Below you will find important information in relation to the FitnessGenes saliva-based, health screening test kit for the detection of the SARS-CoV-2 virus that causes coronavirus disease (COVID-19).


Important information

  • If your test comes back positive for COVID-19 then we can be very confident that you do have COVID-19
  • However no test is 100% accurate, people with COVID-19 can be missed by these tests and you should not use a negative result to undertake activities or behaviour contrary to current government guidance
  • If you have symptoms of COVID-19, it is safest to self-isolate, even if the test does not show COVID-19.

If you have any doubts about what to do, please contact us at support@fitnessgenes.com.


About the test

The FitnessGenes COVID-19 saliva test is a health screen that assesses whether you are carrying the SARS-CoV-2 virus (the virus responsible for COVID-19) at the time you provided your saliva sample.

The test works by analysing your saliva sample for the presence of genetic material (RNA) that is specific to the SARS-CoV-2 virus using a method called RT-PCR.

The primers and probes used in this assay were selected as the best performing in our trials and approved by the US Centre for Disease Control (CDC) and the World Health Organisation (WHO) for their specificity to SARS-CoV-2. The test is validated as having 100% sensitivity at viral loads in excess of 750 copies/mL in in vitro limit of detection (LOD) testing.

Please note, this is not an antibody test: it does not inform you whether you have previously been infected with the virus and have now developed antibodies to SARS-CoV-2.


Possible results

Results will be sent to you via SMS text message as soon as they are available. You will receive one of four possible test results:

  • Positive – SARS-CoV-2 was detected in your saliva at the time of testing. This strongly suggests you have an active COVID-19 infection.
  • Negative – SARS-CoV-2 was not detected in your saliva at the time of testing. Assuming you do not have symptoms of COVID-19 (e.g. new onset cough, high temperature, a loss of taste/smell), this suggests you do not currently have an active COVID-19 infection.
  • Inconclusive – our laboratory only partially detected SARS-CoV-2 in your saliva. You may or may not have an active COVID-19 infection. Retesting is recommended - we’ll send you a new saliva test kit free of charge. In the meantime, you are advised to behave as if you have a positive test result and are currently carrying coronavirus – you should therefore self-isolate and stay at home until you receive the results of your retest.
  • Failed – our laboratory was unable to successfully process your sample. Retesting is recommended- we’ll send you a new saliva test kit free of charge.

Responding to results

The following guidance is based on government guidelines produced by Public Health England. More information can be found on the GOV.UK and NHS websites.

Please be aware that these guidelines may be subject to change. We recommend visiting the most up-to-date government guidance when you receive your test results.

Positive

A positive test result means you were highly likely to be infected with coronavirus (SARS-CoV-2) when you provided your saliva sample.

If you had or currently have symptoms of COVID-19 (e.g. a new onset cough, high temperature, and/or loss of taste or smell), you should self-isolate and stay at home for at least 7 days from when your symptoms started.

If you do not have symptoms, you must immediately self-isolate for 14 days.

Anyone you live with, or in your support bubble, must also self-isolate for 14 days.

We also recommend you get in touch with NHS Test and Trace to report your positive test result and aid contact tracing. By providing this vital information, which will be held in strict confidence, you will play your part in the national effort to slow and stop the spread of coronavirus.

Negative

A negative test result means you were unlikely to be infected with coronavirus (SARS-CoV-2) when you provided your saliva sample.

You do not need to self-isolate as long as you fulfil the following criteria:

  • everyone you live with who has COVID-19 symptoms (e.g. new onset cough, high temperature, and/or loss of taste or smell) also tests negative
  • everyone in your support bubble who has COVID-19 symptoms also tests negative
  • you have not otherwise been instructed to self-isolate (e.g. by NHS Test and Trace, your GP)
  • you do not currently have symptoms of COVID-19 (Even if you receive a negative test result, there is a small risk that the test result is incorrect, especially if you have strong symptoms that are suggestive of COVID-19)
  • you feel well – if you feel unwell, you are advised to stay at home until you are feeling better

If you are a health or care worker, please check with your employer before going back to work.

Please note that a negative test result does not exclude the possibility that you have been infected with the SARS-CoV-2 virus after providing your saliva sample. You are advised to remain vigilant and self-isolate if you develop symptoms of COVID-19.

Inconclusive

An inconclusive result means that the test may have partially detected the presence of SARS-CoV-2 in your saliva, but the signal did not meet the criteria to be confirmed as a positive result.

If you receive an ‘inconclusive’ result, we recommend retesting. We will send you a new saliva kit free of charge.

In the meantime, you are advised to behave as if you have a positive test result and are currently carrying coronavirus – you should therefore self-isolate and stay at home for 7-14 days (see below) or until you receive the results of a retest.

If you have symptoms of COVID-19 (e.g. a new cough, temperature, and/or loss of taste or smell), you should self-isolate for 7 days from when symptoms started.

If not showing symptoms, you should self-isolate for 14 days from when your original saliva sample was first provided. If you subsequently receive a negative test result, you can stop self-isolating.

Failed

A failed result means that we were unable to process your saliva sample at our laboratory.

In this event, we will send you a new saliva test kit free of charge for retesting.

If you receive a 'failed' result and are displaying symptoms of COVID-19 (e.g. a new onset cough, high temperature, and/or loss of taste of smell), then you should stay at home and self-isolate for at least 7 days from when symptoms started.

If you receive a 'failed' result and do not have symptoms of COVID-19, then you do not need to self-isolate. You should nevertheless remain vigilant and self-isolate if you go on to develop symptoms of COVID-19.


Important information about interpreting your results

It is important to be aware that no test in healthcare is 100% accurate. There is always a small risk of incorrect results, namely, false positive and false negative results.

A false positive result for this test refers to when you receive a positive test result but, in reality, are not actually carrying the SARS-CoV-2 virus.

A false negative result is when you receive a negative test result but, in reality, are actually carrying the SARS-CoV-2 virus.

Antigen (PCR) tests are demonstrated to have an extremely high specificity, meaning that the risk of receiving a false positive result is very low. This means that if you receive a positive test result, we can be very confident that you are actually carrying the COVID-19 causing coronavirus.

Antigen tests also have a high sensitivity, meaning that the risk of receiving a false negative result is also low. This means that if you receive a negative test result, we can be fairly confident that you are not actually carrying coronavirus.

Nevertheless, clinically speaking, a positive test result carries more weight than a negative test result. Negative results should be interpreted in the context of symptoms and clinical history. If you receive a single negative test result but still have strong symptoms that are suggestive of COVID-19, it is best to self-isolate and behave as if you tested positive.

You should not use a negative test result to undertake activities or behaviour contrary to current government guidance, such as close interaction with a clinically vulnerable or shielding individual.

If you have any further queries in relation to this test, please contact us at support@fitnessgenes.com