La autoridad de Autorización de Uso de Emergencia (EUA) permite a la FDA ayudar a fortalecer las protecciones de salud pública de la nación contra las amenazas químicas, biológicas, radiológicas y nucleares (CBRN), incluyendo las enfermedades infecciosas, facilitando la disponibilidad y el uso de contramedidas médicas (MCM) necesarias durante las emergencias de salud pública.

En virtud de la sección 564 de la Ley Federal de Alimentos, Medicamentos y Cosméticos (FD&C Act), cuando el Secretario del HHS declara que es apropiada una autorización de uso de emergencia, la FDA puede autorizar productos médicos o usos no aprobados de productos médicos aprobados que se utilizarán en una emergencia para diagnosticar, tratar o prevenir enfermedades o afecciones graves o potencialmente mortales causadas por agentes de la amenaza QBRN cuando se cumplan determinados criterios, entre ellos que no haya alternativas adecuadas, aprobadas y disponibles. La declaración del HHS para apoyar dicho uso debe basarse en uno de los cuatro tipos de determinaciones de amenazas o amenazas potenciales por parte del Secretario del HHS, de Seguridad Nacional o de Defensa.

Stepped Micro Tip (includes Interface Washers)
Biologics
Tapered Micro Tips
Biologics
Tapered Micro Tips 5 mm Diameter Tapered Titanium Micro Tip
Biologics
10 mm Diameter Solid Titanium Tip
Biologics

Tenga en cuenta: una determinación en virtud de la sección 319 de la Ley de Servicios de Salud Pública de que existe una emergencia de salud pública, como la emitida el 31 de enero de 2020, no permite a la FDA emitir EUAs. El 4 de febrero de 2020, el Secretario del HHS determinó que existe una emergencia de salud pública que tiene un potencial significativo para afectar la seguridad nacional o la salud y seguridad de los ciudadanos de los Estados Unidos que viven en el extranjero, y que involucra al virus que causa el COVID-19. Las declaraciones posteriores del HHS que apoyan el uso de las AEU y que se basan en esta determinación se describen en los recuadros azules que aparecen a continuación.

Stepped Micro Tip (includes Interface Washers)
0-120-0005 Biologics
Tapered Micro Tips
0-120-0007 Biologics
Tapered Micro Tips 5 mm Diameter Tapered Titanium Micro Tip
0-120-0008 Biologics
10 mm Diameter Solid Titanium Tip
0-120-0009 Biologics

Las pruebas de serología detectan la presencia de anticuerpos en la sangre procedentes de la respuesta inmunitaria adaptativa del organismo a una infección, como la COVID-19. No detectan el virus en sí. En los primeros días de una infección, cuando la respuesta inmunitaria adaptativa del organismo todavía se está desarrollando, es posible que no se detecten los anticuerpos. Esto limita la eficacia de la prueba para diagnosticar el COVID-19 actual y es una de las razones por las que las pruebas serológicas no deben utilizarse para diagnosticar o excluir la infección aguda por COVID-19. Las pruebas serológicas desempeñan un papel en la lucha contra el COVID-19 al ayudar a los profesionales sanitarios a identificar a las personas que pueden haber desarrollado una respuesta inmunitaria adaptativa al SARS-CoV-2.

However, to use serology tests properly, it is important to understand their performance characteristics and limitations. Moreover, studies are underway to address questions that will better inform the appropriate use of these tests, such as which antibodies may indicate a level of protection that would prevent or reduce the severity of infection or re-infection as well as the duration for which this protection may last.

The performance of these tests is described by their “sensitivity,” or their ability to identify those with antibodies to SARS-CoV-2 (true positive rate), and their “specificity,” or their ability to identify those without antibodies to SARS-CoV-2 (true negative rate).

Stepped Micro Tip (includes Interface Washers)
0-120-0005 Biologics
Tapered Micro Tips
0-120-0007 Biologics
Tapered Micro Tips 5 mm Diameter Tapered Titanium Micro Tip
0-120-0008 Biologics
10 mm Diameter Solid Titanium Tip
0-120-0009 Biologics
13 mm Diameter Tapped Titanium Tip
0-120-0010 Biologics

A test’s sensitivity can be estimated by determining whether or not it is able to detect antibodies in blood samples from patients who have been confirmed to have COVID-19 with a nucleic acid amplification test, or NAAT. In some validation studies of these tests, like the one the FDA is conducting in partnership with the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA), the samples used, in addition to coming from patients confirmed to have COVID-19 by a NAAT, may also be confirmed to have antibodies present using other serology tests.

La especificidad de una prueba puede estimarse analizando un gran número de muestras recogidas y congeladas antes de que se sepa que el SARS-CoV-2 ha circulado para demostrar que la prueba no produce resultados positivos ante la presencia de otras causas de una infección respiratoria, como otros coronavirus.

Estas estimaciones de sensibilidad y especificidad son sólo eso: estimaciones. Incluyen intervalos de confianza del 95%, que son el rango de estimaciones en el que estamos seguros en un 95% de que la sensibilidad y la especificidad de una prueba se encontrarán, dado el número de muestras utilizadas en la validación del rendimiento. Cuantas más muestras se utilicen para validar una prueba, menor será el intervalo de confianza, lo que significa que podemos confiar más en las estimaciones de sensibilidad y especificidad proporcionadas.

Rat Cholesterol ELISA ELISA
E01A11128 BlueGene
Goat Cholesterol ELISA ELISA
E01A46041 BlueGene
Panbio Nasopharyngeal Test
Panbio Nasopharyngeal Test

 

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Tests are also described by their Positive and Negative Predictive values (PPV and NPV). These measures are calculated using a test’s sensitivity, its specificity, and using an assumption about the percentage of individuals in the population who have antibodies to SARS-CoV-2 (which is called “prevalence” in these calculations).

Every test returns some false positive and false negative results. The PPV and NPV help those who are interpreting these tests understand, given how prevalent individuals with antibodies are in a population, how likely it is that a person who receives a positive result from a test truly does have antibodies to SARS-CoV-2 and how likely it is that a person who receives a negative result from a test truly does not have antibodies to SARS-CoV-2.

The PPV and NPV of a test depend heavily on the prevalence of what that test is intended to detect. Because all tests will return some false positive and some false negative results, including tests that detect antibodies to SARS-CoV-2, broad use of the tests, when not appropriately informed by other relevant information, such as clinical history or diagnostic test results, could identify too many false-positive individuals.

The prevalence of SARS-CoV-2 antibody positive individuals varies across the United States, and prevalence is changing as the virus infects more individuals and as more individuals are vaccinated. In low prevalence populations, the result of a single antibody test is not likely to be sufficiently accurate to make an informed decision regarding whether or not an individual has had a prior infection or truly has antibodies to the virus. A second test, typically one assessing for the presence of antibodies to a different viral protein, generally would be needed to increase the accuracy of the overall testing results.

Rat Cholesterol ELISA ELISA
E01A11128 BlueGene
Goat Cholesterol ELISA ELISA
E01A46041 BlueGene
Mouse Cholesterol ELISA ELISA
E01A19869 BlueGene
Human Cholesterol ELISA ELISA
E01A2368 BlueGene
Sheep Cholesterol ELISA ELISA
E01A98335 BlueGene

Methodology

For this page, the FDA has summarized the expected performance of the tests it has authorized based on the information the FDA reviewed when deciding whether or not to grant these tests an Emergency Use Authorization and with prevalence assumptions ranging from 5% to 50% for PPV and NPV calculations. For tests that had multiple validation studies or where the tests showed variable performance in samples collected at different times after symptom onset, the FDA analysts selected the results they considered to be most representative of expected test performance.

This is an incomplete representation of the performance of these tests. Always refer to the complete instructions for use to put these estimates into the proper context and to understand how to use and interpret these tests. The FDA is also providing a calculator that will allow users to see the estimated performance of a single test or two independent tests based on their performance characteristics and the estimated prevalence of SARS-CoV-2 antibodies in the target population.

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Rendimiento de la prueba
Abbott AdviseDx SARS-CoV-2 IgG II (Alinity)

Desarrollador: Abbott Laboratories Inc.
Prueba: AdviseDx SARS-CoV-2 IgG II (Alinity)
Tecnología: CMIA semicuantitativa de alto rendimiento
Objetivo: Espiga

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 98.1% (51/52) (89.9%; 99.7%)
IgG Specificity (NPA) 99.6% (2000/2008) (99.2%; 99.8%)
MULTIPLEX KIT PCR MASTITIS PCR kit
Bioingentech
MULTIPLEX KIT PCR MASTITIS PCR kit
Bioingentech
PCR Mix
Biochain
PCR-EZ D-PCR MASTER MIX
Bio Basic
MULTIPLEX KIT PCR Babesia & Theileria PCR kit
Bioingentech
Rabbit Anti-Marburg virus glycoprotein peptide (MARV GP) IgG, aff pure
MVGP12-A
Rabbit anti-MARV GP pAb
0303-007
Rabbit anti-MARV NP pAb
0303-012
Rabbit anti-MARV VLP pAb
04-0005
Rabbit anti-MARV VP40 pAb
0303-001

 

 

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