Roche Diagnostics India has announced bringing serology-based SARS-CoV-2 test — Elecsys Anti-SARS-CoV-2 — to india having received the import licence from the Central Drug Standard Control Organization (CDSCO) due to the emergency health situation in public interest.
The test received CE IVD certification and USFDA emergency use authorisation (EUA) a few days ago.
Elecsys Anti‑SARS‑CoV‑2 is an immunoassay for in-vitro qualitative detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS‑CoV‑2) in human serum and plasma.
The test is intended as an aid in the determination of the immune reaction to SARS‑CoV‑2.
The test runs on all cobas e analysers, and these fully automated systems can provide SARS-CoV-2 test results in approximately 18 minutes for a single test, with a test throughput of up to 300 tests/hour, depending on the analyser, the company said.
Shravan Subramanyam, Managing Director, Roche Diagnostics India, said, “Laboratory-based immunodiagnostic testing will complement the existing reverse transcription polymerase chain reaction (RT-PCR) solutions to possibly ascertain COVID-19 related immunity amongst patients and all who want to ‘go back to work’ to bring the health and economic activity back to normalcy.”
Navin Dang, Founder & Chairman, Dr. Dangs Lab, said “As India works towards ‘flattening of the COVID-19 curve’, we need ability of testing with accuracy and capacity to meet the needs of such large scale testing in both Government and private sectors to revive the economy. Adding standardised immunodiagnostic serology tests could play a pivotal role in this process.”
Antibody tests have multiple utilities at the level of the individual, community such as relating to COVID-19 epidemiology in India and for supporting vaccine development and research activities, he said.
Elecsys Anti‑SARS‑CoV‑2 test may also be used together with molecular tests, like Roche’s cobas SARS-CoV-2 PCR test, to aid in the diagnosis of suspected COVID-19 patients.
The test can support priority screening of high-risk groups, such as healthcare workers, delivery service providers, or food supply workers who might already have been exposed and developed an immune response, the company said.
Currently, it is not known whether the presence of antibody actually confirms immunity and the duration of such immunity, it added.
According to Sandeep Sewlikar, Head – Medical and Scientific Affairs, Roche Diagnostics India, “Roche’s new Elecsys Anti-SARS-CoV-2 serology test has greater than 99.8% specificity and 100% sensitivity in samples taken 14 days after a PCR-confirmed infection. This means it can lower the chance of false positives.”