Is Hydro-X the manufacturer of the Coronavirus Saliva Test Kit?Paul WilsonNo. However, Hydro-X's expertise for more than 35 years has been in supporting our customers to reduce risk within the workplace. We do this in many ways, from specialist compliance service provisions, to accredited training, to PPE and consumables supply. In light of current business risks, along with requests from our customers, Hydro-X have worked hard over recent months to partner with several, specialist, epigenetic coronavirus testing providers. Now we can extend this new facility of coronavirus saliva testing to our customers, without impacting any supply to the UK Government and NHS. As such, the look of the box that the coronavirus test kit arrives in may change over time, whilst we balance capacity between each provider to ensure continuity of supply.
When is the best time to take the coronavirus test?Paul Wilson
The saliva test can be taken at any time of day, although evidence does suggest that it may be better to provide a saliva sample early in the morning rather than later in the day.1 If you have symptoms of COVID-19 (e.g. a new onset cough, high temperature and/or loss of taste or smell), it is generally best to take the test within the first 5 days from when your symptoms started. This is because you shed more virus particles into your saliva during this time period, making it easier to detect the presence of SARS-CoV-2 via testing. 1. Tajima, Y., Suda, Y., & Yano, K. A case report of SARS-CoV-2 confirmed in saliva specimens up to 37 days after onset: Proposal of saliva specimens for COVID-19 diagnosis and virus monitoring. Journal of Infection and Chemotherapy (2020)
I’ve seen coronavirus tests costing much more, what’s the catch?Paul WilsonThere isn't one. Cost of materials has come down significantly in recent months and we are happy to pass on those cost savings to our customers. The Hydro-X Group has never and will never take commercial advantage in matters relating to health, safety and compliance.
Is this an at-home coronavirus test or is the analysis done in the lab?Paul WilsonWith our CE marked Coronavirus Saliva Test, the collection of the sample can be done anywhere - at home, work or in the clinic. Other tests (such as nasopharyngeal swabs) normally require a trained medical professional to administer correctly and are typically much more invasive and painful.
Shouldn’t these tests be going to the NHS if there is a shortage?Paul WilsonWe have worked hard with our supply partners to ensure that any commercial availability to organisations that wish to proactively test their staff for coronavirus, or make tests available to their staff, have the facility to do so without any impact whatsoever on Government and NHS supply. The UK Government's own supply chain sits outside of this one, though should a time come when our supply of tests is called upon in the national interest, we reserve the right to divert supply accordingly. In the meantime we are taking all possible measures to ensure supply to our customers for the near future.
What happens if I receive a positive result?Paul Wilson
A positive test result means that you were most likely infected with coronavirus (SARS-CoV-2) when you provided your saliva sample. Therefore you can spread to virus to others. According to government guidelines, if you had or have symptoms of COVID-19 (e.g. a new continuous cough, high temperature, and/or loss of taste of 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. For more information, please visit the Public Health England and NHS guidance pages.
What do the coronavirus test results show?Paul Wilson
This coronavirus test detects whether or not you are currently carrying the SARS-CoV-2 virus that causes COVID-19 (at time of testing). You may have heard this test also referred to as an antigen test or PCR test. It detects the presence of genetic material, called RNA, that is specific to the SARS-CoV-2 virus. If you are currently infected with this, you will shed coronavirus particles (which contain viral RNA) into your saliva and therefore test positive. There are three possible outcomes from the test:
- Positive - testing positive for coronavirus means that the sample provided contains SARS-CoV-2 RNA. This result could be returned even in the absence of COVID-19 symptoms.
- Negative - this result means that the sample provided does not contain detectable levels of SARS-CoV-2 RNA. However, you could have been previously infected by the virus and you could still be infected at a future date.
- Inconclusive - this result means that the test results did not meet the requirements to be reported as a positive detection of SARS-CoV-2 RNA in the sample. This should be treated clinically as Not Detected. However, this also means that there was partial detection of a signal from SARS-CoV-2 that warrants notification under duty of care for further investigation. Re-testing in these cases is recommended.
- Failed - this result means it was not possible to accurately process your test in the laboratory. This is normally due to an incorrect saliva sample being provided (i.e. not providing enough spit, not mixing with the stabilizing fluid or eating/drinking before the test). We recommended taking another test as soon as possible.
Is this test the same as an antibody test?Paul Wilson
No – this is not a coronavirus antibody test. An antibody test assesses whether you have already had COVID-19. It involves taking a blood sample and testing for the presence of antibodies to the SARS-CoV-2 virus. Generally speaking, antibodies may be found 2 weeks after infection. Scientists are still unsure of how long these antibodies remain in the bloodstream and whether/for how long they confer immunity to redeveloping COVID-19. Our COVID-19 saliva test is an antigen (PCR test). It assesses whether you are currently carrying the SARS-CoV-2 virus. It does NOT assess whether you have had COVID-19 in the past. * Please be aware of at-home antibody tests currently being sold online. It is against Government advice to use these as it is very unclear how effective these tests are at identifying the presence of antibodies from blood from the fingertip.
How accurate is the coronavirus saliva test?Paul Wilson
The test has a high sensitivity and specificity. This means that the likelihood of receiving a false negative or false positive test result is very low. The test is validated as having 100% sensitivity at viral loads of 750 copies/mL or greater in in vitro limit of detection (LOD) testing. In other words, a positive result was correctly called 100% of the time when 750 copies of synthetic viral RNA per mL were spiked into a saliva sample (using ISO approved RNA control spike-in material) To put this figure in context, typical transmissible viral loads (that cause infection) are usually several fold higher, with viral loads between 10,000 and 100,000,000 copies/mL commonly seen in saliva samples of patients who test positive for SARS-CoV-2.2-4 This means there is a very low likelihood of actually carrying coronavirus, but falsely receiving a negative test result. When tested against samples containing other similar human viruses, or those confirmed not to contain SARS-CoV-2, positive results were not seen. Thus, showing the specificity of RT-PCR coronavirus tests to be very high.5-7 This means there is an extremely low likelihood of receiving a positive test result despite not carrying coronavirus. (Note that negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information such as history of exposure to the virus - US FDA advice). 8
2. To et al., Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study, Lancet Infect Dis., 20(5): 565-574 (2020) 3. Yoon et al., Clinical Significance of a High SARS-CoV-2 Viral Load in the Saliva, J Korean Med Sci., 25;35(20): e195 (2020) 4. Wyllie et al., Saliva is more sensitive for SARS-CoV-2 detection in COVID-19 patients than nasopharyngeal swabs. medRxiv 2020.04.16.20067835 (2020) 5. CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel 6. WHO Diagnostic detection of 2019-nCoV by real-time RT-PCR. (2020 7. Watson, J., Whiting, P. F., & Brush, J. E. Interpreting a covid-19 test result. BMJ, 369. (2020). 8. FDA. Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV (2020).
Is the test CE marked?Paul WilsonYes, our Coronavirus Saliva Test Kit is fully CE marked.