Abbott has said it will make its new, European-made laboratory-based antibody blood tests available in India by end of this month.
Abbott received CE mark approval this week for its laboratory-based serology blood (antibody) test for the detection of the antibody, IgG, that identifies if a person has had COVID-19.
The antibody tests will run Abbott's ARCHITECT i1000SR and i2000SR laboratory instruments and will expand to its Alinity I system. These instruments are in use in laboratories throughout India and can run up to 100-200 tests per hour.
Abbott said it will begin shipping to India by the end of May and will scale up to meet the demand subsequently.
The lab-based antibody test while not hugely scalable is still important to increase the pace of testing as India plans to ease lockdown. India's attempts to increase testing by importing rapid antibody test kits from China has hit a roadblock due to issues of accuracy.
India has reported about 46,476 COVID-19 confirmed cases and 1,571 deaths. The numbers have been steadily increasing even as its testing remained low at 864 tests per million population.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
While molecular testing or RT-PCR detects whether someone has the virus, antibody tests determine if someone was infected. Abbott's SARS-CoV-2 IgG test identifies the IgG antibody, which is a protein that the body produces in the late stages of infection and may remain up to months and possibly years after a person has recovered.
The test demonstrated specificity and sensitivity to detect IgG antibodies of greater than 99 percent 14 days or more after symptoms started.
"Abbott has been singularly focused on bringing COVID-19 tests to market as quickly as possible to help address this pandemic," said Narendra Varde, General Manager and Country Head at Abbott’s diagnostics business in India. "We are proud to be providing our antibody tests in the coming weeks as they will help understand who has had the virus, leading to greater confidence as we get to living life.”
Abbott said it is significantly scaling up European manufacturing for antibody testing and will expand testing to its Alinity I system. The company added that it will also be expanding its laboratory antibody testing to the detection of the antibody, IgM, in the near future.
Abbott last month announced that it had received USFDA's Emergency Use Authorisation (EUA) for its 5-minute point-of-care molecular test for the detection of COVID-19.
The company said it has plans to make them available across the world including India, but declined to give a timeframe.