NEW YORK – Roche announced on Monday that it is launching its SARS-CoV-2 Rapid Antibody Test 2.0 in countries accepting the CE mark after receiving the designation in July.
The assay is the next generation of Roche's existing rapid antibody test for SARS-CoV-2, which launched in July 2020. The new test is configured for broader use with patients who have been vaccinated, as well as those who have recovered from previous infection. It has also been updated to improve the detection of antibodies against SARS-CoV-2 variants and "continues to be investigated against new variants of concern," the company said in a statement.
The chromatographic immunoassay is intended for use by healthcare professionals at the point of care with a capillary blood sample to detect IgG antibodies to SARS-CoV-2. Results are returned in 10 to 15 minutes, Roche said. The test is being launched in partnership with SD Biosensor.
When the assay is performed three to four weeks after vaccination, it has a sensitivity of nearly 99 percent after the second shot and 100 percent after the booster shot, Roche said. When performed at least 15 days after symptom onset for someone who has not been vaccinated, the sensitivity is nearly 96 percent and specificity is 100 percent.