CORONAVIRUS SELF-TESTING KIT

Covid-19 Self-Testing Kit: FAQs, Evidence & Product Disclaimer

Introduction

As we are all aware, we are currently experiencing a pandemic of a novel virus that originated in China in December 2019 and has since been rapidly spreading. Medical and public advice is changing on an hourly basis, but one thing we know is we need to do our best to limit the spread of this virus and to take precautions to protect those more vulnerable.

Current guidance is suggesting limiting social/public gatherings, encouraging working from home and self-isolation for anyone with symptoms for 7 days from the onset of symptoms. There is no available testing for sufferers of symptoms who do not require hospital admission at present, therefore many cases of Coronavirus are possibly underdiagnosed.

In order to help guide our clients better, we have partnered with a world-renowned, British, UKAS accredited laboratory that are using state-of-the-art technology in order to accurately test and identify this strain of Coronavirus (namely Covid-19) as well as distinguish it from 9 other viruses.

 

Purpose of the self-testing kits?

This kit can be used for initial screening purposes as a convenient and confidential method of getting tested for a suspected respiratory tract infection. The results of this test are not expected to replace medical advice nor should they be interpreted on their own as a full diagnosis. Our laboratory works within strict industry standards to provide exceptionally high accuracy, however 100% accuracy of test results cannot be guaranteed.

If you are positive for Coronavirus, one of our doctors shall contact you immediately and advise you what to do next (in line with guidance from Public Health England PHE). All positive results for Coronavirus are automatically reported to PHE by our laboratory. Negative results and positive results of other viruses (not Covid-19) will be also be reported to you by our team.

 

What does the test involve?

Once you order a self-test kit from us, we shall aim to get one sent out to you ASAP from our base in Chelsea, London. You should receive the following kit in a transportation box:

1 swab

1 sample collection tube

Transportation tube

Pathoseal bag

1 large postal envelope, sample collection instructions and a screening request form

 

Sample collection

Full instructions are provided with our self-testing kit. It is safe, quick and easy to do. A swab is inserted into the back of your throat and then into each nostril and rotated 5 times. The swab is then placed into the collection tube, the end of the swab breaks off and you can screw the lid back on. You then place the collection tube in the transport tube and seal it with the lid provided.

 

Sample Posting

Our test is specially designed to be transported at ambient conditions. The transportation tube is to be placed in the Pathoseal bag provided, sealed and then placed into the transportation box which should then be placed into the provided postal envelope and either arranged to be couriered to the address provided and/or taken to the post office.

Effect Doctors cannot be held responsible for delays due to a restriction of postal / courier services as a result of this crisis.

 

What is the timescale?

Due to the current high demand for testing kits around the world, we are doing our best to get kits from our laboratory to you as fast as possible. We are currently expecting a large stock of kits to be delivered to our base in Chelsea, London in the week commencing 23rd March 2020. We are then able to send out your kit to your postal address by 1st class post or alternatively by prior arrangement we can arrange for a courier delivery of the self-testing kit to you.

Once you have received your kit and collected your sample, please return it to the laboratory address on the same day. The laboratory is currently turning around results in 3 working days. In special circumstances, they have even facilitated same-day turnaround of results (sample air-couriered via helicopter from Central London to the laboratory).

Due to the current crisis, the timescale could be subject to change. Effect Doctors does not accept any responsibility for a change in timescale and cannot guarantee a timescale.

 

What happens if this test becomes available for free on the NHS?

Unfortunately, we are unable to provide refunds for self-testing kits that are already purchased from us.

 

I want to buy this test kit in case I develop symptoms and think I have the virus. How long can I keep the kit?

The test kits are valid for 6 months.

 

Can I get an appointment to do the test?

This is a self-testing kit that is very simple and safe to use and therefore does not require an appointment. If you have any questions, our team are here as always to help.

 

Is there an age restriction for this test?

As per the manufacturer’s guidelines, you must be at least 16 years of age.

 

Product Liability

Nothing in our terms and conditions excludes or limits the liability of Effect Doctors as follows:

1) For death or personal injury caused by negligence, or

2) Under section 2 of the Consumer Protection Act 1987, or

3) For fraud or fraudulent misrepresentation, or

4) By the conditions implied under section 12 of the Sale of Goods Act 1979 or

5) By the conditions implied under section 2 of the Supply of Goods and Services Act 1982. Effect Doctors shall not be liable to you for any loss of profit, loss of business, loss of opportunity, loss of goodwill, or any claims for indirect compensation whatsoever, which may arise out of, or in connection with, the use of the goods or services provided. Effect Doctors total liability in contract, tort, misrepresentation, or otherwise; arising in connection with the performance of these conditions, shall be limited to losses which are a foreseeable consequence of the failure to comply with these terms and conditions only.

 

 

Who we are

Effect Doctors is the trading name of Mobile Doctors Collective Ltd. We are a team of GMC registered, NHS doctors providing a range of private, on-demand medical services to clients in London and beyond. We are registered with the Care Quality Commission (CQC).

 

Personal Information

As Doctors working in the private medical industry, we take the privacy and confidentiality of all our patients and clients extremely seriously. The use of any personal information that we collect in relation to this self-testing kit, will be in accordance with the Data Protection Act 1998 and other applicable laws.

The information requested on our laboratory’s questionnaire provided in the self-testing kit is essential for them to conduct the coronavirus extended assay testing service for you and/or to communicate with you. We will only use the information provided to allow us to undertake a contractual commitment between you and us. All data is stored in a controlled and secure environment. Your personal information will only be accessed by authorised personnel who require the information to perform a specific task.

 

Your Sample

You are providing our partner laboratory with consent to allow us to retain DNA from your sample/s. You agree that after your sample has been tested, residual sample may be retained for Quality Control troubleshooting purposes and for the validation of new diagnostic tests. It is not possible to return your sample.   

 

Who does the testing?

The laboratory that we use is one of the largest laboratories of it’s kind and is based in the United Kingdom. The particular testing method used for the Covid-19 virus utilises a molecular assay based on the detection of nucleic material (RNA) within the virus. There are other methods of testing based on the detection of antibodies which are only produced as a response to infection (i.e. after someone has become symptomatic). Our labs method allows for identification of an infection at a much earlier stage after an initial exposure.       

 

Analytical Sensitivity & Specificity

The analytical sensitivity for the Extended Coronavirus Multiplex Array 2019-Novel Coronavirus (SARS-CoV-2) target was established using dilutions of quantified nucleic acid extracts derived from clinical specimens, as no quantified virus isolates are currently available (see Table below).

 

Pathogen Strain Source Concentration
SARS-CoV-2 BetaCoV/Germany/BavPat1/2020 EVAg 50 copies/test
Sarbecovirus (SARS, SARS like, SARS-CoV-2) SARS-CoV Frankfurt 1 EVAg 50 copies/test

 

The specificity of the Extended Coronavirus Multiplex Array for 2019-Novel Coronavirus (SARS-CoV-2) was primarily ensured by selection of the primers and probes.

The Extended Coronavirus Multiplex Array was also challenged using QCMD 2019 Coronavirus RNA and MERS Coronavirus EQA Programmes, which include seasonal Coronavirus such NL63, OC43, 229E and HKU as well as MERS samples, which are derived from clinical isolates. The Extended Coronavirus Multiplex Array detected all ‘Core’ samples correctly. The SARS-CoV-2 / Sarbecovirus did not show any cross-reactivity with these panels.

What test do we use? 

We use the Abbott IgG test (PHE approved) with a specificity of 100% & sensitivity of 97.5%.

Are you Immune? 

The scientists are not yet sure. In general IgG antibodies to a particular virus usually implies a degree of immunity to further infection however in the case of the SARS-CoV-2 virus, it is not yet known to what extent immunity is conferred, and if so for how long. What we can say is that having IgG antibodies to other viruses within the coronavirus group is associated with at least short-term immunity to re-infection. However, you should continue to follow the governments’ guidelines regarding social distancing and protecting yourself and others against infection. At this moment there is insufficient scientific knowledge about immunity to the SARS-CoV-2 virus for you to be confident that you can behave any differently from someone who has not been infected.

Further resources

Please check here for the latest advice as Government advice is subject to change.

If you are feeling short of breath or have concerns that you are not coping with the illness you can contact 111 for further advice.

If you have any uncertainty about what you should do now visit the NHS website.

More information about Covid-19 can be found here.