India’s indigenous mpox kit has been approved by the Central Protection Drugs Standard Control Organisation (CDSCO). Read on to know about the kit and how it may detect the infection.
India’s Mpox kit has got its approval and will soon be seen on the shelves. It comes at a time when the Mpox cases are taking on the health sector across the globe. New strain of mpox have been detected in different countries. The World Health Organisation (WHO) has already announced its second public health emergency of international concern (PHEIC) due to Monkey Pox. The move came after a sudden increase in cases was recorded in parts of Africa. In India, around 30 M-pox cases have been detected since 2022. The most recent case in the country was reported in March 2024.
Henceforth, all countries have been sounded an alert to be ready with their health protocols. After cases were detected in neighbouring countries like Pakistan, India has also set aside beds in hospitals and issued advisory.
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The new strain of this virus (Clad-1) is considered to be more transmissible and has higher mortality rates. Now, India has developed its own home-grown indigenous RT-PCR testing kit to fight against Mpox, which has been approved by Central Protection Drugs Standard Control Organisation (CDSCO).
India’s Mpox RT-PCR Kit Now Approved
IMDX Monkeypox Detection RT-PCR Assay by Siemens Healthineers has received manufacturing approval from the Central Drugs Standard Control Organisation (CDSCO). This is a significant achievement for our “Make in India” initiative and a critical advancement in the fight against the Monkeypox public health emergency.
“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,” said Siemens Healthcare Private Ltd.
All About Mpox RT-PCR Kit
- Reportedly the diagnostic test will target 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.
- 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. Hariharan Subramanian, Managing Director, Siemens Healthcare Private Limited, said that the urgency for precise and accurate diagnostics couldn’t be more crucial than now.
- 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.
Rashes, persistent fever, headache, nausea, muscle ache etc are few signs and symptoms of mpox. Incase one sees a combination of such warning signs, it is better to immediately get tested and start the treatment as soon as possible.
(With Agency Inputs)