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1.
Eur J Endocrinol ; 184(2): E5-E9, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33410763

RESUMO

Diagnostic accuracy studies are fundamental for the assessment of diagnostic tests. Researchers need to understand the implications of their chosen design, opting for comparative designs where possible. Researchers should analyse test accuracy studies using the appropriate methods, acknowledging the uncertainty of results and avoiding overstating conclusions and ignoring the clinical situation which should inform the trade-off between sensitivity and specificity. Test accuracy studies should be reported with transparency using the STAndards for the Reporting of Diagnostic accuracy studies (STARD) checklist.


Assuntos
Técnicas de Diagnóstico Endócrino/normas , Testes Diagnósticos de Rotina/métodos , Testes Diagnósticos de Rotina/normas , Lista de Checagem , Humanos , Distribuição Aleatória , Valores de Referência , Projetos de Pesquisa , Tamanho da Amostra , Sensibilidade e Especificidade
2.
Ann Biol Clin (Paris) ; 78(5): 547-554, 2020 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-33026349

RESUMO

Biochemical diagnosis of hereditary metabolic diseases requires the detection and simultaneous identification of a large number of compounds, hence the interest in metabolic profiles. Organic acid chromatography allows the identification of several hundred compounds and the quantification of the main molecules of interest. As part of the accreditation process for medical biology examinations according to standard NF EN ISO 15189, the group from the French society for inborn errors of metabolism (SFEIM) recommends an approach to accredit organic acid chromatography. Validation parameters and recommendations are discussed in this specific framework.


Assuntos
Ácidos/urina , Cromatografia Gasosa-Espectrometria de Massas/normas , Erros Inatos do Metabolismo/diagnóstico , Compostos Orgânicos/urina , Urinálise/normas , Acreditação , Ácidos/análise , Adulto , Bioquímica/métodos , Bioquímica/normas , Criança , Serviços de Laboratório Clínico/normas , Testes Diagnósticos de Rotina/métodos , Testes Diagnósticos de Rotina/normas , Feminino , Cromatografia Gasosa-Espectrometria de Massas/métodos , Humanos , Recém-Nascido , Compostos Orgânicos/análise , Fase Pré-Analítica/métodos , Fase Pré-Analítica/normas , Gravidez , Urinálise/métodos , Coleta de Urina/métodos , Coleta de Urina/normas , Estudos de Validação como Assunto
3.
Ann Biol Clin (Paris) ; 78(5): 555-564, 2020 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-33026350

RESUMO

Biochemical diagnosis of hereditary metabolic diseases requires the detection and simultaneous identification of a large number of compounds, hence the interest in metabolic profiles. Amino acid chromatography allows the identification and quantification of more than forty compounds. As part of the accreditation process for medical biology examinations according to standard NF EN ISO 15189, the group from SFEIM recommends an approach to accredit amino acid chromatography. Validation parameters and recommendations are discussed in this specific framework.


Assuntos
Aminoácidos/análise , Cromatografia/normas , Testes Diagnósticos de Rotina/normas , Erros Inatos do Metabolismo/diagnóstico , Acreditação/normas , Adulto , Aminoácidos/sangue , Aminoácidos/líquido cefalorraquidiano , Aminoácidos/urina , Amniocentese/normas , Líquido Amniótico/química , Análise Química do Sangue/métodos , Análise Química do Sangue/normas , Coleta de Amostras Sanguíneas/normas , Criança , Cromatografia/métodos , Cromatografia Líquida/normas , Testes Diagnósticos de Rotina/métodos , Feminino , Humanos , Recém-Nascido , Erros Inatos do Metabolismo/sangue , Erros Inatos do Metabolismo/líquido cefalorraquidiano , Erros Inatos do Metabolismo/urina , Triagem Neonatal/métodos , Triagem Neonatal/normas , Fase Pré-Analítica , Gravidez , Diagnóstico Pré-Natal/métodos , Diagnóstico Pré-Natal/normas , Espectrometria de Massas em Tandem/normas , Urinálise/métodos , Urinálise/normas , Coleta de Urina/normas
4.
Ann Biol Clin (Paris) ; 78(5): 565-573, 2020 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-33026351

RESUMO

The interpretation of the variation between the results of two dosages performed on the same patient is generally quite empirical. It is usually based on the experience of the biologist or physician. Through two examples, total PSA and hemoglobin, we hoped to set up an indicator of the significance variation between results: The Reference change value or RCV to provide assistance to the validator biologist and prescriber based on measured statistical arguments. This article describes the methodology used for the RCV calculation, the formatting on analysis reports and the limitations of the system.


Assuntos
Variação Biológica Individual , Serviços de Laboratório Clínico/normas , Testes Diagnósticos de Rotina/normas , Hemoglobinas/análise , Antígeno Prostático Específico/análise , Automação Laboratorial/instrumentação , Automação Laboratorial/normas , Interpretação Estatística de Dados , Testes Diagnósticos de Rotina/instrumentação , Testes Diagnósticos de Rotina/métodos , Feminino , Humanos , Ensaio de Proficiência Laboratorial , Masculino , Metanálise como Assunto , Variações Dependentes do Observador , Neoplasias da Próstata/sangue , Neoplasias da Próstata/diagnóstico , Padrões de Referência , Valores de Referência , Reprodutibilidade dos Testes , Sensibilidade e Especificidade
5.
Ann Biol Clin (Paris) ; 78(5): 537-546, 2020 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-32933890

RESUMO

Biochemical diagnosis of hereditary metabolic diseases requires the detection and simultaneous identification of a large number of compounds, hence the interest in metabolic profiles. Acylcarnitine profile allows the identification and quantification of more than thirty compounds. As part of the accreditation process for medical biology examinations according to standard NF EN ISO 15189, the group from SFEIM recommends an approach to accredit acylcarnitine profile. Validation parameters and recommendations are discussed in this specific framework.


Assuntos
Carnitina/análogos & derivados , Serviços de Laboratório Clínico/normas , Testes Diagnósticos de Rotina/normas , Erros Inatos do Metabolismo/diagnóstico , Acreditação , Adulto , Amniocentese/métodos , Amniocentese/normas , Líquido Amniótico/química , Análise Química do Sangue/métodos , Análise Química do Sangue/normas , Coleta de Amostras Sanguíneas/métodos , Coleta de Amostras Sanguíneas/normas , Carnitina/análise , Carnitina/sangue , Carnitina/urina , Criança , Cromatografia em Papel/normas , Feminino , Humanos , Recém-Nascido , Masculino , Erros Inatos do Metabolismo/sangue , Erros Inatos do Metabolismo/urina , Triagem Neonatal/métodos , Triagem Neonatal/normas , Fase Pré-Analítica/métodos , Fase Pré-Analítica/normas , Gravidez , Diagnóstico Pré-Natal/métodos , Diagnóstico Pré-Natal/normas , Urinálise/métodos , Urinálise/normas , Coleta de Urina/métodos , Coleta de Urina/normas
6.
Zhongguo Xue Xi Chong Bing Fang Zhi Za Zhi ; 32(4): 374-379, 2020 Aug 24.
Artigo em Chinês | MEDLINE | ID: mdl-32935511

RESUMO

OBJECTIVE: To analyze the diagnosis of imported malaria cases in Henan Province from 2015 to 2019, so as to provide the evidence for malaria surveillance during the post-elimination stage. METHODS: The data pertaining to malaria cases in Henan Province from 2015 to 2019 were extracted via the web-based Chinese Information System for Infectious Diseases Control and Prevention and the Parasitic Diseases Information Reporting Management System (PDIRMS) of Chinese Center for Disease Control and Prevention, and the diagnostic methods, diagnostic institutions and diagnostic time of imported malaria cases were analyzed. RESULTS: A total of 952 imported malaria cases were reported in Henan Province during the period from 2015 through 2019, and all cases were laboratory-confirmed. The positive rate of malaria rapid diagnostic tests (RDTs) was 98.61% (779/790), which was significantly greater than that (94.22%, 897/952) of microscopic examinations (χ2 = 22.773, P < 0.05). The proportion of imported malaria cases diagnosed in medical institutions increased from 65.22% (120/184) in 2015 to 81.50% (185/227) in 2019. Among the 238 imported malaria cases diagnosed in centers for disease control and prevention (CDC), 71.01% (169/238) were diagnosed in county-level CDC, and among the 704 cases diagnosed in medical institutions, only 8.38% (59/704) were diagnosed at county-level medical institutions. The median time from onset to definitive diagnosis of malaria was 3 days, and the median duration between onset and initial diagnosis of malaria was 1 day. The duration between initial diagnosis and definitive diagnosis of malaria varied significantly among years (χ2 = 24.956, P < 0.05), and the interquartile range from initial diagnosis to definitive diagnosis reduced from 4 days in 2016 to 2 days in 2019. In addition, the median time from initial diagnosis to definitive diagnosis was significantly longer in severe falciparum malaria cases than in non-severe falciparum malaria cases (2 days vs. 1 day; Z = 7.557, P < 0.05). CONCLUSIONS: Medical institutions play a more and more important role in the identification and surveillance of malaria cases; however, the diagnostic capability of malaria remains low in county-level medical institutions. The diagnostic awareness and capability of county-level medical institutions requires to be improved, in order to play their roles as sentinel hospitals in the malaria surveillance during the post-elimination stage.


Assuntos
Doenças Transmissíveis Importadas , Malária , China/epidemiologia , Doenças Transmissíveis Importadas/diagnóstico , Doenças Transmissíveis Importadas/epidemiologia , Testes Diagnósticos de Rotina/normas , Humanos , Malária/diagnóstico , Malária/epidemiologia , Microscopia , Vigilância da População
8.
Medicine (Baltimore) ; 99(31): e21385, 2020 Jul 31.
Artigo em Inglês | MEDLINE | ID: mdl-32756129

RESUMO

BACKGROUND: To perform a cost-error analysis based on a quasi-experimental pre-post study of the preanalytical errors in 2 hospital laboratories. The real cost and theoretical cost are defined as the cost resulting from errors with or without the training intervention. The real impact associated to the training program was estimated, calculated as the total associated to the preanalytical errors cost difference. The costs were measured using Andalusian Public Health Service fees. Cost analysis of an educational intervention presented in a previous study from 2017. Preanalytical errors were detected in the laboratories of the University Hospital Virgen de la Victoria (Málaga, Spain) and in the University Hospital Juan Ramón Jiménez (Huelva, Spain). METHODS: The founded errors were divided into blood and urine samples. Univariate sensitivity analysis was used to assess how parameter uncertainty impacted on overall results. Variations of parameters between 0% and 5% were substituted into the base case. RESULTS: The real impact associated with educational intervention in LAB1 was an increase of &OV0556;16,961.378, and the expected impact was an increase &OV0556;78,745.27 (difference of &OV0556;61,783.9). In LAB2, the real impact in the same period amounted to &OV0556;260,195.37, and the expected impact was &OV0556;193,905.83 (difference of -&OV0556;66,289.54). The results were different in the 2 laboratories, proving the intervention in only one of them to be more effective. CONCLUSIONS: Costs analysis determined that this training intervention can provide saves in the costs, as the effectiveness of the educational sessions in reducing preanalytical errors currently results in a significant decrease of the costs associated with these errors.


Assuntos
Erros de Diagnóstico/economia , Capacitação em Serviço/economia , Laboratórios Hospitalares/normas , Análise Custo-Benefício , Erros de Diagnóstico/prevenção & controle , Testes Diagnósticos de Rotina/economia , Testes Diagnósticos de Rotina/normas , Humanos , Ensaios Clínicos Controlados não Aleatórios como Assunto , Atenção Primária à Saúde/organização & administração , Manejo de Espécimes/normas
9.
Int J Infect Dis ; 98: 408-419, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32659450

RESUMO

BACKGROUND: Diagnosis is a challenging issue for eliminating malaria. Loop-mediated isothermal amplification (LAMP) could be an alternative to conventional methods. This study aimed to evaluate the diagnostic accuracy of LAMP for malaria compared with microscopy, polymerase chain reaction (PCR) and rapid diagnostic tests (RDTs). METHODS AND DESIGN: MEDLINE, Web of Science and Scopus were searched from inception to 1 July 2019. Prospective and retrospective, randomised and non-randomised, mono-center and multi-center studies, including symptomatic or asymptomatic patients, that reported one LAMP method and one comparator (microscopy, RDT or PCR) were included. PROSPERO registration number: CRD42017075186. RESULTS: Sixty-six studies published between 2006 and 2019 were included, leading to the analysis of 30,641 LAMP tests. The pooled sensitivity of LAMP remained between 96% and 98%, whichever the comparator. The pooled specificity of LAMP was around 95%, but was a little higher if the best PCR studies were considered. The AUC was found to be >0.98, whichever the subgroup of studies was considered. Diagnostic odds ratio (DOR) was found to be around 1000 for all subgroups, except for Plasmodium vivax. CONCLUSION: This meta-analysis confirmed that the LAMP method is robust for diagnosing malaria, both in symptomatic and asymptomatic people. Thus, the impact of LAMP for controlling malaria is expected to be important.


Assuntos
Testes Diagnósticos de Rotina/normas , Malária/diagnóstico , Microscopia/normas , Técnicas de Amplificação de Ácido Nucleico/normas , Plasmodium/isolamento & purificação , Reação em Cadeia da Polimerase/normas , Testes Diagnósticos de Rotina/métodos , Humanos , Malária/parasitologia , Microscopia/métodos , Técnicas de Amplificação de Ácido Nucleico/métodos , Plasmodium/classificação , Plasmodium/genética , Plasmodium/fisiologia , Reação em Cadeia da Polimerase/métodos , Estudos Prospectivos , Estudos Retrospectivos , Sensibilidade e Especificidade
10.
PLoS One ; 15(7): e0236496, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32702008

RESUMO

BACKGROUND: To improve the quality of diagnosing pulmonary tuberculosis (TB), WHO recommends the use of rapid molecular testing as an alternative to conventional microscopic methods. Loop-mediated isothermal amplification assay (LAMP test) is a practical and cost-effective nucleic amplification technique. We evaluated the pragmatic accuracy of an in-house LAMP assay for the diagnosis of TB in a remote health care setting where an advanced rapid molecular test is not available. METHODS: A prospective diagnostic accuracy study was conducted. Patients with clinical symptoms suggestive of TB were consecutively enrolled from April to August 2016. Sputum samples were collected from each patient and were sent for microscopic examination (both acid-fast stain and fluorescence stain), in-house LAMP test, and TB culture. RESULTS: One hundred and seven patients with TB symptoms were used in the final analysis. This included 50 (46.7%) culture-positive TB patients and 57 (53.3%) culture-negative patients. The overall sensitivity of the in-house LAMP based on culture positivity was 88.8% (95/107) with a 95%CI of 81.2-94.1. The sensitivity was 90.9% (40/44) with a 95%CI of 78.3-97.5 for smear-positive, culture-positive patients, and was 16.7% (1/6) with a 95%CI of 0.4-64.1 for smear-negative, culture-positive patients. The overall sensitivity of the in-house LAMP test compared to smear microscopy methods were not significantly different (p = 0.375). The specificity of the in-house LAMP based on non-TB patients (smear-negative, culture-negative) was 94.7% (54/57) with a 95%CI of 85.4-98.9. CONCLUSIONS: The diagnostic accuracy of the in-house LAMP test in a community hospital was comparable to other previous reports in terms of specificity. The sensitivity of the in-house assay could be improved with better sputum processing and DNA extraction method.


Assuntos
Técnicas de Diagnóstico Molecular/normas , Técnicas de Amplificação de Ácido Nucleico/normas , Tuberculose Pulmonar/diagnóstico , Tuberculose Pulmonar/genética , Testes Diagnósticos de Rotina/efeitos adversos , Testes Diagnósticos de Rotina/normas , Feminino , Hospitais Comunitários , Humanos , Masculino , Pessoa de Meia-Idade , Mycobacterium tuberculosis/genética , Mycobacterium tuberculosis/isolamento & purificação , Mycobacterium tuberculosis/patogenicidade , Estudos Prospectivos , Escarro/metabolismo , Tailândia/epidemiologia , Tuberculose Pulmonar/epidemiologia , Tuberculose Pulmonar/patologia
11.
Am J Clin Pathol ; 154(3): 330-341, 2020 08 05.
Artigo em Inglês | MEDLINE | ID: mdl-32561916

RESUMO

OBJECTIVES: Accurate hematologic test interpretation based on normative reference standards is critical to ensure appropriate clinical decision making. However, healthy pediatric reference data for most hematology parameters are lacking. To address this gap, this study establishes age- and sex-specific hematologic reference standards in the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) cohort of healthy children and adolescents. METHODS: Fresh whole blood samples collected from a total of 566 healthy children and adolescents (birth to <21 years) with informed consent were analyzed for 47 hematologic parameters on the Beckman Coulter DxH 900. Age- and sex-specific reference standards were calculated based on the Clinical and Laboratory Standards Institute guidelines. RESULTS: Reference value distributions for most hematology parameters demonstrated dynamic changes across the pediatric age range with significant age-specific differences observed for 39 of the 47 parameters examined. Sex-specific differences were also observed for eight hematologic parameters, primarily during and after puberty. CONCLUSIONS: This study establishes a robust database of pediatric reference standards for 47 hematologic parameters in the CALIPER cohort for the first time. These comprehensive reference value data sets report potentially important and physiologically relevant trends in hematologic markers, clearly demonstrating the need for pediatric reference standards for hematologic test interpretation.


Assuntos
Testes Diagnósticos de Rotina/normas , Hematologia/normas , Adolescente , Biomarcadores/sangue , Criança , Pré-Escolar , Serviços de Laboratório Clínico , Bases de Dados Factuais , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Padrões de Referência , Adulto Jovem
12.
J Appl Lab Med ; 5(5): 1038-1049, 2020 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-32573713

RESUMO

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 causes coronavirus disease 2019 (COVID-19) and poses substantial challenges for healthcare systems. With a vastly expanding number of publications on COVID-19, clinicians need evidence synthesis to produce guidance for handling patients with COVID-19. In this systematic review and meta-analysis, we examine which routine laboratory tests are associated with severe COVID-19 disease. CONTENT: PubMed (Medline), Scopus, and Web of Science were searched until March 22, 2020, for studies on COVID-19. Eligible studies were original articles reporting on laboratory tests and outcome of patients with COVID-19. Data were synthesized, and we conducted random-effects meta-analysis, and determined mean difference (MD) and standard mean difference at the biomarker level for disease severity. Risk of bias and applicability concerns were evaluated using the Quality Assessment of Diagnostic Accuracy Studies-2. SUMMARY: 45 studies were included, of which 21 publications were used for the meta-analysis. Studies were heterogeneous but had low risk of bias and applicability concern in terms of patient selection and reference standard. Severe disease was associated with higher white blood cell count (MD, 1.28 ×109/L), neutrophil count (MD, 1.49 ×109/L), C-reactive protein (MD, 49.2 mg/L), lactate dehydrogenase (MD, 196 U/L), D-dimer (standardized MD, 0.58), and aspartate aminotransferase (MD, 8.5 U/L); all p < 0.001. Furthermore, low lymphocyte count (MD -0.32 × 109/L), platelet count (MD -22.4 × 109/L), and hemoglobin (MD, -4.1 g/L); all p < 0.001 were also associated with severe disease. In conclusion, several routine laboratory tests are associated with disease severity in COVID-19.


Assuntos
Betacoronavirus/isolamento & purificação , Técnicas de Laboratório Clínico , Infecções por Coronavirus , Testes Diagnósticos de Rotina , Pandemias , Pneumonia Viral , Técnicas de Laboratório Clínico/métodos , Técnicas de Laboratório Clínico/normas , Infecções por Coronavirus/sangue , Infecções por Coronavirus/diagnóstico , Testes Diagnósticos de Rotina/métodos , Testes Diagnósticos de Rotina/normas , Humanos , Avaliação de Resultados em Cuidados de Saúde , Seleção de Pacientes , Pneumonia Viral/sangue , Pneumonia Viral/diagnóstico , Padrões de Referência
13.
J Hosp Infect ; 106(1): 102-106, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32593608

RESUMO

Staff working in units that were highly exposed to coronavirus disease 2019 were invited to participate in a 6-month study on the carriage and seroprevalence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). The results from visits on Day 1 and Day 15 show that 41 cases of SARS-CoV-2 infection were confirmed by reverse transcriptase polymerase chain reaction and/or serology in 326 participants (overall infection rate 12.6%). The presence of comorbidities or symptoms at the time of sample collection was a risk factor for infection, but working as a physician/nurse was not a risk factor. Universal screening in high-risk units, irrespective of symptoms, allowed the identification of asymptomatic and potentially contagious infected workers, enabling them to self-isolate for 7 days.


Assuntos
Doenças Assintomáticas , Infecções por Coronavirus/imunologia , Testes Diagnósticos de Rotina/estatística & dados numéricos , Testes Diagnósticos de Rotina/normas , Recursos Humanos em Hospital/estatística & dados numéricos , Pneumonia Viral/imunologia , Reação em Cadeia da Polimerase Via Transcriptase Reversa/estatística & dados numéricos , Reação em Cadeia da Polimerase Via Transcriptase Reversa/normas , Adulto , Bélgica , Betacoronavirus/imunologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Medição de Risco , Fatores de Risco , Estudos Soroepidemiológicos
14.
Eur J Radiol ; 129: 109092, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32485335

RESUMO

PURPOSE: To evaluate the diagnostic accuracy and the imaging features of routine admission chest X-ray in patients suspected for novel Coronavirus 2019 (SARS-CoV-2) infection. METHOD: We retrospectively evaluated clinical and X-ray features in all patients referred to the emergency department for suspected SARS-CoV-2 infection between March 1st and March 13th. A single radiologist with more than 15 years of experience in chest-imaging evaluated the presence and extent of alveolar opacities, reticulations, and/or pleural effusion. The percentage of lung involvement (range <25 % to 75-100 %) was also calculated. We stratified patients in groups according to the time interval between symptoms onset and X-ray imaging (≤ 5 and > 5 days) and according to age (≤ 50 and > 50 years old). RESULTS: A total of 518 patients were enrolled. Overall 314 patients had negative and 204 had positive RT-PCR results. Lung lesions in patients with SARS-Cov2 pneumonia primarily manifested as alveolar and interstitial opacities and were mainly bilateral (60.8 %). Lung abnormalities were more frequent and more severe by symptom duration and by increasing age. The sensitivity and specificity of chest X-ray at admission in the overall cohort were 57 % (95 % CI = 47-67) and 89 % (83-94), respectively. Sensitivity was higher for patients with symptom onset > 5 days compared to ≤ 5 days (76 % [62-87] vs 37 % [24-52]) and in patients > 50 years old compared to ≤ 50 years (59 % [48-69] vs 47 % [23-72]), at the expense of a slightly lower specificity (68 % [45-86] and 82 % [73-89], respectively). CONCLUSIONS: Overall chest X-ray sensitivity for SARS-CoV-2 pneumonia was 57 %. Sensitivity was higher when symptoms had started more than 5 days before, at the expense of lesser specificity, while slightly higher in older patients in comparison to younger ones.


Assuntos
Betacoronavirus , Técnicas de Laboratório Clínico/normas , Infecções por Coronavirus/diagnóstico por imagem , Pneumonia Viral/diagnóstico por imagem , Adulto , Idoso , Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/diagnóstico , Testes Diagnósticos de Rotina/métodos , Testes Diagnósticos de Rotina/normas , Dispneia/diagnóstico por imagem , Dispneia/virologia , Serviço Hospitalar de Emergência , Feminino , Febre/diagnóstico por imagem , Febre/virologia , Hospitalização , Humanos , Itália , Pulmão/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Pandemias , Admissão do Paciente/normas , Derrame Pleural/diagnóstico por imagem , Derrame Pleural/virologia , Testes Imediatos/normas , Alvéolos Pulmonares/diagnóstico por imagem , Radiografia , Estudos Retrospectivos , Sensibilidade e Especificidade , Tempo para o Tratamento , Tomografia Computadorizada por Raios X , Raios X , Adulto Jovem
15.
JAMA Netw Open ; 3(5): e203871, 2020 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-32356885

RESUMO

Importance: Incomplete reporting of diagnostic accuracy research impairs assessment of risk of bias and limits generalizability. Point-of-care ultrasound has become an important diagnostic tool for acute care physicians, but studies assessing its use are of varying methodological quality. Objective: To assess adherence to the Standards for Reporting of Diagnostic Accuracy (STARD) 2015 guidelines in the literature on acute care point-of-care ultrasound. Evidence Review: MEDLINE was searched to identify diagnostic accuracy studies assessing point-of-care ultrasound published in critical care, emergency medicine, or anesthesia journals from 2016 to 2019. Studies were evaluated for adherence to the STARD 2015 guidelines, with the following variables analyzed: journal, country, STARD citation, STARD-adopting journal, impact factor, patient population, use of supplemental material, and body region. Data analysis was performed in November 2019. Findings: Seventy-four studies were included in this systematic review for assessment. Overall adherence to STARD was moderate, with 66% (mean [SD], 19.7 [2.9] of 30 items) of STARD items reported. Items pertaining to imaging specifications, patient population, and readers of the index test were frequently reported (>66% of studies). Items pertaining to blinding of readers to clinical data and to the index or reference standard, analysis of heterogeneity, indeterminate and missing data, and time intervals between index and reference test were either moderately (33%-66%) or infrequently (<33%) reported. Studies in STARD-adopting journals (mean [SD], 20.5 [2.9] items in adopting journals vs 18.6 [2.3] items in nonadopting journals; P = .002) and studies citing STARD (mean [SD], 21.3 [0.9] items in citing studies vs 19.5 [2.9] items in nonciting studies; P = .01) reported more items. Variation by country and journal of publication were identified. No differences in STARD adherence were identified by body region imaged (mean [SD], abdominal, 20.0 [2.5] items; head and neck, 17.8 [1.6] items; musculoskeletal, 19.2 [3.1] items; thoracic, 20.2 [2.8] items; and other or procedural, 19.8 [2.7] items; P = .29), study design (mean [SD], prospective, 19.7 [2.9] items; retrospective, 19.7 [1.8] items; P > .99), patient population (mean [SD], pediatric, 20.0 [3.1] items; adult, 20.2 [2.7] items; mixed, 17.9 [1.9] items; P = .09), use of supplementary materials (mean [SD], yes, 19.2 [3.0] items; no, 19.7 [2.8] items; P = .91), or journal impact factor (mean [SD], higher impact factor, 20.3 [3.1] items; lower impact factor, 19.1 [2.4] items; P = .08). Conclusions and Relevance: Overall, the literature on acute care point-of-care ultrasound showed moderate adherence to the STARD 2015 guidelines, with more complete reporting found in studies citing STARD and those published in STARD-adopting journals. This study has established a current baseline for reporting; however, future studies are required to understand barriers to complete reporting and to develop strategies to mitigate them.


Assuntos
Fidelidade a Diretrizes , Sistemas Automatizados de Assistência Junto ao Leito/normas , Guias de Prática Clínica como Assunto , Ultrassonografia/normas , Testes Diagnósticos de Rotina/normas , Humanos
16.
Rev Med Suisse ; 16(694): 1026-1033, 2020 May 20.
Artigo em Francês | MEDLINE | ID: mdl-32432419

RESUMO

Today, there are more and more self-test kits available on the high street. With a few exceptions (HIV, FIT), it is currently unclear whether they are effective, neither beneficial for the consumer, nor useful for the Swiss healthcare system. Is there a favorable impact for the health system? This article tries to help doctors find their way among the many self-test available, providing them a reading grid and recommendations for their patients.


Assuntos
Atitude do Pessoal de Saúde , Testes Diagnósticos de Rotina/normas , Médicos , Autocuidado/métodos , Humanos , Autocuidado/normas , Suíça
17.
Ann Biol Clin (Paris) ; 78(3): 329-342, 2020 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-32420887

RESUMO

Accreditation of an in vitro diagnostic assay according to the NF/EN/ISO 15189 standard requires to analyze its technical performance before implementation for routine use, and annually when reviewing effectiveness of quality controls. Performance is evaluated through repeatability, intermediate fidelity, accuracy and uncertainty of measurement. The coefficients of variation (CV) of the intra-assay and inter-assay precision tests must be compared with those of "peers" (results from laboratories employing the same method) and also with those obtained with "all methods", i.e., results from all laboratories performing the same assay, irrespective of the method. To our best knowledge, there is currently no French or international recommendation on what the acceptable limits of performance for specific IgE and tryptase assays should be. Therefore, the AllergoBioNet network of hospital allergy laboratories set out to characterize the performance of their current methods as a basis for the development of recommendations. The results provided by 24 centers were analyzed and led to consensus recommendations for specific IgE, total IgE and tryptase assays.


Assuntos
Bioensaio/métodos , Imunoglobulina E/análise , Triptases/análise , Acreditação , Bioensaio/normas , Consenso , Testes Diagnósticos de Rotina/métodos , Testes Diagnósticos de Rotina/normas , França , Humanos , Laboratórios/normas , Controle de Qualidade , Reprodutibilidade dos Testes
18.
PLoS One ; 15(5): e0231217, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32374728

RESUMO

During influenza epidemics, Japanese clinicians routinely perform rapid influenza diagnostic tests (RIDTs) in the examination of patients who have an influenza-like illness, and patients with positive test results, including otherwise healthy individuals, are treated with anti-influenza drugs. However, it was recently reported that the sensitivity of RIDTs was extremely low in adult patients. We examined the sensitivity and specificity of an RIDT that is widely used in Japan, ImunoAce Flu (TAUNS, Shizuoka, Japan), in comparison to reverse transcriptase polymerase chain reaction (RT-PCR). The sensitivity and specificity of the ImunoAce Flu test were 97.1% (95%CI: 93.8-98.9) and 89.2% (95%CI: 84.1-93.1), respectively. The ImunoAce Flu test is designed to not only detect influenza A or B, but also to detect H1N1pdm09 with the use of an additional test kit (Linjudge FluA/pdm). Its sensitivity and specificity for A/H1N1pdm09 were 97.6% (95%CI: 87.4-99.9) and 92.6% (95%CI: 82.1-97.9), respectively. Thus, by consecutively testing patients with the ImunoAce Flu test followed by the Linjudge FluA/pdm test, we are able to diagnose whether a patient has A/H1N1pdm09 or A/H3N2 infection within a short time. The reliability of rapid test results seems to be much higher in Japan than in other countries, because approximately 90% of influenza patients are tested and treated within 48 hours after the onset of illness, when the influenza viral load in the upper respiratory tract is high. From the Japanese experience, RIDTs are sufficiently sensitive and highly useful, if patients are tested within 48 hours after the onset of illness.


Assuntos
Testes Diagnósticos de Rotina , Influenza Humana/diagnóstico , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Testes Diagnósticos de Rotina/métodos , Testes Diagnósticos de Rotina/normas , Feminino , Humanos , Imunoensaio/métodos , Imunoensaio/normas , Vírus da Influenza A Subtipo H1N1/genética , Vírus da Influenza A Subtipo H1N1/imunologia , Vírus da Influenza A Subtipo H3N2/genética , Vírus da Influenza A Subtipo H3N2/imunologia , Influenza Humana/sangue , Influenza Humana/epidemiologia , Influenza Humana/imunologia , Japão , Masculino , Programas de Rastreamento/métodos , Programas de Rastreamento/normas , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Sensibilidade e Especificidade , Fatores de Tempo
19.
AIDS Patient Care STDS ; 34(4): 147-156, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32324482

RESUMO

HIV self-testing (HIVST) allows individuals to interpret and report their own test results, thus decentralizing testing. Yet, this decentralization can make it difficult to verify self-testing results, which is important for linkage to care and surveillance. The aim of this systematic review is to summarize methods for verifying HIVST use and results. We followed guidance from the Cochrane Handbook 5.1 on systematic reviews. We searched four journal databases (PubMed, Embase, Scopus, and Cochrane Library), one clinical trials database (ClinicalTrials.gov), two conference abstract databases (International AIDS Society and Conference on Retroviruses and Opportunistic Infections) and one gray literature database (OpenGrey). We included studies that verified opening of kits or test results. Two researchers independently screened articles and extracted data regarding HIVST location, method of verification, who performed verification, proportion of results verified, and primary or secondary kit distribution. The search yielded 3853 unique citations, of which 40 contained information on HIVST verification and were included. Among these 40 studies, 13 were in high-income countries, 16 were in middle-income countries, and 11 were in low-income countries. Seventeen studies included key populations and two focused on youth. Three methods verified results: supervision by a health provider, returning used test kits, and electronic transmission of photographs. One method verified opening of kits using Bluetooth sensors. Although HIVST has increased worldwide, strategies to verify self-testing results remain limited. These findings suggest a need for additional innovative strategies for verifying HIVST use and results and linkage of self-testing results to surveillance and care systems.


Assuntos
Testes Diagnósticos de Rotina/normas , Infecções por HIV/diagnóstico , Programas de Rastreamento/métodos , Autoadministração/normas , Adolescente , Adulto , Testes Diagnósticos de Rotina/métodos , Infecções por HIV/epidemiologia , Humanos , Masculino , Autoadministração/métodos , Testes Sorológicos
20.
PLoS One ; 15(4): e0231358, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32310983

RESUMO

BACKGROUND: Malaria data reported through Mozambique's routine health information system are used to guide the implementation of prevention and control activities. Although previous studies have identified issues with the quality of aggregated data reported from public health facilities in the country, no studies have evaluated the quality of routine indicators recorded in health facility registries. This study addresses this issue by comparing indicators calculated from data from exit interviews and re-examinations of patients with data based on registry records from health facilities in order to measure the quality of registry data and data reporting in three provinces in Mozambique. METHODS: Data were collected from 1,840 outpatients from 117 health facilities in Maputo, Zambézia, and Cabo Delgado Provinces interviewed and examined as part of a malaria-specific health facility survey. Key indicators based on exit interview / re-examination data were compared to the same indicators based on records from health facility registries. Multivariable regression was performed to identify factors associated with indicators matching in re-examination / exit interview data and health facility registries. Aggregated indicators abstracted from facility registries were compared to those reported through the routine health management information system (HMIS) for the same time period. RESULTS: Sensitivity of exit interview / re-examination data compared with those recorded in facility registries was low for all indicators in all facilities. The lowest sensitivities were in Maputo, where the sensitivity for recording negative RDT results was 9.7%. The highest sensitivity was for recording positive RDT results in Cabo Delgado, at 75%. Multivariable analysis of factors associated with agreement between gold standard and registry data showed patients were less likely to be asked about having a fever in the triage ward in Maputo and Cabo Delgado (adjusted Odds Ratio 0.75 and 0.39 respectively), and in the outpatient ward in Cabo Delgado (aOR = 0.37), compared with the emergency department. Patients with positive RDT were also more likely to have RDT results recorded in all three provinces when patients had been managed according to national treatment guidelines during initial examination. Comparison of retrospective data abstracted from facility registries to HMIS data showed discrepancies in all three provinces. The proportion of outpatient cases with suspected and confirmed malaria were similar in registry and HMIS data across all provinces (a relatively low difference between registry and HMIS data of 3% in Maputo and Zambézia), though the total number of all-cause outpatient cases was consistently higher in the HMIS. The largest difference was in Maputo, where a total of 87,992 all-cause outpatient cases were reported in HMIS, compared with a total of 42,431 abstracted from facility registries. CONCLUSION: This study shows that care should be taken in interpreting trends based solely on routine data due to data quality issues, though the discrepancy in all-cause outpatient cases may be indicative that register availability and storage are important factors. As such, simple steps such as providing consistent access and storage of registers that include reporting of patient fever symptoms might improve the quality of routine data recorded at health facilities.


Assuntos
Testes Diagnósticos de Rotina/normas , Malária/diagnóstico , Estudos Transversais , Coleta de Dados , Testes Diagnósticos de Rotina/métodos , Febre/etiologia , Instalações de Saúde , Pessoal de Saúde/psicologia , Humanos , Imunoensaio/métodos , Imunoensaio/normas , Entrevistas como Assunto , Malária/parasitologia , Malária/patologia , Moçambique , Plasmodium falciparum/metabolismo , Proteínas de Protozoários/análise , Sistema de Registros , Estudos Retrospectivos
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