COVID-19

Rapid Testing

IgG / IgM

In order to make it's contribute for the international effort to fight the COVID-19 pandemic, Enzifarma S.A. now offers its customers rapid testing equipment for IgG/ IgM detection, with CE and IVD Certificates. These immunochromatographic tests, only for professional usehave the ability to make a qualitative detection of imunoglobuline G (IgG) and imunoglobuline M (IgM) antibodies against COVID-19, in human blood, serum or plasma samples, in just a few minutes.

Coronavirus a atacar uma célula

ABOUT COVID-19

Coronaviruses are viruses that can cause infection in humans, other mammals and birds. To date, eight coronaviruses are known to cause disease in humans. Typically, these infections affect the respiratory system and may be similar to common colds or progress to more serious illnesses, such as pneumonia. The new coronavirus, also named SARS-CoV-2 (meaning “severe acute respiratory syndrome - coronavirus 2”), is the virus that originates the disease COVID-19, which was first identified in December 2019 in China.

What are the most frequent symptoms?

 

Fever (temperature ≥ 38.0ºC)

Cough and sore throat

Tiredness and muscle pain

In some cases, a lack of taste or smell has been reported.

What is the incubation / transmission period?  

The time between exposure to the virus and the appearance of symptoms (incubation) varies between 1 to 14 days. The transmission period can begin 1 to 3 days before the first symptoms and last for 7 days after the onset of symptoms.

If you have any of these symptoms , please contact Saúde 24 immediately (808 24 24 24) .

According to the European Commission Directive (98/79 / EC) for COVID-19 testing:

 

"The performance of tests to detect the presence or previous exposure to the SARS-CoV-2 virus is an essential aspect of the fight against the outbreak of COVID-19 and the associated public health crisis. More widespread tests for pandemic control to be successful. "

 

WHAT IT IS USED FOR

We believe that the possibility for institutions to know the reality of their employees' or patients' immune status can bring greater confidence and security in this new reality.

Therefore, these quick testing equipments to detect IgG / IgM antibodies make it possible to assess the immunity of groups of individuals at a significantly lower cost (compared to existing PCR tests).

Within an institution (company, organization, ...), COVID-19 quick testing allow to:

- Monitor patients, employees and general population;

- Reduce the risk of unexpected outbreaks;

- Assess the epidemiological status, anticipating possible containment measures;

- Create confidence in the adopted prophylactic measures.

 

ABOUT ENZIFARMA

Since our mission is to know how to be rigorous and efficient with us and our suppliers, we strive to understand, satisfy and anticipate our customers' needsFor that reason, we decided to do our part in combating the pandemic COVID-19 and provide rapid testing to detect IgG / IgM antibodies , which allow greater calm and security in the institutions that trust us and collaborate with us.

 

HOW IT WORKS

After COVID-19 infection, the body's immune system reacts with the production of antibodies (proteins to fight bacteria and viruses).

After 5 to 7 days, it becomes possible to detect antibodies (immunoglobulins) in the blood. The first antibody to be produced to fight a new infection and, therefore, the first to be detectable is IgM; soon followed by IgG.

The immunochromatographic test should then be done from the 5th day after the appearance of the first symptoms, in order to make a qualitative detection of IgM and IgG antibodies against COVID-19.

This kit includes all the necessary materials (test cassettes, capillary pipettes, lancets and alcohol wipes) and, with just a finger prick, allows to test the individual's immunity (with results in about 5 to 10 minutes).

For more information

Enzifarma S.A has established a partnership with Atlas Link Technology Co. Ltd. in order to offer its clients COVID-19 Quick Testing Equipment, developed in the epicentre of this pandemic, with CE and IVD certificates. 

Portuguese INFARMED registration:

Registo no Infarmed

Sensibilidade: 96,3%; Especificidade: 96,2%; Precisão: 96%

Performance data:

Sensibilidade: 95,8%; Especificidade: 96,8%; Precisão: 96,3%

 

HOW IT WORKS

After COVID-19 infection, the body's immune system reacts with the production of antibodies (proteins to fight bacteria and viruses).

After 5 to 7 days, it becomes possible to detect antibodies (immunoglobulins) in the blood. The first antibody to be produced to fight a new infection and, therefore, the first to be detectable is IgM; soon followed by IgG.

The immunochromatographic test should then be done from the 5th day after the appearance of the first symptoms, in order to make a qualitative detection of IgM and IgG antibodies against COVID-19.

This kit includes all the necessary materials (test cassettes, capillary pipettes, lancets, diluent and alcohol wipes) and, with just one finger prick, allows to test the individual's immunity (with results between 5 to 10 minutes).

For more information

Enzifarma S.A. established a partnership with Atlas Link Technology Co. Ltd. for the commercialization of tests

developed at the epicenter of this pandemic, with CE and IVD certification.

INFARMED Registration:

Registo no Infarmed

Sensitivity: 96.3% ; Specificity: 96.2% ; Accuracy: 96%

Performance Data:

Sensitivity: 95.8% ; Specificity: 96.8% ; Accuracy: 96.3%

    You can download the tests' informative leaflet, here >

REFERENCES

1. Direção-Geral de Saúde (DGS). Coronavirus. https://covid19.min-saude.pt/

 

2. Serviço Nacional de Saúde (SNS). Teste COVID-9, https://www.sns24.gov.pt/guia/teste-covid-19/

3. Infarmed. Circular Informativa Conjunta N.º 003/CD/100.20.200 - Testes Laboratoriais para SARS-CoV-2; Testes Rápidos; 27 Maio 2020.

4. World Health Organization (WHO). WHO Statement Regarding Cluster of Pneumonia Cases in Wuhan, China. Beijing: WHO; 9 Jan 2020. 

5. Weiss SR, Leibowitz JL. Coronavirus pathogenesis. Adv Virus Res 2011;81:85-164. PMID:22094080 DOI:10.1016/B978-0-12-385885-6.00009-2

6. Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol 2016;24:490-502. PMID:27012512 DOI:10.1016/j.tim.2016.03.003

7. Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol 2019;17:181-192.PMID:30531947 DOI:10.1038/s41579-018-0118-9

8. World Health Organization (WHO). Coronavirus. https://www.who.int/health-topics/coronavirus

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Enzifarma - Diagnostics and Pharmaceutical, S.A.

Registration with the Lisbon Conservatory under no. 11925

NIF: 503 636 975  |  CAE: 46762 Rev 3

Share Capital: 500.000 EUR

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