Test hailed as game changer in fight against COVID-19 and reopening of global economy
A quick test developed by Manchester-based company Medusa 19 can give results on coronavirus infection within 10 minutes.
The Rapid Saliva Protein Test (RSPT) is a saliva test to indicate the immune response to infection, particularly in patients who do not know they have an active SARS-CoV-2 infection and have no specific symptoms.
The 10-minute result window is a significant breakthrough for the COVID-19 testing market, providing rapid results on the spot.
The non-invasive test requires simple saliva collection, and is less intrusive than a blood sample, nasal or throat swab.
Developed in the UK and Spain, the test indicates a user’s immune response to SARS-CoV-2, the virus underlying COVID-19.
Users provide a saliva sample into a collection tube, mixing this with a solution, which isolates and solubilises the protein structure present in saliva.
This mixture is applied to a device which identifies antibodies unique to COVID-19.
At the early stage of infection, human cells produce an immune response and generate IgG (immunoglobulin G), but more specifically IgM (immunoglobulin M) at the point of contact with the virus, which for COVID-19 is in the throat and respiratory tract.
The antibodies are then transported from the lymph nodes into blood and saliva. In the early stage, detection in blood is not sensitive enough due to a high dilution effect, whereas in saliva, the independent clinical data indicates it is detectable.
Importantly, since this test indicates an immune response to current, or recent infection, it can alert users if they should immediately self-isolate to stop the spread of the disease.
Independent clinical trials were conducted in collaboration with Hospital Carlos III/Institute Carlos III – Hospital La PAZ, Madrid, on 254 participants.
In patients with no specific symptoms, the trial demonstrated relative sensitivity of 96% – ability to detect true positives – relative specificity of 92% – ability to detect true negatives – and 94% accuracy in patients with the absence of specific symptoms and who did not know they had an active SARS-CoV-2 infection.
The test could prove pivotal in helping companies safely reopen workplaces and take action in line with government guidance.
The RSPT is under application with the FDA Emergency Use Authorisation for approval in the USA.
Medusa 19 is currently working to develop an app which will act as a digital passport to verify and validate RSPT results, the Saturn Pass.
Christian Stephenson, Medusa 19 chief development officer, said: “Testing for infection is pivotal to navigating the pandemic.
“The clinical evaluation showed the detection of an immune response to the virus could be detected in patients with no specific symptoms rapidly and accurately from a saliva sample which is a game-changer.
“By testing on a mass scale, outbreaks can be quickly pinpointed and brought under control, therefore avoiding the imposition of strict blanket lockdowns.
“The ability to rapidly test on a mass scale represents a huge leap forward for the global recovery from COVID-19, pioneered here in the UK.
“Clinical trial results are encouraging, and this could provide the global workforce with an accessible, reliable test, that can indicate an immune response to current or recent infection, even in carriers with no specific symptoms.
“It could be a lifeline for businesses struggling to safely reopen, and we are working tirelessly to seek approval for use for the general public, too.”
Andy White, Medusa 19 managing director, said: “The Medusa 19 team has worked with extraordinary dedication to produce this unique test in a matter of months, alongside the necessary infrastructure and fulfilment capability and we are delighted with the clinical results.
“Global demand for a reliable and rapid test of this nature is expected to be in the billions of tests per annum, and, therefore, it is important that we are able to manufacture and distribute this test widely, both at home and overseas.
“The infrastructure behind the test means it can be produced en masse, and by investing in a wide roll-out of this unique test, businesses can take a vital step forward in getting back to work safely, in line with government guidance.”
Medusa 19 is also exploring a number of other complementary tests and diagnostic products, and earlier this year entered an exclusive distribution agreement with Avacta Group for direct-to-consumer sales of a saliva-based antigen test.
It will utilise its infrastructure to distribute this product worldwide once available.