First ICMR-approved Covid-19 antibody tests launched in India

By: |
May 21, 2020 1:30 AM

CPC, a manufacturer and marketer of in-vitro diagnostic products, has three decades of experience in the industry. It operates in India, Sri Lanka and Bangladesh.

According to the company statement, the antibody tests are very valuable in community screening and surveillance and they eminently complement the RT-PCR tests.According to the company statement, the antibody tests are very valuable in community screening and surveillance and they eminently complement the RT-PCR tests.

Chennai-headquartered CPC Diagnostics (CPC), a portfolio company of Everstone-backed healthcare platform Everlife Holdings, has launched Covid-19 antibody tests — SARS COV-2 IgM and SARS COV-2 IgG in India. Both CE-approved tests are the first of their kinds to be approved by the Indian Council of Medical Research (ICMR).

CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The CE marking is also found on products sold outside the EEA that have been manufactured to EEA standards.

The Clinical Laboratory Improvement Amendments (CLIA)-based tests are developed by Shenzhen-based YHLO Biotech, and run on the fully automated analysers iFlash 1800/3000, offering sensitivity of 97.3% and 86.1% for IgG and IgM, respectively, with specificity of 96.3% and 99.2%, respectively.

R Kailasnath, MD, 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.”

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 1,000 to 2,000 results per day on a single instrument, with the flexibility for facilities to add further modules to ramp up output substantially, said a statement on behalf of Everstone Group.

CPC is also planning to launch another antibody ELISA-based testing solution, 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% and 100% for IgG and IgA, respectively, with specificity of 99.3% and 90.5% respectively. An enzyme-linked immunosorbent assay, also called ELISA or EIA, is a test that detects and measures antibodies in the blood.

CPC, a manufacturer and marketer of in-vitro diagnostic products, has three decades of experience in the industry. It operates in India, Sri Lanka and Bangladesh.

According to the company statement, the antibody tests are very valuable in community screening and surveillance and they eminently complement the RT-PCR tests.

Unlike qualitative rapid tests, CPC’s CLIA and ELISA tests provide semi-quantitative values. This feature is useful to assess the suitability of plasma (from individuals who have recovered) for therapy.

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. 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.”

Get live Stock Prices from BSE, NSE, US Market and latest NAV, portfolio of Mutual Funds, calculate your tax by Income Tax Calculator, know market’s Top Gainers, Top Losers & Best Equity Funds. Like us on Facebook and follow us on Twitter.

Financial Express is now on Telegram. Click here to join our channel and stay updated with the latest Biz news and updates.

Next Stories
1Good news for COVID treatment! Antibody therapy lowers hospitalisations, emergency visits, finds study
2Lockdown Extension in India: Odisha extends lockdown in containment zones till November 31
3India’s COVID-19 caseload goes past 81 lakh with 48,648 fresh infections