Roche has launched its new SARS-CoV-2 Rapid Antibody Test 2.0 for use by healthcare professionals in point-of-care settings outside clinical labs.
Launched in partnership with SD Biosensor in markets accepting the CE Mark, it is the next generation of the company’s existing SARS-CoV-2 Rapid Antibody Test, which was launched in July 2020.
The latest test offers broader use compared to its original configuration and now includes vaccinated individuals.
It has been updated to improve the detection of antibodies against virus variants.
Using the SARS-CoV-2 Rapid Antibody Test 2.0, healthcare professionals are expected to identify patients who have developed antibodies against the virus, indicating previous infection or vaccination.
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Roche Diagnostics Point of Care head Ian Parfrement said: “The next generation of our SARS-CoV-2 Rapid Antibody Test demonstrates Roche’s continued commitment to innovate as the Covid-19 pandemic evolves.
“We are proud to introduce an improved antibody test that, given its point of care use, offers healthcare professionals greater speed and accessibility in providing the right care to those that need it.”
Intended for the detection of SARS-CoV-2 qualitative IgG antibodies in plasma, human serum or whole blood, the rapid chromatographic immunoassay test can be performed using blood obtained from a finger prick.
The test produces results within ten to 15 minutes in point-of-care settings.
The test demonstrated a sensitivity of 98.67% after the second vaccination shot and 100% after the booster shot when conducted three to four weeks following vaccination.
Additionally, the test has 95.83% sensitivity and 100% specificity when performed at least 15 days after symptom development for a non-vaccinated population.
A clinical trial in patients vaccinated with Moderna, Pfizer/BioNTech, AstraZeneca and Johnson & Johnson vaccines confirmed the ability of the test to detect antibodies after vaccination.
In August, Roche introduced the new Elecsys IGRA SARS-CoV-2 diagnostic test, which helps provide a better understanding of the body’s immune response to SARS-CoV-2 infection and vaccination.
