The Rapid Saliva Protein Test (RSPT) is a non-invasive test indicating the immune response to infection from SARS-CoV-2, the virus underlying COVID-19, using a simple saliva sample. Less intrusive than a swab or blood test, the RSPT provides results on the spot within 15 minutes, and can be taken on the premises, with a healthcare professional present.
It is easy to use and indicates whether someone is currently infected.
Developed in the UK and Spain, the test is CE marked to 98/79/EC, registered with the MHRA, and is for use under supervision from a medical professional throughout Europe. It's proving pivotal in helping companies regulalrly test employees, safely reopen workplaces and take action in line with government guidance.
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 lateral flow device which migrates the saliva sample along the device. The test identifies antibodies unique to COVID-19, capturing them on test and control lines.
The RSPT isolates the protein complexes in saliva, allowing for recognition of saliva antibodies produced after the first contact with the virus, immunoglobulin M (IgM) and immunoglobulin G (IgG). Antibodies are produced when a virus is present as part of the body’s immune system response to infection.
At the early stage of infection, human cells produce an immune response and generate IgG, but more specifically IgM 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.
Medusa 19 Life Sciences also hold ISO 13485:2016 certification, and cGMP Good Manufacturing Practice Certification for the quality production of medical devices.