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US healthcare major Abbott is set to roll out its laboratory-based antibody test in India.
The company has just received European regulatory approval or the CE mark on its laboratory-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had the novel coronavirus (COVID-19).
Antibody tests are not used for diagnosis of infection. Instead, these tests can tell if a person has been previously infected. And this would help in understanding how long antibodies stay in the body and if they do in fact provide immunity to reinfection, for example. And this information can support the development of treatments and vaccines, the company said.
Narendra Varde, General Manager and Country Head at Abbott’s diagnostics business in India, said the antibody tests would be rolled-out in the coming weeks. The decision comes even as India recently put on hold rapid antibody tests following a spate of complaints from states on faulty tests and inaccurate results.
Giving details on the test, Abbott said its SARS-CoV-2 IgG test identifies the IgG antibody, which is a protein that the body produces in the late stages of infection and could remain in the body for months and possibly years after a person has recovered. The test demonstrates specificity and sensitivity to detect IgG antibodies of greater than 99 per cent 14 days or more after symptoms have started.
Abbott's IgG antibody test will initially be available on its ARCHITECT® i 1000 SR and i 2000 SR laboratory instruments.* ARCHITECT is a widely used laboratory system that has been used for decades. In use in laboratories throughout India, these instruments can run up to 100-200 tests per hour, the company said.
Abbott is significantly scaling up its European manufacturing for antibody testing and will expand testing to its Alinity™ i system. Abbott will also be expanding its laboratory antibody testing for the detection of the antibody, IgM, in the near future, the company said.
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