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Test Rapido Covid 19 – Caja 10 Test

TEST RÁPIDO COVID-19

COVID-19 IgG/IgM Rapid Test

Cat # R0199C**

  • The Biopanda COVID-19 Rapid Test Kit is a qualitative lateral flow immunochromatographic assay for the detection of IgM and IgG antibodies to SARS-CoV-2 in human whole blood, serum or plasma samples.
    It is intended for use as a tool to assist in the diagnosis of SARS-CoV-2 infections. It is also intended as a tool for carrying out serological epidemiological investigations.

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Test Rapido Covid-19

Existe una necesidad urgente de test rápidos para gestionar la pandemia creciente. La prueba rápida qSARS-CoV-2 IgG / IgM está diseñada para la detección rápida y cualitativa de anticuerpos indicadores de infección por SARS-CoV-2 y se usa como ayuda para el diagnóstico de la infección.

  • Test de diagnóstico 15-20 minutos para covid-19.
  • Muestra: Suero, plasma o sangre total.
  • Fácil de usar.
  • Proporciona un diagnóstico eficiente y preciso para pacientes con sospecha de infección nCoV-2019.
  • Proporciona orientación para el tratamiento y manejo de pacientes.
  • Proporciona información epidemiológica para la vigilancia del virus nCoV-2019.

Test Attributes

  • Whole blood, serum, or plasma may be used for testing
  • Results available in only 10 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting in diagnosing COVID-19 disease.

Test Rápido Covid-19

Principle

El test rápido covid 19 The COVID-19 Rapid Test is a qualitative lateral flow immunoassay for the simultaneous detection of IgM and IgG antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens.

The test cassette contains recombinant SARS-CoV-2 antigen conjugated to coloured particles. When a specimen is added to the sample well of the cassette, any IgM and IgG present in the specimen will bind to the antigen conjugate, forming coloured coronavirus antigen-antibody complexes. This mixture migrates laterally along the membrane to the test region. In this test region, anti-human IgM and anti-human IgG have been immobilised onto the membrane. These capture any IgM and IgG complexes that have formed, resulting in the appearance of coloured lines.

Therefore, if the specimen contains SARS-CoV-2 IgM antibodies, a coloured line will appear in the IgM test line region. If the specimen contains SARS-CoV-2 IgG antibodies, a coloured line will appear in the IgG test line region. To serve as an internal control, a coloured line will always appear in the control line region, indicating that the proper volume of specimen and buffer has been added, and correct procedure has been followed.

Sensitivity and Specificity

To determine specificity, samples were taken from 60 patients who tested negative for COVID-19. The specificity of the IgM and IgG components are presented separately:

IgM Specificity: 96.7% (95%CI*: 88.5%-99.6%) *Confidence Interval
IgG Specificity: 98.3% (95%CI: 91.1%-99.9%)

To determine sensitivity, samples were taken from 239 patients who were confirmed positive by PCR. Samples were taken at a range of times from onset of symptoms.

Days from onset when sample was taken No. of Samples IgM Positive IgG Positive Combined Positive (Sensitivity)
Asymptomatic † 36 55.6% 44.4% 69.4% (95%CI: 51.9-83.7%)
2-10 days 106 80.2% 19.8% 81.1% (95%CI: 72.4-88.1%)
11-20 days 55 88.7% 87.1% 93.5% (95%CI: 84.3-98.2%)
21+ days 35 42.9% 100% 100% (95%CI: 90.0-100%)

† Most of these asymptomatic patients were picked up during screening, and remained asymptomatic throughout the course of their illness.

Storage Conditions

+ 2 – 30 °C, DO NOT FREEZE. Unopened test cassettes and buffer are stable for up to 24 months from date of manufacture.

Further reading on COVID-19 diagnostics

Laboratory methods for diagnosing COVID-19 follow two pathways – the detection of the coronavirus itself, and the detection of the body’s adaptive immune response to the virus. Test rápido covid-19.
The stage of COVID-19 disease progression determines which detection method is most effective. This antibody rapid test complements nucleic acid methods such as RT-PCR to improve speed of diagnosis and monitor disease progression.As the disease primarily attacks the lungs, specimens taken from the upper respiratory tract may be poor in quality and could lead to false-negatives with PCR.
To understand the clinical significance of results obtained from the antibody rapid test, the following information must be considered:

  • The median incubation period is estimated to be 5.1 days.
  • Specific IgM antibodies to SARS-CoV-2 can become detectable 3-5 days after onset of symptoms, but the intensity of this response varies between patients.

Therefore, for the application of diagnosing an active infection, this COVID-19 Rapid Test should not be used until symptoms have been present for at least 3 days, and results must be complemented by other tests such as RT-PCR.
If used to determine a suspected infection in the past, this test is best used after 28 days from first onset of symptoms, when the antibody response has peaked.

Protocolo de Uso

Test Rapid

Certificado CE

Test Rapid

Importante:

Este es un producto de catalogado como de “Diagnóstico In Vitro”, no es un producto de “Autodiagnóstico”, por tanto no puede ser vendido a personar particulares, sino a Hospitales, Centros de Salud, Clínicas, Laboratorios, Residencias de Ancianos, Servicios Públicos, Mutuas de Prevención de Riesgos o Empresas, siempre que se cumplan las directrices establecidas por la orden Ministerial publicada en el BOE de 14 de abril de 2020, en el que se establece que “se limita la realización de las pruebas diagnósticas para la detección del COVID-19 a aquellos casos en los que exista una prescripción previa por un facultativo y se ajusten a criterios establecidos por la autoridad sanitaria competente”

En cumplimiento de las directrices

SKU: R0199C Categorías: , Etiquetas: ,
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