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1.
J Pers Med ; 14(8)2024 Aug 03.
Artículo en Inglés | MEDLINE | ID: mdl-39202015

RESUMEN

BACKGROUND: Respiratory infections pose a major public health threat. The predominant viruses causing viral respiratory infections are influenza A and B (Flu-A, Flu-B), coronaviruses, respiratory syncytial virus (RSV), and adenovirus. This study aims to investigate the proportion of these cases via rapid antigen tests and assess seasonal patterns. METHODS: Clinical samples were collected from symptomatic adults presenting to the Emergency and Respiratory Medicine Departments of the University Hospital of Larissa (UHL), Greece from 16 October 2023 to 31 March 2024. Nasal specimens were antigen-tested for Flu-A/B, SARS-CoV-2, RSV, and adenovirus. RESULTS: The total sample of specimens collected was 1434, of which 739 (51.5%) were female and 695 were male (48.5%). The mean age of participants was 57 ± 5.5 years. Among the positive results, we recorded a proportion of 40.18% and 11.40% for influenza A and B, respectively, followed by 35.79% for SARS-CoV-2, 10.70% for RSV, and 1.93% for adenovirus. CONCLUSIONS: In Greece, surveillance systems in infection control are underutilized. Rapid tests via multiple antigens can quickly identify viral infections, making them a valuable tool with financial benefits for health systems. Early detection of respiratory infections helps allocate resources efficiently, ensures adequate staff and facilities are available, and improves patient care through refined clinical management.

2.
Med Microbiol Immunol ; 213(1): 10, 2024 Jun 22.
Artículo en Inglés | MEDLINE | ID: mdl-38907945

RESUMEN

Rapid tests allow outpatient, low cost, reliable, screening for chronic HIV infection. However, data regarding their sensitivity on primary infection remain scarce. The objective of this study was to assess sensitivity of nine HIV rapid tests for primary HIV-1 infection screening. Seventy-five serum samples from patients during HIV-1 primary infection were included. Primary infection was diagnosed by a positive 4th generation ELISA and HIV-1 RNA positivity confirmed by Western blot patterns associated with HIV-1 primary infection. Early seroconversion was defined as the absence of antibodies on HIV-1 Western blot associated with HIV-1 RNA and p24-antigen positivity. An identical sensitivity (95% CI) of 76.7% (65.2-84.2%) was observed for HIV 1/2 STAT-PAK® Assay (STAT-PAK), INSTI™ HIV-1/HIV-2 antibody Test (INSTI), SURE CHECK® HIV 1/2 (SURE CHECK) and MULTISURE HIV rapid test (MULTISURE) with visual reading. Sensitivity was 74.7% (63.8-83.1%) for MULTISURE (automatic reading), 77.0% (66.3-85.1%) for FIRST RESPONSE® Test VIH 1-2.O CARTE (FIRST RESPONSE), 83.8% (73.8-90.5%) for VIKIA HIV1/2® (VIKIA), 88.0% (78.7-93.6%) for Genie™ Fast HIV 1/2 (Genie Fast), 88.6% (79.0-94.1%) for Hexagon HIV (Hexagon), and 92.8% (83.6-96.3%) for Exacto® TEST HIV Pro (Exacto). However, rapid tests performed poorly for the early seroconversion subgroup (n = 14), with sensitivities ranging from 7% (1.3-31.5%) for STAT-PAK, INSTI, SURE CHECK, MULTISURE (automatic reading), to 29% (12-55%) for FIRST RESPONSE, 31% (13-58%) for VIKIA, 43% (21-67%) for Hexagon and 57.1% (32.6-78.6%) for Exacto and Genie Fast. Overall, despite significant discrepancies in sensitivity, HIV rapid tests should be used with caution in the context of a suspected primary infection.


Asunto(s)
Anticuerpos Anti-VIH , Infecciones por VIH , VIH-1 , Tamizaje Masivo , Sensibilidad y Especificidad , Humanos , Infecciones por VIH/diagnóstico , VIH-1/inmunología , VIH-1/aislamiento & purificación , Masculino , Tamizaje Masivo/métodos , Femenino , Adulto , Anticuerpos Anti-VIH/sangre , Persona de Mediana Edad , ARN Viral/sangre , Ensayo de Inmunoadsorción Enzimática/métodos , Adulto Joven , Western Blotting/métodos , Pruebas Diagnósticas de Rutina/métodos , Prueba de VIH/métodos
3.
Sci Rep ; 14(1): 7319, 2024 03 27.
Artículo en Inglés | MEDLINE | ID: mdl-38538635

RESUMEN

Compared to other infectious diseases, for which LFT development can take years, SARS-CoV-2 antigen LFTS were developed and deployed within months. LFTS for antigen detection were adopted on an unprecedented scale during the COVID-19 pandemic, but many of them lack the sensitivity especially for samples with low viral load. In our previous work, we developed an enhanced signal strip for detection of SARS CoV-2 SI antigens in saliva. Here we introduce some modification to improve the sensitivity, and specificity, and to lower the cost of the strip, by using biotin streptavidin (BS) system. In the modified BS strip, gold-streptavidin and biotinylated Nanobodies (Nbs) against S1 antigen were externally mixed with the tested samples (saliva or nasopharyngeal swab) before their application on the sample pad of the test strip containing angiotensin converting enzyme (ACE-2), as the capturing probe. The study included 320 individuals, with 180 being positively confirmed by RT-PCR and 140 confirmed negative, as well as, 45 health care workers, who were responsible for screening and handling of surgical cases in General Surgery Department and COVID clinic of TBRI. Our results proved that modified BS strip improved the overall sensitivity and specificity of S1antigen detection in saliva samples (95.21% and 99.29% respectively) compared to our previously developed enhanced LFTS (91.66% and 98.57% respectively). Also, the sensitivity of cases with Ct ≤ 30, Ct ≤ 35, and Ct ≤ 40 using the modified BS strip showed higher values (98.54%, 95.38%, and 88.89% respectively), compared to the corresponding results of our previously developed enhanced LFTS (95.86%, 92.31%, and 82.22% respectively). There were no cross-reactions with either Middle East respiratory syndrome corona virus MERS-CoV or SARS-CoV antigens. Furthermore, we found that the lower viral detection limit (LVD) of BS strip was obviously lower than our previous LVD limit of the enhanced LFTS (0.2 × 104 copies/ml vs. 0.4 × 104 copies/ml, respectively). Our developed BS strip showed that saliva samples gave better results than nasopharyngeal swabs of the same patients. The fact of using smaller amounts of Nbs, and ACE2, as well as the dispensing off of conjugate pad when applying BS strip modifications, justified the expected reduction in the costs of the strip. The implementation of BS strips on saliva samples of 45 health co-workers, who were tested 4 and 6 days after exposure to infection, showed an increase in the sensitivity, starting from the 4th day and reaching its highest level on the 6th day in both high risk and paramedic groups (90.9%, and 80.0%, respectively). This study provides evidence that employment of the modified BS system could increase the sensitivity of the strips, lower their cost, and render them an effective screening tool for early detection of the virus in saliva of suspected Covid-19 patients.


Asunto(s)
Biotina , COVID-19 , Proteínas de Neoplasias , Humanos , Estreptavidina , SARS-CoV-2 , Pandemias , Saliva , COVID-19/diagnóstico , Antígenos Virales , Nasofaringe , Manejo de Especímenes
4.
Diseases ; 11(3)2023 Sep 15.
Artículo en Inglés | MEDLINE | ID: mdl-37754318

RESUMEN

Respiratory infections constitute a major reason for infants and children seeking medical advice and visiting health facilities, thus remaining a significant public threat with high morbidity and mortality. The predominant viruses causing viral respiratory infections are influenza A and B viruses (Flu-A, Flu-B), respiratory syncytial virus (RSV), adenovirus and coronaviruses. We aimed to record the proportion of RSV, SARS-CoV-2, influenza A/B and adenovirus cases with rapid antigen tests and validate the results with RT-PCR assays of upper respiratory specimens with a wide range of viral loads and (co)-infection patterns in children. Clinical samples were collected from early symptomatic children (presenting with fever and/or cough and/or headache within 5-7 days). The surveillance program was conducted in five private pediatric dispensaries and one pediatric care unit, from 10 January 2023 to 30 March 2023 in central Greece. The total sample of specimens collected was 784 young children and infants, of which 383 (48.8%) were female and 401 were male (51.2%). The mean age of participants was 7.3 + 5.5 years. The sensitivity of the FLU A & B test was 91.15% (95% CI: 84.33-95.67%), and the specificity was 98.96% (95% CI: 97.86-99.58%). The sensitivity and specificity of the adenovirus and RSV test was {92.45% (95% CI: 81.79-97.91%), 99.32% (95% CI: 98.41-99.78%)} and {92.59% (95% CI: 75.71-99.09%), 99.47% (95% CI: 98.65-99.86%)} respectively. Lastly, the sensitivity of the SARS-CoV-2 test was 100.00% (95% CI: 79.41-100.00%) and the specificity was 99.74% (95% CI: 99.06-99.97%). We recorded a proportion of 14.3% and 3.44% for influenza A and B, respectively, followed by a proportion of 6.9% for adenovirus, a proportion of 3.7% for RSV, and finally, a proportion of 2.3% for SARS-CoV-2. The combination of a new multiple rapid test with multiple antigens will probably be a useful tool with a financial impact for health systems targeting the early detection and appropriate treatment of respiratory infections in emergency departments in primary health care facilities.

5.
Animals (Basel) ; 13(7)2023 Apr 05.
Artículo en Inglés | MEDLINE | ID: mdl-37048519

RESUMEN

In livestock, the importance of hygiene management is gaining importance within the context of biosecurity. The aim of this study was to monitor the implementation of biosecurity and hygiene procedures in 20 swine herds over a 12-month period, as driven by tailor-made plans, including training on-farm. The measure of adenosine triphosphate (ATP) environmental contents was used as an output biomarker. The presence of livestock-associated methicillin-resistant Staphylococcus aureus (LA-MRSA) and extended-spectrum ß-lactamase producing Escherichia coli (ESBL-E. coli) was also investigated as sentinels of antibiotic resistance. A significant biosecurity improvement (p = 0.006) and a reduction in the ATP content in the sanitised environment (p = 0.039) were observed. A cluster including 6/20 farms greatly improved both biosecurity and ATP contents, while the remaining 14/20 farms ameliorated them only slightly. Even if the ESBL-E. coli prevalence (30.0%) after the hygiene procedures significantly decreased, the prevalence of LA-MRSA (22.5%) was unaffected. Despite the promising results supporting the adoption of tailor-made biosecurity plans and the measure of environmental ATP as an output biomarker, the high LA-MRSA prevalence still detected at the end of the study underlines the importance of improving even more biosecurity and farm hygiene in a one-health approach aimed to preserve also the pig workers health.

6.
Rev. habanera cienc. méd ; 22(1)feb. 2023.
Artículo en Español | LILACS, CUMED | ID: biblio-1560081

RESUMEN

Introducción: La detección del virus SARS-CoV-2, agente causal de la COVID-19, es determinante para disminuir la propagación de la actual pandemia. Si bien el procedimiento de elección es la determinación del ácido nucleico del virus mediante la reacción en cadena de la polimerasa, también es necesario disponer de pruebas rápidas, con alta sensibilidad y precisión. Objetivo: Analizar la validez diagnóstica de un ensayo rápido de antígeno SARS-CoV-2, utilizado para la detección de la COVID-19 en el policlínico "5 de Septiembre" del municipio Playa. Material y Métodos: Se realizó un estudio analítico de corte transversal con 590 pacientes atendidos en la consulta de infecciones respiratorias agudas, en el período de enero a agosto de 2021. La determinación de antígeno SARS-CoV-2 se realizó con un ensayo rápido y la confirmación se hizo mediante la reacción en cadena de la polimerasa. Resultados: La prueba rápida de antígeno tuvo una elevada sensibilidad (98,19 %) y especificidad (92,39 %). La concordancia de los resultados obtenidos entre ambas pruebas fue elevada (0,868). Las sintomatologías más frecuentes reportadas, fueron, cefalea (51,69 %), fiebre (39,15 %), tos (37,16 %), pérdida del gusto/olfato (34,06 %) y rinorrea (30,16 %). Conclusiones: El ensayo rápido de antígeno del SARS-CoV-2 usado para la detección de la COVID-19 demostró validez y puede ser utilizado para el diagnóstico de la enfermedad. Las sintomatologías cefalea, fiebre, tos, pérdida del gusto/olfato y rinorrea fueron las más frecuentes, reportadas en más de 30 de los casos.


Introduction: The detection of the SARS-CoV-2 virus, the causal agent of COVID-19, is decisive to reduce the spread of the current pandemic. Although the procedure of choice is the determination of the nucleic acid of the virus using the polymerase chain reaction, the availability of rapid, highly sensitive, and accurate tests is also necessary. Objective: To analyze the diagnostic validity of a SARS-CoV-2 antigen rapid diagnostic test for the detection of COVID-19 in the "5 de Septiembre" Polyclinic in Playa municipality. Material and Methods: A cross-sectional analytical study was carried out on 590 patients seen in the acute respiratory infections consulting room in the period from January to August 2021. The detection of the SARS-CoV-2 antigen was performed using a rapid test and it was confirmed by polymerase chain reaction. Results: The rapid antigen test had a high sensitivity (98.19%) and specificity (92.39%). The concordance of the results obtained from both tests was high (0.868). The most frequent reported symptoms were headache (51.69%), fever (39.15%), cough (37.16%), loss of taste/smell (34.06%), and runny nose (30.16%). Conclusions: The SARS-CoV-2 antigen rapid diagnostic test used for the detection of COVID-19 is valid and can be used in the diagnosis of the disease. Symptoms such as headache, fever, cough, loss of taste/smell, and runny nose were the most frequently reported in more than 30% of cases.


Asunto(s)
Humanos , COVID-19/diagnóstico
7.
Rev. Soc. Bras. Med. Trop ; Rev. Soc. Bras. Med. Trop;56: e0167, 2023. tab
Artículo en Inglés | LILACS-Express | LILACS | ID: biblio-1441074

RESUMEN

ABSTRACT Background: SARS-CoV-2 virus originated in Wuhan (China) in December (2019) and quickly spread worldwide. Antigen tests are rapid diagnostic tests (RDT) that produce results in 15-30 min and are an important tool for the scale-up of COVID-19 testing. COVID-19 diagnostic tests are authorized for self-testing at home in some countries, including Brazil. Widespread COVID-19 diagnostic testing is required to guide public health policies and control the speed of transmission and economic recovery. Methods: Patients with suspected COVID-19 were recruited at the Hospital da Baleia (Belo Horizonte, Brazil). The SARS-CoV-2 antigen-detecting rapid diagnostic tests were evaluated from June 2020 to June 2021 using saliva, nasal, and nasopharyngeal swab samples from 609 patients. Patient samples were simultaneously tested using a molecular assay (RT-qPCR). Sensitivity, specificity, accuracy, and positive and negative predictive values were determined using the statistical program, MedCalc, and GraphPad Prism 8.0. Results: The antigen-detecting rapid diagnostic tests displayed 98% specificity, 60% sensitivity, 96% positive predictive value, and moderate concordance with RT-qPCR. Substantial agreement was found between the two methods for patients tested < 7 days of symptom onset. Conclusions: Our findings support the use of Ag-RDT as a valuable and safe diagnostic method. Ag-RDT was also demonstrated to be an important triage tool for suspected COVID-19 patients in emergencies. Overall, Ag-RDT is an effective strategy for reducing the spread of SARS-CoV-2 and contributing to COVID-19 control.

8.
Int J Public Health ; 67: 1605386, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36531607

RESUMEN

Objectives: This study aimed to report the protocol and results from the pilot phase of an opportunistic CP-based CD screening program in Barcelona, Spain. Methods: Three strategies according to recruitment approach were designed: passive, active and active-community. The study process consisted of signing the informed consent form, recording the patient's data in a web-based database system, and performing the rapid test and blood collection on dry paper. Results: Nineteen pharmacies participated and 64 patients were included during the pilot phase of the study. The rapid diagnostic test (RDT) was positive in 2/64 (3.13%) cases. Of the 49 DBS samples that arrived at the laboratory, 22 (45%) were collected incorrectly. After quantitative and qualitative assessment of the program, the dry paper sample and passive strategy were ruled out. Conclusion: DBS sampling and the passive strategy are not suitable for CD screening in community pharmacies. There is a need to expand the number of participating pharmacies and individuals to determine whether conducting a RDT in community pharmacies is an effective screening method to increase access to CD diagnosis in a non-endemic area.


Asunto(s)
Enfermedad de Chagas , Farmacias , Humanos , España , Tamizaje Masivo/métodos , Hispánicos o Latinos , Enfermedad de Chagas/diagnóstico
9.
Front Cell Infect Microbiol ; 12: 1032052, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36569196

RESUMEN

Phage therapy is one alternative to cure infections caused by antibiotic resistant bacteria. Due to the narrow host range of phages, hundreds to thousands of phages are required to cover the diversity of bacterial pathogens. In personalized phage therapy, fast selection of the phages for individual patients is essential for successful therapy. The aims of this study were to set up a rapid hydrogel-based liquid phage susceptibility assay (PST) for the selection of phages for therapeutic use and to establish a "ready-to-screen" plate concept, where phages are readily stored in hydrogel as small droplets in microtiter plate wells. We first tested four commercially available hydrogels (GrowDex, Askina, Purilon, and Intrasite) for their suitability as phage matrices in PSTs with four phages, two of which infecting Escherichia coli and two Staphylococcus aureus. Of these four hydrogels, GrowDex was the best matrix for PST, as it did not inhibit bacterial growth, released phages quickly when mixed with bacterial culture, and maintained phage viability well. We then optimized the assay for both optical density and microscopy readers using GrowDex as matrix with 23 bacterial strains representing 10 different species and 23 phages possessing different morphologies and genome sizes. When the bacterial growth was monitored by microscopy reader, the PST was executed in just 3 hours, and there was no need for overnight culturing bacterial cells prior to the assay, whereas using optical density reader, bacteria had to be pre-cultured overnight, and the assay time was five hours. Finally, we evaluated the effect of three different chemical stabilizers (trehalose, hyaluronic acid, and gelatin) in a six-month stability assay with six model phages. These phages assay behaved very differently in respect to the chemical stabilizers, and there was not a single stabilizer suitable for all phages. However, when gelatin (0.01%) or hyaluronic acid (0.2 mg/ml) was used as stabilizer, all tested phages were still considered as positives in PST after a six-month storage in 1 ml volume. In "ready-to-screen" plates, the differences in phage stabilities were even more profound, varying from two to six months for the most and least stable phages, respectively.


Asunto(s)
Bacteriófagos , Humanos , Hidrogeles/farmacología , Gelatina/farmacología , Ácido Hialurónico/farmacología , Staphylococcus aureus , Escherichia coli
10.
Rev. peru. med. exp. salud publica ; 39(4): 434-441, oct. 2022. tab
Artículo en Español | LILACS, LIPECS | ID: biblio-1424343

RESUMEN

Objetivos. Determinar el rendimiento diagnóstico de la prueba rápida SD dengue DUO (Inyecta) para la detección de NS1, IgM e IgG en comparación con la prueba de ELISA. Materiales y métodos. Es una evaluación de prueba diagnóstica que incluyó 286 muestras de suero de pacientes con sintomatología atribuible a dengue de zonas endémicas del Perú. Las muestras se analizaron por ELISA y la prueba rápida SD dengue DUO (Inyecta) para IgM, NS1 e IgG en el Instituto de Investigación Nutricional en Lima. Resultados. La sensibilidad de la prueba rápida fue de 68% para NS1 e IgM, y 86% para IgG, mejorando este parámetro a 75% y 81% para NS1 e IgM, respectivamente, en los tres primeros días. La especificidad para los tres analitos fue mayor a 87%. La concordancia de los resultados obtenidos medidos por el coeficiente Kappa para los tres analitos fue buena y no se encontró reacción cruzada con otros arbovirus. Conclusiones. La prueba rápida SD Dengue DUO permite detectar con una adecuada sensibilidad y especificidad NS1, IgM e IgG. La sensibilidad para IgM y NS1 aumenta cuando se detecta en los tres primeros días de síntomas, por lo que se recomienda su implementación en los centros de primer nivel de atención para un diagnóstico temprano y oportuno.


Objectives . To assess the diagnostic performance of the SD dengue DUO rapid test (Inyecta) for the detection of NS1, IgM and IgG in comparison to the ELISA test. Materials and methods . This is a diagnostic test evaluation that included 286 serum samples from patients with symptomatology attributable to dengue from endemic areas of Peru. The samples were analyzed by ELISA and the SD dengue DUO rapid test (Inyecta) for IgM, NS1 and IgG at the Instituto de Investigación Nutricional in Lima. Results . The sensitivity of the rapid test was 68.0% for NS1 and IgM, and 86.0% for IgG, improving to 75.0% and 81.0% for NS1 and IgM, respectively, during the first three days. The specificity for all three analytes was greater than 87.0%. The concordance of the results, measured by the Kappa coefficient for the three analytes, was good and no cross-reaction with other arboviruses was found. Conclusions . The SD dengue DUO rapid test allows detection of NS1, IgM and IgG with adequate sensitivity and specificity. Sensitivity for IgM and NS1 increases when detected during the first three days of symptoms. Therefore, we recommend its implementation in primary care centers for early and timely diagnosis.


Asunto(s)
Humanos , Masculino , Femenino , Inmunoglobulina M , Dengue , Virus del Dengue , Antígenos , Signos y Síntomas , Inmunoglobulina G , Sensibilidad y Especificidad
11.
Cancer Genet ; 264-265: 66-70, 2022 06.
Artículo en Inglés | MEDLINE | ID: mdl-35436678

RESUMEN

This study evaluated a rapid fluorescence in-situ hybridization (FISH) method with a novel 10 min hybridization time to identify the presence of recurrent gene re-arrangements in patients with Haematological malignancies (HMs). A method comparison experimental approach was used to compare this rapid method to the standard method. Hybridization results using the rapid method were comparable to standard methods in terms of result, signal strength and hybridization quality. This rapid FISH turn around time (TAT) was 1 h and enabled same day reporting of genetic and morphology results for a prompt diagnosis and timely access to targeted therapies.


Asunto(s)
Neoplasias Hematológicas , Neoplasias Hematológicas/diagnóstico , Neoplasias Hematológicas/genética , Humanos , Hibridación Fluorescente in Situ/métodos
12.
BJU Int ; 130(6): 754-763, 2022 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-34928524

RESUMEN

OBJECTIVES: To evaluate the clinical utility of the urinary bladder cancer antigen test UBC® Rapid for the diagnosis of bladder cancer (BC) and to develop and validate nomograms to identify patients at high risk of primary BC. PATIENTS AND METHODS: Data from 1787 patients from 13 participating centres, who were tested between 2012 and 2020, including 763 patients with BC, were analysed. Urine samples were analysed with the UBC® Rapid test. The nomograms were developed using data from 320 patients and externally validated using data from 274 patients. The diagnostic accuracy of the UBC® Rapid test was evaluated using receiver-operating characteristic curve analysis. Brier scores and calibration curves were chosen for the validation. Biopsy-proven BC was predicted using multivariate logistic regression. RESULTS: The sensitivity, specificity, and area under the curve for the UBC® Rapid test were 46.4%, 75.5% and 0.61 (95% confidence interval [CI] 0.58-0.64) for low-grade (LG) BC, and 70.5%, 75.5% and 0.73 (95% CI 0.70-0.76) for high-grade (HG) BC, respectively. Age, UBC® Rapid test results, smoking status and haematuria were identified as independent predictors of primary BC. After external validation, nomograms based on these predictors resulted in areas under the curve of 0.79 (95% CI 0.72-0.87) and 0.95 (95% CI: 0.92-0.98) for predicting LG-BC and HG-BC, respectively, showing excellent calibration associated with a higher net benefit than the UBC® Rapid test alone for low and medium risk levels in decision curve analysis. The R Shiny app allows the results to be explored interactively and can be accessed at www.blucab-index.net. CONCLUSION: The UBC® Rapid test alone has limited clinical utility for predicting the presence of BC. However, its combined use with BC risk factors including age, smoking status and haematuria provides a fast, highly accurate and non-invasive tool for screening patients for primary LG-BC and especially primary HG-BC.


Asunto(s)
Neoplasias de la Vejiga Urinaria , Humanos , Neoplasias de la Vejiga Urinaria/diagnóstico , Neoplasias de la Vejiga Urinaria/orina , Nomogramas , Hematuria , Curva ROC , Factores de Riesgo
13.
Artículo en Inglés | LILACS-Express | LILACS | ID: biblio-1387338

RESUMEN

ABSTRACT This study assessed the technical performance of a rapid lateral flow immunochromatographic assay (LFIA) for the detection of anti-SARS-CoV-2 IgG and compared LFIA results with chemiluminescent immunoassay (CLIA) results and an in-house enzyme immunoassay (EIA). To this end, a total of 216 whole blood or serum samples from three groups were analyzed: the first group was composed of 68 true negative cases corresponding to blood bank donors, healthy young volunteers, and eight pediatric patients diagnosed with other coronavirus infections. The serum samples from these participants were obtained and stored in a pre-COVID-19 period, thus they were not expected to have COVID-19. In the second group of true positive cases, we chose to replace natural cases of COVID-19 by 96 participants who were expected to have produced anti-SARS-CoV-2 IgG antibodies 30-60 days after the vaccine booster dose. The serum samples were collected on the same day that LFIA were tested either by EIA or CLIA. The third study group was composed of 52 participants (12 adults and 40 children) who did or did not have anti-SARS-CoV-2 IgG antibodies due to specific clinical scenarios. The 12 adults had been vaccinated more than seven months before LFIA testing, and the 40 children had non-severe COVID-19 diagnosed using RT-PCR during the acute phase of infection. They were referred for outpatient follow-up and during this period the serum samples were collected and tested by CLIA and LFIA. All tests were performed by the same healthcare operator and there was no variation of LFIA results when tests were performed on finger prick whole blood or serum samples, so that results were grouped for analysis. LFIA's sensitivity in detecting anti-SARS-CoV-2 IgG antibodies was 90%, specificity 97.6%, efficiency 93%, PPV 98.3%, NPV 86.6%, and likelihood ratio for a positive or a negative result were 37.5 and 0.01 respectively. There was a good agreement (Kappa index of 0.677) between LFIA results and serological (EIA or CLIA) results. In conclusion, LFIA analyzed in this study showed a good technical performance and agreement with reference serological assays (EIA or CLIA), therefore it can be recommended for use in the outpatient follow-up of non-severe cases of COVID-19 and to assess anti-SARS-CoV-2 IgG antibody production induced by vaccination and the antibodies decrease over time. However, LFIAs should be confirmed by using reference serological assays whenever possible.

14.
Ribeirão Preto; s.n; 2022. 212 p. ilus, tab.
Tesis en Portugués | LILACS, BDENF - Enfermería | ID: biblio-1532323

RESUMEN

INTRODUÇÃO: Em 2010 a OMS autorizou o uso do sistema GeneXpert® MTB/RIF para a realização do Teste Rápido Molecular para TB (TRM-TB). Objetivou-se-se analisar o impacto do GeneXpert® MTB/RIF na detecção da TB e da TB multidroga-resistente e seu padrão de distribuição espacial em Ribeirão Preto-SP. MÉTODOS: Estudo ecológico realizado em Ribeirão Preto-SP. A população do estudo foi composta de casos de TB notificados no Sistema de Controle de Pacientes com Tuberculose (TBWeb) no período de 2006 a 2017. A análise descritiva dos casos foi realizada por meio de estatística descritiva dos parâmetros quantitativos através do software IBM SPS Statistics versão 25. Para classificar a tendência temporal e observar o impacto da implementação do TRM-TB, foram utilizadas as metodologias Prais-Winsten e Série Temporal Interrompida (STI) através do software StataSE versão 14 e também a modelagem ARIMA com a finalidade de obter uma previsão da taxa de TB para os próximos anos através do software RStudio. Para identificar os padrões espaciais da doença no município foram empregadas as técnicas de estimador de densidade de Kernel, G e G* e varredura (puramente espacial, variação nas tendências temporais e espaço-temporal). RESULTADOS: A tendência temporal da TB apresentou decréscimo de 18,1%/ano e de 6,9%/ano para em crianças. O Distrito Norte apresentou decréscimo de 6,67%/ano e o distrito Leste crescimento de 17,5%/ano na incidência de TB. A TB resistente, após a implementação do TRM-TB, apresentou aumento de 0,6% por ano. Na maioria dos anos analisados, a cultura é solicitada para menos da metade dos casos de TB. Foi identificado um aumento no número de solicitações de TMR e estacionariedade nas solicitações de baciloscopia. A maior parte dos casos foi diagnóstica por meio de demanda ambulatorial. Com as análises espaciais utilizadas foi observado que os casos e os aglomerados não se formam de maneira aleatória no espaço, verificando-se que a TB é distribuída desigualmente no município. CONCLUSÃO: Apesar da TB resistente não ser um problema no cenário, o estudo evidenciou um crescimento na sua incidência, o que o coloca em estado de alerta. O uso da análise espacial possibilitou a identificação das áreas prioritárias, colocando-as em evidência para ações de vigilância em saúde. Ressalta-se a importância do uso de ferramentas de análise espacial na identificação de áreas que devem ser priorizadas para o controle da TB, sendo necessária maior atenção aos indivíduos que se enquadram no perfil indicado como "de risco" para a doença


INTRODUCTION: In 2010, the WHO authorized the use of the GeneXpert® MTB/RIF system to perform the Molecular Rapid Test for TB (TRM-TB). The objective was to analyze the impact of GeneXpert® MTB/RIF in the detection of TB and multidrug-resistant TB and its spatial distribution pattern in Ribeirão Preto-SP. METHODS: Ecological study carried out in Ribeirão Preto-SP. The study population consisted of TB cases reported in the Tuberculosis Patient Control System (TBWeb) from 2006 to 2017. Descriptive analysis of cases was performed using descriptive statistics of quantitative parameters through the IBM SPS Statistics software version 25. To classify the temporal trend and observe the impact of the TRM-TB implementation, the Prais-Winsten and Interrupted Time Series (STI) methodologies were used through the StataSE software version 14 and also the ARIMA modeling in order to obtain a prediction of the TB rate for the coming years through RStudio software. To identify the spatial patterns of the disease in the city, the techniques of Kernel density estimator, G and G* and scanning (purely spatial, variation in temporal and spatio-temporal trends) were used. RESULTS: The temporal trend of TB showed a decrease of 18.1%/year and of 6.9%/year for children. The Northern District showed a decrease of 6.67%/year and the East District a growth of 17.5%/year in the incidence of TB. Resistant TB, after the implementation of the TRM-TB, increased by 0.6% per year. In most of the years analyzed, culture is requested for less than half of TB cases. An increase in the number of RMT requests and stationarity in smear microscopy requests was identified. Most cases were diagnosed through outpatient demand. With the spatial analysis used, it was observed that cases and clusters do not form randomly in space, verifying that TB is unevenly distributed in the municipality. CONCLUSION: Although resistant TB is not a problem in the scenario, the study showed an increase in its incidence, which puts it on alert. The use of spatial analysis made it possible to identify priority areas, putting them in evidence for health surveillance actions. We emphasize the importance of using spatial analysis tools to identify areas that should be prioritized for TB control, requiring greater attention to individuals who fit the profile indicated as "at risk" for the disease


Asunto(s)
Humanos , Tuberculosis , Técnicas de Diagnóstico Molecular , Análisis Espacial
15.
Ribeirão Preto; s.n; ago.2022. 212 p.
Tesis en Portugués | LILACS, BDENF - Enfermería | ID: biblio-1561125

RESUMEN

INTRODUÇÃO: Em 2010 a OMS autorizou o uso do sistema GeneXpert® MTB/RIF para a realização do Teste Rápido Molecular para TB (TRM-TB). Objetivou-se-se analisar o impacto do GeneXpert® MTB/RIF na detecção da TB e da TB multidroga-resistente e seu padrão de distribuição espacial em Ribeirão Preto-SP. MÉTODOS: Estudo ecológico realizado em Ribeirão Preto-SP. A população do estudo foi composta de casos de TB notificados no Sistema de Controle de Pacientes com Tuberculose (TBWeb) no período de 2006 a 2017. A análise descritiva dos casos foi realizada por meio de estatística descritiva dos parâmetros quantitativos através do software IBM SPS Statistics versão 25. Para classificar a tendência temporal e observar o impacto da implementação do TRM-TB, foram utilizadas as metodologias Prais-Winsten e Série Temporal Interrompida (STI) através do software StataSE versão 14 e também a modelagem ARIMA com a finalidade de obter uma previsão da taxa de TB para os próximos anos através do software RStudio. Para identificar os padrões espaciais da doença no município foram empregadas as técnicas de estimador de densidade de Kernel, G e G* e varredura (puramente espacial, variação nas tendências temporais e espaço-temporal). RESULTADOS: A tendência temporal da TB apresentou decréscimo de 18,1%/ano e de 6,9%/ano para em crianças. O Distrito Norte apresentou decréscimo de 6,67%/ano e o distrito Leste crescimento de 17,5%/ano na incidência de TB. A TB resistente, após a implementação do TRM-TB, apresentou aumento de 0,6% por ano. Na maioria dos anos analisados, a cultura é solicitada para menos da metade dos casos de TB. Foi identificado um aumento no número de solicitações de TMR e estacionariedade nas solicitações de baciloscopia. A maior parte dos casos foi diagnóstica por meio de demanda ambulatorial. Com as análises espaciais utilizadas foi observado que os casos e os aglomerados não se formam de maneira aleatória no espaço, verificando-se que a TB é distribuída desigualmente no município. CONCLUSÃO: Apesar da TB resistente não ser um problema no cenário, o estudo evidenciou um crescimento na sua incidência, o que o coloca em estado de alerta. O uso da análise espacial possibilitou a identificação das áreas prioritárias, colocando-as em evidência para ações de vigilância em saúde. Ressalta-se a importância do uso de ferramentas de análise espacial na identificação de áreas que devem ser priorizadas para o controle da TB, sendo necessária maior atenção aos indivíduos que se enquadram no perfil indicado como "de risco" para a doença.


INTRODUCTION: In 2010, the WHO authorized the use of the GeneXpert® MTB/RIF system to perform the Molecular Rapid Test for TB (TRM-TB). The objective was to analyze the impact of GeneXpert® MTB/RIF in the detection of TB and multidrug-resistant TB and its spatial distribution pattern in Ribeirão Preto-SP. METHODS: Ecological study carried out in Ribeirão Preto-SP. The study population consisted of TB cases reported in the Tuberculosis Patient Control System (TBWeb) from 2006 to 2017. Descriptive analysis of cases was performed using descriptive statistics of quantitative parameters through the IBM SPS Statistics software version 25. To classify the temporal trend and observe the impact of the TRM-TB implementation, the Prais-Winsten and Interrupted Time Series (STI) methodologies were used through the StataSE software version 14 and also the ARIMA modeling in order to obtain a prediction of the TB rate for the coming years through RStudio software. To identify the spatial patterns of the disease in the city, the techniques of Kernel density estimator, G and G* and scanning (purely spatial, variation in temporal and spatio-temporal trends) were used. RESULTS: The temporal trend of TB showed a decrease of 18.1%/year and of 6.9%/year for children. The Northern District showed a decrease of 6.67%/year and the East District a growth of 17.5%/year in the incidence of TB. Resistant TB, after the implementation of the TRM-TB, increased by 0.6% per year. In most of the years analyzed, culture is requested for less than half of TB cases. An increase in the number of RMT requests and stationarity in smear microscopy requests was identified. Most cases were diagnosed through outpatient demand. With the spatial analysis used, it was observed that cases and clusters do not form randomly in space, verifying that TB is unevenly distributed in the municipality. CONCLUSION: Although resistant TB is not a problem in the scenario, the study showed an increase in its incidence, which puts it on alert. The use of spatial analysis made it possible to identify priority areas, putting them in evidence for health surveillance actions. We emphasize the importance of using spatial analysis tools to identify areas that should be prioritized for TB control, requiring greater attention to individuals who fit the profile indicated as "at risk" for the disease.


Asunto(s)
Humanos
16.
Acta bioquím. clín. latinoam ; Acta bioquím. clín. latinoam;55(4): 475-483, dic. 2021. graf
Artículo en Español | LILACS, BINACIS | ID: biblio-1393751

RESUMEN

Resumen Un diagnóstico rápido y seguro de la infección por Trypanosoma cruzi permite la administración inmediata de un tratamiento etiológico específico, en los casos clínicamente manifiestos. En el presente trabajo, en 100 sueros de pacientes con diagnóstico presuntivo de infección por T. cruzi, se evaluó el desempeño de la prueba rápida Chagas Ab Rapid SD Bioline (PDR) para el diagnóstico serológico, se la comparó con el estándar diagnóstico (par serológico) y se la valoró para su empleo en la rutina del laboratorio. La PDR reveló un índice de concordancia muy bueno respecto del estándar diagnóstico (Kappa=0,989 [IC95% 0,965-1,000]) y los parámetros de sensibilidad, especificidad, valores predictivos positivos y negativos revelaron un buen desempeño. El índice de Youden informó un buen rendimiento de la prueba (J=0,98 [IC95% 0,93-1,02]); y en el mismo sentido, tanto la razón de verosimilitud positiva (RV (+)= infinito), como la negativa (RV (-)= 0,02 [IC95% 0,00-0,16]), mostraron aumentada la probabilidad que la enfermedad blanco esté presente o ausente, cuando la técnica así lo determinaba. El empleo de una PDR, por su simpleza y buen desempeño (con resultados disponibles el mismo día) produciría una optimización de recursos, podría realizarse en lugares donde el acceso al diagnóstico es limitado y donde su incorporación no requeriría de una infraestructura importante. Por otro lado, en nuestro caso, podría ser utilizada como segunda prueba, para incrementar la especificidad del diagnóstico serológico de la infección por T. cruzi.


Abstract A quick and safe diagnosis of Trypanosoma cruzi infection allows the immediate etiological treatment in clinically manifested cases. In the present work, the performance of the rapid Chagas Ab Rapid SD Bioline (PDR) test for serological diagnosis was evaluated in 100 sera from patients with a presumptive diagnosis of T. cruzi infection, it was compared with the diagnostic standard (serological pair) and this technique was valued to be used within the laboratory routine. The PDR revealed a very good concordance index with respect to the diagnostic standard (Kappa=0.989 [95% CI 0.965-1.000]) and the parameters of sensitivity, specificity, positive and negative predictive values revealed good performance. The Youden index reported good performance of the diagnostic test (J = 0.98 [95% CI 0.93-1.02]); and in the same sense, both the positive likelihood ratio (RV (+) = infinity), and the negative (RV (-) = 0.02 [95% CI 0.00-0.16]) showed an increased probability whether the target disease was present or absent, when the technique so determined. The use of a PDR, due to its simplicity and good performance (with results available on the same day) would produce an optimization of resources, could be carried out in places where access to the diagnosis is limited and where its incorporation would not require an important infrastructure. On the other hand, in our case, it could be used as a second test, to increase the specificity of the serological diagnosis of T. cruzi infection.


Resumo Um diagnóstico rápido e seguro da infecção pelo Trypanosoma cruzi permite a administração imediata de um tratamento etiológico específico nos casos clinicamente manifestos. No presente trabalho, o desempenho do teste rápido Chagas Ab Rapid SD Bioline (PDR) para o diagnóstico sorológico foi avaliado em 100 soros de pacientes com diagnóstico provável de infecção por T. cruzi, foi comparado com o padrão diagnóstico (par sorológico) e essa técnica foi avaliada para ser utilizada na rotina do laboratório. O PDR revelou um índice de concordância muito bom em relação ao padrão diagnóstico (Kappa=0,989 [IC 95% 0,965-1.000]) e os parâmetros de sensibilidade, especificidade, valores preditivos positivos e negativos revelaram bom desempenho. O índice de Youden informou um bom desempenho do teste diagnóstico (J = 0,98 [IC 95% 0,93-1,02]); e, no mesmo sentido, tanto a razão de verossimilhança positiva (RV (+) = infinito), quanto a negativa (RV (-) = 0,02 [IC 95% 0,00-0,16]), mostraram uma probabilidade aumentada de a doença-alvo estar presente ou ausente, quando a técnica assim o determinar. A utilização de um PDR, pela sua simplicidade e por um bom desempenho (com resultados disponíveis no mesmo dia) produziria uma otimização de recursos, podendo ser realizado em locais onde o acesso ao diagnóstico é limitado, e onde a sua incorporação não exigiria um infraestrutura importante. Por outro lado, no nosso caso, poderia ser utilizado como segundo teste, para aumentar a especificidade do diagnóstico sorológico da infecção pelo T. cruzi.


Asunto(s)
Humanos , Trypanosoma cruzi/crecimiento & desarrollo , Cromatografía de Afinidad , VIH , Parasitología , Rutina , Enfermedad , Valor Predictivo de las Pruebas , Sensibilidad y Especificidad , Enfermedad de Chagas , Técnicas de Laboratorio Clínico , Técnicas y Procedimientos Diagnósticos , Pruebas Diagnósticas de Rutina , Eficiencia , Recursos en Salud , Infecciones , Laboratorios , Métodos
17.
BMC Urol ; 21(1): 135, 2021 Sep 27.
Artículo en Inglés | MEDLINE | ID: mdl-34579701

RESUMEN

BACKGROUND: To enhance the convenience and reduce the cost of prostate cancer (PC) screening, a one-step prostate-specific antigen (PSA) test was evaluated in a large population. The PSA SPOT test kit enables rapid detection of human PSA in serum or plasma at or above a cutoff level of 4 ng/mL to aid in the diagnosis of PC. METHODS: PC screening using the PSA SPOT test was offered to male participants in educational public lectures that we conducted in various cities. Test results were reported to participants at the end of the lectures. Blood samples from 1429 men were evaluated. Two independent observers interpreted the tests at 15 and 30 min. The remaining serum samples were subsequently tested using a conventional quantitative assay. RESULTS: The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the test were 79.9, 93.0, 65.4, 96.6, and 91.2%, respectively. The sensitivity and specificity of the test changed with variations in the reading time. Quantitative assessment of the intensity of the band was correlated with the PSA value. CONCLUSIONS: PSA testing using this kit can be easily performed. The low cost and speed of the test make it a useful and convenient tool for primary PC screening.


Asunto(s)
Detección Precoz del Cáncer/métodos , Pruebas Hematológicas/métodos , Antígeno Prostático Específico/sangre , Neoplasias de la Próstata/sangre , Neoplasias de la Próstata/diagnóstico , Adulto , Anciano , Anciano de 80 o más Años , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Factores de Tiempo
18.
J Clin Microbiol ; 59(11): e0264620, 2021 10 19.
Artículo en Inglés | MEDLINE | ID: mdl-34076475

RESUMEN

The coronavirus disease 2019 (COVID-19) pandemic reduced the sexually transmitted infection (STI) testing volume due to social-distancing and stay-at-home orders, among other reasons. These events highlighted previously known benefits of at-home STI self-testing or specimen self-collection and accelerated testing demand via telemedicine. We review testing outside traditional clinical settings. We focus on three curable bacterial STIs among the top 10 U.S. nationally notifiable conditions with screening recommendations: syphilis, gonorrhea (Neisseria gonorrhoeae, also known as the gonococcus [GC]), and chlamydia (Chlamydia trachomatis). At least 19 million GC/C. trachomatis (GC/CT) screening or diagnostic tests are performed annually, presenting a considerable challenge during the pandemic. Unlike for HIV, STI at-home tests are currently not commercially available. However, innovative telemedicine providers currently offer services where specimen self-collection kits are mailed to patients at home who then ship them to laboratories for processing. We discuss technical and regulatory aspects of modifications for home-based specimen self-collection. The telemedicine provider typically manages and communicates results, provides linkage to care, and is responsible for billing and case reporting. We also describe rapid testing devices in development that may present an opportunity for future self-testing. In summary, COVID-19 has accelerated the evaluation and development of STI self-tests and specimen self-collection. The remaining obstacles are high price, regulatory approval, support for laboratories offering the service, and uncertainty regarding whether target populations with the greatest need are reached effectively. However, increased testing, convenience, and privacy are potential benefits that may enhance uptake and outlast the pandemic.


Asunto(s)
COVID-19 , Infecciones por Chlamydia , Gonorrea , Enfermedades de Transmisión Sexual , Infecciones por Chlamydia/epidemiología , Chlamydia trachomatis , Gonorrea/epidemiología , Humanos , Laboratorios , Tamizaje Masivo , Neisseria gonorrhoeae , Pandemias , SARS-CoV-2 , Autoevaluación , Enfermedades de Transmisión Sexual/diagnóstico , Enfermedades de Transmisión Sexual/epidemiología
19.
Biosensors (Basel) ; 11(4)2021 Apr 03.
Artículo en Inglés | MEDLINE | ID: mdl-33916834

RESUMEN

In this paper, a rapid test system with high sensitivity, linearity, and stability is presented for fecal occult blood (FOB) detection. The coloration results of the immune response are used as the basis for the determination of the detection target in combination with an immunochromatographic strip. The rapid test system can be used to detect and calculate the concentration of the sample, so detection of the immune coloration response is more accurate in a quantitative analysis. The system is composed of both hardware and software. The programs used for the analysis and programmed by Python include the main program, polarization calibration, QR Code decoding, Bluetooth transmission, and image processing. After verification of each part of the system, it was found that the rapid test system successfully detects from 0 ng/mL to 400 ng/mL of FOB with coefficients of variation (CV) below 3.7% and 1000 ng/mL with a CV only at 7.41%.


Asunto(s)
Cromatografía de Afinidad , Sangre Oculta , Neoplasias Colorrectales , Heces , Humanos , Sensibilidad y Especificidad
20.
Semin Oncol ; 48(2): 152-155, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33468332

RESUMEN

The current SARS-CoV-2 infection or the COVID 19 pandemic has taken the world by storm, where the best health care systems in the world seem to be overwhelmed and still this virus is eluding us as we are compelled to explore the preventive and/or therapeutic interventions to control the disease outbreak as well as to prevent deaths. In parallel to clinical services, laboratories have been overwhelmed with task of keeping up with ever increasing demand for testing. Real time PCR detection of COVID19 is the gold standard method, however, has certain shortcomings in terms of availability of infrastructure, reagents, consumables, and technical expertise. All these have paved the way for the alternative testing algorithms and strategies. Countries like United States and Italy have struggled with these issues. India has been criticized for not testing enough and not adopting the right policy, but has been managing the disease within its resource limited health care system to a fair extent. The present review provides the Indian perspective of COVID 19 testing, the journey from not testing enough in the past to a vast expanse and depth of testing in present time.


Asunto(s)
Prueba de COVID-19/métodos , Prueba de COVID-19/normas , COVID-19/diagnóstico , SARS-CoV-2/aislamiento & purificación , COVID-19/epidemiología , COVID-19/virología , Humanos , India/epidemiología
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