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2.
PLoS Med ; 17(10): e1003358, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-33001967

RESUMO

BACKGROUND: Loss of smell and taste are commonly reported symptoms associated with coronavirus disease 2019 (COVID-19); however, the seroprevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in people with acute loss of smell and/or taste is unknown. The study aimed to determine the seroprevalence of SARS-CoV-2 antibodies in a community-based population with acute loss of smell and/or taste and to compare the frequency of COVID-19 associated symptoms in participants with and without SARS-CoV-2 antibodies. It also evaluated whether smell or taste loss are indicative of COVID-19 infection. METHODS AND FINDINGS: Text messages, sent via primary care centers in London, United Kingdom, invited people with loss of smell and/or taste in the preceding month, to participate. Recruitment took place between 23 April 2020 and 14 May 2020. A total of 590 participants enrolled via a web-based platform and responded to questions about loss of smell and taste and other COVID-19-related symptoms. Mean age was 39.4 years (SD ± 12.0) and 69.1% (n = 392) of participants were female. A total of 567 (96.1%) had a telemedicine consultation during which their COVID-19-related symptoms were verified and a lateral flow immunoassay test that detected SARS-CoV-2 immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies was undertaken under medical supervision. A total of 77.6% of 567 participants with acute smell and/or taste loss had SARS-CoV-2 antibodies; of these, 39.8% (n = 175) had neither cough nor fever. New loss of smell was more prevalent in participants with SARS-CoV-2 antibodies, compared with those without antibodies (93.4% versus 78.7%, p < 0.001), whereas taste loss was equally prevalent (90.2% versus 89.0%, p = 0.738). Seropositivity for SARS-CoV-2 was 3 times more likely in participants with smell loss (OR 2.86; 95% CI 1.27-6.36; p < 0.001) compared with those with taste loss. The limitations of this study are the lack of a general population control group, the self-reported nature of the smell and taste changes, and the fact our methodology does not take into account the possibility that a population subset may not seroconvert to develop SARS-CoV-2 antibodies post-COVID-19. CONCLUSIONS: Our findings suggest that recent loss of smell is a highly specific COVID-19 symptom and should be considered more generally in guiding case isolation, testing, and treatment of COVID-19. TRIALS REGISTRATION: ClinicalTrials.gov NCT04377815.


Assuntos
Anticorpos Antivirais/sangue , Infecções por Coronavirus/complicações , Transtornos do Olfato/virologia , Pneumonia Viral/complicações , Distúrbios do Paladar/virologia , Adulto , Betacoronavirus , Técnicas de Laboratório Clínico , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/imunologia , Feminino , Humanos , Imunoglobulina G/sangue , Imunoglobulina M/sangue , Londres , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/imunologia , Testes Imediatos , Soroconversão , Estudos Soroepidemiológicos , Envio de Mensagens de Texto
3.
Arch Pathol Lab Med ; 144(10): 1191-1192, 2020 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-33002151
4.
Arch Pathol Lab Med ; 144(10): 1199-1203, 2020 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-33002152

RESUMO

CONTEXT.­: The burden of chronic kidney disease in Indigenous Australians is 7.3 times higher than that of non-Indigenous Australians. If chronic kidney disease is detected early and managed, deterioration in kidney function can be reduced. Urine albumin to creatinine ratio is a key marker of early renal damage. OBJECTIVE.­: To report on 16 years of analytic quality of urine albumin to creatinine ratio testing on Siemens DCA devices enrolled in the national Quality Assurance for Aboriginal and Torres Strait Islander Medical Services point-of-care testing program. DESIGN.­: Quality Assurance for Aboriginal and Torres Strait Islander Medical Services participants are required to test 2 quality assurance samples each month across two 6-monthly testing cycles per year. Participants also test 2 quality control samples monthly. RESULTS.­: The percentage of urine albumin, creatinine, and albumin to creatinine ratio results for quality assurance point-of-care testing that were within assigned allowable limits of performance averaged 96.9%, 95.9%, and 97.5%, respectively. The percentage acceptable quality control results for urine albumin and creatinine averaged 93.5% and 86.8%. The median imprecision for urine albumin, creatinine, and albumin to creatinine ratio quality assurance testing averaged 5.5%, 4.1%, and 3.3%, respectively, and the median within-site imprecision for quality control testing averaged 5.4%, 4.3%, and 5.7%, respectively, for the low sample and 4.0%, 4.1%, and 4.5%, respectively, for the high sample. CONCLUSIONS.­: For 16 years the DCA system has proven to be reliable and robust and operators at Aboriginal medical services have demonstrated they are able to conduct point-of-care testing for urine albumin to creatinine ratio that consistently meets analytic performance standards.


Assuntos
Albuminúria/urina , Creatinina/urina , Testes Imediatos , Insuficiência Renal Crônica/diagnóstico , Austrália , Humanos , Grupo com Ancestrais Oceânicos , Garantia da Qualidade dos Cuidados de Saúde , Controle de Qualidade , Insuficiência Renal Crônica/urina , Urinálise
6.
Proc Natl Acad Sci U S A ; 117(37): 22727-22735, 2020 09 15.
Artigo em Inglês | MEDLINE | ID: mdl-32868442

RESUMO

The COVID-19 pandemic provides an urgent example where a gap exists between availability of state-of-the-art diagnostics and current needs. As assay protocols and primer sequences become widely known, many laboratories perform diagnostic tests using methods such as RT-PCR or reverse transcription loop mediated isothermal amplification (RT-LAMP). Here, we report an RT-LAMP isothermal assay for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus and demonstrate the assay on clinical samples using a simple and accessible point-of-care (POC) instrument. We characterized the assay by dipping swabs into synthetic nasal fluid spiked with the virus, moving the swab to viral transport medium (VTM), and sampling a volume of the VTM to perform the RT-LAMP assay without an RNA extraction kit. The assay has a limit of detection (LOD) of 50 RNA copies per µL in the VTM solution within 30 min. We further demonstrate our assay by detecting SARS-CoV-2 viruses from 20 clinical samples. Finally, we demonstrate a portable and real-time POC device to detect SARS-CoV-2 from VTM samples using an additively manufactured three-dimensional cartridge and a smartphone-based reader. The POC system was tested using 10 clinical samples, and was able to detect SARS-CoV-2 from these clinical samples by distinguishing positive samples from negative samples after 30 min. The POC tests are in complete agreement with RT-PCR controls. This work demonstrates an alternative pathway for SARS-CoV-2 diagnostics that does not require conventional laboratory infrastructure, in settings where diagnosis is required at the point of sample collection.


Assuntos
Infecções por Coronavirus/diagnóstico , Técnicas de Diagnóstico Molecular/métodos , Pneumonia Viral/diagnóstico , Testes Imediatos/normas , Reação em Cadeia da Polimerase Via Transcriptase Reversa/métodos , Betacoronavirus/genética , Betacoronavirus/patogenicidade , Humanos , Limite de Detecção , Técnicas de Diagnóstico Molecular/instrumentação , Técnicas de Diagnóstico Molecular/normas , Mucosa Nasal/virologia , Pandemias , Reprodutibilidade dos Testes , Reação em Cadeia da Polimerase Via Transcriptase Reversa/instrumentação , Reação em Cadeia da Polimerase Via Transcriptase Reversa/normas , Smartphone
7.
Monaldi Arch Chest Dis ; 90(3)2020 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-32875776

RESUMO

Lung Ultrasound (LUS) is regarded to be potentially useful to diagnose lung injury in older adults living in nursing homes with suspected COVID-19 pneumonia. We aimed at evaluating presence lung injury among senior nursing home residents by LUS performed with portable wireless scanner echography. The study population consisted of 150 residents with a mean age of 88 years (85% female) residing in 12 nursing homes in Northern Italy. Subjects had to have a history of recent onset of symptoms compatible with COVID-19 pneumonia or have been exposed to the contagion of patients carrying the disease. COVID-19 testing was performed with SARS-CoV-2 nasal-pharyngeal (NP) swabs. Positive subjects to LUS scanning were considered those with non-coascelent B-lines in >3 zones, coalescent B-lines in >3 zones and with iperdensed patchy non-consolidated lungs. Sixty-three percent had positive NP testing and 65% had LUS signs of pulmonary injury. LUS had a sensitivity of 79% in predicting positive NP testing. Sixteen percent of residents tested negative for SARSCoV-2 carried the signs of COVID-19 lung injury at LUS. There were 92 patients (61%) with current or recent symptoms.Positivity to LUS scanning was reported in 73% of residents with symptoms, while it was 53% in those without (P=0.016). A positive NP testing was observed in 66% of residents with symptoms and in 57% of those without (P=0.27). We conclude that assessment of LUS by portable wireless scanner echography can be profitability utilized to diagnose lung injury among senior nursing home residents with or without symptoms compatible with COVID-19 pneumonia.


Assuntos
Infecções por Coronavirus , Lesão Pulmonar/diagnóstico por imagem , Pandemias , Pneumonia Viral/diagnóstico , Testes Imediatos , Ultrassonografia , Idoso de 80 Anos ou mais , Betacoronavirus/isolamento & purificação , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/fisiopatologia , Feminino , Instituição de Longa Permanência para Idosos/estatística & dados numéricos , Humanos , Itália/epidemiologia , Masculino , Casas de Saúde/estatística & dados numéricos , Pneumonia Viral/epidemiologia , Pneumonia Viral/etiologia , Pneumonia Viral/fisiopatologia , Valor Preditivo dos Testes , Sensibilidade e Especificidade , Ultrassonografia/instrumentação , Ultrassonografia/métodos , Tecnologia sem Fio
8.
Biosens Bioelectron ; 166: 112431, 2020 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-32862842

RESUMO

Last few decades, viruses are a real menace to human safety. Therefore, the rapid identification of viruses should be one of the best ways to prevent an outbreak and important implications for medical healthcare. The recent outbreak of coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus which belongs to the single-stranded, positive-strand RNA viruses. The pandemic dimension spread of COVID-19 poses a severe threat to the health and lives of seven billion people worldwide. There is a growing urgency worldwide to establish a point-of-care device for the rapid detection of COVID-19 to prevent subsequent secondary spread. Therefore, the need for sensitive, selective, and rapid diagnostic devices plays a vital role in selecting appropriate treatments and to prevent the epidemics. During the last decade, electrochemical biosensors have emerged as reliable analytical devices and represent a new promising tool for the detection of different pathogenic viruses. This review summarizes the state of the art of different virus detection with currently available electrochemical detection methods. Moreover, this review discusses different fabrication techniques, detection principles, and applications of various virus biosensors. Future research also looks at the use of electrochemical biosensors regarding a potential detection kit for the rapid identification of the COVID-19.


Assuntos
Betacoronavirus , Técnicas Biossensoriais/instrumentação , Técnicas de Laboratório Clínico/instrumentação , Infecções por Coronavirus/diagnóstico , Técnicas Eletroquímicas/instrumentação , Pneumonia Viral/diagnóstico , Vírus/isolamento & purificação , Animais , Betacoronavirus/isolamento & purificação , Betacoronavirus/patogenicidade , Infecções por Coronavirus/virologia , Desenho de Equipamento , Humanos , Nanopartículas Metálicas/química , Nanopartículas Metálicas/ultraestrutura , Microscopia Eletrônica de Varredura , Pandemias , Pneumonia Viral/virologia , Testes Imediatos , Vírus/patogenicidade
10.
PLoS One ; 15(9): e0237694, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32941461

RESUMO

BACKGROUND: The SARS-CoV-2 (Severe Acute Respiratory Syndrome CoronaVirus 2) is responsible for the infectious respiratory disease called COVID-19 (COronaVIrus Disease 2019). In response to the growing COVID-19 pandemic, point-of-care (POC) tests have been developed to detect specific antibodies, IgG and IgM, to SARS-CoV-2 virus in human whole blood. We conducted a prospective observational study to evaluate the performance of two POC tests, COVID-PRESTO® and COVID-DUO®, compared to the gold standard, RT-PCR (real-time reverse transcriptase polymerase chain reaction). METHODS: RT-PCR testing of SARS-Cov-2 was performed from nasopharyngeal swab specimens collected in adult patients visiting the infectious disease department at the hospital (Orléans, France). Capillary whole blood (CWB) samples from the fingertip taken at different time points after onset of the disease were tested with POC tests. The specificity and sensitivity of the rapid test kits compared to test of reference (RT-PCR) were calculated. RESULTS: Among 381 patients with symptoms of COVID-19 who went to the hospital for a diagnostic, 143 patients were RT-PCR negative. Results of test with POC tests were all negative for these patients, indicating a specificity of 100% for both POC tests. In the RT-PCR positive subgroup (n = 238), 133 patients were tested with COVID-PRESTO® and 129 patients were tested with COVID-DUO® (24 patients tested with both). The further the onset of symptoms was from the date of collection, the greater the sensitivity. The sensitivity of COVID-PRESTO® test ranged from 10.00% for patients having experienced their 1st symptoms from 0 to 5 days ago to 100% in patients where symptoms had occurred more than 15 days before the date of tests. For COVID-DUO® test, the sensitivity ranged from 35.71% [0-5 days] to 100% (> 15 days). CONCLUSION: COVID-PRESTO® and DUO® POC tests turned out to be very specific (none false positive) and to be sensitive enough after 15 days from onset of symptom. These easy to use IgG/IgM combined test kits are the first ones allowing a screening with CWB sample, by typing from a finger prick. These rapid tests are particularly interesting for screening in low resource settings.


Assuntos
Anticorpos Antivirais/sangue , Betacoronavirus/imunologia , Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/diagnóstico , Imunoensaio/métodos , Imunoglobulina G/sangue , Imunoglobulina M/sangue , Pneumonia Viral/diagnóstico , Kit de Reagentes para Diagnóstico , Adulto , Idoso , Especificidade de Anticorpos , Betacoronavirus/genética , Betacoronavirus/isolamento & purificação , Capilares , Infecções por Coronavirus/sangue , Dedos/irrigação sanguínea , Humanos , Pessoa de Meia-Idade , Nasofaringe/virologia , Pandemias , Pneumonia Viral/sangue , Testes Imediatos , Estudos Prospectivos , Reação em Cadeia da Polimerase em Tempo Real , Sensibilidade e Especificidade , Adulto Jovem
11.
Emerg Microbes Infect ; 9(1): 2212-2221, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32969769

RESUMO

Background: Several serological tests for SARS-CoV-2 have been developed or use, but most have only been validated on few samples, and none provide medical practitioners with an easy-to-use, self-contained, bedside test with high accuracy. Material and methods: Two-hundred fifty-six sera from 101 patients hospitalized with SARS-CoV-2 infection (positive RT-PCR) and 50 control sera were tested for IgM/IgG using the NG-Test IgM-IgG COVID all-in-one assay. The seroconversion dynamic was assessed by symptom onset and day of RT-PCR diagnosis. Results: Among the SARS-CoV-2 infected patients, positive IgG and/or IgM result was observed for 67.3% of patients (68/101), including 17 (16.8%) already positive at the day of RT-PCR, and 51 (50.5%) with observable seroconversion, and 32.7% (33/101) remained negative as subsequent sampling was not possible (patient discharge or death). The sensitivity increased with the delay between onset of symptoms and sampling, going from 29.1%, 78.2% and 86.5% for the time periods of 0-9-, 10-14- and >14-days after the onset of symptoms, respectively. Cumulative sensitivity, specificity, Positive Predictive Value and Negative Predictive Value were 97.0%, 100%, 100% and 96.2%, respectively 15-days after the onset of symptoms. No difference in seroconversion delay was observed regardless of whether patients received ventilation. Conclusions: The NG-test is a bedside serological assay that could serve as a complementary source of diagnostic information to RT-PCR and chest imaging. It may also be useful to monitor immunological status of medical and non-medical workers during the ongoing pandemic, and the general population after social distancing measures have eased.


Assuntos
Anticorpos Antivirais/imunologia , Betacoronavirus/imunologia , Técnicas de Laboratório Clínico , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/imunologia , Pneumonia Viral/diagnóstico , Pneumonia Viral/imunologia , Testes Imediatos , Testes Sorológicos/métodos , Adulto , Anticorpos Antivirais/sangue , Betacoronavirus/genética , Estudos de Casos e Controles , Infecções por Coronavirus/virologia , Feminino , Humanos , Imunoglobulina G/sangue , Imunoglobulina G/imunologia , Imunoglobulina M/sangue , Imunoglobulina M/imunologia , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/virologia , Reação em Cadeia da Polimerase , Fitas Reagentes , Sensibilidade e Especificidade , Soroconversão , Testes Sorológicos/normas
12.
Ann Biol Clin (Paris) ; 78(4): 363-382, 2020 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-32753365

RESUMO

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.


Assuntos
Técnicas de Laboratório Clínico , Saúde Global , Laboratórios/estatística & dados numéricos , Laboratórios/normas , Testes Imediatos , Acreditação , Serviços de Laboratório Clínico/normas , Serviços de Laboratório Clínico/estatística & dados numéricos , Técnicas de Laboratório Clínico/normas , Técnicas de Laboratório Clínico/estatística & dados numéricos , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , França/epidemiologia , Saúde Global/normas , Saúde Global/estatística & dados numéricos , História do Século XXI , Humanos , Internacionalidade , Ensaio de Proficiência Laboratorial/normas , Pandemias , Pneumonia Viral/diagnóstico , Pneumonia Viral/epidemiologia , Sistemas Automatizados de Assistência Junto ao Leito/normas , Sistemas Automatizados de Assistência Junto ao Leito/estatística & dados numéricos , Testes Imediatos/organização & administração , Testes Imediatos/normas , Testes Imediatos/estatística & dados numéricos , Garantia da Qualidade dos Cuidados de Saúde/organização & administração , Inquéritos e Questionários
13.
Sheng Wu Gong Cheng Xue Bao ; 36(7): 1283-1292, 2020 Jul 25.
Artigo em Chinês | MEDLINE | ID: mdl-32748586

RESUMO

Point-of-care testing (POCT) is a test method performed on the sampling site or patient bedside. Accurate results can be achieved rapidly by the application of portable analytical instruments and compatible reagents. It has been widely used in the field of in vitro diagnosis (IVD). Paper-based microfluidics technology has great potential in developing POCT due to its advantages in low cost, simple operation, rapid detection, portable equipment, and unrestricted application conditions. In recent years, the development of paper-based microfluidic technology and its integration with various new technologies and methods have promoted the substantial development of POCT technology and methods. The classification and characteristic of the paper are summarized in this review. Paper-based microfluidic sample pretreatment methods, the flow control in the process of reaction and the signal detecting and analyzing methods for the testing results are introduced. The research progress of various kinds of microfluidic paper-based analytical devices (µPADs) toward POCT in recent years is reviewed. Finally, remaining problems and the future prospects in POCT application of paper-based microfluidics are discussed.


Assuntos
Testes Diagnósticos de Rotina , Técnicas Analíticas Microfluídicas , Papel , Testes Imediatos , Testes Diagnósticos de Rotina/métodos , Humanos , Técnicas Analíticas Microfluídicas/instrumentação
14.
BMC Res Notes ; 13(1): 372, 2020 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-32762746

RESUMO

OBJECTIVE: COVID19 has caused a global and ongoing pandemic. The need for population seroconversion data is apparent to monitor and respond to the pandemic. Using a lateral flow assay (LFA) testing platform, the seropositivity in 63 New York Blood Center (NYBC) Convelescent Plasma (CP) donor samples were evaluated for the presence of COVID19 specific IgG and IgM. RESULTS: CP donors showed diverse antibody result. Convalescent donor plasma contains SARS-CoV-2 specific antibodies. Weak antibody bands may identify low titer CP donors. LFA tests can identify antibody positive individuals that have recovered from COVID19. Confirming suspected cases using antibody detection could help inform the patient and the community as to the relative risk to future exposure and a better understanding of disease exposure.


Assuntos
Anticorpos Antivirais/sangue , Antígenos Virais/imunologia , Betacoronavirus/imunologia , Doadores de Sangue , Técnicas de Laboratório Clínico/métodos , Convalescença , Infecções por Coronavirus/diagnóstico , Imunoensaio/métodos , Imunoglobulina G/sangue , Imunoglobulina M/sangue , Proteínas do Nucleocapsídeo/imunologia , Pandemias , Pneumonia Viral/diagnóstico , Testes Imediatos , Glicoproteína da Espícula de Coronavírus/imunologia , Especificidade de Anticorpos , Infecções por Coronavirus/terapia , Coloide de Ouro , Humanos , Imunização Passiva , Plasma , Domínios Proteicos , Proteínas Recombinantes/imunologia , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Soroconversão
15.
BMC Infect Dis ; 20(1): 555, 2020 Jul 31.
Artigo em Inglês | MEDLINE | ID: mdl-32736601

RESUMO

BACKGROUND: Determine TB-LAM is the first point-of-care test (POC) for HIV-associated tuberculosis (TB) and rapidly identifies TB in those at high-risk for short-term mortality. While the relationship between urine-LAM and mortality has been previously described, the outcomes of those undergoing urine-LAM testing have largely been assessed during short follow-up periods within diagnostic accuracy studies. We therefore sought to assess the relationship between baseline urine-LAM results and subsequent hospitalization and mortality under real-world conditions among outpatients in the first year of ART. METHODS: Consecutive, HIV-positive adults with a CD4 count < 100 cells/uL presenting for ART initiation were enrolled. TB diagnoses and outcomes (hospitalization, loss-to-follow and mortality) were recorded during the first year following enrolment. Baseline urine samples were retrospectively tested using the urine-LAM POC assay. Kaplan Meier survival curves were used to assess the cumulative probability of hospitalization or mortality in the first year of follow-up, according to urine-LAM status. Cox regression analyses were performed to determine independent predictors of hospitalization and mortality at three months and one year of follow-up. RESULTS: 468 patients with a median CD4 count of 59 cells/uL were enrolled. There were 140 patients (29.9%) with newly diagnosed TB in the first year of follow-up of which 79 (56.4%) were microbiologically-confirmed. A total of 18% (n = 84) required hospital admission and 12.2% (n = 57) died within a year of study entry. 38 out of 468 (8.1%) patients retrospectively tested urine-LAM positive - including 19.0% of those with microbiologically-proven TB diagnoses (n = 15/79) and 23.0% (n = 14/61) of those with clinical-only TB diagnoses; 9 of 38 (23.7%) of patients retrospectively testing LAM positive were never diagnosed with TB under routine program conditions. Among all patients (n = 468) in the first year of follow-up, a positive urine-LAM result was strongly associated with all-cause hospitalization and mortality with a corresponding adjusted hazard ratio (aHR) of 3.7 (95%CI, 1.9-7.1) and 2.6 (95%, 1.2-5.7), respectively. CONCLUSIONS: Systematic urine-LAM testing among ART-naïve HIV-positive outpatients with CD4 counts < 100 cells/uL detected TB cases that were missed under routine programme conditions and was highly predictive for subsequent hospitalization and mortality in the first year of ART.


Assuntos
Infecções por HIV/complicações , Lipopolissacarídeos/urina , Tuberculose/diagnóstico , Adulto , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/urina , Contagem de Linfócito CD4 , Feminino , Seguimentos , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Pacientes Ambulatoriais/estatística & dados numéricos , Testes Imediatos , Estudos Prospectivos , Estudos Retrospectivos , África do Sul/epidemiologia , Resultado do Tratamento , Tuberculose/mortalidade , Tuberculose/terapia , Tuberculose/urina , Urinálise/métodos
16.
BMC Infect Dis ; 20(1): 580, 2020 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-32762658

RESUMO

BACKGROUND: Dengue virus (DENV) causes the hospitalisation of an estimated 500,000 people every year. Outbreaks can severely stress healthcare systems, especially in rural settings. It is difficult to discriminate patients who need to be hospitalized from those that do not. Earlier work identified thrombocyte count and subsequent function as a promising prognostic marker of DENV severity. Herein, we investigated the potential of quantitative thrombocyte function tests in those admitted in the very early phase of acute DENV infections, using Multiplate™ multiple-electrode aggregometry to explore its potential in triage. METHODS: In this prospective cohort study all patients aged ≥13 admitted to Universitas Airlangga Hospital in Surabaya, Indonesia with a fever (≥38 °C) between 25 January and 1 August 2018 and with a clinical suspicion of DENV, were eligible for inclusion. Exclusion criteria were a thrombocyte count below 100 × 109/L and the use of any medication with a known anticoagulant effect, nonsteroidal anti-inflammatory drugs and acetyl salicylic acid. Clinical data was collected and blood was taken on admission, day 1 and day 7. Samples were tested for acute DENV, using Panbio NS1 ELISA. Platelet aggregation using ADP-, TRAP- and COL-test were presented as Area Under the aggregation Curve (AUC). Significance was tested between DENV+, probably DENV, fever of another origin, and healthy controls (HC). RESULTS: A total of 59 patients (DENV+ n = 10, DENV probable n = 25, fever other origin n = 24) and 20 HC were included. We found a significantly lower thrombocyte aggregation in the DENV+ group, compared with both HCs and the fever of another origin group (p < .001). Low ADP AUC values on baseline correlated to a longer hospital stay in DENV+ and probable DENV cases. CONCLUSION: Thrombocyte aggregation induced by Adenosine diphosphate, Collagen and Thrombin receptor activating peptide-6 is impaired in human DENV cases, compared with healthy controls and other causes of fever. This explorative study provides insights to thrombocyte function in DENV patients and could potentially serve as a future marker in DENV disease.


Assuntos
Plaquetas/metabolismo , Vírus da Dengue/imunologia , Dengue/diagnóstico , Dengue/epidemiologia , Sistemas Automatizados de Assistência Junto ao Leito , Testes Imediatos , Difosfato de Adenosina/sangue , Adolescente , Adulto , Idoso , Biomarcadores/sangue , Colágeno/metabolismo , Dengue/virologia , Ensaio de Imunoadsorção Enzimática , Feminino , Febre/diagnóstico , Humanos , Indonésia/epidemiologia , Masculino , Pessoa de Meia-Idade , Fragmentos de Peptídeos/sangue , Agregação Plaquetária , Contagem de Plaquetas , Estudos Prospectivos , Índice de Gravidade de Doença , Adulto Jovem
17.
Biosens Bioelectron ; 166: 112455, 2020 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-32739797

RESUMO

The rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to the coronavirus disease 2019 (COVID-19) worldwide pandemic. This unprecedented situation has garnered worldwide attention. An effective strategy for controlling the COVID-19 pandemic is to develop highly accurate methods for the rapid identification and isolation of SARS-CoV-2 infected patients. Many companies and institutes are therefore striving to develop effective methods for the rapid detection of SARS-CoV-2 ribonucleic acid (RNA), antibodies, antigens, and the virus. In this review, we summarize the structure of the SARS-CoV-2 virus, its genome and gene expression characteristics, and the current progression of SARS-CoV-2 RNA, antibodies, antigens, and virus detection. Further, we discuss the reasons for the observed false-negative and false-positive RNA and antibody detection results in practical clinical applications. Finally, we provide a review of the biosensors which hold promising potential for point-of-care detection of COVID-19 patients. This review thereby provides general guidelines for both scientists in the biosensing research community and for those in the biosensor industry to develop a highly sensitive and accurate point-of-care COVID-19 detection system, which would be of enormous benefit for controlling the current COVID-19 pandemic.


Assuntos
Betacoronavirus/isolamento & purificação , Técnicas Biossensoriais/métodos , Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/virologia , Pandemias , Pneumonia Viral/diagnóstico , Pneumonia Viral/virologia , Anticorpos Antivirais/isolamento & purificação , Antígenos Virais/isolamento & purificação , Betacoronavirus/genética , Betacoronavirus/imunologia , Técnicas Biossensoriais/instrumentação , Técnicas Biossensoriais/tendências , Técnicas de Laboratório Clínico/instrumentação , Técnicas de Laboratório Clínico/tendências , Infecções por Coronavirus/epidemiologia , Desenho de Equipamento , Genoma Viral , Humanos , Técnicas de Diagnóstico Molecular , Técnicas de Amplificação de Ácido Nucleico , Pneumonia Viral/epidemiologia , Testes Imediatos , RNA Viral/genética , RNA Viral/isolamento & purificação , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Vírion/isolamento & purificação
18.
JAMA ; 324(8): 761-771, 2020 08 25.
Artigo em Inglês | MEDLINE | ID: mdl-32840598

RESUMO

Importance: After percutaneous coronary intervention (PCI), patients with CYP2C19*2 or *3 loss-of-function (LOF) variants treated with clopidogrel have increased risk of ischemic events. Whether genotype-guided selection of oral P2Y12 inhibitor therapy improves ischemic outcomes is unknown. Objective: To determine the effect of a genotype-guided oral P2Y12 inhibitor strategy on ischemic outcomes in CYP2C19 LOF carriers after PCI. Design, Setting, and Participants: Open-label randomized clinical trial of 5302 patients undergoing PCI for acute coronary syndromes (ACS) or stable coronary artery disease (CAD). Patients were enrolled at 40 centers in the US, Canada, South Korea, and Mexico from May 2013 through October 2018; final date of follow-up was October 2019. Interventions: Patients randomized to the genotype-guided group (n = 2652) underwent point-of-care genotyping. CYP2C19 LOF carriers were prescribed ticagrelor and noncarriers clopidogrel. Patients randomized to the conventional group (n = 2650) were prescribed clopidogrel and underwent genotyping after 12 months. Main Outcomes and Measures: The primary end point was a composite of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia at 12 months. A secondary end point was major or minor bleeding at 12 months. The primary analysis was in patients with CYP2C19 LOF variants, and secondary analysis included all randomized patients. The trial had 85% power to detect a minimum hazard ratio of 0.50. Results: Among 5302 patients randomized (median age, 62 years; 25% women), 82% had ACS and 18% had stable CAD; 94% completed the trial. Of 1849 with CYP2C19 LOF variants, 764 of 903 (85%) assigned to genotype-guided therapy received ticagrelor, and 932 of 946 (99%) assigned to conventional therapy received clopidogrel. The primary end point occurred in 35 of 903 CYP2C19 LOF carriers (4.0%) in the genotype-guided therapy group and 54 of 946 (5.9%) in the conventional therapy group at 12 months (hazard ratio [HR], 0.66 [95% CI, 0.43-1.02]; P = .06). None of the 11 prespecified secondary end points showed significant differences, including major or minor bleeding in CYP2C19 LOF carriers in the genotype-guided group (1.9%) vs the conventional therapy group (1.6%) at 12 months (HR, 1.22 [95% CI, 0.60-2.51]; P = .58). Among all randomized patients, the primary end point occurred in 113 of 2641 (4.4%) in the genotype-guided group and 135 of 2635 (5.3%) in the conventional group (HR, 0.84 [95% CI, 0.65-1.07]; P = .16). Conclusions and Relevance: Among CYP2C19 LOF carriers with ACS and stable CAD undergoing PCI, genotype-guided selection of an oral P2Y12 inhibitor, compared with conventional clopidogrel therapy without point-of-care genotyping, resulted in no statistically significant difference in a composite end point of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia based on the prespecified analysis plan and the treatment effect that the study was powered to detect at 12 months. Trial Registration: ClinicalTrials.gov Identifier: NCT01742117.


Assuntos
Clopidogrel/uso terapêutico , Doença da Artéria Coronariana/genética , Inibidores do Citocromo P-450 CYP2C19/uso terapêutico , Citocromo P-450 CYP2C19/genética , Intervenção Coronária Percutânea/efeitos adversos , Medicina de Precisão , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Ticagrelor/uso terapêutico , Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/genética , Síndrome Coronariana Aguda/cirurgia , Idoso , Idoso de 80 Anos ou mais , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/mortalidade , Clopidogrel/efeitos adversos , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/terapia , Inibidores do Citocromo P-450 CYP2C19/efeitos adversos , Feminino , Genótipo , Técnicas de Genotipagem , Hemorragia/induzido quimicamente , Heterozigoto , Humanos , Mutação com Perda de Função , Masculino , Pessoa de Meia-Idade , Testes Imediatos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Ticagrelor/efeitos adversos
19.
SEMERGEN, Soc. Esp. Med. Rural Gen. (Ed. Impr.) ; 46(supl.1): 28-32, ago. 2020. tab
Artigo em Inglês | IBECS | ID: ibc-192619

RESUMO

OBJECTIVE: To assess the agreement between two rapid detection tests (RDT) for antibodies against SARS-CoV-2 infection. MATERIALS AND METHODS: This was a cross-sectional study that used a random sample of non-hospitalized patients from the primary care management division of the Healthcare Area of Leon (58 RT-PCR-positive cases and 52 RT-PCR-negative cases). Information regarding symptoms was collected and all patients were simultaneously tested using two RDTs (Combined - cRDT and Differentiated - dRDT). The results of both tests were evaluated using the chi-square test and, for degree of agreement, the kappa coefficient. RESULTS: About 52% of the participants were women (mean age: 48.2±11.0 years). A total of 58.2% were positive for d-RDT and 41.2% were positive for c-RDT. In the subjects who were RT-PCR-positive, d-RDT was positive in 72.4% and c-RDT in 55.2%; in those who were RT-PCR-negative, the percentages were 42.3% and 26.9%, respectively. The kappa coefficient observed between the two RDTs was 0.644, and was higher in patients without a fever or anosmia (0.725) and lower in those with a fever or anosmia (0.524). CONCLUSIONS: There is good agreement between the tests used in this study. Given the sensitivity observed, they can be very useful as a complement to RT-PCR


OBJETIVO: Evaluar la concordancia entre dos pruebas de detección rápida (PDR) de anticuerpos en la infección por SARS-CoV-2. MATERIALES Y MÉTODOS: Estudio transversal. Se utilizó una muestra aleatoria de pacientes no hospitalizados de la Gerencia de Atención Primaria del Área de Salud de León (58 con RT-PCR positiva y 52 con RT-PCR negativa). Se recogió información sobre síntomas y a todos se les realizó simultáneamente dos PDR (combinada: PRD-C y diferenciada: PRD-D). Los resultados de ambas pruebas fueron evaluados mediante X2 y el grado de concordancia con el índice Kappa. RESULTADOS: Un 52% de los participantes fueron mujeres (edad media: 48,2 ± 11,0 años). El 58,2% fue positivo a la PDR-D y 41,2% a la PDR-C. En los sujetos RT-PCR + la PDR-D fue positiva en el 72,4% y la PDR-C en el 55,2%; en el caso de los RT-PCR - en el 42,3% y 26,9%, respectivamente. El índice Kappa observado entre las dos PDR fue del 0,644, siendo mayor en pacientes sin fiebre ni anosmia (0,725) y menor en aquellos con fiebre o anosmia (0,524). CONCLUSIONES: Existe una buena concordancia entre los test utilizados en este estudio. Dada la sensibilidad obtenida, pueden ser de gran utilidad como complemento a las RT-PCR


Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Infecções por Coronavirus/diagnóstico , Síndrome Respiratória Aguda Grave/diagnóstico , Vírus da SARS/isolamento & purificação , Anticorpos Antivirais/isolamento & purificação , Sensibilidade e Especificidade , Testes Imediatos/estatística & dados numéricos , Reação em Cadeia da Polimerase em Tempo Real/estatística & dados numéricos , Estudos Transversais
20.
PLoS One ; 15(8): e0238035, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32833976

RESUMO

BACKGROUND: Whereas 72% of hepatitis C virus (HCV)-infected people worldwide live in low- and middle-income countries (LMICs), only 6% of them have been diagnosed. Innovative technologies for HCV diagnosis provide opportunities for developing testing strategies more adapted to resource-constrained settings. However, studies about their economic feasibility in LMICs are lacking. METHODS: Adopting a health sector perspective in Cameroon, Cote-d'Ivoire, and Senegal, a decision tree model was developed to compare 12 testing strategies with the following characteristics: a one-step or two-step testing sequence, HCV-RNA or HCV core antigen as confirmative biomarker, laboratory or point-of-care (POC) tests, and venous blood samples or dried blood spots (DBS). Outcomes measures were the number of true positives (TPs), cost per screened individual, incremental cost-effectiveness ratios, and nationwide budget. Corresponding time horizon was immediate, and outcomes were accordingly not discounted. Detailed sensitivity analyses were conducted. FINDINGS: In the base-case, a two-step POC-based strategy including anti-HCV antibody (HCV-Ab) and HCV-RNA testing had the lowest cost, €8.18 per screened individual. Assuming a lost-to-follow-up rate after screening > 1.9%, a DBS-based laboratory HCV-RNA after HCV-Ab POC testing was the single un-dominated strategy, requiring an additional cost of €3653.56 per additional TP detected. Both strategies would require 8-25% of the annual public health expenditure of the study countries for diagnosing 30% of HCV-infected individuals. Assuming a seroprevalence > 46.9% or a cost of POC HCV-RNA < €7.32, a one-step strategy based on POC HCV-RNA dominated the two-step POC-based strategy but resulted in many more false-positive cases. CONCLUSIONS: POC HCV-Ab followed by either POC- or DBS-based HCV-RNA testing would be the most cost-effective strategies in the study countries. Without a substantial increase in funding for health or a dramatic decrease in assay prices, HCV testing would constitute an economic barrier to the implementation of HCV elimination programs in LMICs.


Assuntos
Análise Custo-Benefício , Hepatite C/diagnóstico , Modelos Estatísticos , África Central , África Ocidental , Árvores de Decisões , Estudos de Viabilidade , Humanos , Testes Imediatos/economia , Fatores de Tempo
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