Drug Regulator Approves 40-Minute RT-PCR Detection Kit As India Prepares for Possible Mpox Outbreak

New Delhi: India is preparing to tackle the potential mpox cases in the country and has developed an RT-PCR Detection Kit for the same.

These preparations are being done amid the global monkeypox scare after WHO declared it as a public health emergency.

India Preparing for Possible Mpox Outbreak, Develops RT-PCR Detection Kit

As monkeypox cases continue to rise in several countries across the world, India is preparing for a possible outbreak in the country.

As part of the preparations, the Central Drugs Standard Control Organisation (CDSCO) has approved to manufacture the IMDX Monkeypox Detection RT-PCR Assay by Siemens Healthineers.

India's home-grown indigenous RT-PCR Detection Kit for mpox is a victory for the centre's ‘Make in India’ initiative and is also a critical move to control a possible spread of mpox in India.

Siemens Healthcare Pvt Ltd Issue Statement

“IMDX Monkeypox Detection RT-PCR Assay will be manufactured at our molecular diagnostics manufacturing unit in Vadodara, which has a manufacturing capacity of 1 million reactions per year. The factory is all set to make the kits available. The IMDX Monkeypox Detection RT-PCR Assay is a ground-breaking molecular diagnostic test that targets two distinct regions in the viral genome, spanning both clade I and clade II variants of the virus. This ensures thorough detection across various viral strains, providing comprehensive results", Siemens Healthcare Private Ltd said.

The organisation further said, "Notably, this assay is platform-agnostic and seamlessly fits into existing lab workflows with standard PCR setups, eliminating the need for new instruments. The ability to use existing COVID testing infrastructure would enhance efficiency." 

How Will Mpox RT-PCR Detection Kit Help?

Explaining how the RT-PCR Detection Kit will help in controlling the potential mpox, Hariharan Subramanian, Managing Director, Siemens Healthcare Private Limited said, "By providing India with advanced assay kits tailored to combat Monkeypox, we are taking a proactive stance in battling this disease and prioritising prompt and precise detection that can truly make a difference in saving lives. These kits are a testament to our focus on improving 'Access to Care' and these assay kits are a significant step towards that goal." 

Mpox Cases: RT-PCR Detection Kit to Give Test Result in 40 Minutes

According to Siemens Healthcare Private Ltd, once the test is conducted, the results will be available in just 40 minutes.

The organisation said, “With results available in just 40 minutes, significantly faster than traditional methods (which take 1-2 hours), the assay helps reduce the turnaround time for reporting, leading to quicker responses. Clinically validated by ICMR-National Institute of Virology, Pune, the assay boasts an impressive 100 per cent sensitivity and specificity. IMDX Monkeypox RTPCR Assay kits adhere to Indian statutory guidelines and comply with the highest global standards.”