India’s indigenous Monkeypox RT-PCR testing kit receives CDSCO approval
The company has announced that results from the test will be ready within 40 minutes.
India has launched a homemade RT-PCR testing kit to contain Monkeypox, reported news agency ANI on Tuesday. The new testing kit has been cleared by the Central Drugs Standard Control Organization (CDSCO).
The IMDX Monkeypox Detection RT-PCR Assay by one of the leading Siemens healthineers has received manufacturing approval by the Central Drugs Standard Control Organisation (CDSCO). This is a major achievement for the ‘Make in India’ mission, and is considered as a giant leap towards responding to the Monkeypox public health threat.
Siemens Healthcare Private Ltd stated “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 company has announced that results from the test will be ready within 40 minutes. They 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.”
The Managing Director of Siemens Healthcare Private Limited,Hariharan Subramanian emphasized that the need for precise and accurate diagnostics has never been more urgent. He said “By providing India with advanced assay kits tailored to combat Monkeypox, we are taking a proactive stance in battling this disease and prioritizing 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.”
Monkeypox has been regarded as the second global health emergency by the World Health Organization (WHO). The new strain of the virus identified as Clad-1 is said to be more contagious and has been linked to high mortality levels.
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