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Homepage2020-04-06T11:13:53+01:00

WHO WE ARE

UK MHRA (Medicines and Healthcare products regulatory Agency) has authorised My DNA Health (myDNAhealth) to supply the COVID-19 IgM/IgG Rapid Test in the UK market for professional use only. Legally the product is available on the UK market but it is not for sale direct-to-consumers. This test is strictly available to  purchase by health professionals only.

myDNAhealth is an award-winning health tech company with a proven history in supplying test kits, nutritional supplements and nutritional genomic tests. Working with health and nutritional professionals since 2014, myDNAhealth has been at the forefront of biotechnology, testing and data from the get-go.

More about us

The CE-IVD Marked Covid-19 IgG/IgM Rapid Test kits are strictly available to order by Health Professionals Only.

PRODUCT INFORMATION

Whole blood, Serum, Plasma, Finger Prick

10 minutes read time

High Accuracy 98.6% for IgG

Fast and Reliable results

If you are a health professional, please contact us.

COVID-19 IgG/IgM Rapid Test

The COVID-19 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to COVID-19 in human blood.

COVID-19 IgG/IgM Rapid Test Offers:

  • High accuracy – 98.6% for IgG/ 92.9% for IgM

  • Fast results with 10-minutes assay time

  • Results displayed visually

  • Single use finger prick test kit

  • CE-IVD Certified

  • ISO 13485:2016

WHAT IS CORONAVIRUS, AND WHY IS IT

SO CRUCIAL TO TEST EXTENSIVELY?

The novel coronavirus (COVID-19) is a new worldwide pandemic currently gripping the planet. The outbreak began in China and the virus spread across the planet at speed. Presently in April 2020 the current hot spots or epicentres are Europe and the USA. It appears to be very contagious and is spreading quickly across the globe.

COVID-19 is a new illness it is very contagious. In severe cases it can affect your lungs and airways. Luckily a significant percentage of cases will involve a mild or moderate flu-like illness. COVID-19 is part of the family of so-called coronavirus’, hence the name. The disease appears to spread by coughing and sneeze droplets and direct contact with contaminated surfaces.

Two recent coronaviruses – Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) have caused similar outbreaks. These diseases were more severe. However, this new coronavirus affects a far greater number of people worldwide.

COVID-19, can be dangerous to anyone with underlying health issues. It can lead to pneumonia and airway damage in vulnerable people. Globally the fatality rate is estimated to be around 3-4%.

The World Health Organisation (WHO) and every Government affected by the virus have made a single point crystal clear. TESTING is the single most important intervention we can make.

We need to shine a light on this invisible, deadly enemy.

Only testing, via a reliable ANTIBODY TEST, can help us understand:

  • how many people are infected? (early stage IgM positive, later IgG positive)
  • how many people have previously been exposed to the virus and recovered? (IgG positive only)
  • how many people have had the virus without any noticeable symptoms whatsoever? (asymptomatic infection)

Understanding these KEY FACTS will enable us to gain clarity on whether symptoms are related to coronavirus or other illnesses. It will let us know the length of time required to self-isolate after exposure and when it’s safe to return to work and to re-integrate into society. It will tell us which cases require contact tracing and give us any other options.

This knowledge is crucial to gain a complete understanding of this new disease. It will allow us to monitor the spread, the hot spot activity and ultimately enable us to eradicate the disease and save lives.


WHAT ARE THE
SYMPTOMS?

Typical symptoms of coronavirus (COVID-19) are a high temperature, coughing and shortness of breath.

Some people are thought to be carriers without any significant symptoms, called asymptomatic carriers.

If you have the following symptoms:

  • Sore Throat

  • High Fever

  • Cough

  • Headache

  • Shortness of breath.

HOW YOU CAN BEST PROTECT YOURSELF


FREQUENTLY ASKED QUESTIONS

What to do if the Covid-19 Rapid Test cassette displays a positive result?2020-04-03T14:25:41+01:00

If your test is positive, please remain calm and call 111 (or the emergency number in your country) and follow your local government and health authority advice.

Is the Covid-19 test being used by governments and health authorities?2020-04-03T14:19:34+01:00

The Covid-19 Rapid Test is being used by governments and health authorities around the world, including China. The combination use of IgM and IgG test can detect virus infection and the immune status of the body effectively.

What is the COVID-19 Rapid Test?2020-04-03T14:24:34+01:00

COVID-19 Rapid test is a single use finger prick test kit which detects IgG and IgM antibodies to COVID-19 in human whole blood with only 10 minutes assay time. This type of test is self-administered at home and is less invasive than a venous sample.

The individual test kits contain instructions, a finger prick, pipette, cassette, buffer and plastic disposal bag. The finger prick is used to prick the finger which allows the individual to collect a small blood sample using the pipette. A drop of blood is then dropped into the cassette followed by 2 drops of the buffer liquid. The cassette then displays either a positive or negative result.

Is the test CE marked?2020-04-03T14:19:57+01:00

Yes, CE-IVD Certified and therefore registered IVD device.

How does the test differentiate between virus carriers and those without symptoms?2020-04-03T14:19:10+01:00

The COVID-19 IgG/IgM Rapid Test Cassette is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to COVID-19 in whole blood, serum or plasma specimen. The test identifies whether the person is either positive or negative for the antibodies. That means if a person is a carrier but not symptomatic, they will still test positive.

What are the test limitations?2020-04-03T14:20:32+01:00

The COVID-19 IgG/IgM Rapid Test Cassette should be used only for the detection of IgG and IgM antibody to COVID-19. Neither the quantitative value nor the rate of increase in the concentration of IgG or IgM antibodies to COVID-19 can be determined by this qualitative test. In short it can only tell if the subject has the antibodies associated with the virus and cannot be used to diagnose or determine the severity of the condition or monitor their progress.

The COVID-19 IgG/IgM Rapid Test Cassette will only indicate the presence of IgG and IgM antibodies to COVID-19 in the specimen and should not be used as the sole criteria for the diagnosis of COVID-19 infections.

As with all diagnostic tests, all results must be considered alongside other clinical information available to a health professional.

If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is suggested. A negative result at any time does not preclude the possibility of COVID-19 infection. Always follow the advice published by your government and health authority.

The haematocrit level of the whole blood can affect the test results. Haematocrit level needs to be between 25% and 65% for accurate results.

Do you have a confirmation lab test for Coronavirus to confirm positive samples?2020-04-03T14:15:37+01:00

No. We would recommend any positive results are referred to a medical health practitioner through the NHS who have access to confirmatory testing through a laboratory. Phone 111 or visit https://111.nhs.uk/ for further information. Do NOT visit your local surgery to avoid spreading any potential infections.

Has the test been accredited by the NHS or Public Health England (PHE)?2020-04-03T14:17:24+01:00

Not at present as it is a brand new test. The FDA in the US are starting to approve Covid-19 Tests for home use. The COVID-19 test kit has a CE-IVD Marking which is required for all in vitro diagnostic (IVD) devices sold in Europe. CE Marking indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC) and that the device may be legally commercialised in the EU.

What is the evidence for reliability of this test?2020-04-03T14:25:18+01:00

The COVID-19 test has undergone comparative studies for CE certification using PCR analysis, using 181 samples for both IgG and IgM antibodies. This test is actually an evolution of a well-established influenza rapid test that has been on the market for many years and demonstrated excellent accuracy and diagnostic value.

Is this a new product exclusively for Coronovirus?2020-04-03T14:20:13+01:00

Yes, this test is COVID-19 specific. This test is very new to the market and is a way to test quickly for the COVID-19 pathogen.


IN THE
NEWS

Here are a few recent articles from around the world regarding COVID-19. Please remember that this is a highly infectious virus and can be lethal to the elderly and at-risk people. Take care and please follow government advice with respect to social distancing.

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CONTACT US TODAY

Please feel free to contact the Covid-19 Rapid Test team at My DNA Health via email or phone: +44(0)20 37738641 if you have any queries regarding the COVID-19 IgG/IgM Rapid Test. We will respond to all email enquiries on the same day, usually within an hour.

If you represent a charity or care group and want to discuss how we can help please contact us via email or phone: +44(0)20 37738641.