India has introduced a new, indigenous RT-PCR testing kit for Monkeypox, which has received approval from the Central Drugs Standard Control Organisation (CDSCO). This development marks a major milestone in the country's efforts to combat the Monkeypox outbreak.
The newly approved IMDX Monkeypox Detection RT-PCR Assay by Siemens Healthineers is a significant addition to India's "Make in India" initiative. This kit will be produced at Siemens' molecular diagnostics unit in Vadodara, which is equipped to handle up to 1 million tests annually. The testing results are expected to be available in just 40 minutes, offering a quicker alternative to traditional methods that typically take 1 to 2 hours.
The assay has been clinically validated by the ICMR-National Institute of Virology in Pune and boasts 100% sensitivity and specificity. It adheres to both Indian regulatory standards and international guidelines, ensuring high-quality performance.
Hariharan Subramanian, Managing Director of Siemens Healthcare Private Limited, emphasized the critical need for accurate and rapid diagnostics. "These advanced assay kits are essential in our fight against Monkeypox, offering swift and precise detection that can make a real difference in managing the disease," he said.
The World Health Organisation (WHO) recently declared Monkeypox a public health emergency of international concern. The new Clad-1 strain of the virus is noted for its increased transmissibility and higher mortality rates.
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