27 auugust 2024 : The World Health Organization (WHO) has declared its second public health emergency of international concern due to the emergence of Monkeypox. The newly identified strain of this virus, known as Clad-1, is recognized for its increased transmissibility and elevated mortality rates.
In response, India has successfully developed an indigenous RT-PCR testing kit to combat Mpox, which has received approval from the Central Drugs Standard Control Organisation (CDSCO).
The IMDX Monkeypox Detection RT-PCR Assay, produced by Siemens Healthineers, has also obtained manufacturing approval from the CDSCO. This marks a significant milestone for the “Make in India” initiative and represents a crucial step forward in addressing the Monkeypox public health crisis.
According to Siemens Healthcare Private Ltd., “The IMDX Monkeypox Detection RT-PCR Assay will be produced at our molecular diagnostics manufacturing facility in Vadodara, which has the capacity to conduct 1 million reactions annually. The facility is fully prepared to supply the kits.”
The IMDX Monkeypox Detection RT-PCR Assay is an innovative molecular diagnostic test that targets two specific regions within the viral genome, covering both clade I and clade II variants of the virus. This design ensures comprehensive detection across multiple viral strains, yielding thorough results.
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.” It went further.
Hariharan Subramanian, Managing Director, Siemens Healthcare Private Limited, said that the urgency for precise and accurate diagnostics couldn’t be more crucial than now.
“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,” he said.
According to Siemens Healthcare Private Ltd, the test results will be available in 40 minutes.
“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,” it said.