Thursday, 02 July 2020

CPC Diagnostics launches COVID-19 CLIA Ab tests in India

21 May 2020 | News

Both are CE-approved antibody tests and are the first of their kind to get approved by the Indian Council of Medical Research

Image credit- shutterstock.com

Image credit- shutterstock.com

CPC Diagnostics , Chennai, a portfolio company of Everstone backed healthcare platform Everlife Holdings Pte. Ltd, 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 Chemiluminescence immunoassay (CLIA) based tests, developed by Shenzhen-based YHLO Biotech Co. Ltd, run on the fullyautomated analysers iFlash 1800/3000, offering sensitivity of 97.3% and 86.1% for IgG and IgM with specificity of 96.3% and 99.2% respectively.

The IgM assay is capable of detecting the disease as early as the 7th day after infection. The iFlash system minimizes 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% and 100% for IgG and IgA with specificity of 99.3% and 90.5% respectively.

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