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Roche Diagnostics India receives Import License for serology-based SARS-CoV-2 test

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The license was issued by CDSCO due to emergency health situation in public interest

Roche Diagnostics India announced that it is readying to bring their serology-based SARS-CoV-2 test – Elecsys Anti-SARS-CoV-2 [i]– having received the Import License issued by the Central Drug Standard Control Organisation (CDSCO) [ii], due to the emergency health situation in public interest. It is significant to note that the test received CE IVD certification [iii] and US FDA emergency use authorisation (EUA) [iv] a few days ago.

Elecsys Anti‐SARS‐CoV‐2 is an immunoassay for the 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.

Dr Shravan Subramanyam, Managing Director – Roche Diagnostics India, said, “India is adopting a testing strategy that has been at par with international standards. From bringing the globally used tests to the country in record time to establishing the disease control measures by creating COVID-19 diagnostic hubs and enabling different types of testing at various stages of disease spread, the Indian Government and the State Governments have been collaborating with various sections of the healthcare system to manage the situation. 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.”

Prof (Dr) Navin Dang, Founder & Chairman, Dr Dangs Lab, highlighted the need for antibody testing for India by saying, “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. It is imperative that we catalyse the adoption of antibody tests to formulate an appropriate strategy to curtail the epidemic. In my view, a SARS-CoV-2 antibody test used in conjunction with a RT-PCR test would be the need of the hour in India.”

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. Currently, it is not known whether the presence of antibody actually confirms immunity and the duration of such immunity. Once we understand more about immunity to SARS-CoV-2, it could also help society return faster to normality by helping to decide on application, enforcement or relaxation of containment measures. This test may also be used together with molecular tests, like Roche’s cobas SARS-CoV-2 Polymerase chain reaction (PCR) test, to aid in the diagnosis of suspected COVID-19 patients.

According to Dr Sandeep Sewlikar, Head – Medical and Scientific Affairs, Roche Diagnostics India, said, “Roche’s new Elecsys Anti-SARS-CoV-2 serology test has greater than 99.8 per cent specificity and 100 per cent sensitivity in samples taken 14 days after a PCR-confirmed infection. This means it can lower the chance of false positives due to the detection of antibodies to coronaviruses other than SARS-CoV-2. This means that chances of labelling patients with other coronaviruses as having COVID-19 are minimal. The Roche assay design ensures preferential detection of mature, high affinity antibodies that appear later in infection.”

The test is run on the cobas e 411 analyser that can process up to 86 tests per hour, while the cobas e 601 / 602 module can process up to 170 tests per hour, and the cobas e 801 module up to 300 tests / hour. We are working with authorities to receive the test at the earliest possible date in India, once received; testing will begin in Indian Council of Medical Research approved labs.

References

[i] Full specifications of Roche’s Elecsys Anti-SARS-CoV-2 antibody test and immunoassay systems, including throughput, can be found on our diagnostics.roche website

[ii] India Import License issued by Central Drug Standard Control Organization (CDSCO) under Drugs and Cosmetics Act, 1940 and Medical Device Rules 2017 in public interest due to emergency health situation https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTkwMQ

[iii] CE-IVD marking is granted through completion of a comprehensive technical validation and self-declaration under the European Directive for In Vitro Diagnostic Medical Devices.

[iv] The Emergency Use Authorisation (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of medical countermeasures needed during public health emergencies https://www.fda.gov/media/137602/download

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