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1.
Am J Emerg Med ; 39: 143-145, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33039212

RESUMO

Facing the novel coronavirus disease (COVID-19) pandemic, evidence to inform decision-making at all care levels is essential. Based on the results of a study by Petrilli et al., we have developed a calculator using patient data at admission to predict critical illness (intensive care, mechanical ventilation, hospice care, or death). We report a retrospective validation of the calculator on 145 consecutive patients admitted with COVID-19 to a single hospital in Israel. Despite considerable differences between the original and validation study populations, of 18 patients with critical illness, 17 were correctly identified (sensitivity: 94.4%, 95% CI, 72.7%-99.9%; specificity: 81.9%, 95% CI, 74.1%-88.2%). Of 127 patients with non-critical illness, 104 were correctly identified. Our results indicate that published knowledge can be reliably applied to assess patient risk, potentially reducing the cognitive burden on physicians, and helping policymakers better prepare for future needs.


Assuntos
/fisiopatologia , Técnicas de Laboratório Clínico/normas , Cuidados Críticos/organização & administração , Estado Terminal/terapia , Idoso , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Israel , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Medição de Risco/normas , Fatores de Risco
2.
CMAJ Open ; 8(4): E887-E894, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33355274

RESUMO

BACKGROUND: The prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among asymptomatic patients admitted to hospital has implications for personal protective equipment use, testing strategy and confidence in the safety of acute care services. Our aim was to estimate the positivity rate of reverse transcription polymerase chain reaction (RT-PCR) testing among people admitted to hospital without symptoms of coronavirus disease 2019 (COVID-19) in Alberta, Canada. METHODS: Between Apr. 9 and May 24, 2020, we screened for COVID-19 symptoms and tested for SARS-CoV-2 infection in all consecutive adult patients (≥ 18 yr) admitted via emergency department to 3 Alberta hospitals. We summarized the parameters of the epidemic curve and assessed the performance of symptom screening versus RT-PCR results on nasopharyngeal or oropharyngeal swab samples. RESULTS: The study period encompassed Alberta's initial epidemic curve, with peak active cases per 100 000 of 71.4 (0.07%) on Apr. 30, 2020, and 14.7 and 14.6 at the beginning (Apr. 9, 2020) and end (May 24, 2020), respectively. Testing for SARS-CoV-2 infection (64.9% throat and 35.1% nasopharyngeal swabs) was done on 3375 adults (mean age 51, standard deviation 21, yr; 51.5% men). None of the asymptomatic patients (n = 1814) tested positive, and 71 of those with symptoms tested positive (n = 1561; 4.5%, 95% confidence interval [CI] 3.6%-5.7%). Sensitivity of symptom screening (v. RT-PCR) was 100% (95% CI 95%-100%), and specificity was 55% (95% CI 53%-57%). Posttest probabilities for prevalence of SARS-CoV-2 infection ranging from 1.5 to 14 times the peak prevalence of active cases during the study did not change when we assumed lower sensitivity (92%). INTERPRETATION: In a region with low disease prevalence where protocolized symptom assessment was in place during the admission process, we did not identify people admitted to hospital without COVID-19 symptoms who were RT-PCR positive. There may not be additive benefit to universal testing of asymptomatic patients on hospital admission in a setting of low pretest probability and strong public health containment.


Assuntos
Doenças Assintomáticas/epidemiologia , Técnicas de Laboratório Clínico/normas , Serviço Hospitalar de Emergência/estatística & dados numéricos , Programas de Rastreamento/métodos , Melhoria de Qualidade , Alberta/epidemiologia , Comorbidade , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
3.
Zhongguo Xue Xi Chong Bing Fang Zhi Za Zhi ; 32(6): 627-630, 2020 Apr 08.
Artigo em Chinês | MEDLINE | ID: mdl-33325199

RESUMO

OBJECTIVE: To analyze the quality of malaria blood smears from fever patients in Zibo City from 2011 to 2018, so as to provide the scientific evidence for the development of the malaria post-elimination surveillance strategy. METHODS: All negative malaria blood smears from fever patients reexamined in the municipal microscopic examination station and all positive blood smears in Zibo City during the period from 2011 to 2018 were reexamined, and the blood smear preparation, dyeing, cleanliness and reexamination results were analyzed. RESULTS: A total of 2 141 negative malaria blood smears and 39 positive blood smears were re-reviewed by the municipal microscopic examination station of Zibo City from 2011 to 2018, with a 99.44% qualification rate of negative blood smears preparation, a 97.62% qualification rate of dyeing, a 93.65% qualification rate of cleanliness, and a 100% consistence with the re-review, and no missing diagnosis was found. A total of 39 positive blood smears were re-reviewed, with a 46.15% qualification rate of blood smears preparation, a 61.54% qualification rate of dyeing, a 76.92% qualification rate of cleanliness, and a 97.44% consistence with the re-review, and a blood smear mistaking the Plasmodium species was found. There were significant differences in the qualification rate of blood smears preparation and dyeing among all districts (counties) in Zibo City (all P values < 0.05), and no significant difference was detected in the qualification rate of blood smear cleanliness (χ2 = 13.72, P >0.05), while significant differences were seen in the qualification rate of blood smears preparation, dyeing and cleanliness each year from 2011 to 2018 (all P values < 0.05). CONCLUSIONS: The quality of malaria blood smears is high in all districts of Zibo City; however, the quality of city-level blood smears remains to be improved. Further actions to improve the training of grassroots microscopic examinations and quality control of malaria blood smears are required to ensure the capability of microscopic examinations of Plasmodium during the malaria post-elimination stage.


Assuntos
Sangue/parasitologia , Técnicas de Laboratório Clínico/normas , Malária/diagnóstico , Plasmodium , China , Cidades , Febre/parasitologia , Humanos , Malária/sangue , Microscopia
4.
Klin Lab Diagn ; 65(12): 778-784, 2020 Dec 29.
Artigo em Inglês | MEDLINE | ID: mdl-33373510

RESUMO

A literature review in the article presents an analysis of the influence of endogenous and exogenous factors on quality of preanalytical phase of laboratory testing. The review shows significance of external and internal factors influencing blood samples at preanalytical phase of laboratory testing. Among the exogenous factors considered: phlebotomy, test tubes for samples, transportation and storage. A number of factors exist at this phase that significantly affect test results. We examined these aspects of phlebotomy process: staff training, disinfectant contamination, needle diameter, needle material contamination. The review considers possible contamination with tube components and the importance of choosing the right anticoagulants and excipients. Transportation and storage of biological samples can be a source of errors at the preanalytical phase of laboratory testing. We analyzed the problem of determining the stability of analytes during storage and aspects of transportation samples by modern means. Among the endogenous factors considered: hemolysis, lipemia, icterricity, cell metabolism.. Hemolysis is one of the most frequent consequences of errors at the preanalytical phase. We analyzed importance of choosing a method for identifying hemolized tubes and the heterogeneity of bias results on different analytical systems. The review shows contribution of various classes of lipoproteins to turbidity of sample, possible preanalytical errors and impact on analytical tests. We examined possible effects of high bilirubin concentrations on analyte measurements. In the review, we also examined metabolism of some cells and its effect on samples.


Assuntos
Técnicas de Laboratório Clínico/normas , Fase Pré-Analítica , Técnicas de Laboratório Clínico/métodos , Hemólise , Humanos , Flebotomia , Manejo de Espécimes
5.
Ann Biol Clin (Paris) ; 78(6): 609-616, 2020 Dec 01.
Artigo em Francês | MEDLINE | ID: mdl-33361015

RESUMO

Confronted with the COVID-19 crisis, healthcare professionals have had to tackle an epidemic crisis of a huge magnitude for which they were not prepared. Medical laboratories have been on the front line, from collecting samples to performing the analysis required to diagnose this new pathology. Responding to the needs and to the urgency of the situation, the authorities relied on the network of private laboratories. In France, private laboratory medicine represents 70% of overall activity, and with a network of more than 4,000 local laboratories, private laboratory medicine has been the cornerstone of the « screen-trace-isolate ¼ strategy. This article gives feedback from private laboratory medicine professionals, directly involved in the reorganization carried out at the pre-analytical, analytical and post-analytical stages, during the crisis from March to October 2020.


Assuntos
/epidemiologia , Serviços de Laboratório Clínico/organização & administração , Pandemias , Setor Privado/organização & administração , Manejo de Espécimes/normas , /diagnóstico , Serviços de Laboratório Clínico/normas , Técnicas de Laboratório Clínico/instrumentação , Técnicas de Laboratório Clínico/métodos , Técnicas de Laboratório Clínico/normas , Infecção Hospitalar/epidemiologia , Infecção Hospitalar/prevenção & controle , Segurança de Equipamentos/métodos , Segurança de Equipamentos/normas , França/epidemiologia , Unidades Hospitalares/organização & administração , Humanos , Colaboração Intersetorial , Corpo Clínico/organização & administração , Corpo Clínico/normas , Segurança do Paciente/normas , Fase Pré-Analítica/métodos , Fase Pré-Analítica/normas , Setor Privado/normas , Manejo de Espécimes/métodos
6.
Sci Rep ; 10(1): 18899, 2020 11 03.
Artigo em Inglês | MEDLINE | ID: mdl-33144632

RESUMO

Severe acute respiratory coronavirus 2 (SARS-CoV-2) testing reagents are expected to become scarce worldwide. However, little is known regarding whether pooling of samples accurately detects SARS-CoV-2. To validate the feasibility of pooling samples, serial dilution analysis and spike-in experiments were conducted using synthetic DNA and nucleic acids extracted from SARS-CoV-2-positive and -negative patients. Furthermore, we studied 1000 individuals, 667 of whom were "healthy" individuals (195 healthcare workers and 472 hospitalized patients with disorders other than COVID-19 infection), and 333 infection-suspected patients with cough and fever. Serial dilution analysis showed a limit of detection of around 10-100 viral genome copies according to the protocol of the National Institute of Infectious Diseases, Japan. Spike-in experiments demonstrated that RT-qPCR detected positive signals in pooled samples with SARS-CoV-2-negative and -positive patients at 5-, 10-, 20-fold dilutions. By screening with this pooling strategy, by the end of April 2020 there were 12 SARS-CoV-2-positive patients in 333 infection-suspected patients (3.6%) and zero in 667 "healthy" controls. We obtained these results with a total of 538 runs using the pooling strategy, compared with 1000 standard runs. In a prospective study, we successfully detected SARS-CoV-2 using 10- to 20-fold diluted samples of nasopharyngeal swabs from eighteen COVID-19 patients with wide ranges of viral load. Pooling sample is feasible for conserving test reagents and detecting SARS-CoV-2 in clinical settings. This strategy will help us to research the prevalence infected individuals and provide infected-status information to prevent the spread of the virus and nosocomial transmission.


Assuntos
Técnicas de Laboratório Clínico/métodos , Programas de Rastreamento/métodos , Reação em Cadeia da Polimerase Via Transcriptase Reversa/métodos , Betacoronavirus/genética , Betacoronavirus/patogenicidade , Técnicas de Laboratório Clínico/normas , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Humanos , Limite de Detecção , Programas de Rastreamento/normas , Reprodutibilidade dos Testes , Mucosa Respiratória/virologia , Reação em Cadeia da Polimerase Via Transcriptase Reversa/normas
8.
World J Gastroenterol ; 26(40): 6270-6278, 2020 Oct 28.
Artigo em Inglês | MEDLINE | ID: mdl-33177799

RESUMO

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, mostly causing respiratory symptoms, is also known to affect the gastrointestinal tract. Several case reports hypothesize that SARS-CoV-2 could be an etiological factor in acute pancreatitis (AP). AIM: To assess all the available evidence in the literature relating to coronavirus disease 2019 (COVID-19) and AP. METHODS: We performed a systematic review of the available literature on the topic. The systematic search was conducted on 15 May 2020 on MEDLINE, EMBASE, CENTRAL, Web of Science and Scopus with a search key using the terms "amylase," "lipase," "pancr*," "COVID-19" and synonyms. Due to the low quality and poor comparability of the studies, a meta-analysis was not performed. RESULTS: Six case reports and two retrospective cohorts were included, containing data on eleven COVID-19 patients with AP. Five patients had AP according to the Atlanta classification. Other publications did not provide sufficient information on the diagnostic criteria. Most cases were considered SARS-CoV-2-induced, while several established etiological factors were not investigated. We were able to identify other possible causes in most of them. CONCLUSION: We strongly highlight the need for adherence to the guidelines during a diagnostic and etiological workup, which could alter therapy.


Assuntos
Betacoronavirus/isolamento & purificação , Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/diagnóstico , Pancreatite/virologia , Pneumonia Viral/diagnóstico , Doença Aguda , Técnicas de Laboratório Clínico/normas , Infecções por Coronavirus/complicações , Fidelidade a Diretrizes , Humanos , Pandemias , Pneumonia Viral/complicações , Guias de Prática Clínica como Assunto
9.
Eur Rev Med Pharmacol Sci ; 24(21): 11445-11454, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33215472

RESUMO

In Italy, SARS-CoV-2 outbreak registered a high transmission and disease rates. During the acute phase, oncologists provided to re-organize services and prioritize treatments, in order to limit viral spread and to protect cancer patients. The progressive reduction of the number of infections has prompted Italian government to gradually loosen the national confinement measures and to start the "Second phase" of measures to contain the pandemic. The issue on how to organize cancer care during this post-acute SARS-CoV-2 phase appears crucial and a reassessment of healthcare services is needed requiring new models of care for oncological patients. In order to address major challenges in cancer setting during post-acute SARS-CoV-2 phase, this work offers multidimensional solutions aimed to provide a new way to take care of cancer patients.


Assuntos
Controle de Doenças Transmissíveis/organização & administração , Infecções por Coronavirus/prevenção & controle , Oncologia/organização & administração , Modelos Organizacionais , Neoplasias/terapia , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Betacoronavirus/patogenicidade , Técnicas de Laboratório Clínico/normas , Controle de Doenças Transmissíveis/normas , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/transmissão , Serviços Hospitalares de Assistência Domiciliar/organização & administração , Serviços Hospitalares de Assistência Domiciliar/normas , Humanos , Itália/epidemiologia , Oncologia/normas , Neoplasias/diagnóstico , Pneumonia Viral/diagnóstico , Pneumonia Viral/epidemiologia , Pneumonia Viral/transmissão , Triagem/organização & administração , Triagem/normas
11.
BMJ ; 371: m4262, 2020 11 11.
Artigo em Inglês | MEDLINE | ID: mdl-33177070

RESUMO

OBJECTIVE: To assess the accuracy of the AbC-19 Rapid Test lateral flow immunoassay for the detection of previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. DESIGN: Test accuracy study. SETTING: Laboratory based evaluation. PARTICIPANTS: 2847 key workers (healthcare staff, fire and rescue officers, and police officers) in England in June 2020 (268 with a previous polymerase chain reaction (PCR) positive result (median 63 days previously), 2579 with unknown previous infection status); and 1995 pre-pandemic blood donors. MAIN OUTCOME MEASURES: AbC-19 sensitivity and specificity, estimated using known negative (pre-pandemic) and known positive (PCR confirmed) samples as reference standards and secondly using the Roche Elecsys anti-nucleoprotein assay, a highly sensitive laboratory immunoassay, as a reference standard in samples from key workers. RESULTS: Test result bands were often weak, with positive/negative discordance by three trained laboratory staff for 3.9% of devices. Using consensus readings, for known positive and negative samples sensitivity was 92.5% (95% confidence interval 88.8% to 95.1%) and specificity was 97.9% (97.2% to 98.4%). Using an immunoassay reference standard, sensitivity was 94.2% (90.7% to 96.5%) among PCR confirmed cases but 84.7% (80.6% to 88.1%) among other people with antibodies. This is consistent with AbC-19 being more sensitive when antibody concentrations are higher, as people with PCR confirmation tended to have more severe disease whereas only 62% (218/354) of seropositive participants had had symptoms. If 1 million key workers were tested with AbC-19 and 10% had actually been previously infected, 84 700 true positive and 18 900 false positive results would be projected. The probability that a positive result was correct would be 81.7% (76.8% to 85.8%). CONCLUSIONS: AbC-19 sensitivity was lower among unselected populations than among PCR confirmed cases of SARS-CoV-2, highlighting the scope for overestimation of assay performance in studies involving only PCR confirmed cases, owing to "spectrum bias." Assuming that 10% of the tested population have had SARS-CoV-2 infection, around one in five key workers testing positive with AbC-19 would be false positives. STUDY REGISTRATION: ISRCTN 56609224.


Assuntos
Técnicas de Laboratório Clínico/normas , Infecções por Coronavirus/diagnóstico , Imunoensaio/normas , Pneumonia Viral/diagnóstico , Betacoronavirus , Feminino , Bombeiros , Pessoal de Saúde , Humanos , Masculino , Pandemias , Polícia , Valor Preditivo dos Testes , Kit de Reagentes para Diagnóstico/normas , Sensibilidade e Especificidade , Reino Unido
12.
Genes (Basel) ; 11(10)2020 10 12.
Artigo em Inglês | MEDLINE | ID: mdl-33053675

RESUMO

WHO declared the novel coronavirus (COVID-19) outbreak a global pandemic on 11 March 2020. The establishment of standardized RT-qPCR protocols for respiratory secretions testing, as well as sharing of specimens, data, and information became critical. Here, we investigate the analytical performance of two interim RT-qPCR protocols (Charité and Centers for Disease Control (CDC)) for the qualitative detection of SARS-CoV-2 executed in a fully automated platform. Analytical specificity, PCR amplification efficiency, analytical sensitivity (limit of detection), and cross-reactivity were evaluated using contrived samples. The on-going accuracy was evaluated by retrospective analysis of our test results database (real clinical samples). N1, E, and a modified version of RdRP assays presented adequate analytical specificity, amplification efficiency, and analytical sensitivity using contrived samples. The three assays were applied to all individuals who requested the SARS-CoV-2 molecular test assay in our laboratory and it was observed that N1 gave more positive results than E, and E gave more positive results than RdRP (modified). The RdRP and E were removed from the test and its final version, based on N1 assay only, was applied to 30,699 Brazilian individuals (from 19 February 2020 to 8 May 2020). The aggregated test results available in the database were also presented.


Assuntos
Automação Laboratorial/normas , Técnicas de Laboratório Clínico/normas , Reação em Cadeia da Polimerase em Tempo Real/normas , Reação em Cadeia da Polimerase Via Transcriptase Reversa/normas , Automação Laboratorial/métodos , Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/diagnóstico , Humanos , Limite de Detecção , Reação em Cadeia da Polimerase em Tempo Real/métodos , Reprodutibilidade dos Testes , Reação em Cadeia da Polimerase Via Transcriptase Reversa/métodos
13.
Emerg Microbes Infect ; 9(1): 2358-2360, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33054582

RESUMO

Under the ongoing COVID-19 prevention and control measures in China, increasing the laboratory severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid testing capacity has become the top priority. Since the COVID-19 outbreak in Xinfadi market in Beijing in June 2020, large-scale screening of key populations has been carried out, challenging the nucleic acid testing capabilities of hospital laboratories. Therefore, within 48 hours, Peking University People's Hospital (PKUPH) transformed a non-nucleic acid testing laboratory into a SARS-CoV-2 nucleic acid testing laboratory. Based on the original structure of the building, we adapted measures to local conditions, sorted out a new testing process, and quickly started testing for COVID-19. The nucleic acid testing process has been optimized, including quality control, personal operating specifications, and the timeliness of the release of LIS results to form closed-loop management. This high-throughput COVID-19 testing optimization process provides a reference model for other countries that are fighting the epidemic.


Assuntos
Betacoronavirus/genética , Técnicas de Laboratório Clínico/normas , Infecções por Coronavirus/virologia , Pneumonia Viral/virologia , Reação em Cadeia da Polimerase/normas , RNA Viral/genética , Pequim/epidemiologia , Betacoronavirus/isolamento & purificação , Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/diagnóstico , Ensaios de Triagem em Larga Escala , Hospitais Gerais/estatística & dados numéricos , Humanos , Pandemias , Pneumonia Viral/diagnóstico , Reação em Cadeia da Polimerase/métodos
14.
PLoS One ; 15(10): e0240783, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33057403

RESUMO

BACKGROUND: Understanding and monitoring the demographics of SARS-CoV-2 infection can inform strategies for prevention. Surveillance monitoring has suggested that the age distribution of people infected with SARS-CoV-2 has changed since the pandemic began, but no formal analysis has been performed. METHODS: Retrospective review of SARS-CoV-2 molecular testing results from a national reference laboratory was performed. Result distributions by age and positivity were compared between early period (March-April 2020) and late periods (June-July 2020) of the COVID-19 pandemic. Additionally, a sub-analysis compared changing age distributions between inpatients and outpatients. RESULTS: There were 277,601 test results of which 19320 (7.0%) were positive. The median age of infected people declined over time (p < 0.0005). In March-April, the median age of positive people was 40.8 years (Interquartile range (IQR): 29.0-54.1). In June-July, the median age of positive people was 35.8 years (IQR: 24.0-50.2). The positivity rate of patients under 50 increased from 6.0 to 10.6 percent and the positivity rate for those over 50 decreased from 6.3 to 5.0 percent between the early and late periods. The trend was only observed for outpatient populations. CONCLUSIONS: We confirm that there is a trend toward decreasing age among persons with laboratory-confirmed SARS-CoV-2 infection, but that these trends seem to be specific to the outpatient population. Overall, this suggests that observed age-related trends are driven by changes in testing patterns rather than true changes in the epidemiology of SARS-CoV-2 infection. This calls for caution in interpretation of routine surveillance data until testing patterns stabilize.


Assuntos
Técnicas de Laboratório Clínico/estatística & dados numéricos , Infecções por Coronavirus/epidemiologia , Monitoramento Epidemiológico , Pneumonia Viral/epidemiologia , Adolescente , Adulto , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Técnicas de Laboratório Clínico/normas , Infecções por Coronavirus/diagnóstico , Humanos , Lactente , Pessoa de Meia-Idade , Pandemias , Estados Unidos
15.
PLoS Comput Biol ; 16(10): e1008388, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-33057438

RESUMO

A stochastic compartmental network model of SARS-CoV-2 spread explores the simultaneous effects of policy choices in three domains: social distancing, hospital triaging, and testing. Considering policy domains together provides insight into how different policy decisions interact. The model incorporates important characteristics of COVID-19, the disease caused by SARS-CoV-2, such as heterogeneous risk factors and asymptomatic transmission, and enables a reliable qualitative comparison of policy choices despite the current uncertainty in key virus and disease parameters. Results suggest possible refinements to current policies, including emphasizing the need to reduce random encounters more than personal contacts, and testing low-risk symptomatic individuals before high-risk symptomatic individuals. The strength of social distancing of symptomatic individuals affects the degree to which asymptomatic cases drive the epidemic as well as the level of population-wide contact reduction needed to keep hospitals below capacity. The relative importance of testing and triaging also depends on the overall level of social distancing.


Assuntos
Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/transmissão , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Pneumonia Viral/transmissão , Isolamento Social , Betacoronavirus , Técnicas de Laboratório Clínico/normas , Controle de Doenças Transmissíveis , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Serviço Hospitalar de Emergência , Hospitais/normas , Humanos , Modelos Teóricos , Pneumonia Viral/epidemiologia , Políticas , Fatores de Risco
16.
PLoS One ; 15(10): e0240779, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33057446

RESUMO

The practicability of a prototype capillary whole-blood IgG-IgM COVID-19 self-test (Exacto® COVID-19 self-test, Biosynex Swiss SA, Freiburg, Switzerland) as a serological screening tool for SARS-CoV-2 infection adapted to the general public was evaluated in a cross-sectional, general adult population study performed between April and May 2020 in Strasbourg, France, consisting of face-to-face, paper-based, semi-structured, and self-administrated questionnaires. Practicability was defined as the correct use of the self-test and the correct interpretation of the result. The correct use of self-test was conditioned by the presence of the control band after 15-min of migration. The correct interpretation of the tests was defined by the percent agreement between the tests results read and interpret by the participants compared to the expected results coded by the numbers and verified by trained observers. A total of 167 participants (52.7% female; median age, 35.8 years; 82% with post-graduate level) were enrolled, including 83 and 84 for usability and test results interpretation substudies, respectively. All participants (100%; 95% CI: 95.6-100) correctly used the self-test. However, 12 (14.5%; 95% CI: 8.5-23.6) asked for verbal help. The percent agreement between the tests results read and interpret by the participants compared to the expected results was 98.5% (95% CI: 96.5-99.4). However, misinterpretation occurred in only 2.3% of positive and 1.2% of invalid test results. Finally, all (100%) participants found that performing the COVID-19 self-test was easy; and 98.8% found the interpretation of the self-test results easy. Taken together, these pilot observations demonstrated for the first-time, high practicability and satisfaction of COVID-19 self-testing for serological IgG and IgM immune status, indicating its potential for use by the general public to complete the arsenal of available SARS-CoV-2 serological assays in the urgent context of the COVID-19 epidemic.


Assuntos
Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/diagnóstico , Pneumonia Viral/diagnóstico , Kit de Reagentes para Diagnóstico/normas , Adulto , Técnicas de Laboratório Clínico/normas , Infecções por Coronavirus/sangue , Feminino , Humanos , Imunoglobulina G/sangue , Imunoglobulina M/sangue , Masculino , Programas de Rastreamento/métodos , Programas de Rastreamento/normas , Pandemias , Pneumonia Viral/sangue , Testes Imediatos , Autoadministração , Sensibilidade e Especificidade
17.
PLoS Biol ; 18(10): e3000896, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-33006983

RESUMO

The ongoing COVID-19 pandemic has created an unprecedented need for rapid diagnostic testing. The World Health Organization (WHO) recommends a standard assay that includes an RNA extraction step from a nasopharyngeal (NP) swab followed by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) to detect the purified SARS-CoV-2 RNA. The current global shortage of RNA extraction kits has caused a severe bottleneck to COVID-19 testing. The goal of this study was to determine whether SARS-CoV-2 RNA could be detected from NP samples via a direct RT-qPCR assay that omits the RNA extraction step altogether. The direct RT-qPCR approach correctly identified 92% of a reference set of blinded NP samples (n = 155) demonstrated to be positive for SARS-CoV-2 RNA by traditional clinical diagnostic RT-qPCR that included an RNA extraction. Importantly, the direct method had sufficient sensitivity to reliably detect those patients with viral loads that correlate with the presence of infectious virus. Thus, this strategy has the potential to ease supply choke points to substantially expand COVID-19 testing and screening capacity and should be applicable throughout the world.


Assuntos
Betacoronavirus/genética , Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/diagnóstico , Pneumonia Viral/diagnóstico , RNA Viral/genética , Kit de Reagentes para Diagnóstico/normas , Reação em Cadeia da Polimerase Via Transcriptase Reversa/normas , Betacoronavirus/patogenicidade , Técnicas de Laboratório Clínico/normas , Infecções por Coronavirus/virologia , Primers do DNA/normas , Humanos , Nasofaringe/virologia , Pandemias , Pneumonia Viral/virologia , Sensibilidade e Especificidade , Estados Unidos , Carga Viral
18.
Biomed Eng Online ; 19(1): 75, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33008462

RESUMO

BACKGROUND: The world is facing an unprecedented outbreak affecting all aspects of human lives which is caused by the COVID-19 pandemic. Due to the virus novelty, healthcare systems are challenged by a high rate of patients and the shortage of medical products. To address an increased need for essential medical products, national authorities, worldwide, made various legislative concessions. This has led to essential medical products being produced by automotive, textile and other companies from various industries and approved under the emergency use authorizations or legal concessions of national regulatory bodies. This paper presents a narrative commentary of the available documentation on emergency use authorizations and legal concessions for medical products during COVID-19 pandemic. METHODOLOGY: The basis for narrative commentary includes scientific articles published in Web of Science, Scopus, PubMed and Embase databases, official publications of international organizations: Food and Drug Agency (FDA), World Health Organisation (WHO), World Bank and United Nations (UN), and national regulatory agency reports in native languages (English, German, Bosnian, and Croatian) published from November 1, 2019 to May 1, 2020. This paper focuses on three types of essential medical products: mechanical ventilators, personal protective equipment (PPE) and diagnostic tests. Evidence-informed commentary of available data and potential identified risks of emergency use authorizations and legal concessions is presented. DISCUSSION: It is recognized that now more than ever, raising global awareness and knowledge about the importance of respecting the essential requirements is needed to guarantee the appropriate quality, performance and safety of medical products, especially during outbreak situation, such as the COVID-19 pandemic. Emergency use authorizations for production, import and approval of medical products should be strictly specified and clearly targeted from case to case and should not be general or universal for all medical products, because all of them are associated with different risk level. CONCLUSION: Presented considerations and experiences should be taken as a guide for all possible future outbreak situations to prevent improvised reactions of national regulatory bodies.


Assuntos
Betacoronavirus , Comércio/legislação & jurisprudência , Infecções por Coronavirus , Licenciamento/legislação & jurisprudência , Indústria Manufatureira/legislação & jurisprudência , Pandemias , Equipamento de Proteção Individual/provisão & distribução , Pneumonia Viral , Kit de Reagentes para Diagnóstico/provisão & distribução , Ventiladores Mecânicos/provisão & distribução , Técnicas de Laboratório Clínico/normas , Infecções por Coronavirus/diagnóstico , Falha de Equipamento , União Europeia , Saúde Global , Humanos , Equipamento de Proteção Individual/normas , Kit de Reagentes para Diagnóstico/normas , Medição de Risco , Estados Unidos , United States Food and Drug Administration , Ventiladores Mecânicos/normas
19.
PLoS Biol ; 18(10): e3000867, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-33027248

RESUMO

The current quantitative reverse transcription PCR (RT-qPCR) assay recommended for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing in the United States requires analysis of 3 genomic targets per sample: 2 viral and 1 host. To simplify testing and reduce the volume of required reagents, we devised a multiplex RT-qPCR assay to detect SARS-CoV-2 in a single reaction. We used existing N1, N2, and RP primer and probe sets by the Centers for Disease Control and Prevention, but substituted fluorophores to allow multiplexing of the assay. The cycle threshold (Ct) values of our multiplex RT-qPCR were comparable to those obtained by the single assay adapted for research purposes. Low copy numbers (≥500 copies/reaction) of SARS-CoV-2 RNA were consistently detected by the multiplex RT-qPCR. Our novel multiplex RT-qPCR improves upon current single diagnostics by saving reagents, costs, time, and labor.


Assuntos
Betacoronavirus/genética , Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/diagnóstico , Reação em Cadeia da Polimerase Multiplex/normas , Pneumonia Viral/diagnóstico , RNA Viral/genética , Kit de Reagentes para Diagnóstico/normas , Reação em Cadeia da Polimerase Via Transcriptase Reversa/normas , Betacoronavirus/patogenicidade , Estudos de Casos e Controles , Técnicas de Laboratório Clínico/normas , Infecções por Coronavirus/virologia , Primers do DNA/normas , Células HEK293 , Humanos , Limite de Detecção , Nasofaringe/virologia , Pandemias , Pneumonia Viral/virologia , Estados Unidos
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