Roche announced the launch of the SARS-CoV-2 Rapid Antibody Test 2.0 in markets accepting the CE Mark.
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The test is the next generation of Roche's existing SARS-CoV-2 Rapid Antibody Test, which launched in July 2020.
The SARS-CoV-2 Rapid Antibody Test 2.0 offers broader use than its original configuration, which focused on recovered patients, to now include vaccinated individuals as well. The test has also been updated to improve the detection of antibodies against variants of the virus, and continues to be investigated against new variants of concern.
The SARS-CoV-2 Rapid Antibody Test 2.0 can be used by healthcare professionals in point of care settings outside clinical labs and near to patients with a capillary sample. The test should help healthcare professionals to identify patients that have developed antibodies against SARS-CoV-2, indicating prior infection or vaccination.
The SARS-CoV-2 Rapid Antibody Test 2.0 is beneficial in situations where timely decisions are needed, laboratory SARS-CoV-2 testing is not available, or finger prick sampling is the better option over a venous blood draw.
Healthcare professionals can further use the test to help patients check their antibody status and to determine whether they still have a detectable antibody response from prior vaccination.
The test's launch is in partnership with SD Biosensor Inc., with whom Roche has a global distribution agreement and launched a range of rapid antigen and antibody tests in more than 50 countries worldwide.
The SARS-CoV-2 Rapid Antibody Test 2.0 joins Roche's comprehensive diagnostic portfolio of solutions to help healthcare systems combat COVID-19, which also includes molecular, serology and digital solutions.
Roche's SARS-CoV-2 Rapid Antibody Test 2.0 is a rapid chromatographic immunoassay intended for qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, plasma or whole blood.
This test can be performed using blood from a finger prick to produce high performance results within 10-15 minutes in a point of care setting. The results can help identify an adaptive immune response to the virus.
When performed 3-4 weeks after vaccination, when IgG antibody levels are anticipated to reach their plateau, the test has a sensitivity of 98.67% and 100.00% after the second and booster shot, respectively. When performed at least 15 days after symptom onset for a non-vaccinated population, the test has a sensitivity of 95.83% and a specificity of 100.00%.
The test's ability to detect antibodies after vaccination against SARS-CoV-2 was confirmed through a clinical trial which included patients vaccinated with vaccines from Moderna, Pfizer/BioNTech, AstraZeneca and Johnson & Johnson. ■