Both are CE-approved antibody tests and have been approved by ICMR
CPC Diagnostics (CPC), Chennai, a portfolio company of Everstone backed healthcare platform Everlife Holdings has launched SARS COV-2 IgM and SARS COV-2 IgG tests in India. Both are CE-approved antibody tests and are the first of their kind to get approved by the Indian Council of Medical Research (ICMR).
The CLIA-based tests, developed by Shenzhen-based YHLO Biotech, run on the fully-automated analysers iFlash 1800 / 3000, offering sensitivity of 97.3 per cent and 86.1 per cent for IgG and IgM with specificity of 96.3 per cent and 99.2 per cent respectively. The IgM assay is capable of detecting the disease as early as the seventh day after infection. The iFlash system minimises human error, while being able to handle large volumes. Depending on the analyser model, a lab can report up to 1000 to 2000 results per day on a single instrument, with the flexibility for facilities to add further modules to ramp up output substantially.
CPC is also planning to launch another antibody testing solution that is ELISA-based, which is under the process of ICMR approval. The ELISA tests developed by EUROIMMUN AG in Germany can be programmed on any automated ELISA processor or ELISA reader in addition to the dedicated EUROIMMUN analysers. These tests offer high sensitivity of 93.8 per cent and 100 per cent for IgG and IgA with specificity of 99.3 per cent and 90.5 per cent respectively.
Antibody tests are very valuable in community screening and surveillance. They are a vital tool in disease monitoring and they eminently complement the RT-PCR tests. Unlike rapid tests which are qualitative, CPC’s CLIA and ELISA tests provide semi-quantitative values. This feature is also useful to assess the suitability of plasma (from individuals who have recovered) for therapy.
Commenting on the launch, R Kailasnath, Managing Director, CPC Diagnostics, said “Our government recognises the need for more and better testing, and we are happy to be contributing to India’s fight against COVID-19 with these highly sensitive and specific assays. Our priority now is to work closely with all stakeholders such as the government, the private sector as well as the medical research fraternity to make these tests available to them.”
Raman Gandotra, CEO, Everlife, said, “Everlife is committed to support its portfolio companies to fight COVID-19 in all the countries where it operates, by providing safe and accurate testing of COVID-19. Quantitative serological antibody testing is uniquely suited in the current COVID environment where countries are not only looking at detecting and controlling the spread but also preparing to re-open their economies.”
YHLO’s COVID-19 CLIA antibody tests have CE-IVD and Australian FSC certifications, and have been exported to Australia, France, Germany and Italy.
EUROIMMUN’s COVID-19 ELISA antibody tests have CE-IVD certification and the IgG test has received US FDA EUA approval. The tests are available in Germany, the US, Italy, Canada and Brazil.