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1.
Int J Toxicol ; 40(2): 143-152, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33530813

RESUMEN

Good Laboratory Practices (GLP) is a well-established global system that encompass a set of principles or a framework for defining how laboratory studies are planned, performed, monitored, recorded, reported, and stored for future reference. It is important that compliance with the principles of GLP continues to be maintained. Coronavirus disease 2019 (COVID-19) pandemic lockdowns in various countries, including India, have been sudden and over an extended duration. Although every GLP laboratory has Standard Operating Procedure for disaster management, the sudden lockdown due to COVID-19 created specific emergency procedures related to this situation such as travel bans, safe distancing, and work from home notifications. Good Laboratory Practice compliances in the context of animal experimentation during and post lockdown period need effective managerial responses that are not just flexible and innovative but can ensure they are well-calibrated to the challenges of business continuity and maintenance of health directives. On-the-ground realities suggest there may still be practical challenges to compliance, and guidelines may not always be complied with. This article discusses the issues that may be encountered due to COVID-19 that could potentially impact the GLP status of a study and suggests ways to manage them so as to minimize or prevent infection with COVID-19. We propose an MMM (Man, Material, and Medium) strategy to ensure compliance with health directives and guidelines that will help staff to keep themselves and others safe in the workplace while endeavoring to comply with GLP requirements.


Asunto(s)
/prevención & control , Control de Enfermedades Transmisibles/normas , Adhesión a Directriz , Laboratorios/normas , Lugar de Trabajo , Experimentación Animal , Animales , Humanos , Laboratorios/organización & administración , Pandemias
3.
Arch Pathol Lab Med ; 145(2): 201-207, 2021 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-33501495

RESUMEN

CONTEXT.­: Body fluid specimens are regularly submitted to the hematology laboratory for cell count and differential. Unless there is high clinical suspicion for malignancy, most cases lack concurrent cytology review and may not benefit from more focused examination for malignancy. OBJECTIVE.­: To compare rates of malignancy detection before and after fluid-focused training for hematology technologists as part of a quality improvement initiative. DESIGN.­: During an 8-week pretraining period, body fluids submitted to the cytology laboratory were correlated with concurrent hematology specimens. After slide review and training sessions for the hematology technologists, the same data were collected for a 4-week period. Discrepant cases were reviewed by hematology laboratory supervisors and pathologists. RESULTS.­: We collected 465 pretraining and 249 posttraining body fluids with concurrent cytology and hematology evaluation. In the pretraining cohort, 48 cases (10.3%) were diagnosed as malignant by cytology; of those, 33 were detected by hematology. In the posttraining cohort, 30 cases (12.0%) were diagnosed as malignant by cytology of which 27 were detected by hematology. Of the 18 discrepant cases (all carcinomas), hematology slide review showed definite features of malignancy in 15 and no tumor cells in 3. The malignancy detection rate by the hematology laboratory significantly improved after training (68.8% versus 90.0%, P = .01). CONCLUSIONS.­: We demonstrate the comparatively lower malignancy detection rate for body fluid specimens processed in our hematology laboratory, particularly for carcinomas. Hematology technologist education/training improved the malignancy detection rate, an important quality improvement given the large proportion of body fluids undergoing hematology evaluation without concurrent cytology reviews.


Asunto(s)
Líquidos Corporales/citología , Carcinoma/diagnóstico , Laboratorios/normas , Citodiagnóstico , Eritroblastos/citología , Pruebas Hematológicas , Hematología , Humanos , Mejoramiento de la Calidad , Manejo de Especímenes
4.
J Chromatogr A ; 1635: 461767, 2021 Jan 04.
Artículo en Inglés | MEDLINE | ID: mdl-33310281

RESUMEN

Asymmetric-flow field-flow fractionation (AF4) has been recognized as an invaluable tool for the characterisation of particle size, polydispersity, drug loading and stability of nanopharmaceuticals. However, the application of robust and high quality standard operating procedures (SOPs) is critical for accurate measurements, especially as these complex drug nanoformulations are most often inherently polydisperse. In this review we describe a unique international collaboration that lead to the development of a robust SOP for the measurement of physical-chemical properties of nanopharmaceuticals by multi-detector AF4 (MD-AF4) involving two state of the art infrastructures in the field of nanomedicine, the European Union Nanomedicine Characterization Laboratory (EUNCL) and the National Cancer Institute-Nanotechnology Characterisation Laboratory (NCI-NCL). We present examples of how MD-AF4 has been used for the analysis of key quality attributes, such as particle size, shape, drug loading and stability of complex nanomedicine formulations. The results highlight that MD-AF4 is a very versatile analytical technique to obtain critical information on a material particle size distribution, polydispersity and qualitative information on drug loading. The ability to conduct analysis in complex physiological matrices is an additional very important advantage of MD-AF4 over many other analytical techniques used in the field for stability studies. Overall, the joint NCI-NCL/EUNCL experience demonstrates the ability to implement a powerful and highly complex analytical technique such as MD-AF4 to the demanding quality standards set by the regulatory authorities for the pre-clinical safety characterization of nanomedicines.


Asunto(s)
Fraccionamiento de Campo-Flujo , Nanomedicina/métodos , Tamaño de la Partícula , Composición de Medicamentos/normas , Unión Europea , Humanos , Laboratorios/normas , Nanomedicina/normas , Nanotecnología , National Cancer Institute (U.S.) , Preparaciones Farmacéuticas/normas , Estados Unidos
5.
Glob Health Sci Pract ; 8(4): 689-698, 2020 12 23.
Artículo en Inglés | MEDLINE | ID: mdl-33361236

RESUMEN

BACKGROUND: Providing professional development opportunities to staff working in clinical laboratories undergoing quality improvement programs can be challenged by limited funding, particularly in resource-limited countries such as Cambodia. Using innovative approaches such as video conferencing can connect mentors with practitioners regardless of location. This study describes and evaluates the methods, outputs, and outcomes of a quality improvement program implemented in 12 public hospital laboratories in Cambodia between January 2018 and April 2019. The program used mixed intervention methods including both in-person and remote-access training and mentorship. METHODS: Training outputs were quantified from the activity reports of program trainers and mentors. Program outcomes were measured by pre- and postimplementation audits of laboratory quality management system conformity to international standards. Variations in improved outcomes were assessed in relation to the time spent by laboratory personnel in video conference training and mentoring activity. An additional cross-sectional comparison described the difference in final audit scores between participating and nonparticipating laboratories. RESULTS: Laboratories significantly improved their audit scores over the project period, showing significant improvement in all sections of the ISO 15189 standard. Pre- and postaudit score differences and laboratory personnel participation time in remote mentoring activities showed a strong monotonic relationship. Average input per laboratory was 6,027±2,454 minutes of participation in video conference activities with mentors. Audit scores of participating laboratories were significantly higher than those of laboratories with no quality improvement program. CONCLUSION: Laboratories improved significantly in ISO 15189 conformity following structured laboratory quality management systems training supported by remote and on-site mentoring. The correlation of laboratory participation in video conference activities highlights the utility of remote video conferencing technology to strengthen laboratories in resource-limited settings and to build communities of practice to address quality improvement issues in health care. These findings are particularly relevant in light of the COVID-19 pandemic.


Asunto(s)
Laboratorios/organización & administración , Tutoría/organización & administración , Mejoramiento de la Calidad/organización & administración , Comunicación por Videocoferencia/organización & administración , Cambodia , Estudios Transversales , Humanos , Laboratorios/normas , Mejoramiento de la Calidad/normas , Desarrollo de Personal/organización & administración , Estados Unidos
6.
Ann Biol Clin (Paris) ; 78(6): 655-664, 2020 Dec 01.
Artículo en Francés | MEDLINE | ID: mdl-33361016

RESUMEN

The lack of quality control for patient point-of-care (POC) INR devices is an issue that has led the French health authorities to make recommendations: a laboratory INR (lab INR) has to be performed at the same time as the POC INR every 6 months. However, the differences observed between the two INRs, POC and lab INRs, are not necessarily due to a failure of the POC INR device. We present here a review of the different causes of discrepancies between INR results, which are the basis of the proposals of the Groupe français d'études sur l'hémostase et la thrombose (GFHT) on the management of lab and POC INR discrepancies. Pre-analytical conditions may account for discrepancies (sampling, transport and storage conditions), as well as analytical factors (mainly the nature of the thromboplastin used) and the clinical context (inflammatory or autoimmune diseases, polycythaemia...). The interpretation of INR discrepancies is not always easy and these proposals aim at standardizing the procedure to be followed in order to make the most appropriate decision for the patient.


Asunto(s)
Técnicas de Laboratorio Clínico/normas , Relación Normalizada Internacional/métodos , Relación Normalizada Internacional/normas , Juego de Reactivos para Diagnóstico/normas , 4-Hidroxicumarinas/uso terapéutico , Anticoagulantes/uso terapéutico , Francia , Humanos , Indenos/uso terapéutico , Laboratorios/normas , Ensayos de Aptitud de Laboratorios/métodos , Ensayos de Aptitud de Laboratorios/normas , Estándares de Referencia , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Sociedades Científicas/normas , Trombosis/sangre , Trombosis/tratamiento farmacológico , Vitamina K/antagonistas & inhibidores , Vitamina K/uso terapéutico
7.
Zhongguo Xue Xi Chong Bing Fang Zhi Za Zhi ; 32(6): 631-634, 2020 Jul 31.
Artículo en Chino | MEDLINE | ID: mdl-33325200

RESUMEN

OBJECTIVE: To analyze the re-examination results of malaria cases captured from the National Notifiable Communicable Disease Reporting System in Hubei Provincial Malaria Diagnostic Reference Laboratory from 2017 to 2019, so as to pro- vide the scientific evidence for improving the malaria control capability in the province. METHODS: Microscopy and nested PCR assay were performed to re-examine the diagnosis of malaria cases registered in the National Notifiable Communicable Disease Reporting System in Hubei Provincial Malaria Diagnostic Reference Laboratory from 2017 to 2019, and the coincidences of ma- laria diagnosis and malaria parasite species were evaluated. RESULTS: A total of 410 malaria cases were reported in Hubei Province from 2017 to 2019 according to the data retrieved from the National Notifiable Communicable Disease Reporting System. Among the 407 samples re-examined by Hubei Provincial Malaria Diagnostic Reference Laboratory from 2017 to 2019, the diag- nosis 374 malaria cases were confirmed, with an overall coincidence of 91.89% (374/407) for malaria diagnosis and 89.04% (333/374) for parasite species identification. The coincidence rates of malaria diagnosis and parasite species identification were 50.00% to 100.00% and 66.67% to 100.00% in 16 cities (prefectures) of Hubei Province during the re-examinations, which both varied in regions (χ2 = 40.46 and 42.30, both P values < 0.01). The coincidence rates of Plasmodium falciparum, P. vivax, P. malariae and P. ovale identification were 95.80%, 100.00%, 58.33% and 51.92% during the re-examinations, respectively (χ2 = 76.66, P < 0.01). The consistency rate between microscopic and nested PCR results was 89.83% (362/403). CONCLUSIONS: The overall diagnostic quality of malaria is high in medical institutions at all levels in Hubei Province; however, the diagnostic capability of malaria remains to be improved in some regions.


Asunto(s)
Laboratorios/normas , Malaria , China , Pruebas Diagnósticas de Rutina , Humanos , Malaria/diagnóstico , Malaria/epidemiología , Plasmodium/clasificación
8.
J Occup Environ Hyg ; 17(10): 447-456, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32960737

RESUMEN

Bioaerosols are known to be an important transmission pathway for SARS-CoV-2. We report a framework for estimating the risk of transmitting SARS-CoV-2 via aerosols in laboratory and office settings, based on an exponential dose-response model and analysis of air flow and purification in typical heating, ventilation, and air conditioning (HVAC) systems. High-circulation HVAC systems with high-efficiency particulate air (HEPA) filtration dramatically reduce exposure to the virus in indoor settings, and surgical masks or N95 respirators further reduce exposure. As an example of our risk assessment model, we consider the precautions needed for a typical experimental physical science group to maintain a low risk of transmission over six months of operation. We recommend that, for environments where fewer than five individuals significantly overlap, work spaces should remain vacant for between one (high-circulation HVAC with HEPA filtration) to six (low-circulation HVAC with no filtration) air exchange times before a new worker enters in order to maintain no more than 1% chance of infection over six months of operation in the workplace. Our model is readily applied to similar settings that are not explicitly given here. We also provide a framework for evaluating infection mitigation through ventilation in multiple occupancy spaces.


Asunto(s)
Contaminación del Aire Interior/prevención & control , Infecciones por Coronavirus/transmisión , Laboratorios/normas , Modelos Estadísticos , Neumonía Viral/transmisión , Ventilación/normas , Lugar de Trabajo/normas , Aire Acondicionado/normas , Betacoronavirus , Infecciones por Coronavirus/epidemiología , Humanos , Salud Laboral , Pandemias , Neumonía Viral/epidemiología , Medición de Riesgo
9.
Am J Gastroenterol ; 115(10): 1575-1583, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32868631

RESUMEN

The American Neurogastroenterology and Motility Society Task Force recommends that gastrointestinal motility procedures should be performed in motility laboratories adhering to the strict recommendations and personal protective equipment (PPE) measures to protect patients, ancillary staff, and motility allied health professionals. When available and within constraints of institutional guidelines, it is preferable for patients scheduled for motility procedures to complete a coronavirus disease 2019 (COVID-19) test within 48 hours before their procedure, similar to the recommendations before endoscopy made by gastroenterology societies. COVID-19 test results must be documented before performing procedures. If procedures are to be performed without a COVID-19 test, full PPE use is recommended, along with all social distancing and infection control measures. Because patients with suspected motility disorders may require multiple procedures, sequential scheduling of procedures should be considered to minimize need for repeat COVID-19 testing. The strategies for and timing of procedure(s) should be adapted, taking into consideration local institutional standards, with the provision for screening without testing in low prevalence areas. If tested positive for COVID-19, subsequent negative testing may be required before scheduling a motility procedure (timing is variable). Specific recommendations for each motility procedure including triaging, indications, PPE use, and alternatives to motility procedures are detailed in the document. These recommendations may evolve as understanding of virus transmission and prevalence of COVID-19 infection in the community changes over the upcoming months.


Asunto(s)
Infecciones por Coronavirus/prevención & control , Gastroenterología/normas , Enfermedades Gastrointestinales/diagnóstico , Control de Infecciones/normas , Laboratorios/normas , Pandemias/prevención & control , Neumonía Viral/prevención & control , Comités Consultivos/normas , Betacoronavirus/patogenicidad , Técnicas de Laboratorio Clínico/normas , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/transmisión , Gastroenterología/métodos , Enfermedades Gastrointestinales/fisiopatología , Motilidad Gastrointestinal/fisiología , Humanos , Control de Infecciones/instrumentación , Transmisión de Enfermedad Infecciosa de Paciente a Profesional/prevención & control , Transmisión de Enfermedad Infecciosa de Profesional a Paciente/prevención & control , Selección de Paciente , Equipo de Protección Personal/normas , Neumonía Viral/diagnóstico , Neumonía Viral/epidemiología , Neumonía Viral/transmisión , Prevalencia , Sociedades Médicas/normas , Triaje/normas , Estados Unidos/epidemiología
12.
Ann Biol Clin (Paris) ; 78(4): 363-382, 2020 Aug 01.
Artículo en Inglés | MEDLINE | ID: mdl-32753365

RESUMEN

The point-of-care tests (POCT) are subject to accreditation. A national inventory survey provides a synthesis of knowledge. The survey distributed 31 questions in 2019. 147 responses were received (75% biologists, 49% CHU, 42% CHG). Only 20.41% are accredited ISO22870, the majority for <50% of the medical departments; 70% say they are going there at the end of 2019 or in 2020. The maps are unknown for 32% (EBMD) and 82% (TROD). Visibility is poor with: medical establishment committee (40%), IT department (31%). Connection is necessary for 87-95% depending on the criterion (QC, authorizations, etc.) and 66% of answers highlight that less than 50% of connexion is effective. The major advantage is the delay of the result (62.5%), then the relationship with the health teams (33.3%). The disadvantages: difficulty of the quality approach (45%), cost of tests (34.3%). Human resource requirements are identified for technicians (82%) and biologists (76%). The multiplicity of sites, devices and operators means that it is difficult to set up and maintain. Biology outside the laboratories, under biological responsibility, must meet a rigorous imperative quality approach.


Asunto(s)
Técnicas de Laboratorio Clínico , Salud Global , Laboratorios/estadística & datos numéricos , Laboratorios/normas , Pruebas en el Punto de Atención , Acreditación , Servicios de Laboratorio Clínico/normas , Servicios de Laboratorio Clínico/estadística & datos numéricos , Técnicas de Laboratorio Clínico/normas , Técnicas de Laboratorio Clínico/estadística & datos numéricos , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/epidemiología , Francia/epidemiología , Salud Global/normas , Salud Global/estadística & datos numéricos , Historia del Siglo XXI , Humanos , Internacionalidad , Ensayos de Aptitud de Laboratorios/normas , Pandemias , Neumonía Viral/diagnóstico , Neumonía Viral/epidemiología , Sistemas de Atención de Punto/normas , Sistemas de Atención de Punto/estadística & datos numéricos , Pruebas en el Punto de Atención/organización & administración , Pruebas en el Punto de Atención/normas , Pruebas en el Punto de Atención/estadística & datos numéricos , Garantía de la Calidad de Atención de Salud/organización & administración , Encuestas y Cuestionarios
13.
Indian J Pathol Microbiol ; 63(3): 350-357, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32769321

RESUMEN

Declared as a pandemic by WHO on March 11, 2020, COVID-19 has brought about a dramatic change in the working of different laboratories across the country. Diagnostic laboratories testing different types of samples play a vital role in the treatment management. Irrespective of their size, each laboratory has to follow strict biosafety guidelines. Different sections of the laboratory receive samples that are variably infectious. Each sample needs to undergo a proper and well-designed processing system so that the personnel involved are not infected and also their close contacts. It takes a huge effort so as to limit the risk of exposure of the working staff during the collection, processing, reporting or dispatching of biohazard samples. Guidelines help in preventing the laboratory staff and healthcare workers from contracting the disease which has a known human to human route of transmission and high rate of mortality. A well-knit approach is the need of the hour to combat this fast spreading disease. We anticipate that the guidelines described in this article will be useful for continuing safe work practices by all the laboratories in the country.


Asunto(s)
Contención de Riesgos Biológicos/métodos , Infecciones por Coronavirus/prevención & control , Infecciones por Coronavirus/transmisión , Exposición Profesional/prevención & control , Pandemias/prevención & control , Neumonía Viral/prevención & control , Neumonía Viral/transmisión , Manejo de Especímenes/métodos , Betacoronavirus , Desinfección/métodos , Guías como Asunto , Sustancias Peligrosas , Personal de Salud/normas , Humanos , Laboratorios/normas , Patólogos/normas , Administración de Residuos/métodos
14.
Sheng Wu Gong Cheng Xue Bao ; 36(7): 1459-1464, 2020 Jul 25.
Artículo en Chino | MEDLINE | ID: mdl-32748604

RESUMEN

The teaching laboratory is the central place to teach lab courses to undergraduate students. It is thus critical to evaluate how lab skills of students will be affected by the management of this lab. This study attempts to introduce the 6S concept, referring to "Seiri", "Seiton", "Seiso", "Seiketsu", "Shisuke", and "Safety", to the management of teaching laboratory, in particular, to the management of environments, safety, item deposition, reagents and consumables in the laboratory. We find that applying the "6S" management maintains a tidy lab environment, facilitates teaching the lab skills, and improves the quality of teaching, which together achieves the goal of education with the atmosphere. This study can provide a guideline for establishing and managing teaching laboratories in universities.


Asunto(s)
Educación , Laboratorios , Universidades , Educación/organización & administración , Educación/normas , Planificación Ambiental , Humanos , Laboratorios/organización & administración , Laboratorios/normas , Estudiantes , Universidades/organización & administración , Universidades/normas
15.
Artículo en Ruso | MEDLINE | ID: mdl-32827381

RESUMEN

The analysis of various needs in medical laboratory services among physicians of the Samara oblast is targeted to further improvement of laboratory service at oblast level. It is established that effectiveness of laboratory service depends on the needs of customer of service sector which are both physicians and patients. Ignoring their needs results in an increasing both of number of unsatisfied customers and level of mistrust individual operators and laboratory service itself. On the contrary, client-centric approach facilitates dialog of all participants of process of providing laboratory services.


Asunto(s)
Laboratorios/organización & administración , Laboratorios/normas , Médicos , Humanos , Federación de Rusia
16.
Acta Cytol ; 64(6): 597-606, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32829336

RESUMEN

BACKGROUND: The Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) offers a comprehensive range of External Quality Assurance programs for all disciplines of pathology and is committed to delivering programs to advance outcomes in patient care and promote excellence in laboratory diagnostic and technical proficiency. Proficiency testing in cytopreparatory techniques became available for formal enrolment in 2018. The 2019 technical program focused on the demonstration of a laboratory to troubleshoot problems encountered during staining and processing. The exercise provided a peer comparison of a laboratory's ability to (1) identify the problem viewed from a digital image and (2) describe the troubleshooting steps to rectify the problem using assessment guidelines. METHODS: Ten troubleshooting exercises including whole-slide z-stacked virtual images, a reference slide, and an online Result Entry questionnaire were provided. Common staining and processing problems were demonstrated in these exercises. Multiple-choice responses were made available to participants for each case with 1 response requiring submission. Participants were then allowed free text to describe how they would rectify the problem. RESULTS: Of the 72 participants who participated, 62 participants (86%) achieved a satisfactory assessment, 6 participants (8%) received a borderline assessment, and 4 participants (6%) received an unsatisfactory assessment. The average mark obtained was 32.7 out of a total of 45 marks, which equates to a satisfactory assessment. The highest mark obtained for this survey was 42.5. CONCLUSIONS: Quality cytopathology preparatory techniques are integral to mitigating the risk of diagnostic error. The digital pathology platform allowed homogeneity of samples for all participants and appeared to be a satisfactory mode for demonstrating the technical problems to participants. Laboratories participating in this survey showed good performance in identifying processing and staining problems on virtual images and working through the troubleshooting steps. The exercise also identified a method for troubleshooting formalin vapour-affected slides using citrate buffer which may be useful for laboratories following in-house validation.


Asunto(s)
Laboratorios/normas , Prueba de Papanicolaou/normas , Patología Clínica/normas , Garantía de la Calidad de Atención de Salud/normas , Pruebas Diagnósticas de Rutina , Femenino , Humanos , Control de Calidad , Coloración y Etiquetado/métodos , Frotis Vaginal/métodos
17.
Toxicol Lett ; 333: 242-250, 2020 Oct 15.
Artículo en Inglés | MEDLINE | ID: mdl-32841739

RESUMEN

The Buccal Micronucleus Cytome Assay (BMCyt) has become an important biomonitoring tool for assessing cytogenetic damage in many studied populations. Each laboratory applies protocols that vary according to the method of collecting and preparing samples. Besides, Brazil is a country of great territorial extensions that received immigrants from various parts of the world with different genetic backgrounds. Therefore, the present study aimed to evaluate the inter-laboratory variation in scoring the same set of slides using the more comprehensive scoring criteria, to standardize the BMCyt protocol, to observe the basal alterations in populations of different Brazilian regions and to compare it with other places around the world. Our results showed that a valuable number of laboratories participated, ten laboratories from different regions of the country, for the validation of the BMCyt in human biomonitoring studies, resulting in the 804 healthy individuals. This was possible because we observed: a range of measures needs to be considered, such as the baseline frequency of DNA damage and cell death in non-exposed individuals; age when grouped showed an influence on DNA damage, although when evaluated by group we did not see an influence; association between smoking habit and all endpoints of the BMCyt (except karyolytic cells) was evident; the basal MN frequency, in the majority of groups, follows those around the world; and the BMCyt was confirmed as a good health status biomarker. We emphasize the need for constant discussions on the parameters of cell death due to greater difficulty among the analyzers.


Asunto(s)
Bioensayo/normas , Núcleo Celular/genética , Células Epiteliales/ultraestructura , Laboratorios/normas , Micronúcleos con Defecto Cromosómico , Pruebas de Micronúcleos/normas , Mucosa Bucal/citología , Adolescente , Adulto , Bioensayo/métodos , Brasil , Muerte Celular/genética , Núcleo Celular/ultraestructura , Daño del ADN , Femenino , Humanos , Masculino , Micronúcleos con Defecto Cromosómico/estadística & datos numéricos , Pruebas de Micronúcleos/métodos , Persona de Mediana Edad , Mucosa Bucal/ultraestructura , Adulto Joven
20.
Ann Biol Clin (Paris) ; 78(4): 383-397, 2020 Aug 01.
Artículo en Inglés | MEDLINE | ID: mdl-32666924

RESUMEN

The SFBC-CNBH-CNRHP "Neonatal bilirubin" working group performed a biological and clinical study on bilirubin use in neonates for reliable diagnosis and appropriate management of neonatal jaundice. A brief report of a national survey on analytical and biological practices in France is shown. The guidelines of the French Society of Neonatology (SFN) founded the decision of phototherapy set up upon an accurate lab measurement of total serum bilirubin. An abacus is proposed with defined thresholds, as a function of neonate lifetime in hours. However, several studies evidenced poor comparability of results obtained with the different available methods. This situation is partly due to the lack of reference materials, especially for high bilirubin concentrations. Clinical consequences might be observed. We present in this paper the results of a national harmonization study to progress on this issue. Beyond the analytical aspects, the clinical consequences of harmonization defects were investigated. Finally, guidelines for clinical laboratories are proposed, to be locally adapted.


Asunto(s)
Pruebas Hematológicas/normas , Hiperbilirrubinemia Neonatal/diagnóstico , Ictericia Neonatal/diagnóstico , Tamizaje Neonatal/normas , Guías de Práctica Clínica como Asunto , Bilirrubina/sangre , Francia , Pruebas Hematológicas/métodos , Humanos , Hiperbilirrubinemia Neonatal/sangre , Hiperbilirrubinemia Neonatal/terapia , Recién Nacido , Ictericia Neonatal/sangre , Ictericia Neonatal/terapia , Laboratorios/normas , Ensayos de Aptitud de Laboratorios/normas , Tamizaje Neonatal/métodos , Fototerapia/métodos , Fototerapia/normas , Estándares de Referencia
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