Abbott to Supply More Than a Million Tests of IgG Lab-based Antibody Tests to India

• Abbott’s SARS-CoV-2 IgG test can be used for highly-reliable, large-scale antibody testing, in line with the ICMR recommendation for the use of IgG CLIA (Chemiluminescence immunoassay) tests
• Abbott’s antibody test is being deployed by many hospitals and labs across the country to understand the extent of infection in population exposed, as well as for surveying high risk or vulnerable populations *
• Test demonstrated reliable results with 99.6% specificity and 100% sensitivity for patients tested 14 days or more after symptoms started MUMBAI, India, 22 June, 2020 — Abbott announced today that it has begun supply of its laboratory-based serology blood test for the detection of the antibody, IgG (Immunoglobulin G), that identifies if a person has had the novel coronavirus (COVID-19). Abbott has the capacity to provide millions of tests to India and is already in the process of delivering antibody tests to leading government and private hospitals and labs in Maharashtra, Delhi, West Bengal, Uttar Pradesh, Jammu & Kashmir and Gujarat.

“Abbott is pleased to contribute to ICMR’s COVID-19 antibody testing strategy to use IgG CLIA antibody tests. Abbott’s recently launched SARS-CoV-2 IgG test can be used to understand the spread of transmission in high risk populations such as healthcare workers, immune-compromised individuals, frontline workers, or those in containment zones. These tests also provide valuable information to the public health officials about the spread in asymptomatic cases, helping us assess the impact of our public health efforts now and guide our COVID-19 response moving forward,” said Narendra Varde, General Manager and Country Head at Abbott’s diagnostics business in India.

Mumbai’s Hinduja hospital was one of the first hospitals to evaluate the test in India. Dr. Tester F. Asha Vaid, Chief of Labs (Admn), Director Lab Research at Hinduja Hospital and Medical Research Centre, Mumbai, said, “This test is useful to clinicians and the community – our initial testing has yielded specific results for patients who were RT-PCR positive for COVID-19.”

Dr. Jayanthi Shastri, Professor & Head Microbiology, Kasturba Gandhi Hospital for Infectious Diseases in Mumbai said, “For a city like Mumbai, it’s critical to assess the level of exposure of population in the community, which can be done ward-wise, guiding authorities on re-assessing containment strategies. The test gains significant relevance in high-risk populations such as front line and healthcare workers, where outcomes will enable us in understanding contagiousness of COVID-19.”

Dr. Ujjwayini Ray MD (AIIMS), Consultant Microbiologist, Apollo Gleneagles Hospitals, Kolkata said, “We have found that patients who have clinically recovered or are on path of recovery have developed significant levels of IgG antibody against COVID-19. The IgG assay could be included in the discharge policy of hospitalised COVID-19 patients.”

Abbott’s SARS-CoV-2 IgG test specifically identifies the IgG antibody, which is a protein that the body produces in the late stages of infection and may remain for up to months and possibly years after a person has recovered. The test is used on the ARCHITECT^® i1000SR and i2000SR laboratory instruments**, which are installed in hospitals or laboratories throughout India and can run up to 100-200 tests per hour to help with reliable antibody testing during the pandemic.  Independent researchers** found the test to have 99.9% specificity and 100% sensitivity for patients tested 17 days or more after symptoms began.***

Abbott designed its test to detect the IgG antibody specifically as it can better help physicians determine recovery from infection, versus looking at a combination of antibodies. Abbott is also developing an IgM antibody test.