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1.
PLoS One ; 16(3): e0248729, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33725025

RESUMEN

BACKGROUND: As COVID-19 vaccines become available, screening individuals for prior COVID-19 infection and vaccine response in point-of-care (POC) settings has renewed interest. We prospectively screened at-risk individuals for SARS-CoV-2 spike and nucleocapsid protein antibodies in a POC setting to determine if it was a feasible method to identify antibody from prior infection. METHODS: Three EUA-approved lateral flow antibody assays were performed on POC finger-stick blood and compared with serum and a CLIA nucleocapsid antibody immunoassay. Variables including antibody class, time since PCR, and the assay antigen used were evaluated. RESULTS: 512 subjects enrolled, of which 104 had a COVID-19 history and positive PCR. Only three PCR-positive subjects required hospitalization, with one requiring mechanical ventilation. The POC results correlated well with the immunoassay (93-97% sensitivity) and using serum did not improve the sensitivity or specificity. CONCLUSIONS: Finger-stick, POC COVID-19 antibody testing was highly effective in identifying antibody resulting from prior infections in mildly symptomatic subjects. Using high-complexity serum immunoassays did not improve the screening outcome. Almost all individuals with COVID-19 infection produced detectable antibodies to the virus. POC antibody testing is useful as a screen for prior COVID-19 infection, and should be useful in assessing vaccine response.


Asunto(s)
/diagnóstico , Sistemas de Atención de Punto , Adulto , Anciano , Anticuerpos Antivirales/sangre , Femenino , Humanos , Inmunoensayo , Inmunoglobulina G/sangre , Inmunoglobulina M/sangre , Masculino , Persona de Mediana Edad , Nucleocápside/inmunología , Juego de Reactivos para Diagnóstico , /aislamiento & purificación , Sensibilidad y Especificidad , Adulto Joven
2.
BMC Infect Dis ; 21(1): 261, 2021 Mar 12.
Artículo en Inglés | MEDLINE | ID: mdl-33711936

RESUMEN

BACKGROUND: Tuberculosis is a devastating and a deadly disease despite the novel advances in its diagnostic tools and drug therapy. Drug resistant Mycobacterium contributes a great share to tuberculosis mortality. Status of drug resistance and patients' awareness toward the disease is unknown in northeastern Ethiopia. Thus, the aim of this study was to determine the phenotypic and genotypic drug sensitivity patterns and associated factors in Oromia Special Zone and Dessie Town, northeastern Ethiopia. METHODS: In a cross-sectional study, 384 smear positive tuberculosis cases were recruited and Löwenstein-Jensen culture was done. The performance of GenoTypic MTBDRplus assay using the conventional BACTEC MGIT 960 as a "gold standard" was determined. Drug resistant strains were identified using spoligotyping. Pearson Chi-square test was used to determine the association of drug sensitivity test and tuberculosis type, lineages, dominant strains and clustering of the isolates. RESULTS: The 384 smear positive Mycobacterium samples were cultured on LJ media of which 29.2% (112/384) as culture positive. A fair agreement was found between MTBDRplus assay and the conventional MGIT test in detecting the Mycobacterium tuberculosis with sensitivity, specificity, positive and negative predictive value of 94.2, 30.2, 68.4 and 76.5%, respectively. Among LJ culture positive samples 95 of them gave valid result for MTBDRplus assay and 16.8% (16/95) as drug resistant. Similarly, MGIT subculture was made for the 112 isolates and 69 of them gave positive result with 15.9% (11/69) as drug resistant. Cohen's kappa value showed almost a perfect agreement between the two testing methods in detecting rifampicin (sensitivity 100% and specificity 98.3%) and multi-drug resistance (sensitivity 83.3% and specificity 100%). Spoligotyping identified 76.5% (13/17) of the drug resistant isolates as Euro-American and family 33 as the predominant family. Significant association was observed between drug resistant isolates and the dominant strains (χ2: 34.861; p = 0.040) of the Mycobacterium. CONCLUSION: Higher magnitude of drug resistance was found in the study area. The GenoTypic MDRTBplus assay had an acceptable drug sensitivity testing performance.


Asunto(s)
Mycobacterium tuberculosis/genética , Tuberculosis/diagnóstico , Adolescente , Adulto , Anciano , Antituberculosos/farmacología , Antituberculosos/uso terapéutico , Estudios Transversales , Farmacorresistencia Bacteriana/efectos de los fármacos , Farmacorresistencia Bacteriana/genética , Etiopía , Femenino , Genotipo , Humanos , Isoniazida/farmacología , Isoniazida/uso terapéutico , Masculino , Pruebas de Sensibilidad Microbiana , Persona de Mediana Edad , Mycobacterium tuberculosis/aislamiento & purificación , Fenotipo , Juego de Reactivos para Diagnóstico , Rifampin/farmacología , Rifampin/uso terapéutico , Tuberculosis/tratamiento farmacológico , Adulto Joven
3.
Sci Rep ; 11(1): 5491, 2021 03 09.
Artículo en Inglés | MEDLINE | ID: mdl-33750810

RESUMEN

Antibodies testing in the coronavirus era is frequently promoted, but the underlying statistics behind their validation has come under more scrutiny in recent weeks. We provide calculations, interpretations, and plots of positive and negative predictive values under a variety of scenarios. Prevalence, sensitivity, and specificity are estimated within ranges of values from researchers and antibodies manufacturers. Illustrative examples are highlighted, and interactive plots are provided in the Supplementary Information. Implications are discussed for society overall and across diverse locations with different levels of disease burden. Specifically, the proportion of positive serology tests that are false can differ drastically from up to 3%-88% for people from different places with different proportions of infected people in the populations while the false negative rate is typically under 10%.


Asunto(s)
Infecciones por Coronavirus/diagnóstico , Pruebas Serológicas/métodos , Anticuerpos Antivirales/sangre , /virología , Infecciones por Coronavirus/virología , Humanos , Valor Predictivo de las Pruebas , Juego de Reactivos para Diagnóstico , Incertidumbre
4.
J Korean Med Sci ; 36(9): e64, 2021 Mar 08.
Artículo en Inglés | MEDLINE | ID: mdl-33686810

RESUMEN

BACKGROUND: In Korea, there were issues regarding the use of immunoassays for anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies to detect infection. So, we compared antibody results of eight kinds of commercial immunoassays using clinical remnant specimens. METHODS: We compared the results of several immunoassay kits tested on 40 serum samples from 15 confirmed patients and 86 remnant serum samples from clinical laboratory. Eight kinds of IVD kits-four enzyme-linked immunosorbent assay, two lateral flow rapid immunochromatographic assays, and two chemiluminescent immunoassays with one RUO kit were tested. RESULTS: Among 40 serum samples from 15 coronavirus disease 2019 (COVID-19) patients, 35 yielded at least one positive result for detecting antibodies in the combined assessment. There were inconsistent results in 12 (28%) samples by single immunoassay. Forty samples collected in 2019 before the first COVID-19 Korean case showed negative results except for one equivocal result. CONCLUSION: The discrepant results obtained with different immunoassay kits in this study show that serological assessment of SARS-CoV-2 by a single immunoassay requires caution not only in detecting infection but also in assessing immunologic status.


Asunto(s)
Anticuerpos Antivirales/sangre , Inmunoensayo/métodos , /inmunología , /virología , Hospitalización , Humanos , Inmunoglobulina G/sangre , Juego de Reactivos para Diagnóstico , /aislamiento & purificación
5.
J Appl Lab Med ; 6(2): 421-428, 2021 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-33674879

RESUMEN

BACKGROUND: Detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcription PCR is the primary method to diagnose coronavirus disease 2019 (COVID-19). However, the analytic sensitivity required is not well defined and it is unclear how available assays compare. METHODS: For the Abbott RealTime SARS-CoV-2 assay (m2000; Abbott Molecular), we determined that it could detect viral concentrations as low as 26 copies/mL, we defined the relationship between cycle number and viral concentrations, and we tested naso- and oropharyngeal swab specimens from 8538 consecutive individuals. Using the m2000 as a reference assay method, we described the distribution of viral concentrations in these patients. We then used selected clinical specimens to determine the positive percent agreement of 2 other assays with more rapid turnaround times [Cepheid Xpert Xpress (GeneXpert; Cepheid); n = 27] and a laboratory developed test on the Luminex ARIES system [ARIES LDT (Luminex); n = 50] as a function of virus concentrations, from which we projected their false-negative rates in our patient population. RESULTS: SARS-CoV-2 was detected in 27% (95% CI: 26%-28%) of all specimens. Estimated viral concentrations were widely distributed, and 17% (95% CI: 16%-19%) of positive individuals had viral concentrations <845 copies/mL. Positive percent agreement was strongly related to viral concentration, and reliable detection (i.e., ≥95%) was observed at concentrations >100 copies/mL for the GeneXpert but not the ARIES LDT, corresponding to projected false-negative rates of 4% (95% CI: 0%-21%) and 27% (95% CI: 11%-46%), respectively. CONCLUSIONS: Substantial proportions of clinical specimens have low to moderate viral concentrations and may be missed by methods with less analytic sensitivity.


Asunto(s)
/instrumentación , Juego de Reactivos para Diagnóstico , Reacción en Cadena en Tiempo Real de la Polimerasa/instrumentación , /aislamiento & purificación , Adulto , Anciano , Anciano de 80 o más Años , Reacciones Falso Negativas , Femenino , Humanos , Límite de Detección , Masculino , Persona de Mediana Edad , ARN Viral/aislamiento & purificación , Reproducibilidad de los Resultados , Estudios Retrospectivos , /genética
6.
Vopr Virusol ; 66(1): 17-28, 2021 03 07.
Artículo en Ruso | MEDLINE | ID: mdl-33683062

RESUMEN

This review presents the basic principles of application of the loop-mediated isothermal amplification (LAMP) reaction for the rapid diagnosis of coronavirus infection caused by SARS-CoV-2. The basic technical details of the method, and the most popular approaches of specific and non-specific detection of amplification products are briefly described. We also discuss the first published works on the use of the method for the detection of the nucleic acid of the SARS-CoV-2 virus, including those being developed in the Russian Federation. For commercially available and published LAMP-based assays, the main analytical characteristics of the tests are listed, which are often comparable to those based on the method of reverse transcription polymerase chain reaction (RT-PCR), and in some cases are even superior. The advantages and limitations of this promising methodology in comparison to other methods of molecular diagnostics, primarily RT-PCR, are discussed, as well as the prospects for the development of technology for the detection of other infectious agents.


Asunto(s)
/métodos , Técnicas de Diagnóstico Molecular/normas , Técnicas de Amplificación de Ácido Nucleico/normas , ARN Viral/genética , /genética , Artefactos , /normas , Cartilla de ADN/genética , Cartilla de ADN/metabolismo , Sondas de ADN/genética , Sondas de ADN/metabolismo , Humanos , Juego de Reactivos para Diagnóstico , Sensibilidad y Especificidad
7.
J Med Microbiol ; 70(3)2021 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-33734960

RESUMEN

Introduction. The COVID-19 pandemic, which began in 2020 is testing economic resilience and surge capacity of healthcare providers worldwide. At the time of writing, positive detection of the SARS-CoV-2 virus remains the only method for diagnosing COVID-19 infection. Rapid upscaling of national SARS-CoV-2 genome testing presented challenges: (1) Unpredictable supply chains of reagents and kits for virus inactivation, RNA extraction and PCR-detection of viral genomes. (2) Rapid time to result of <24 h is required in order to facilitate timely infection control measures.Hypothesis. Extraction-free sample processing would impact commercially available SARS-CoV-2 genome detection methods.Aim. We evaluated whether alternative commercially available kits provided sensitivity and accuracy of SARS-CoV-2 genome detection comparable to those used by regional National Healthcare Services (NHS).Methodology. We tested several detection methods and tested whether detection was altered by heat inactivation, an approach for rapid one-step viral inactivation and RNA extraction without chemicals or kits.Results. Using purified RNA, we found the CerTest VIASURE kit to be comparable to the Altona RealStar system currently in use, and further showed that both diagnostic kits performed similarly in the BioRad CFX96 and Roche LightCycler 480 II machines. Additionally, both kits were comparable to a third alternative using a combination of Quantabio qScript one-step Quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) mix and Centre for Disease Control and Prevention (CDC)-accredited N1 and N2 primer/probes when looking specifically at borderline samples. Importantly, when using the kits in an extraction-free protocol, following heat inactivation, we saw differing results, with the combined Quantabio-CDC assay showing superior accuracy and sensitivity. In particular, detection using the CDC N2 probe following the extraction-free protocol was highly correlated to results generated with the same probe following RNA extraction and reported clinically (n=127; R2=0.9259).Conclusion. Our results demonstrate that sample treatment can greatly affect the downstream performance of SARS-CoV-2 diagnostic kits, with varying impact depending on the kit. We also showed that one-step heat-inactivation methods could reduce time from swab receipt to outcome of test result. Combined, these findings present alternatives to the protocols in use and can serve to alleviate any arising supply-chain issues at different points in the workflow, whilst accelerating testing, and reducing cost and environmental impact.


Asunto(s)
/diagnóstico , Manejo de Especímenes/métodos , Medios de Cultivo , Calor , Humanos , ARN Viral/genética , ARN Viral/aislamiento & purificación , Juego de Reactivos para Diagnóstico , Sensibilidad y Especificidad , Inactivación de Virus
8.
BMC Infect Dis ; 21(1): 181, 2021 Feb 16.
Artículo en Inglés | MEDLINE | ID: mdl-33593278

RESUMEN

BACKGROUND: Numerous multiplex-PCR assays are now available in routine diagnostics but their clinical value is controversial if a clear association between clinical symptoms and the detection of a particular pathogen is missing. The objective of this work was to evaluate a multiplex-PCR assay for the diagnosis of traveller's diarrhoea (TD) in a case-control study and to assess the concordance with the BioFire® FilmArray® Gastrointestinal Panel. METHODS: Stool samples from cases (n = 61) and controls (n = 30) were collected during travel and analysed by the GI-EB Screening assay (Seegene) in a case-control study. The concordance with the BioFire® FilmArray® Gastrointestinal Panel was expressed as the proportion of participants in which both tests agreed in the category "detected" and "not detected". RESULTS: None of the test-target organisms (Campylobacter spp., Clostridioides difficile toxin A/B, Salmonella spp., Shigella spp./enteroinvasive Escherichia coli, E. coli O157, Shiga toxin-producing E. coli, Yersinia enterocolitica) was significantly associated with TD GI-EB Screening assay. The GI-EB Screening assay had an agreement with the BioFire® FilmArray® of 86.8-100%. CONCLUSION: The selection of test-target organisms included in the GI-EB Screening assay appears inappropriate for the diagnostic work-up of TD as none of the detected pathogens was associated with TD. The GI-EB Screening assay had a good concordance with BioFire® FilmArray®.


Asunto(s)
Diarrea/diagnóstico , Heces/microbiología , Reacción en Cadena de la Polimerasa Multiplex/métodos , Adulto , Anciano , Estudios de Casos y Controles , ADN Bacteriano/genética , ADN Bacteriano/metabolismo , Diarrea/microbiología , Escherichia coli/genética , Escherichia coli/aislamiento & purificación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Técnicas de Diagnóstico Molecular/métodos , Juego de Reactivos para Diagnóstico , Salmonella/genética , Salmonella/aislamiento & purificación , Shigella/genética , Shigella/aislamiento & purificación , Viaje
9.
Medicine (Baltimore) ; 100(6): e24539, 2021 Feb 12.
Artículo en Inglés | MEDLINE | ID: mdl-33578547

RESUMEN

ABSTRACT: The purpose of the present study was to investigate the accuracy of a screening method using salivary tests to screen for periodontal disease.In total, 1888 individuals older than 30 years in 2017 and 2296 in 2018 who underwent medical check-ups for metabolic syndrome agreed to participate and simultaneously underwent a dental examination by dentists and salivary tests. Salivary occult blood, protein, and ammonia levels and white blood cell counts were evaluated in salivary tests using commercially available kits. The relationship between the results of the salivary tests and dental examination was examined and classification performance was analyzed.The prevalence of periodontal disease was 69.9% in 2017 and 66.8% in 2018. Salivary ammonia showed the highest classification performance in both years (sensitivity 83.5 and 83.1%, precision 73.0 and 69.3%, F-measure 0.779 and 0.756). Occult blood, which was assessed using a monoclonal antibody to human hemoglobin, also showed good performance (sensitivity 69.5%, precision 70.6%, F-measure 0.701). Questions regarding self-reported gingival bleeding were not sufficient to screen for periodontitis. The present results suggest that screening tests using salivary samples may detect periodontal disease in approximately 70% to 80% of subjects in a large population.Conclusion: Salivary ammonia and hemoglobin have potential as salivary markers in the screening of periodontal disease.


Asunto(s)
Tamizaje Masivo , Enfermedades Periodontales/diagnóstico , Saliva/química , Anciano , Amoníaco/análisis , Femenino , Humanos , Japón , Recuento de Leucocitos , Masculino , Tamizaje Masivo/métodos , Persona de Mediana Edad , Sangre Oculta , Examen Físico/métodos , Juego de Reactivos para Diagnóstico , Reproducibilidad de los Resultados , Proteínas y Péptidos Salivales/análisis , Sensibilidad y Especificidad
10.
Bioanalysis ; 13(3): 161-167, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33538622

RESUMEN

Aim: Several automated immunoassays have been validated on serum/plasma to evaluate the presence of significant levels of anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies, signs of a present or past infection, but the use of dried blood spots (DBS) would facilitate sampling, shipping and storage. Objective: The aim of this project was to give proof of concept of the possibility to use of the automatized Elecsys® anti-SARS-CoV-2 immunoassay with a volumetric DBS device. Results: Linearity and correlation were satisfactory between volumetric DBS and plasma. A cut-off value was suggested and should be validated with more samples. Conclusion: this study strongly support the possibility to work with volumetric DBS instead of serum/plasma to test for anti-SARS-CoV-2 antibodies.


Asunto(s)
/diagnóstico , Inmunoensayo/métodos , Anticuerpos Antivirales/sangre , Pruebas con Sangre Seca , Humanos , Mediciones Luminiscentes , Juego de Reactivos para Diagnóstico , Reproducibilidad de los Resultados , /aislamiento & purificación
11.
PLoS One ; 16(2): e0246867, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33566873

RESUMEN

Widespread diagnostic testing is needed to reduce transmission of COVID-19 and manage the pandemic. Effective mass screening requires robust and sensitive tests that reliably detect the SARS-CoV-2 virus, including asymptomatic and pre-symptomatic infections with a low viral count. Currently, the most accurate tests are based on detection of viral RNA by RT-PCR. We developed a method to process COVID-19 specimens that simplifies and increases the sensitivity of viral RNA detection by direct RT-qPCR, performed without RNA purification. In the method, termed Alkaline-Glycol Processing (AG Processing), a SARS-CoV-2-containing biological specimen, such as saliva or a swab-collected suspension, is processed at pH 12.2 to 12.8 for 5 min at room temperature. An aliquot of the AG-processed specimen is used for detection of SARS-CoV-2 RNA by direct RT-qPCR. AG processing effectively lyses viruses and reduces the effect of inhibitors of RT-PCR that are present in biological specimens. The sensitivity of detecting viral RNA using AG processing is on par with methods that include a viral RNA purification step. One copy of SARS-CoV-2 virus per reaction, equivalent to 300 copies per ml of saliva, is detectable in the AG-processed saliva. The LOD is 300 viral copies per ml of initial saliva specimen. AG processing works with saliva specimens or swab specimens collected into Universal Transport Medium, is compatible with heat treatment of saliva, and was confirmed to work with a range of CDC-approved RT-qPCR products and kits. Detection of SARS-CoV-2 RNA using AG processing with direct RT-qPCR provides a reliable and scalable diagnostic test for COVID-19 that can be integrated into a range of workflows, including automated settings.


Asunto(s)
/diagnóstico , Técnicas de Diagnóstico Molecular/métodos , ARN Viral/genética , /aislamiento & purificación , Humanos , Límite de Detección , Tamizaje Masivo , Juego de Reactivos para Diagnóstico , Reacción en Cadena en Tiempo Real de la Polimerasa , Saliva/virología , Manejo de Especímenes , Factores de Tiempo
13.
PLoS One ; 16(2): e0246302, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33591986

RESUMEN

BACKGROUND: Two automatable in-house protocols for high-troughput RNA extraction from nasopharyngeal swabs for SARS-CoV-2 detection have been evaluated. METHODS: One hundred forty one SARS-CoV-2 positive samples were collected during a period of 10-days. In-house protocols were based on extraction with magnetic beads and designed to be used with either the Opentrons OT-2 (OT-2in-house) liquid handling robot or the MagMAXTM Express-96 system (MMin-house). Both protocols were tested in parallel with a commercial kit that uses the MagMAXTM system (MMkit). Nucleic acid extraction efficiencies were calculated from a SARS-CoV-2 DNA positive control. RESULTS: No significant differences were found between both in-house protocols and the commercial kit in their performance to detect positive samples. The MMkit was the most efficient although the MMin-house presented, in average, lower Cts than the other two. In-house protocols allowed to save between 350€ and 400€ for every 96 extracted samples compared to the commercial kit. CONCLUSION: The protocols described harness the use of easily available reagents and an open-source liquid handling system and are suitable for SARS-CoV-2 detection in high throughput facilities.


Asunto(s)
Automatización de Laboratorios/métodos , ARN Viral/normas , Automatización de Laboratorios/economía , Automatización de Laboratorios/normas , /normas , Costos y Análisis de Costo , Humanos , ARN Viral/química , ARN Viral/genética , Juego de Reactivos para Diagnóstico/economía , Juego de Reactivos para Diagnóstico/normas , Sensibilidad y Especificidad
14.
Virol J ; 18(1): 34, 2021 02 13.
Artículo en Inglés | MEDLINE | ID: mdl-33581714

RESUMEN

Rapid diagnosis of SARS-CoV-2 during pandemic enables timely treatment and prevention of COVID-19. Evaluating the accuracy and reliability of rapid diagnostic testing kits is crucial for surveillance and diagnosis of SARS-CoV-2 infections in general population, injection drug users, multi-transfused populations, healthcare workers, prisoners, barbers and other high risk populations. The aim of this study was to evaluate performance and effectiveness of nasopharyngeal swab (NSP) and saliva based rapid antigen detection testing kits in comparison with USFDA approved triple target gold standard real-time polymerase chain reaction. A cross-sectional study was conducted on 33,000 COVID-19 suspected patients. From RT-PCR positive patients, nasopharyngeal swab (NSP) and saliva samples were obtained for evaluation of rapid COVID-19 testing kits (RDT). 100/33,000 (0.3%) of specimens were RT-PCR positive for SARS-CoV-2. Among RT-PCR positive, 62% were males, 34% were females, and 4% were children. The NSP-RDT (Lepu Medical China) analysis revealed 53% reactivity among males, 58% reactivity among females, and 25% reactivity among children. However saliva based RDT (Lepu Medical China) analysis showed 21% reactivity among males and 23% among females, and no reactivity in children. False negative results were significantly more pronounced in saliva based RDT as compared to NSP-RDT. The sensitivity of these NSP-RDT and saliva based RDT were 52% and 21% respectively. The RDTs evaluated in this study showed limited sensitivities in comparison to gold standard RT-PCR, indicating that there is a dire need in Pakistan for development of suitable testing to improve accurate COVID-19 diagnosis in line with national demands.


Asunto(s)
Antígenos Virales/aislamiento & purificación , /diagnóstico , /aislamiento & purificación , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Antígenos Virales/inmunología , /inmunología , Niño , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pakistán/epidemiología , Juego de Reactivos para Diagnóstico , Reacción en Cadena en Tiempo Real de la Polimerasa , Reproducibilidad de los Resultados , /inmunología , Adulto Joven
15.
Clin Lab ; 67(2)2021 Feb 01.
Artículo en Inglés | MEDLINE | ID: mdl-33616332

RESUMEN

BACKGROUND AND METHODS: 2019 Corona Virus Disease (COVID-19) caused by SARS-CoV-2 is still pandemic now. RT-qPCR detection was the most common method for the diagnosis of SARS-CoV-2 infection, facilitated by amounts of nucleic acid testing kits. However, the accuracy of nucleic acid detection is affected by various factors such as specimen collection, specimen preparation, reagents deficiency, and personnel quality. RESULTS: In this study, we found that unmatched virus preservation solution will inhibit N gene and OFR-1ab gene (two independent genes of SARS-CoV-2) amplification in one-step detection reagent. CONCLUSIONS: Despite just being a particular phenomenon we found in our work to fight 2019-nCoV, we concluded that unmatched virus preservation solution may have an inhibitory effect on SARS-CoV-2 nucleic acid detection which may lead to incorrect clinical diagnosis.


Asunto(s)
/métodos , Genes Virales/efectos de los fármacos , Soluciones Preservantes de Órganos/farmacología , Manejo de Especímenes , /diagnóstico , Errores Diagnósticos/prevención & control , Humanos , Juego de Reactivos para Diagnóstico/normas , /aislamiento & purificación , Manejo de Especímenes/efectos adversos , Manejo de Especímenes/métodos
16.
Euro Surveill ; 26(6)2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33573710

RESUMEN

We report the performance of a variety of commercially available SARS-CoV-2 PCR kits, used in several different sites across Ireland to determine if Ct values across platforms are comparable. We also investigate whether a Ct value, a surrogate for calculated viral loads in the absence of viral culture of > 34 can be used to exclude SARS-CoV-2 infection and its complications. We found a variation in Ct values from different assays for the same calculated viral load; this should be taken into consideration for result interpretation.


Asunto(s)
Juego de Reactivos para Diagnóstico , Reacción en Cadena en Tiempo Real de la Polimerasa , /aislamiento & purificación , /diagnóstico , Humanos , Irlanda , Reproducibilidad de los Resultados , /genética
17.
PLoS One ; 16(2): e0246536, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33556086

RESUMEN

We examined the usefulness of five COVID-19 antibody detection tests using 114 serum samples at various time points from 34 Japanese COVID-19 patients. We examined Elecsys Anti-SARS-CoV-2 from Roche, and four immunochromatography tests from Hangzhou Laihe Biotech, Artron Laboratories, Chil, and Nadal. In the first week after onset, Elecsys had 40% positivity in Group S (severe cases) but was negative in Group M (mild-moderate cases). The immunochromatography kits showed 40-60% and 0-8% positivity in Groups S and M, respectively. In the second week, Elecsys showed 75% and 50% positivity, and the immunochromatography tests showed 5-80% and 50-75% positivity in Groups S and M, respectively. After the third week, Elecsys showed 100% positivity in both groups. The immunochromatography kits showed 100% positivity in Group S. In Group M, positivity decreased to 50% for Chil and 75-89% for Artron and Lyher. Elecsys and immunochromatography kits had 91-100% specificity. Elecsys had comparable chronological change of cut-off index values in the two groups from the second week to the sixth week. The current SARS-CoV-2 antibody detection tests do not provide meaningful interpretation of severity and infection status. Its use might be limited to short-term epidemiological studies.


Asunto(s)
Anticuerpos Antivirales/inmunología , /diagnóstico , /inmunología , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Juego de Reactivos para Diagnóstico , Sensibilidad y Especificidad
19.
Zhongguo Yi Liao Qi Xie Za Zhi ; 45(1): 105-108, 2021 Feb 08.
Artículo en Chino | MEDLINE | ID: mdl-33522188

RESUMEN

In recent years, the IVD industry has developed rapidly based on the increasing market demand, and plays an important role in disease prevention, clinical diagnosis, health monitoring and guiding treatment. Therefore, followed quality and safety issues are highly concerned. The unique advantages of blockchain technology, decentralization, distrust and non-tampering, can write into trusted node data in every link covering production, circulation and usage of IVD reagents, and establish a distributed ledger with full backup, which makes the anti-conterfeiting and traceability for IVD reagents possible. We discuss whole process intelligent tracing system for IVD reagents based on blockchain technology. Through the strong mechanism of pre-supervision and post-punishment, the source of reagents can be traced, quality and responsibility can be investigated, and the medical inspection quality and diagnostic safety can be guarded.


Asunto(s)
Cadena de Bloques , Tecnología , Indicadores y Reactivos , Juego de Reactivos para Diagnóstico
20.
J Appl Lab Med ; 6(2): 451-462, 2021 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-33463684

RESUMEN

BACKGROUND: Patient surges beyond hospital capacity during the initial phase of the COVID-19 pandemic emphasized a need for clinical laboratories to prepare test processes to support future patient care. The objective of this study was to determine if current instrumentation in local hospital laboratories can accommodate the anticipated workload from COVID-19 infected patients in hospitals and a proposed field hospital in addition to testing for non-infected patients. METHODS: Simulation models predicted instrument throughput and turn-around-time for chemistry, ion-selective-electrode, and immunoassay tests using vendor-developed software with different workload scenarios. The expanded workload included tests from anticipated COVID patients in 2 local hospitals and a proposed field hospital with a COVID-specific test menu in addition to the pre-pandemic workload. RESULTS: Instrumentation throughput and turn-around time at each site was predicted. With additional COVID-patient beds in each hospital, the maximum throughput was approached with no impact on turnaround time. Addition of the field hospital workload led to significantly increased test turnaround times at each site. CONCLUSIONS: Simulation models depicted the analytic capacity and turn-around times for laboratory tests at each site and identified the laboratory best suited for field hospital laboratory support during the pandemic.


Asunto(s)
/instrumentación , Asignación de Recursos para la Atención de Salud/métodos , Laboratorios de Hospital/organización & administración , Pandemias/estadística & datos numéricos , /epidemiología , /estadística & datos numéricos , Servicios de Laboratorio Clínico/organización & administración , Servicios de Laboratorio Clínico/estadística & datos numéricos , Simulación por Computador , Conjuntos de Datos como Asunto , Predicción/métodos , Asignación de Recursos para la Atención de Salud/estadística & datos numéricos , Asistencia Técnica a la Planificación en Salud , Capacidad de Camas en Hospitales/estadística & datos numéricos , Humanos , Unidades de Cuidados Intensivos/organización & administración , Unidades de Cuidados Intensivos/estadística & datos numéricos , Unidades de Cuidados Intensivos/tendencias , Laboratorios de Hospital/provisión & distribución , Laboratorios de Hospital/tendencias , Modelos Estadísticos , Juego de Reactivos para Diagnóstico/provisión & distribución , Juego de Reactivos para Diagnóstico/tendencias , Saskatchewan/epidemiología , Programas Informáticos , Factores de Tiempo , Carga de Trabajo/estadística & datos numéricos
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