The Medicines and Healthcare Products Regulatory Agency has already approved Attomarker's Triple Antibody Test for NHS use in the UK.
The Smiths Detection team has been working alongside Attomarker since April on the design and performance of the device and has manufactured 10 pre-production units, with the ability to ramp up volume according to demand.
Attomarker's Triple Antibody Test device is a portable, desktop, antibody-testing device designed to provide laboratory-standard results in any environment. It delivers rapid, accurate, quantitative results in just seven minutes compared with up to 72 hours for tests that require to be sent away for laboratory analysis.
The result of a trial at St Thomas' Hospital in London published this week in the Royal Society of Chemistry's journal Analyst shows that the Attomarker Triple Antibody Test delivers a sensitivity of up to 96% in detecting COVID-19 antibodies, including in patients who have previously presented false negatives.
This is a significant improvement on recently announced tests, which range between 83.9% - 93.9% - though not with real world patients.
A developer and manufacturer of leading-edge threat-detection equipment for security industries, Smiths Detection frequently partners with companies and governments to develop equipment that is both highly accurate in detection and offers the highest standard of technical performance.
Attomarker's technology uses a multiplex platform that tests simultaneously for multiple clinically relevant biomarkers against the SARS-CoV-2 virus.
Attomarker tests for three virus proteins (Spike 1, Spike 2 and N) and three classes of antibodies (IgM, IgG and IgA), giving a more powerful profile of the patient's immune response to COVID-19. This could help validate a COVID-19 vaccine when a viable candidate completes development.
The Triple Antibody Test device is being manufactured at Smiths Detection's site at Hemel Hempstead.
Smiths Detection, part of Smiths Group, is in threat detection and screening technologies for aviation, ports and borders, defence and urban security markets.
Attomarker Ltd. is a spin-out company from the University of Exeter. Its focus is the development of multiplex blood-testing technology, networked via the Cloud, helping health services, NGOs, governments and consumers monitor and manage infectious and non-infectious diseases.
Saluda Medical secures CE certification for EVA Sensing Technology in Europe
Antin to acquire clinical trial equipment provider Emsere
Hyphens Pharma licenses Cerapro skin cream to Louis Widmer for six European markets
Profusa signs French distributor to expand Lumee Oxygen rollout in Europe
Sensiva Health names new chief operating officer
BrioHealth Solutions enrols 100th participant in BrioVAD System trial
Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark
Amphix Bio announces initial closing of USD12.5m seed financing round
Bioretec wins FDA breakthrough status for biodegradable orthopaedic DrillPin
Amferia raises EUR3.5m to advance antimicrobial wound-care platform
BioCryst wins FDA approval for oral HAE prophylaxis in young children
ALR Technologies announces GluCurve Pet CGM relaunch in Canada
Galderma secures EU MDR certification for Sculptra, expanding use to multiple body areas
Clinical Laserthermia Systems applies for CE marking of ClearPoint Prism neuro laser system