclusão: Os resultados deste trabalho ratificam um percentual elevado de hipovitaminose D em todas as faixas etárias, suscitando necessidade de reflexão pelos órgãos competentes sobre o ajuste dos valores de referência ou suplementação de vitamina D na população.

Objective: To assess the frequency of vitamin D hypo-sufficiency in patients at a clinical analysis laboratory in Salvador between the years 2015 and 2018. Methods: This is a cross-sectional study with a convenience sample. Data on the dosage of 25-hydroxy-vitamin D (OH25) from patients seen at the Clinical Analysis Laboratory of APAE were prospected. Statistical analyzes were performed using the GraphPad Prism software based on stratification by serum vitamin D levels, gender, age and origin of the patient. The reference values used in the analysis of vitamin D are in line with the recommendations of the Brazilian Society of Endocrinology. Results: 2,263 patients aged 1 to 99 years (median = 53; IQ = 35 and 64) were evaluated, 82.39% of whom were female. Among the 1,863 women analyzed, 602 (32.31%) revealed deficient levels and 731 (39.24%) insuficiente levels. Among men, 105 (26.38%) were categorized as deficient and 150 (37.69%) were insufficient. Children under 12 years old had the highest levels of vitamin D (median = 32.69) and adults over 80 years old had the lowest levels (median = 20.95). All age groups showed more than 40% of individuals with low vitamin D deficiency. Conclusion: The studied sample showed a high percentage of hypovitaminosis D, to be revealing the need for reflection by organs competent of vitamin D supplementation in the general population or the adjustment of reference values.

Laboratory approach to investigation of anemia in pregnancy.

Anemia is a global health problem in all age groups. According to World Health Organization (WHO), approximately 40% of pregnant women are anemic. Iron deficiency anemia (IDA) due to nutritional deficiency is the most common cause. The incidence of IDA varies worldwide depending on the socioeconomic status, but it remains the leading cause even in developed countries. Physiologic anemia of pregnancy due to relatively higher expansion of blood volume in comparison with elevated red blood cell mass also occurs frequently. Complete blood count (CBC) in the first trimester is recommended for all pregnant women to screen for anemia. The screening of pregnant women for IDA in absence of anemia is still debatable. If IDA is suspected, ferritin level of <30 ng/ml is diagnostic. Iron supplementation is recommended for all pregnant women to compensate the increased demand.

Parámetros de laboratorio clínico en pacientes con la COVID-19 / Clinical laboratory parameters in patients with COVID-19

Introducción: Conocer las alteraciones en exámenes de laboratorio clínico, es de utilidad en el diagnóstico y el progreso de pacientes con la COVID-19. Objetivo: Describir los parámetros de laboratorio clínico en pacientes diagnosticados con la COVID-19. Métodos: Estudio descriptivo en 82 pacientes hospitalizados con la COVID-19. Las variables analizadas fueron edad, sexo, comorbilidad, reporte de paciente, estado al egreso, hemoglobina, recuento de glóbulos blancos, conteo absoluto de neutrófilos, conteo absoluto de linfocitos, conteo de plaquetas, eritrosedimentación, dímero D, creatinina, urea, alanina aminotransferasa, aspartato aminotransferasa, #947;-glutamil transpeptidasa, fosfatasa alcalina, lactato deshidrogenasa, relación neutrófilos/ linfocitos y de plaquetas/ linfocitos. Resultados: La edad promedio fue de 55,61 ± 22,04, fue mayoría el sexo femenino (57,3 por ciento), hipertensos (41,5 por ciento), el 18,3 por ciento reportados de grave y el 14,6 por ciento falleció. La edad avanzada y la comorbilidad se asociaron al reporte de gravedad. Hubo disminución significativa de la hemoglobina, linfocitos; elevación de la eritrosedimentación, dímero D, creatinina, #947;-glutamil transpeptidasa y lactato deshidrogenasa, sobre todo en graves. La relación neutrófilos/ linfocitos y de plaquetas/ linfocitos alertaron sobre el agravamiento del paciente y la posibilidad de fallecer. Conclusiones: Los pacientes tenían una media de edad de 55,61, del sexo femenino, con hipertensión arterial; egresaron vivos, reportados de no graves. Disminuyen los valores medios de hemoglobina, conteo global de los linfocitos, sobre todo en graves; aumenta el dímero D, creatinina, ALT, AST, ALP, GGT, y LD. La relación neutrófilos/ linfocitos y de plaquetas/ linfocitos muestran valores medios altos, sobre todo en graves y en quienes fallecieron (AU)

Introduction: Knowing the alterations in clinical laboratory tests is useful in the diagnosis and progress of patients with COVID-19. Objective: To describe the clinical laboratory parameters in patients diagnosed with COVID-19. Methods: Descriptive study in 82 hospitalized patients with COVID-19. The variables analyzed were age, sex, comorbidity, patient report, discharge status, hemoglobin, white blood cell count, absolute neutrophil count, absolute lymphocyte count, platelet count, erythrocyte sedimentation rate, D-dimer, creatinine, urea, alanine aminotransferase, aspartate aminotransferase, γ-glutamyl transpeptidase, alkaline phosphatase, lactate dehydrogenase, neutrophil / lymphocyte and platelet / lymphocyte ratio. Results: The average age was 55.61 ± 22.04, the majority were female (57.3 percent), hypertensive (41.5 percent), 18.3 percent reported serious and 14.6 percent died. Advanced age and comorbidity were associated with the severity report. There was a significant decrease in hemoglobin, lymphocytes; elevated erythrocyte sedimentation rate, D-dimer, creatinine, γ-glutamyl transpeptidase, and lactate dehydrogenase, especially in severe patients. The neutrophil / lymphocyte and platelet / lymphocyte ratio warned about the worsening of the patient and the possibility of death. Conclusions: The patients a mean age of 55.61, female, with arterial hypertension; they were discharged alive, reported as not serious. Mean hemoglobin values ​​decrease, global lymphocyte count, especially in severe patients; increases D-dimer, creatinine, ALT, AST, ALP, GGT, and LD. The neutrophil / lymphocyte and platelet / lymphocyte ratio show high mean values, especially in severely ill patients and in those who died(AU)

Características clínico-epidemiológicas de pacientes cubanos residentes en La Habana afectados por la COVID-19 / Clinical-epidemiological characteristics of patients affected by COVID-19 residing in Havana

Introducción: La Habana fue el territorio más complejo a nivel nacional en el enfrentamiento al primer brote de la COVID-19. Su condición de capital, la densidad poblacional, la escasa delimitación geográfica entre sus municipios, el elevado flujo intermunicipal e interprovincial de personas, sumado a que es la provincia que mayor número de viajeros recibe procedentes del extranjero, confirieron a este territorio particularidades en el enfrentamiento a la pandemia. Objetivo: Determinar las principales características clínico-epidemiológicas de pacientes cubanos residentes en La Habana afectados por la COVID-19. Métodos: Se realizó un estudio observacional, analítico, de corte transversal. La muestra quedó formada por 431 pacientes, mayores de un año, de alta epidemiológica de la infección por SARS-CoV-2. Para la recolección de información se aplicó un cuestionario a través de una entrevista. Resultados: La edad promedio de la muestra fue de 45 años. Más de la mitad de los casos evolucionaron de modo sintomático (no grave o grave). La fiebre fue la manifestación clínica más frecuente. Los individuos incluidos en la muestra, con grupo sanguíneo O, o con antecedentes de asma, mostraron menos riesgo de presentar formas sintomáticas de la enfermedad. Conclusiones: Los resultados sugieren que la edad constituye el principal factor de riesgo para desarrollar formas sintomáticas (no graves o graves) de la COVID-19. De modo contrario, el grupo sanguíneo O y el antecedente de asma son factores de protección para estas formas de evolución clínica(AU)

Introduction: Havana city was the most complex territory at the national level facingthe first outbreak of COVID-19. Its condition of capital, the population density, the limited geographical delimitation between its municipalities, the high inter-municipal and inter-provincial flow of people, added to the fact that it is the province that receives the largest number of travelers from abroad, conferred particularities on this territory. Objective: To determine the main clinical-epidemiological characteristics of patients affected by COVID-19 living in Havana. Methods: An observational, analytical, cross-sectional study was carried out. The sample contained 431 patients, older than one year, with epidemiological discharge from the SARS-CoV-2 infection. To collect information, a questionnaire was applied through an interview. Results: The average age of the sample was 45 years. More than half of the cases evolved in a symptomatic way (not serious or serious). Fever was the most frequent clinical manifestation. The individuals included in the sample, with blood group O or with a background of asthma, showed less risk of presenting symptomatic forms of the disease. Conclusions: The results suggest that age is the main risk factor for developing symptomatic forms (not severe or severe) of COVID-19. On the contrary, blood group O and a history of asthma are protective factors for these forms of clinical evolution(AU)

Does the use of fish oil-based lipid emulsion in the clinical setting of total parenteral nutrition and lipid rescue therapy interfere with common laboratory analytes on Roche Cobas 6000?

BACKGROUND: Lipaemic interference on automated analysers has been widely studied using soy-based emulsion such as Intralipid. Due to the greater adoption of fish oil-based lipid emulsion for total parenteral nutrition in view of improved clinical outcomes, we seek to characterize the optical properties of SMOFlipid 20% (Fresenius Kabi, Bad Homburg, Germany), a fish oil-based emulsion, on the Roche Cobas 6000 chemistry analyser (Roche Diagnostic, Basel, Switzerland). METHOD: Various amounts of SMOFlipid were spiked into pooled serums. We plotted Roche Cobas Serum Index Gen.2 Lipaemia Index (L-index) against the amount of SMOFlipid added. We then studied the interference thresholds for aspartate aminotransferase, alanine aminotransferase, albumin and renal panel analytes using SMOFlipid. We subjected five levels of spiked lipaemia to high-speed centrifugation and analysed the specimens pre- and post-centrifugation. To postulate whether fish oil-based lipid emulsion interferes with laboratory results in the clinical setting, we calculated concentrations of SMOFlipid post-lipid rescue therapy and steady-state concentration of a typical total parenteral nutrition regime using pharmacokinetic principles. RESULTS: SMOFlipid optical behaviour is similar to Intralipid using the Serum Index Gen.2 L-index, with 1 mg/dL of SMOFlipid representing 1 unit of L-index. Manufacturer-stated interference thresholds are accurate for alanine aminotransferase, aspartate aminotransferase, albumin, urea and creatinine. High-speed centrifugation at 60 min 21,100g facilitates the removal of fish oil-based SMOFlipid. CONCLUSION: Based on the interference thresholds we verified and pharmacokinetics parameters provided by SMOFlipid manufacturer, total parenteral nutrition may not interfere with chemistry analytes given sufficient clearance, but lipid rescue therapy will interfere. Further studies assessing lipaemic interference on immunoassays are needed.

Síndrome Inflamatorio Sistémico Pediátrico Asociado a SARS-CoV-2 / Pediatric Systemic Inflammatory Syndrome Associated with SARS-CoV-2

La infección por SARS-CoV-2 es poco frecuente en niños, niñas y adolescentes, con manifestaciones clínicas leves o asintomáticos, pero desde abril del 2020, se han reportado niños gravemente enfermos en las zonas de mayor incidencia de infecciones por coronavirus, caracterizado por fiebre, síntomas gastrointestinales y marcadores de inflamación sistémica, compromiso cardiovascular importante (shock, disfunción miocárdica o miocarditis), con semejanzas a la Enfermedad de Kawasaki, tormenta de citoquinas y síndrome de activación macrofágica, denominado Síndrome Inflamatorio Multisistémico Pediátrico (PIMS/MIS-C). La patogénesis no se conoce exactamente, pero una respuesta inmune innata y adaptativa alterada asociada a autoinmunidad podría ser el mecanismo. Si bien no existe una guía terapéutica estandarizada, la mayoría de los pacientes reciben gamaglobulina intravenosa y corticoides sistémicos, y en algunos casos se requiere el uso inhibidores de interleuquinas. Se ha reportado una buena respuesta y mejoría en casi todos los niños, con una baja letalidad de 1,7-2%.

SARS-CoV-2 infection is rare in children and adolescents, with mild or asymptomatic clinical manifestations, but since April 2020, seriously ill children have been reported in areas with the highest incidence of coronavirus infections, characterized by fever, gastrointestinal symptoms and markers of systemic inflammation, significant cardiovascular compromise (shock, myocardial dysfunction or myocarditis), with similarities to Kawasaki disease, cytokine storm and macrophage activation syndrome, called Pediatric Multisystemic Inflammatory Syndrome (PIMS / MIS-C) ). The pathogenesis is not exactly known, but an altered innate and adaptive immune response associated with autoimmunity could be the mechanism. Although there is no standardized therapeutic guide, most patients receive intravenous gamma globulin and systemic corticosteroids, and in some cases the use of interleukin inhibitors is required. A good response and improvement has been reported in almost all children, with a low fatality rate of 1.7-2%.

The management of "fragile" and suspected COVID-19 surgical patients during pandemic: an Italian single-center experience.

BACKGROUND: During Coronavirus disease (COVID-19) pandemic entire countries rapidly ran out of intensive care beds, occupied by critically ill infected patients. Elective surgery was initially halted and acute non-deferrable surgical care drastically limited. The presence of COVID-19 patients into intensive care units (ICU) is currently decreasing but their congestion have restricted our therapeutic strategies during the last months. METHODS: In the COVID-19 era eighteen patients (8 men, 10 women) with a mean age of 80 years, needing undelayable abdominal surgery underwent awake open surgery at our Department. Prior to surgery, all patients underwent COVID-19 investigation. In all cases locoregional anesthesia (LA) was performed. Intraoperative and postoperative pain has been monitored and regularly assessed. A distinct pathway has been set up to keep patients of uncertain COVID-19 diagnosis separated from all other patients. RESULTS: Mean operative time was 104 minutes. In only one case conversion to general anesthesia was necessary. Postoperative pain was always well controlled. None of them required postoperative intensive care support. Only one perioperative complication occurred. Early readmissions after surgery were never observed. CONCLUSIONS: On the basis of our experience awake laparotomy under LA resulted feasible, safe, painless and, in specific cases, the only viable option. For patients presenting fragile cardiovascular and respiratory, reserves and in whom general anesthesia (GA) would presumably increase morbidity and mortality we encourage LA as an alternative to GA. In the COVID-19 era, it has become part of our ICU-preserving strategy allowing us to carry out undeferrable surgeries.

COVID-19 pandemic and biological therapy in rheumatologic disorders: how to deal with?

The outbreak of coronavirus disease 2019 (COVID-19) has involved more than 159 countries and more than 5 million people worldwide. A 40-year-old man with a history of rheumatoid arthritis treated with prednisolone, Disease-Modifying Anti-Rheumatic Drugs (DMARDs), and biologic agents was admitted with chief complaints of fever, chills, malaise, myalgia, and dyspnea. Chest computed tomography showed bilateral subsegmental atelectasis and diffuse ground-glass opacities in both lungs inducing the suspicion of COVID-19 infection. The oro-nasopharynx swab sample for COVID-19 polymerase chain reaction was positive. In addition to supportive care, lopinavir/ritonavir 400/100 mg twice daily and oseltamivir (75 mg) twice daily were started in combination with a starting dose of hydroxychloroquine (400 mg). The methotrexate dose was decreased, and the dose of prednisolone was increased to 30 mg for 10 days. Azathioprine and adalimumab were continued at previous doses. The use of biologic agents and DMARDs in rheumatic patients is a serious challenge in the COVID-19 pandemic. In conclusion, during the COVID-19 pandemic, due to the key roles of cytokines in the promotion of the disease, the rheumatic patients may benefit from continuing their previous treatment, which may have protective effects.

COVID-19: the novel coronavirus disease and its manifestations and management in ophthalmology.

Coronavirus disease 2019 (COVID-19), a newly identified acute respiratory disease caused by a strain of novel coronavirus (SARS-CoV-2), has become a worldwide pandemic. From December 2019 to present, millions of cases have been reported, bringing unprecedented pressure on both health and epidemic prevention services in every country. As frontline healthcare workers, ophthalmologists face an increased threat of viral infection, not only because of close contact with patients during examinations or operations, but also due to evidence showing that ocular fluids such as tears or conjunctival secretions may carry the virus. The risk that healthcare workers face is emphasized by the loss of our colleagues who have sacrificed themselves in combating the virus. As a result, it is necessary to have a comprehensive understanding of the threats that we face. In the first part of this review, we start by explaining the structure of SARS-CoV-2 and examining its transmission and means of infection. Next, we summarize the latest scientific advancements of epidemiology, clinical presentations, and current treatments of COVID-19. In the second half of the review, we emphasize the ocular transmission, symptomatic manifestations, and the essential knowledge in an ophthalmology clinic setting. As the pandemic of COVID-19 continues to pose a threat to global health, we hope that this review makes a contribution to combating COVID-19.

The first cohort of the COVID-19 patients in Vietnam and the national response to the pandemic.

The COVID-19 pandemic is a novel infectious disease pandemic with the agent SARS-CoV-2 virus which is currently affecting and causing damage globally. The outbreak has been crossing over 200 countries in the world. In the situation of the outbreak of COVID-19, Vietnam has first sixteen typical cases confirmed positive updated to Feb 28th, 2020. After completely applying the medical prevention and active control, Vietnam has the ability to take control of the outbreak of COVID-19 as a recent of WHO assessment. Vietnam has been reported as an effective country for prevention and control the outbreak of COVID-19. We retroactive reviewed our experience with 16 positive cases isolation. This article aims to present the first cohort of COVID-19 patients updated to Feb 28th, 2020 in Vietnam and sharing the national response to the pandemic.

Performance of the Kato-Katz method and real time polymerase chain reaction for the diagnosis of soil-transmitted helminthiasis in the framework of a randomised controlled trial: treatment efficacy and day-to-day variation.

BACKGROUND: Accurate, scalable and sensitive diagnostic tools are crucial in determining prevalence of soil-transmitted helminths (STH), assessing infection intensities and monitoring treatment efficacy. However, assessments on treatment efficacy comparing traditional microscopic to newly emerging molecular approaches such as quantitative Polymerase Chain Reaction (qPCR) are scarce and hampered partly by lack of an established diagnostic gold standard. METHODS: We compared the performance of the copromicroscopic Kato-Katz method to qPCR in the framework of a randomized controlled trial on Pemba Island, Tanzania, evaluating treatment efficacy based on cure rates of albendazole monotherapy versus ivermectin-albendazole against Trichuris trichiura and concomitant STH infections. Day-to-day variability of both diagnostic methods was assessed to elucidate reproducibility of test results by analysing two stool samples before and two stool samples after treatment of 160 T. trichiura Kato-Katz positive participants, partially co-infected with Ascaris lumbricoides and hookworm, per treatment arm (n = 320). As negative controls, two faecal samples of 180 Kato-Katz helminth negative participants were analysed. RESULTS: Fair to moderate correlation between microscopic egg count and DNA copy number for the different STH species was observed at baseline and follow-up. Results indicated higher sensitivity of qPCR for all three STH species across all time points; however, we found lower test result reproducibility compared to Kato-Katz. When assessed with two samples from consecutive days by qPCR, cure rates were significantly lower for T. trichiura (23.2 vs 46.8%), A. lumbricoides (75.3 vs 100%) and hookworm (52.4 vs 78.3%) in the ivermectin-albendazole treatment arm, when compared to Kato-Katz. CONCLUSIONS: qPCR diagnosis showed lower reproducibility of test results compared to Kato-Katz, hence multiple samples per participant should be analysed to achieve a reliable diagnosis of STH infection. Our study confirms that cure rates are overestimated using Kato-Katz alone. Our findings emphasize that standardized and accurate molecular diagnostic tools are urgently needed for future monitoring within STH control and/or elimination programmes.

A point-of-care selenium nanoparticle-based test for the combined detection of anti-SARS-CoV-2 IgM and IgG in human serum and blood.

COVID-19 is a widespread and highly contagious disease in the human population. COVID-19 is caused by SARS-CoV-2 infection. There is still a great demand for point-of-care tests for detection, epidemic prevention and epidemiological investigation, both now and after the epidemic. We present a lateral flow immunoassay kit based on a selenium nanoparticle-modified SARS-CoV-2 nucleoprotein, which detects anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human serum, and the results can be read by the naked eye in 10 minutes. We expressed and purified the SARS-CoV-2 nucleoprotein in HEK293 cells, with a purity of 98.14% and a concentration of 5 mg mL-1. Selenium nanoparticles were synthesized by l-ascorbic acid reduction of seleninic acid at room temperature. After conjugation with the nucleoprotein, a lateral flow kit was successfully prepared. The IgM and IgG detection limits of the lateral flow kit reached 20 ng mL-1 and 5 ng mL-1, respectively, in human serum. A clinical study sample comprising 90 COVID-19-diagnosed patients and 263 non-infected controls was used to demonstrate a sensitivity and specificity of 93.33% and 97.34%, respectively, based on RT-PCR and clinical results. No cross-reactions with rheumatoid factor and positive serum for anti-nuclear antibodies, influenza A, and influenza B were observed. Moreover, the lateral flow kit remained stable after storage for 30 days at 37 °C. Our results demonstrate that the selenium nanoparticle lateral flow kit can conveniently, rapidly, and sensitively detect anti-SARS-CoV-2 IgM and IgG in human serum and blood; it can also be suitable for the epidemiological investigation of COVID-19.

Vaginal delivery in women with COVID-19: report of two cases.

BACKGROUND: During the ongoing global outbreak of COVID-19, pregnant women who are susceptible to COVID-19 should be highly concerned. The issue of vertical transmission and the possibility of neonatal infection is a major concern. CASE PRESENTATION: Case 1: A 35-year-old pregnant woman with a gestational age of 37 weeks and 6 days was admitted to our hospital at the point of giving birth. Except for the abnormalities in her chest CT image, she was asymptomatic. She had an uncomplicated spontaneous vaginal delivery, and her infant was discharged home for isolation. Because of the positive result of the maternal swabs for SARS-CoV-2 obtained on the 2nd day after sampling, we transferred the mother to the designated hospital and followed up with her by telephone interviews. Luckily, it was confirmed on February 23 that the newborn did not develop any COVID-19 symptoms after observation for 14 days after birth. Case 2: Another pregnant woman, with a gestational age of 38 weeks and 2 days, was also admitted to our hospital because of spontaneous labor with cervical dilation of 5 cm. Since she had the typical manifestations of COVID-19, including cough, lymphopenia, and abnormal chest CT images, she was highly suspected of having COVID-19. Based on the experience from case 1, we helped the mother deliver a healthy baby by vaginal delivery. On the 2nd day after delivery, the maternal nasopharyngeal swab result was positive, while the infant's result was negative. CONCLUSION: There is still insufficient evidence supporting maternal-fetal vertical transmission for COVID-19-infected mothers in late pregnancy, and vaginal delivery may not increase the possibility of neonatal infection.

Factores asociados al estado nutricional de pacientes con ventilación mecánica artificial en unidad de cuidados intensivos / Factors associated to the nutritional status of patients with artificial mechanical ventilation in the intensive care unit

RESUMEN Introducción: la presencia de la ventilación mecánica, crea interrogantes vinculadas con la importancia de conocer la influencia del estado nutricional y su asociación con factores de riesgo. Objetivo: relacionar el estado nutricional según indicadores antropométricos agrupados con variables sociodemográficas, clínicas y de laboratorio. Las que fueron estudiadas en pacientes ventilados artificialmente al ingreso en Unidad de Cuidados Intensivos del Hospital Universitario "Celia Sánchez Manduley", durante los años 2017 al 2018. Materiales y método: se realizó un estudio observacional, analítico de cohorte prospectiva, con pacientes que cumplieron con los criterios de inclusión. Se utilizaron técnicas de estadística descriptiva, medidas de tendencia central y dispersión. El nivel de significación de se halló según p valor ≤ 0,05 a través de Chi cuadrado de Pearson (X2) y la prueba T de student. Resultados: el sexo masculino y la edad mayor de 60 años estuvieron significativamente asociados a los ventilados desnutridos. La medición de los indicadores bioquímicos aislados no fue significativamente útil para la evaluación del estado nutricional en estos pacientes. Conclusiones: la comorbilidad, las infecciones nosocomiales, la ventilación de mediana duración y las entidades clínicas neurológicas, predominaron con alta mortalidad al egreso, pero sin asociación significativa al estado nutricional (AU).

ABSTRACT Introduction: the presence of mechanical ventilation brings about questions related to the importance of knowing the influence of the nutritional status and its relation with risks factors. Objective: to establish a relationship of the nutritional status according to grouped anthropometric indicators with laboratory, clinical and socio-demographic variables that were studied in artificially ventilated patients when admitting them in the Intensive Care Unit of the University Hospital "Celia Sánchez Manduley", during 2017 and 2018. Materials and method: a cohort, prospective, analytical, observational study was carried out with patients who fulfilled the inclusion criteria. Different techniques of descriptive statistics were used, together of with measures of central tendency and dispersion. The level of significance was determined according to value p ≤ 0,05 by means of Pearson's Chi Squared (X2) and the student T test. Results: male sex and ages over 60 years were significantly associated to malnutritioned ventilated patients. Measuring isolated biochemical indicators was not significantly useful to assess nutritional status in these patients. Conclusions: comorbidity, nosocomial infections, average lasting ventilation, and neurological clinical entities predominated, with high mortality at discharging, but without significant association to the nutritional status (AU).

[Expert recommendations for the diagnosis and treatment of interstitial lung disease caused by novel coronavirus pneumonia].

COVID-19 is an acute infectious disease caused by a newly discovered coronavirus (SARS-CoV2). COVID-19 may manifest bilateral interstitial pneumonia on imaging. About 30%-60% of patients present varying degrees of interstitial changes, while most patients have a good prognosis. Since there's little practical instruct on treating interstitial lung disease (ILD) caused by COVID-19, we present this file as references for all the colleagues fighting with this disease. The primary findings on CT are bilateral, peripheral ground-glass opacities (GGO) and consolidation. Inter-/intra-lobular septal thickening are also common. Subpleural lines and traction bronchiectasis can be seen in some cases which indicate the presence of interstitial fibrosis. Images of severe cases are similar with those in advanced stage of nonspecific interstitial pneumonia (NSIP) and organizing pneumonia (OP). COVID-19 could present the typical two phases of diffuse alveolar damage: acute and proliferative phase on pathology. Massive pulmonary interstitial fibrosis may also be present. HRCT is the best radiological approach for the diagnosis and differential diagnosis of COVID-19, and to assess the presence of ILD. Periodical CT following-up is recommended for patients who present interstitial manifestations. Biomarkers such as KL-6, SP-D, RAGE may also helpful on evaluating the severity of interstitial fibrosis and therapeutic response. We do not suggest applying pulmonary function tests and 6-minute walking test on patients in active stage of the disease. The primary treatments in acute phase are antiviral therapy and supportive treatment. We do not suggest routine use of corticosteroids, while on patients with excessive activation of inflammatory response or rapid progression of lung lesions, a low to medium dosage of corticosteroids could be applied for a short course. Pirfenidone and Nintedanib are encouraged to apply on patients in reparative phase with evidence of progressing fibrosis. Low to medium dosage of corticosteroids is also feasible on patients with NSIP or OP manifestation in this phase, with a relatively longer course. Chinese traditional medicine and rehabilitation medicine may also helpful. Lung transplant surgery is an option for severe pulmonary fibrosis patients. Patients should receive CT following-up after be discharged from hospital, especially those whose pulmonary exudation is not well absorbed. We suggest a routine following-up on month 1, 4 and 10 after discharging, and an extended period for those who have developed irreversible interstitial fibrosis.

Patterns of COVID-19 testing and mortality by race and ethnicity among United States veterans: A nationwide cohort study.

BACKGROUND: There is growing concern that racial and ethnic minority communities around the world are experiencing a disproportionate burden of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19). We investigated racial and ethnic disparities in patterns of COVID-19 testing (i.e., who received testing and who tested positive) and subsequent mortality in the largest integrated healthcare system in the United States. METHODS AND FINDINGS: This retrospective cohort study included 5,834,543 individuals receiving care in the US Department of Veterans Affairs; most (91%) were men, 74% were non-Hispanic White (White), 19% were non-Hispanic Black (Black), and 7% were Hispanic. We evaluated associations between race/ethnicity and receipt of COVID-19 testing, a positive test result, and 30-day mortality, with multivariable adjustment for a wide range of demographic and clinical characteristics including comorbid conditions, health behaviors, medication history, site of care, and urban versus rural residence. Between February 8 and July 22, 2020, 254,595 individuals were tested for COVID-19, of whom 16,317 tested positive and 1,057 died. Black individuals were more likely to be tested (rate per 1,000 individuals: 60.0, 95% CI 59.6-60.5) than Hispanic (52.7, 95% CI 52.1-53.4) and White individuals (38.6, 95% CI 38.4-38.7). While individuals from minority backgrounds were more likely to test positive (Black versus White: odds ratio [OR] 1.93, 95% CI 1.85-2.01, p < 0.001; Hispanic versus White: OR 1.84, 95% CI 1.74-1.94, p < 0.001), 30-day mortality did not differ by race/ethnicity (Black versus White: OR 0.97, 95% CI 0.80-1.17, p = 0.74; Hispanic versus White: OR 0.99, 95% CI 0.73-1.34, p = 0.94). The disparity between Black and White individuals in testing positive for COVID-19 was stronger in the Midwest (OR 2.66, 95% CI 2.41-2.95, p < 0.001) than the West (OR 1.24, 95% CI 1.11-1.39, p < 0.001). The disparity in testing positive for COVID-19 between Hispanic and White individuals was consistent across region, calendar time, and outbreak pattern. Study limitations include underrepresentation of women and a lack of detailed information on social determinants of health. CONCLUSIONS: In this nationwide study, we found that Black and Hispanic individuals are experiencing an excess burden of SARS-CoV-2 infection not entirely explained by underlying medical conditions or where they live or receive care. There is an urgent need to proactively tailor strategies to contain and prevent further outbreaks in racial and ethnic minority communities.